H1N1, SWINE FLU VIRUS AND VACCINES, THE X-FILES !!
GRIPE H1N1, VIRUS Y VACUNAS, LOS EXPEDIENTES SECRETOS X. !!
EDITORIAL ENGLISH
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Hello friend of the network, after analyzing the TRAGEDY worldwide with the GARDASIL AND CERVARIX VACCINES created to prevent HPV, HUMAN PAPILLOMA VIRUS, which has caused numerous DEATHS WORLDWIDE, and GREAT SIDE EFFECTS, DISABILITY OF MANY PEOPLE, and the latest LAWSUIT in COLOMBIA on August 4, 2017 against laboratory MERCK SHARP AND DHOME AND THE GARDASIL for collateral damage and death to more than 700 COLOMBIAN GIRLS, I decided to launch the 3 publications OVER THE H1N1 SWINE FLU that carried out in the year 2.009 about he SUPPOSED PANDEMIA by this influenza was spreading all over the world.
In these 3 publications it is narrated ALL THE HISTORY that was behind this FLU AH1N1 whose ultimate goal we can deduce it in the following:
1.) DECREASE THE WORLD POPULATION.
2.) CREATE VACCINES AGAINST THE FLU AND OBLIGATE THE POPULATION TO TAKE IT.
3.) GENERATE MONEY FOR THE SALE OF THESE VACCINES.
This caused worldwide a SOCIAL STRUGGLE against compulsory vaccination, as it was proven that it was a MORE INVENTORY to sell VACCINES whose side effects could leave you DISABLED or KILL you
DERMAGIC EXPRESS who had more than one DECADE publishing on DERMATOLOGICAL AND NON-DERMATOLOGICAL subjects, denouncing BAD medicines, advising the population, DECIDED by then TO REALIZE THESE THREE PUBLICATIONS that today I am going to place you with changing SOME WORDS, with the UNIQUE aim of providing BIBLIOGRAPHIC REFERENCES to all those who struggle today against BAD VACCINES, those that instead of healing you lead to DEATH or PHYSICAL INCAPACITATION.
For that time I decided to take a break which lasted from 2.009 to 2.017, in which I return once more to the same DERMAGIC EXPRESS' MACHINE, perhaps a little quiet, but always telling TRUTHS about MEDICATIONS, DISEASES AND VACCINES.
Always respect the LABORATORIES, because as I have always said THE MISSION of them is to CREATE AND INVENT MEDICINES to heal the diseases of humanity. But I tell you that some of them DO NOT RESPECT YOUR OPINION and when you say and test SCIENTIFICALLY THAT A MEDICINE OR VACCINE IS BAD AND SHOULD BE REMOVED FROM THE MARKET, they attack you without compassion, trying to disqualify your opinions.
For this reason DERMAGIC EXPRESS always launches a BIBLIOGRAPHIC REVIEW does with the technological supports, SCIENTIFIC PUBLICATIONS, WEB PAGES WITH PRESTIGE AND TRUE TESTIMONIALS, I always inquire strongly before publishing an article.
In the case of LAWSUIT IN COLOMBIA against MERCK SHARP & DHOME AND THE GARDASIL VACCINE, this is a fight of DAVID AGAINST GOLIAT, you are facing a MONSTER that will try to disqualify you to continue SELLING the VACCINES, or simply pay the 160 MILLION DOLLARS and will continue in the same.
MERCK SHARP & DHOME has as a whole a very GOOD MEDICINES like FINASTERIDE (PROSCAR AND PROPECIA), contraceptives, etc, but in the case of GARDASIL unfortunately the invention was NOT GOOD and in my opinion they should be withdrawn from the market both GARDASIL as CERVARIX of the laboratory GLAXOSMITHKLINE (GSK), who comes from a bad experience with the vaccine against LYME DISEASE, called LYMErix, which was already withdrawn from the market in the year 2.002.
Here I leave you the first of the three (3) ORIGINAL publications that SPREAD AWARENESS ALL OVER THE PLANET about what happened with the A1H1N1 FLU, but hard the comments, but adjusted to the reality of that time, here you can read, and in this publication I leave the BIBLIOGRAPHY support OF THE REVIEW:
1.) H1N1 INFLUENZE, THE RESIDENT EVIL I, IN THE ROUTE TO THE VIROLOGIC WAR !!!
Where it is widely spoken of the damage caused by ALUMINIUM in the VACCINES and the silence of the MEDIA of the CDC and others.
Let me tell you that this is not new, and I added other BIBLIOGRAPHIC REFERENCES on the subject of VACCINES AND ALUMINUM, (ref. 19,45,46) and OTHERS ADJUVANTS, (THIMEROSAL OTHERS ref, 40,41,42,43,44, 48,49,50,52) and if you think that VACCINES ARE TOTALLY SAFE, I recommend you read ALL THESE BIBLIOGRAPHIC REFERENCES
Greetings to all
Dr. Jose Lapenta.
EDITORIAL ESPAÑOL ===================
Hello friend of the network, after analyzing the TRAGEDY worldwide with the GARDASIL AND CERVARIX VACCINES created to prevent HPV, HUMAN PAPILLOMA VIRUS, which has caused numerous DEATHS WORLDWIDE, and GREAT SIDE EFFECTS, DISABILITY OF MANY PEOPLE, and the latest LAWSUIT in COLOMBIA on August 4, 2017 against laboratory MERCK SHARP AND DHOME AND THE GARDASIL for collateral damage and death to more than 700 COLOMBIAN GIRLS, I decided to launch the 3 publications OVER THE H1N1 SWINE FLU that carried out in the year 2.009 about he SUPPOSED PANDEMIA by this influenza was spreading all over the world.
In these 3 publications it is narrated ALL THE HISTORY that was behind this FLU AH1N1 whose ultimate goal we can deduce it in the following:
1.) DECREASE THE WORLD POPULATION.
2.) CREATE VACCINES AGAINST THE FLU AND OBLIGATE THE POPULATION TO TAKE IT.
3.) GENERATE MONEY FOR THE SALE OF THESE VACCINES.
This caused worldwide a SOCIAL STRUGGLE against compulsory vaccination, as it was proven that it was a MORE INVENTORY to sell VACCINES whose side effects could leave you DISABLED or KILL you
DERMAGIC EXPRESS who had more than one DECADE publishing on DERMATOLOGICAL AND NON-DERMATOLOGICAL subjects, denouncing BAD medicines, advising the population, DECIDED by then TO REALIZE THESE THREE PUBLICATIONS that today I am going to place you with changing SOME WORDS, with the UNIQUE aim of providing BIBLIOGRAPHIC REFERENCES to all those who struggle today against BAD VACCINES, those that instead of healing you lead to DEATH or PHYSICAL INCAPACITATION.
For that time I decided to take a break which lasted from 2.009 to 2.017, in which I return once more to the same DERMAGIC EXPRESS' MACHINE, perhaps a little quiet, but always telling TRUTHS about MEDICATIONS, DISEASES AND VACCINES.
Always respect the LABORATORIES, because as I have always said THE MISSION of them is to CREATE AND INVENT MEDICINES to heal the diseases of humanity. But I tell you that some of them DO NOT RESPECT YOUR OPINION and when you say and test SCIENTIFICALLY THAT A MEDICINE OR VACCINE IS BAD AND SHOULD BE REMOVED FROM THE MARKET, they attack you without compassion, trying to disqualify your opinions.
For this reason DERMAGIC EXPRESS always launches a BIBLIOGRAPHIC REVIEW does with the technological supports, SCIENTIFIC PUBLICATIONS, WEB PAGES WITH PRESTIGE AND TRUE TESTIMONIALS, I always inquire strongly before publishing an article.
In the case of LAWSUIT IN COLOMBIA against MERCK SHARP & DHOME AND THE GARDASIL VACCINE, this is a fight of DAVID AGAINST GOLIAT, you are facing a MONSTER that will try to disqualify you to continue SELLING the VACCINES, or simply pay the 160 MILLION DOLLARS and will continue in the same.
MERCK SHARP & DHOME has as a whole a very GOOD MEDICINES like FINASTERIDE (PROSCAR AND PROPECIA), contraceptives, etc, but in the case of GARDASIL unfortunately the invention was NOT GOOD and in my opinion they should be withdrawn from the market both GARDASIL as CERVARIX of the laboratory GLAXOSMITHKLINE (GSK), who comes from a bad experience with the vaccine against LYME DISEASE, called LYMErix, which was already withdrawn from the market in the year 2.002.
Here I leave you the first of the three (3) ORIGINAL publications that SPREAD AWARENESS ALL OVER THE PLANET about what happened with the A1H1N1 FLU, but hard the comments, but adjusted to the reality of that time, here you can read, and in this publication I leave the BIBLIOGRAPHY support OF THE REVIEW:
1.) H1N1 INFLUENZE, THE RESIDENT EVIL I, IN THE ROUTE TO THE VIROLOGIC WAR !!!
By the way The VACCCINE GARDASIL 9 (VALENTE), contains ALUMINUM adjuvant and today 9 of September 2.017 get in the social MEDIUM network the following post:
French scientists sound the alarm about aluminum in vaccines - crickets from media and health authorities: (Reference 19)
French scientists sound the alarm about aluminum in vaccines - crickets from media and health authorities: (Reference 19)
Where it is widely spoken of the damage caused by ALUMINIUM in the VACCINES and the silence of the MEDIA of the CDC and others.
Let me tell you that this is not new, and I added other BIBLIOGRAPHIC REFERENCES on the subject of VACCINES AND ALUMINUM, (ref. 19,45,46) and OTHERS ADJUVANTS, (THIMEROSAL OTHERS ref, 40,41,42,43,44, 48,49,50,52) and if you think that VACCINES ARE TOTALLY SAFE, I recommend you read ALL THESE BIBLIOGRAPHIC REFERENCES
Dr. Jose Lapenta.
===================
Hola amigo de la red, después de analizar de analizar muy bien la TRAGEDIA a nivel mundial con las VACUNAS GARDASIL Y CERVARIX creadas para prevenir el VPH, VIRUS DEL PAPILOMA HUMANO, el cual lo que ha provocado son numerosas MUERTES EN TODO EL MUNDO, y GRANDES EFECTOS SECUNDARIOS, INCAPACITACION DE MUCHAS PERSONAS, y la ultima demanda en COLOMBIA día 4 de agosto 2.017 contra el laboratorio MERCK SHARP AND DHOME Y EL GARDASIL por daños colaterales y muerte a más DE 700 NIÑAS COLOMBIANAS, decidí sacar a flote las 3 publicaciones SOBRE LA INFLUENZA H1N1 que realice en los años 2.009 la SUPUESTA PANDEMIA por esta gripe estaba diseminándose por todo el mundo.
En estas 3 publicaciones se narra TODA LA HISTORIA que estuvo detrás de esta GRIPE AH1N1 cuyo oblativo final lo podemos deducir en lo sigiuiente:
1.) DISMINUIR LA POBLACION MUNDIAL.
2.) CREAR VACUNAS CONTRA ELLA Y OBLIGAR A LA POBLACION A COLOCARSELAS.
3.) GENERAR DINERO POR LA VENTA DE ESTAS VACUNAS.
Ello provoco a nivel mundial una LUCHA SOCIAL en contra de la VACUNACION OBLIGATORIA, al comprobarse que se trataba de un INVENTO MAS para vender VACUNAS cuyos efectos secundarios podían dejarte INCAPACITADO o MATARTE.
DERMAGIC EXPRESS quien tenía más de una DECADA publicando sobre temas DERMATOLOGICOS Y NO DERMATOLOGICOS, denunciando medicinas MALAS, aconsejando a la población, DECIDIO para aquel entonces REALIZAR ESTAS TRES PUBLICACIONES que hoy te voy a colocar cambiando pocas LETRAS, con el único objetivo de proporcionar REFERENCIAS BIBLIOGRAFICAS a todos aquellos que luchan hoy día contra las MALAS VACUNAS, aquellas que en lugar de sanarte te llevan a la MUERTE o INCAPACITACION FISICA.
Para esa época DECIDI tomarme un descanso el cual duro DESDE 2.009 AL 2.017, en que retorne una vez más con la MISMA MAQUINARIA, quizá un poco más calmado, pero siempre diciendo VERDADES sobre MEDICAMENTOS, ENFERMEDADES Y VACUNAS.
Siempre respete a los LABORATORIOS, porque como he dicho siempre LA MISION de ellos es CREAR E INVENTAR MEDICINAS para sanar las enfermedades de la humanidad. Pero les cuento que algunos de ellos NO RESPETAN TU OPINION y cuando dices y pruebas CIENTIFICAMENTE QUE UNA MEDICINA O VACUNA ES MALA Y DEBE SER RETIRADA DEL MERCADO, te atacan sin compasión, tratando de descalificar tus opiniones.
Por este motivo el DERMAGIC EXPRESS siempre que lanza una REVISION BIBLIOGRAFICA lo hace con los soportes tecnológicos, léase PUBLICACIONES CIENTIFICAS, PAGINAS WEB DE PRESTIGIO Y TESTIMONIALES VERDADEROS, siempre indago fuertemente antes de publicar un artículo.
En al caso DE LA DEMANDA EN COLOMBIA contra MERCK SHARP & DHOME Y LA VACUNA GARDASIL, se trata de una lucha de DAVID CONTRA GOLIAT, te estás enfrentando a un MOUNSTRUO que va a tratar de descalificarte para seguir VENDIENDO SUS VACUNAS, o simplemente pagara LOS 160 MILLONES DE DOLARES y seguirá en lo mismo.
MERCK SHARP & DHOME tiene como todo laboratorio UNAS MUY BUENAS MEDICINAS como el FINASTERIDE (PROSCAR Y PROPECIA), anticonceptivos y otras, Pero en el caso de GARDASIL lamentablemente el invento NO FUE BUENO y en mi opinión deberían ser retiradas del mercados TANTO GARDASIL como CERVARIX del laboratorio GLAXOSMITHKLINE (GSK), quien viene de una mala experiencia con la vacuna contra la ENFERMEDAD DE LYME, denominada LYMErix, LA CUAL ya fue retirada del mercado en él año 2.002.
Aquí les dejo la primera de las (3) publicaciones ORIGINALES QUE SEMBRARON CONCIENCIA EN TODO EL PLANETA sobre lo que ocurrió con la GRIPE A1H1N1, bien duros los comentarios, pero ajustados a la realidad de aquella época, aquí las puedes leer, y en esta publicacion te dejo el soporte BIBLIOGRAFICO DE LA REVISION.
Por cierto La VACUNA GARDASIL 9 (VALENTE), contiende de adyuvante ALUMINIO y hoy 9 de Septiempre 2.017 me consigo en la red Social MEDIUM el siguiente post:
French scientists sound the alarm about aluminum in vaccines — crickets from media and health authorities: (Referencia 19)
Donde se habla extensamente del daño causado por el ALUMINIO en las VACUNAS y el silencio de los MEDIOS DE COMUNICACION el CDC y otros.
Dejenme decirles que esto no es nuevo alli les añadi otras REFERENCIAS BIBLIOGRAFICAS sobre el tema de las VACUNAS Y EL ALUMINIO, (ref. 19,45,46) y OTROS ADYUVANTES (TIMEROSAL, OTROS ref. 40 41,42,43,44 48,49,50,52), y si piensas que las VACUNAS SON TOTALMENTE SEGURAS, te recomiendo que leas TODAS ESTAS RFERENCIAS BIBLIOGRAFICAS.
Saludos a todos
Dr. Jose Lapenta.
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REFERENCIAS BIBLIOGRAFICAS/ BIBLIOGRAPHICAL REFERENCES
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1.) MedImmune patentó el virus AH1N1 en 2008
2.) Medimmune H1N1 Swine Flu Virus - PATENT - 2008, Startling New Evidence That The 'Swine Flu' Pandemic IsMan-Made
3.) Roche Receives FDA Approval Of TAMIFLU™, First Pill To Treat The Most Common Strains Of Influenza (A&B)
4.) "Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events.
5.) Vacuna contra gripe H1N1 está bajo vigilancia por efectos secundarios
6.) Vacuna influenza H1N1 genera problema a fabricantes: FDA de Estados Unidos
7.) El Tamiflu, Donald Rumsfeld y el negocio del miedo
8.) The Tamiflu / Rumsfeld Connection
9.) Donald Rumsfeld's controversial links to drug company behind Tamiflu
10.) China anuncia primera vacuna contra Gripe Porcina H1N1
11.) Baxter, los virus de la gripe extraviados y el plasma sanguíneo contaminado.
12.) OMS a juicio por Bioterrorismo por la Gripe Porcina
13.) Farmacéuticas, las ganadoras frente a la influenza
14.) Big Pharma: Baxter Files Swine Flu Vaccine Patent a Year Ahead of Outbreak
15.) AstraZeneca compra la estadounidense Medimmune por mas de 11.000 millones de euros
16.) Dos mutaciones hacen letal al H5N1
17.) VACUNA H1N1: Múltiples efectos secundarios en Suecia por Pandemrix (GSK) y en Suiza entran grandes dudas
18.) Fort Detrick Inventory Turns Up 9,220 More Vials of Pathogens
19.) French scientists sound the alarm about aluminum in vaccines — crickets from media and health authorities:
20.) Influenza vaccination and Guillain Barre syndrome small star, filled.
21.) Guillain-Barré syndrome following influenza vaccination.
22.) Clinical implications of endotoxin concentrations in vaccines.
23.) Guillain-Barré syndrome after influenza vaccination in adults: a population-based study.24.) Novel Pandemic Influenza A(H1N1) Viruses Are Potently Inhibited by DAS181, a Sialidase Fusion Protein
25.)A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
26.) Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database.
27.) Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-September 2006.
28.) Guillain-Barre syndrome following vaccination in the National Influenza Immunization
Program, United States, 1976--1977.
29.) Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.
30.)Vaccines and Guillain-Barré syndrome.
31.) potential signal of Bell's palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.
32.) Adverse events reported following live, cold-adapted, intranasal influenza vaccine.
33.) Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience.
34.) Are toxic biometals destroying your children's future?
35.) Surveillance for safety after immunization: Vaccine Adverse Event Reporting System
(VAERS)--United States, 1991-2001.
36.) Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States.
37.) A meta-analysis epidemiological assessment of neurodevelopmental disorders following vaccines administered from 1994 through 2000 in the United States.
38.) An evaluation of the effects of thimerosal on neurodevelopmental disorders reported following DTP and Hib vaccines in comparison to DTPH vaccine in the United States.
39.) Neurodevelopmental disorders following thimerosal-containing childhood immunizations: a follow-up analysis.
40.) Neurodevelopmental disorders after thimerosal-containing vaccines: a brief communication.
41.) A comparative evaluation of the effects of MMR immunization and mercury doses from thimerosal-containing childhood vaccines on the population prevalence of autism.
42.) Aluminum adjuvant linked to Gulf War illness induces motor neuron death in mice.
43.) Influenza vaccine with squalene adjuvant: new preparation. No better than available products.
44.) Antibodies to squalene in recipients of anthrax vaccine.
45.)Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration.
46.) Aluminum-induced model of motor neuron degeneration: subperineurial injection of aluminum in rabbits.
47.) Vaccines as a trigger for myopathies.
48.) Induction of metallothionein in mouse cerebellum and cerebrum with low-dose thimerosal injection.
49.) Neonate exposure to thimerosal mercury from hepatitis B vaccines.
50.) Secret CDC vaccine study Thimerosal an autism risk
51.) Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed?
52.) Adjuvants and autoimmunity.
53.)Oseltamivir-Resistant Influenza Virus A (H1N1), Europe, 2007–08 Season
54.) Oseltamivir-Resistant Influenza Viruses A (H1N1), Norway, 2007–08
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1.) MedImmune patentó el virus AH1N1 en 2008
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Source:Http://www.pijamasurf.com/2009/09/medimmune-patento-el-virus-a-h1n1-en-2008/
La controversia por esta extraña mutación del virus de la influenza, conocida como AH1N1, sigue y volverá a escalar, particularmente cuando los gobiernos de la mayor parte de los países del mundo efectuen una campaña masiva de vacunación.
El problema es que según se reporta estas vacunas tienen una serie de efectos secundarios que harían palidecer al mismo virus que buscan prevenir. Por una parte Obama ha”inmunizado” legalmente a los fabricantes. Por otra, al parecer el virus H1N1 fue patentado por MedImmune desde 2008. Baxter patentó una vacuna desde el 2008 y Novartis en febrero de este año, y podría haber participado en la fabricación del virus desde 2005 o antes. El virus, una gripe no demasiado peligrosa agravada por el pánico, sería la excusa para la vacunación global: un enorme negocio y posiblemente, en la más oscura versión de la realidad, un método de control poblacional y arma biológica.
Medimmune tiene sus laboratorios en Gaithersburg, Maryland, muy cerca de la base militar Fort Detrick, antiguamente dedicada a producir armas biológicos y donde se dice se produjo el Antrax y otras armas biológicas/virus.
MedImmune fue comprada por la farmacéutica AstraZeneca en el 2007. La vacuna contra la gripe A H1N1 que AstraZeneca está preparando podría permitirle ingresar 2.300 millones de dólares (1.600 millones) en los dos próximos años. Esto permitiría a la farmacéutica rentabilizar la prima del 21% que pagó al comprar la biotecnológica MedImmune, unos 15.200 millones de dólares (10.674 millones de euros) por encima de la capitalización bursátil de la empresa en el momento de la compra.
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2.) Medimmune H1N1 Swine Flu Virus - PATENT - 2008, Startling New Evidence That The 'Swine Flu' Pandemic IsMan-Made
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Source:ttps://es.scribd.com/document/17718155/Startling-New-Evidence-That-The-Swine-Flu-Pandemic-Is-Man-Made
Startling New Evidence That The 'Swine Flu' Pandemic IsMan-Made
Murder suspects are either convicted or acquitted at trial based on the prosecution's presentation of EVIDENCE which usually hinges on MOTIVE, OPPORTUNITY, and TIME-LINES combined with physical documents. To gather such hard evidence, detectives and/or federal agents often spend monthsfollowing leads and interviewing witnesses. In the trial phase, re-creating the sequence of events isessential. I submit this paper will provide more than enough hard evidence to at least result in a series of criminal indictments of charges of MASS MURDER, and CONSPIRACY TO COMMIT WORLDGENOCIDE against Novartis Pharmaceutical principals and agents and others.
PRIMARY MOTIVE
PRIMARY MOTIVE
The Primary Motive behind this alleged criminal activity is also the primary cause of most murders in theworld today, and that motivation is simply: BIG MONEY. Billions of Dollars of windfall profits fromgovernment contracts worldwide, as a matter of fact.I will provide evidence that will show that Novartis Pharmaceuticals of Basel, Switzerland has conspiredwith corrupt "scientists" at the U.S. Army Institute of Pathology Ft. Detrick, Maryland, to create a "novel"strain of weaponized "influenza" virus by means of "reverse engineering" the deadly 1918 killer strainwhich strain was maliciously and surreptitiously released upon the world in March and April of 2009 for the primary purpose of creating a panic-stricken world-wide demand for Novartis vaccine material.The evidence
will also clearly show that the Novartis vaccine material is in reality designed to facilitatethe further mutation of the pandemic into more lethal waves of increasingly virulent and deadly disease,rather than to curtail and limit the existing outbreak. The evidence will show that Novartis is willingly being used, (and extremely well-paid) to facilitate the edicts of the global elite's Club of Rome; whichedicts clearly call for a massive and sudden depopulation of certain segments of the earth's human population.
PRIMARY EVIDENCE
To realize such windfall profits on an engineered, global flu pandemic, detailed covert planning must take place of course. Patents protecting the proprietary flu vaccine must be applied for and secured before the pandemic virus is released in order to minimize the competition and maximize the profit potentials. In a biological attack of this nature, timing is extremely critical.Indeed, the evidence is clear Novartis applied for just such a patent on Nov. 4, 2005, and the U.S. PatentOffice accepted this application and granted US 20090047353A1 for a "Split Influenza Vaccine withAdjuvants" on February 19, 2009. (See bottom of page).With this patent now secured, the conspirators were now free to create the demand for their "novel" splitinfluenza vaccine by releasing a "novel" split-influenza (combining multiple viruses) pandemic virusfrom a weapons lab test-tube into unsuspecting human hosts.http://www.washingtonpost.com/wp-dyn/content/article/2009/06/17/AR2009061703271.html The so-called "Swine Flu" grabbing headlines today is actually a recombinant, or "split-influenza" virusconsisting of A-strain Bird-Flu (H5N1), Swine Flu (H1N1) and multiple strains of human flu (H3N2).Likewise, the 1918 Killer Flu that killed untold millions of people was a recombinant or "split-influenza"virus composed of Bird flu, Swine Flu, and multiple strains of human flu.
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3.) Roche Receives FDA Approval Of TAMIFLU™, First Pill To Treat The Most Common Strains Of Influenza (A&B)
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Source:http://www.gilead.com/news/press-releases/1999/10/roche-receives-fda-approval-of-tamiflu-first-pill-to-treat-the-most-common-strains-of-influenza-ab
TAMIFLU™ (oseltamivir phosphate) Decreases Duration of Flu Symptoms
NUTLEY, N.J. -- October 27, 1999
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ:GILD), announced today that Roche’s TAMIFLU™ (oseltamivir phosphate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of influenza A&B, which includes all common strains of influenza. TAMIFLU, the first neuraminidase inhibitor in pill form, will be available nationwide in time for the arrival of this year’s flu season.
TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than two days. The recommended oral dose of TAMIFLU is 75 mg twice daily for five days.
Unlike over-the-counter medications that only mask the symptoms of influenza, TAMIFLU is an antiviral agent that, based on in vitro data, targets the actual influenza virus and stops it from replicating from cell to cell.
About TAMIFLU
Co-developed with Gilead Sciences, TAMIFLU is a systemic treatment for influenza. The medication, part of a new class of drugs called neuraminidase inhibitors, targets one of the two major surface structures of the influenza virus, the neuraminidase protein. The neuraminidase site is virtually the same in all common strains of influenza. If neuraminidase is inhibited, the virus is not able to effectively replicate and spread to other cells.
Two Phase III double-blinded, placebo-controlled clinical trials of TAMIFLU were conducted; one in the U.S. and the other in international sites. The two studies enrolled a total of 849 influenza-infected patients, 18-65 years of age. Patients participating in the trials were required to self-assess the influenza-associated symptoms as ‘none’, ‘mild’, ‘moderate’ or ‘severe’. Time to improvement was calculated from the time of treatment initiation to the time when all symptoms (fever, nasal congestion, sore throat, cough, aches, fatigue, headaches, chills, and sweats) were assessed as 'none’ or ‘mild’.
In both statistically significant studies at the recommended dose, there was a 1.3 day (30%) reduction in the median time to improvement in patients receiving TAMIFLU compared to patients receiving placebo. The most frequently reported adverse events in these studies in patients taking TAMIFLU were nausea and vomiting and, to a lesser extent, bronchitis, insomnia, and vertigo. These events were generally mild to moderate and transient. Less than 1% of patients discontinued prematurely from clinical trials due to nausea and vomiting. TAMIFLU may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.
Elderly Patients
In an ongoing study of otherwise healthy elderly patients, 65 years of age and older, given the recommended dose of TAMIFLU, there was a reduction in the duration of flu in patients receiving TAMIFLU similar to that seen in younger adults. Also, no overall difference in safety was observed in clinical trials between the elderly patients and younger adults, and no dose adjustments are required when treating these populations.
“The timing of the FDA’s approval for TAMIFLU is ideal,” said Dr. Dominick Iacuzio, Medical Director, Hoffmann–La Roche. “The early arrival of the 1999-2000 flu season means many Americans may be caught short in taking preventive measures, such as receiving their flu vaccination. This early outbreak, coupled with predictions of a severe flu season, makes TAMIFLU a
welcome treatment alternative to managing the misery of the flu.”
In clinical studies, TAMIFLU showed no interference with the antibody response to the influenza infection. Use of TAMIFLU should not effect the evaluation of patients for annual influenza vaccination, in accordance with the Centers for Disease Control (CDC) guidelines.
“One of the advantages of TAMIFLU is that it is administered orally, which makes it not only convenient, but allows the drug to be distributed throughout the body, reaching all key sites of infection, including the upper and lower respiratory tracts,” said Dr. Frederick Hayden, a lead investigator in the TAMIFLU studies and the Stuart S. Richardson Professor of Clinical Virology in Internal Medicine and Professor of Internal Medicine and Pathology at the University of Virginia School of Medicine.
In clinical studies, TAMIFLU showed no interference with the antibody response to the influenza infection. Use of TAMIFLU should not effect the evaluation of patients for annual influenza vaccination, in accordance with the Centers for Disease Control (CDC) guidelines.
“One of the advantages of TAMIFLU is that it is administered orally, which makes it not only convenient, but allows the drug to be distributed throughout the body, reaching all key sites of infection, including the upper and lower respiratory tracts,” said Dr. Frederick Hayden, a lead investigator in the TAMIFLU studies and the Stuart S. Richardson Professor of Clinical Virology in Internal Medicine and Professor of Internal Medicine and Pathology at the University of Virginia School of Medicine.
Influenza’s Impact
Each year, up to 40 million Americans develop the flu, an average of about 300,000 are hospitalized, and 20,000 to 40,000 people die from influenza and its complications. The risks for hospitalization and death from influenza are higher among persons aged 65 or older, and persons at any age with underlying high risk medical conditions. The economic impact is high as well, costing the United States an annual $14.6 billion in physician visits, lost productivity, and lost wages.
About Hoffmann-La Roche and Gilead Sciences
About Hoffmann-La Roche and Gilead Sciences
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company’s areas of therapeutic interest are: Virology, including HIV/AIDS and hepatitis C; Infectious Diseases, including influenza; Cardiology; Neurology; Oncology; Transplantation; Dermatology; and Metabolic Diseases, including obesity and diabetes.
The Company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. For more information on Roche Pharmaceuticals in the United States, visit the company’s web site at:http://www.rocheusa.com
Gilead Sciences, headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated treatment solutions for patients and the people who care for them. The Company discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA, Boulder, CO, San Dimas, CA, and Cambridge, UK, and sales and marketing organizations in the United States, Europe and Australia. Gilead common stock is traded on The Nasdaq Stock Market under the symbol GILD.
EDITOR’S NOTE: FOR MORE INFORMATION ON INFLUENZA AND TAMIFLU, CONSUMERS CAN LOG ONTOWWW.TAMIFLU.COM.
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4.) "Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events.
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J Infect Dis. 2009 Aug 1;200(3):321-8. doi: 10.1086/603560.
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4.) "Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events.
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J Infect Dis. 2009 Aug 1;200(3):321-8. doi: 10.1086/603560.
Source:https://www.ncbi.nlm.nih.gov/pubmed/19563262
Author: Evans, David · Cauchemez, Simon · Hayden, Frederick G
Published 2009-08-01
Author information
1
The Wellcome Trust, London, United Kingdom. Journal The Journal of infectious diseases
Abstract
1
The Wellcome Trust, London, United Kingdom. Journal The Journal of infectious diseases
Abstract
The availability of immunogenic, licensed H5N1 vaccines and the anticipated development of vaccines against "swine" influenza A(H1N1) have stimulated debate about the possible use of these vaccines for protection of those exposed to potential pandemic influenza viruses and for immunization or "priming" of populations in the so-called "prepandemic" (interpandemic) era. However, the safety of such vaccines is a critical issue in policy development for wide-scale application of vaccines in the interpandemic period. For example, wide-scale interpandemic use of H5N1 vaccines could lead to millions of persons receiving vaccines of uncertain efficacy potentially associated with rare severe adverse events and against a virus that may not cause a pandemic. Here, we first review aspects of the 1976 National Influenza Immunization Programme against "swine flu" and its well-documented association with Guillain-Barré syndrome as a case study illustration of a suspected vaccine-associated severe adverse event in a mass interpandemic immunization setting. This case study is especially timely, given the recent spread of a novel influenza A(H1N1) virus in humans in Mexico and beyond. Following this, we examine available safety data from clinical trials of H5N1 vaccines and briefly discuss how vaccine safety could be monitored in a postmarketing surveillance setting.
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5.) Vacuna contra gripe H1N1 está bajo vigilancia por efectos secundarios
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04 Septiembre de 2009 por Sala de Prensa - 3:35 pm
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5.) Vacuna contra gripe H1N1 está bajo vigilancia por efectos secundarios
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04 Septiembre de 2009 por Sala de Prensa - 3:35 pm
Source:http://www.vanguardia.com/historico/38744-vacuna-de-gripe-ah1n1-bajo-vigilancia-por-efectos-secundarios
Las vacunas contra la gripe H1N1 que llegarán progresivamente al mercado serán productos nuevos, con el consiguiente riesgo de efectos secundarios imprevistos, por lo que las autoridades sanitarias recomiendan que se estreche la vigilancia una vez administradas.
No se pueden “conocer exactamente sus efectos secundarios”, afirma la red de expertos Infovac, creada para los pediatras.
No se pueden “conocer exactamente sus efectos secundarios”, afirma la red de expertos Infovac, creada para los pediatras.
Infovac recuerda que las vacunas similares producidas contra la gripe aviaria “con los mismos coadyudantes (sustancias que favorecen la inducción de inmunidad)” provocan “con más frecuencia relaciones inflamatorias agudas que las vacunas tradicionales contra la gripe estacional”.
Esta red estima que “aún no se puede excluir un riesgo raro (1 a 10 por millón) de efectos indeseables infrecuentes o graves”.
Esta red estima que “aún no se puede excluir un riesgo raro (1 a 10 por millón) de efectos indeseables infrecuentes o graves”.
Si toda la población de Francia se vacunara, como quiere el ministerio de Sanidad francés, esto supondría entre 60 a 600 casos de efectos indeseables graves.
Para Margaret Chan, directora general de la Organización Mundial de la Salud (OMS), los ensayos clínicos en curso deberían dar indicios sobre los posibles efectos secundarios de estas vacunas. Pero debido “al número limitado de personas sometidas a test, los efectos secundarios extremadamente raros no aparecen siempre en las pruebas, explicó.
Para Margaret Chan, directora general de la Organización Mundial de la Salud (OMS), los ensayos clínicos en curso deberían dar indicios sobre los posibles efectos secundarios de estas vacunas. Pero debido “al número limitado de personas sometidas a test, los efectos secundarios extremadamente raros no aparecen siempre en las pruebas, explicó.
Recuerda que el síndrome de Guillain-Barré, enfermedad neurológica que puede ser grave, “surge con una frecuencia de un caso por un millón de personas vacunadas”. “Corremos el riesgo por lo tanto de tenerlos”, dice.
La OMS recomendó que se extreme la vigilancia sanitaria tras la inoculación de la vacuna.
Un sindicato de enfermeros teme “una vacuna desarrollada demasiado rápido”, con pruebas insuficientes, y un coadyudante “susceptible de activar enfermedades autoinmunes”. “El remedio puede ser peor que el mal”, afirma el Sindicato Nacional de Profesionales Enfermeros ((SNPI) francés. Reclama que los pacientes firmen un documento de consentimiento como se hace en el caso de los medicamentos experimentales.
Un sindicato de enfermeros teme “una vacuna desarrollada demasiado rápido”, con pruebas insuficientes, y un coadyudante “susceptible de activar enfermedades autoinmunes”. “El remedio puede ser peor que el mal”, afirma el Sindicato Nacional de Profesionales Enfermeros ((SNPI) francés. Reclama que los pacientes firmen un documento de consentimiento como se hace en el caso de los medicamentos experimentales.
Más de la mitad del personal sanitario de Hong Kong, según un estudio, se muestra reticente a vacunarse. Lo mismo ocurre con las enfermeras británicas, un 30% de las cuales habría rechazado la vacuna, según un sondeo publicado por una revista profesional.
Algunos médicos recuerdan el precedente estadounidense de 1976, cuando por miedo a una epidemia de gripe porcina se lanzó una campaña de vacunación masiva que tuvo que suspenderse ante la aparición de síndromes de Guillain-Barré.
Algunos médicos recuerdan el precedente estadounidense de 1976, cuando por miedo a una epidemia de gripe porcina se lanzó una campaña de vacunación masiva que tuvo que suspenderse ante la aparición de síndromes de Guillain-Barré.
Pero Vincent Enouf, responsable adjunto del Centro nacional de gripe del Instituto Pasteur, sostiene que nada ha permitido establecer que los casos de Guillain-Barré surgidos en 1976 estuvieran “vinculados con la vacunación”.
La bióloga Michèle Rivasi también estima que parece “que se han ignorado” los “riesgos” de la vacunación a pesar de que la “experimentación fue muy limitada”.
Señala con el dedo acusador a los coadyudantes, gracias a los cuales se estimula la inmunidad.
El profesor Daniel Floret, presidente del Comité técnico de vacunaciones, considera que el riesgo de enfermedades autoinmunes provocado por estos coadyudantes es “teórico y en absoluto demostrado”, aunque cree “legítimo” tomarlo en consideración.
Señala con el dedo acusador a los coadyudantes, gracias a los cuales se estimula la inmunidad.
El profesor Daniel Floret, presidente del Comité técnico de vacunaciones, considera que el riesgo de enfermedades autoinmunes provocado por estos coadyudantes es “teórico y en absoluto demostrado”, aunque cree “legítimo” tomarlo en consideración.
“El control de la calidad para la producción de las vacunas antigripales ha mejorado sustancialmente desde los años 1970″, afirma la OMS, que recuerda sin embargo en su página web que “la vigilancia estrecha y la investigación de todas las manifestaciones indeseables graves debidas a la administración de la vacuna serán indispensables”.
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6.) Vacuna influenza H1N1 genera problema a fabricantes: FDA de Estados Unidos
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Source:http://lta.reuters.com/article/topNews/idLTASIE56M0UC20090723
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6.) Vacuna influenza H1N1 genera problema a fabricantes: FDA de Estados Unidos
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Source:http://lta.reuters.com/article/topNews/idLTASIE56M0UC20090723
11:00 AM Washington.- Los fabricantes de la nueva vacuna contra la gripe pandémica H1N1 sólo están obteniendo un rendimiento del 30 por ciento en la inyección contra esa cepa, comparado con el que logran con la estacional, informaron hoy funcionarios de la Administración de Alimentos y Medicamentos de Estados Unidos (FDA)
.
"El trabajo de desarrollo ha indicado que las cepas de referencia existentes tienen un rendimiento esperando de alrededor del 30 por ciento en las cepas de gripe H1N1", dijo el doctor Jerry Weir, director de la división de productos virales de la FDA, en un encuentro de asesores, reseñó Reuters.
Esto implica que los fabricantes terminarán obteniendo menos dosis de lo esperado de la vacuna contra la cepa pandémica.
"El trabajo de desarrollo ha indicado que las cepas de referencia existentes tienen un rendimiento esperando de alrededor del 30 por ciento en las cepas de gripe H1N1", dijo el doctor Jerry Weir, director de la división de productos virales de la FDA, en un encuentro de asesores, reseñó Reuters.
Esto implica que los fabricantes terminarán obteniendo menos dosis de lo esperado de la vacuna contra la cepa pandémica.
A comienzos de este mes, la Organización Mundial de la Salud (OMS) informó que los fabricantes de vacunas no estaban obteniendo el "rendimiento" esperado de las muestras que se les enviaron del virus de la popularmente conocida como gripe porcina, que estaban cultivando en huevos para luego purificar y desarrollar vacunas.
La unidad MedImmune de AstraZeneca, la australiana CSL Ltd, Baxter International, GlaxoSmithKline Plc, Novartis AG y Sanofi-Aventis SA están fabricando vacunas contra la cepa H1N1 y le informarán al comité de la FDA lo que hayan aprendido mientras trabajan con el virus.
Los Institutos Nacionales de Salud de Estados Unidos informaron el miércoles que habían programado para agosto el comienzo de los ensayos clínicos en humanos de las vacunas de CSL y Sanofi, en varios centros y clínicas del país. Pero la FDA debe aprobar la iniciativa antes de su inicio.
Los Institutos Nacionales de Salud de Estados Unidos informaron el miércoles que habían programado para agosto el comienzo de los ensayos clínicos en humanos de las vacunas de CSL y Sanofi, en varios centros y clínicas del país. Pero la FDA debe aprobar la iniciativa antes de su inicio.
El Comité Asesor sobre Vacunas y Productos Biológicos Relacionados de la FDA se reunirá para evaluar esos ensayos clínicos. Funcionarios de salud indicaron que esperan poder comenzar en octubre con la vacunación en personas, siempre que se aprueben las inmunizaciones.
El doctor Wellington Sun de la FDA dijo en el encuentro que la agencia autorizaría la nueva vacuna H1N1 como un cambio de cepa -como sucede con las nuevas formulaciones de la vacuna estacional cada año- a diferencia de hacerlo como si se tratara de una inmunización completamente nueva. Esto aceleraría la aprobación.
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7.) El Tamiflu, Donald Rumsfeld y el negocio del miedo
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miércoles 29 de abril de 2009
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7.) El Tamiflu, Donald Rumsfeld y el negocio del miedo
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miércoles 29 de abril de 2009
source:Http://seniales.blogspot.com/2009/04/el-tamiflu-donald-rumsfeld-y-el-negocio.html
Por: José Antonio Campoy*
Bastó que Estados Unidos tocara la campana de alarma para que el mundo temblara de miedo ante la perspectiva de una pandemia. A pesar de que han transcurrido nueve años desde que el famoso virus de la gripe aviar fuera detectado en Vietnam y no llegan aún a cien las víctimas mortales. Una media pues de once fallecimientos al año… ¡en todo el mundo! Un detalle insignificante que no impidió a George Bush emprender su segunda “guerra preventiva” en poco tiempo, esta vez para luchar contra otra arma de destrucción masiva tan vaporosa como las “encontradas” en Irak: el virus H5N1.
A fin de cuentas había hallado también una poderosa “arma preventiva”, un antiviral llamado Tamiflu que comercializaba la empresa suiza Roche y que en apenas unos días se convirtió en la gallina de los huevos de oro. De hecho, los ingresos por su venta pasaron de 254 millones en el 2004 a más de 1.000 millones en el 2005. Y su techo es imprevisible dada la grotesca reacción de los gobiernos occidentales con peticiones masivas del producto. La realidad, sin embargo, es que la eficacia del Tamiflu es cuestionada por gran parte de la comunidad científica. Muchos se preguntan cómo se espera que pueda servir ante un virus mutante cuando apenas alivia algunos síntomas -y no siempre- de la gripe corriente.
Obviamente la respuesta al protagonismo del Tamiflu en nuestras vidas no es científica sino puramente comercial. El Tamiflu era hasta 1996 propiedad de Gilead Sciences Inc. empresa que ese año vendió la patente a los laboratorios Roche. ¿Y saben quién era entonces su presidente? Pues el actual Secretario de Defensa de Estados Unidos, Donald Rumsfeld, que aún hoy sigue siendo uno de sus principales accionistas. ¿Y recuerdan que pasó el año pasado? Pues que en cuanto empezó a hablarse de la gripe aviar Gilead Sciences Inc quiso recuperar el Tamiflu alegando que Roche no hacía esfuerzos suficientes por fabricarlo y comercializarlo.
Y que tenía “fuerza” para lograrlo lo demuestra que ambas empresas se sentaron a “negociar” y acordaron en un tiempo récord constituir dos comités conjuntos, uno que se encargase de coordinar la fabricación mundial del fármaco y decidir sobre la autorización a terceros para fabricarlo y otro para coordinar la comercialización de las ventas estacionales en los mercados más importantes, incluido Estados Unidos. Además Roche pagó a Gilead Sciences Inc unas regalías retroactivas por valor de 62,5 millones de dólares. Y por si fuera poco la empresa norteamericana se quedó con otros 18,2 millones de dólares extra por unas ventas superiores a las contabilizadas entre 2001 y 2003. A lo que hay que añadir un dato: Roche se ha quedado con el 90% de la producción mundial de anís estrellado, árbol que crece fundamentalmente en China -aunque también se encuentra en Laos y Malasia- y que es la base del Tamiflu. El escenario, qué duda cabe, estaba completo.
Sólo había que empezar a encontrar poco a poco aves contagiadas con el virus en distintos países -un ave aquí, otro par más allá- para crear alarma mundial con la ayuda de científicos y políticos poco escrupulosos o de escasa capacidad intelectual y de los grandes medios de comunicación -que como todo el mundo sabe no se caracterizan precisamente por investigar lo que publican o emiten-. ¿Y qué tiene que ver Donald Rumsfeld en todo esto?
Pues absolutamente nada. Según un comunicado emitido el pasado mes de octubre por el Pentágono el actual Secretario de Estado norteamericano no intervino en las decisiones que tomó el Gobierno de sus amigos Bush -el presidente- y Cheney -el vicepresidente- sobre las medidas preventivas que había que adoptar ante la amenaza de pandemia. El comunicado afirma que se abstuvo, que no tuvo nada que ver en la decisión de la Administración estadounidense de apoyar y aconsejar el uso del Tamiflu a nivel mundial. Y nosotros le creemos. Como cuando aseguró solemnemente que en Irak había armas de destrucción masiva.
Además el hecho de que su nombre aparezca unido a una vacunación masiva contra una supuesta gripe del cerdo durante la Administración de Gerald Ford en la década de los 70 -que dio como resultado más de 50 muertos a causa de los efectos secundarios- no es más que una coincidencia. Como lo es que la FDA aprobara el aspartame a los tres meses de que Rumsfeld se incorporase al Gabinete de Ronald Reagan a pesar de que tras diez años de estudios no se había tomado ninguna decisión. Sólo alguien muy mal pensado puede plantearse que tuviera algo que ver el hecho de que poco antes de incorporarse al Gobierno norteamericano Rumsfeld fuera el presidente del laboratorio fabricante del aspartamo. Y, por supuesto, tampoco tuvo nada que ver con la compra tras el 11-S del Vistide, fármaco adquirido masivamente por el Pentágono para evitar los efectos secundarios que podía producir la vacuna de la viruela entre los soldados norteamericanos a los que se les aplicó masivamente antes de enviarlos a Irak.
Que el Vistide fuera también un producto de los laboratorios Gilead Sciences Inc, creador del Tamiflu, es otra coincidencia. Así que siga usted de cerca todas las informaciones que aún van a darse sobre la gripe aviar y llene su botiquín casero de Tamiflu. Y si hay que comprar algo más, se compra. Faltaba más.
*Director de Discovery DSalud
*Director de Discovery DSalud
La "pandemia”… ¿Será la gripe aviar?
¿Sabes que el virus de la gripe aviar fue descubierto hace 9 años en Vietnam?
¿Sabes que desde entonces han muerto apenas 100 personas, en todo el mundo todos estos años?
¿Sabes que los norteamericanos fueron los que alertaron de la eficacia del Tamiflu (antiviral humano) como preventivo?
¿Sabes que el Tamiflu apenas alivia algunos síntomas de la gripe común?
¿Sabes que su eficacia ante la gripe común está cuestionada por gran parte de la comunidad científica?
¿Sabes que ante un supuesto virus mutante como el H5N1, el Tamiflu apenas aliviara la enfermedad?
¿Sabes que la gripe aviar hasta la fecha sólo afecta a las aves?
¿Sabes quien comercializa el Tamiflu? Laboratorios Roche.
¿Sabes a quién compró Roche la patente del Tamiflu en 1996? a Gilead Sciences Inc.
¿Sabes quien era el Presidente de Gilead Sciences Inc y aun hoy principal accionista?: Donald Rumsfeld, ex-Secretario de Defensa de USA.
¿Sabes que la base del Tamiflu es el anís estrellado?
¿Sabes quien se ha quedado con el 90% de la producción mundial de este árbol?: Roche.
¿Sabes que las ventas del Tamiflu pasaron de 254 millones en el 2004 a más de 1000 millones en el 2005?
¿Sabes cuántos millones más puede ganar Roche en los próximos meses si sigue este negocio del miedo?
O sea que el resumen del cuento es el siguiente: los amigos de Bush deciden que un fármaco como el Tamiflu es la solución para una pandemia que aún no se ha producido y que ha causado en todo el mundo 100 muertos en 9 años.
Este fármaco no cura ni la gripe común. El virus no afecta al hombre en condiciones normales. Rumsfeld vende la patente del Tamiflu a Roche y este le paga una fortuna. Roche adquiere el 90% de
la producción del anís estrellado, base del antivírico.
Los Gobiernos de todo el Mundo amenazan con una pandemia y compran a Roche cantidades industriales del producto. Nosotros acabamos pagando el medicamento y Rumsfeld, Cheney y Bush hacen el negocio….
Extractado de la Editorial del número 81 (abril-2006) de la revista DSalud Colaboración de Irene Solera
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8.) The Tamiflu / Rumsfeld Connection
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8.) The Tamiflu / Rumsfeld Connection
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Forwarded email asserts a conspiratorial connection between the worldwide alarm over a possible flu pandemic and Donald Rumsfeld's financial interest in the company that patented the antiviral drug Tamiflu.
Source:Http://http://urbanlegends.about.com/library/bl_bird_flu.htm broken link
Description: Email rumor
Circulating since: April 2006
Status: Partly true
Circulating since: April 2006
Status: Partly true
Email example contributed by Jennie R., April 28, 2006:
Subject: BIRD FLU - US PROPAGANDA!
"Bird Flu"
"Bird Flu"
Do you know that 'bird flu' was discovered in Vietnam 9 years ago?
Do you know that barely 100 people have died in the whole world in all that time?
Do you know that it was the Americans who alerted us to the efficacy of the human antiviral TAMIFLU as a preventative.
Do you know that TAMIFLU barely alleviates some symptoms of the common flu?
Do you know that its efficacy against the common flu is questioned by a great part of the scientific community?
Do you know that against a SUPPOSED mutant virus such as H5N1, TAMIFLU barely alleviates the illness?
Do you know that to date Avian Flu affects birds only?
Do you know who markets TAMIFLU? ROCHE LABORATORIES.
Do you know who bought the patent for TAMIFLU from ROCHE LABORATORIES in 1996?
GILEAD SCIENCES INC.
GILEAD SCIENCES INC.
Do you know who was the then president of GILEAD SCIENCES INC. and remains a major shareholder? DONALD RUMSFELD, the present Secretary of Defence of the USA.
Do you know that the base of TAMIFLU is crushed aniseed?
Do you know who controls 90% of the world's production of this tree?
ROCHE.
ROCHE.
Do you know that sales of TAMIFLU were over $254 million in 2004 and more than $1000 million in 2005?
Do you know how many more millions ROCHE can earn in the coming months if the business of fear continues?
So the summary of the story is as follows:
So the summary of the story is as follows:
Bush's friends decide that the medicine TAMIFLU is the solution for a pandemic that has not yet occurred and that has caused a hundred deaths worldwide in 9 years.
This medicine doesn't so much as cure the common flu.
In normal conditions the virus does not affect humans.
This medicine doesn't so much as cure the common flu.
In normal conditions the virus does not affect humans.
Rumsfeld sells the patent for TAMIFLU to ROCHE for which they pay him a fortune. Roche acquires 90% of the global production of crushed aniseed, the base for the antivirus.
The f the entie world threaten a pandemic and then buy industrial quantities of the product from Roche.
So we end up paying for medicine while Rumsfeld, Cheney and Bush get richer, thank the RED STATES!
The f the entie world threaten a pandemic and then buy industrial quantities of the product from Roche.
So we end up paying for medicine while Rumsfeld, Cheney and Bush get richer, thank the RED STATES!
Comments: Is U.S. Secretary of Defense Donald Rumsfeld personally profiting from fears that a worldwide bird flu pandemic may occur? Yes. Rumsfeld once served as chairman of Gilead Sciences, Inc., the company that holds the patent on the antiviral drug Tamiflu, currently regarded as the world's best hope for the prevention and treatment of avian influenza. He still owns Gilead stock valued at between $5 million and $25 million.
Is it true that no one really knows whether avian influenza will mutate and take hold in the human population, let alone reach pandemic proportions? Yes. For now, the disease remains mostly confined to the bird population, and the number of cases of bird-to-human transmission remains relatively small.
Is it true that no one really knows whether avian influenza will mutate and take hold in the human population, let alone reach pandemic proportions? Yes. For now, the disease remains mostly confined to the bird population, and the number of cases of bird-to-human transmission remains relatively small.
About Poll
Do you believe there's a conspiracy afoot to spread fear of a bird flu pandemic so members of the Bush administration can profit?
Yes.
No.
Not sure.
Current Results
Yes.
No.
Not sure.
Current Results
Must we therefore conclude that the alarm raised over a possible pandemic and the rush to stockpile Tamiflu amount to a conspiracy to line the pockets of G.W. Bush's cronies? Not necessarily. One strain of the bird flu virus, H5N1, has demonstrated a high mortality rate in both birds and people, and the concern is that it could mutate into much more contagious form in humans. The World Health Organization considers the risk of a pandemic "serious."
Bird flu threat overestimated?
Granted, there are well-informed skeptics in the scientific community who argue that public health officials have overestimated the threat of a pandemic - and the skeptics could be right - but the "better safe than sorry" approach is too widespread to be discounted as an aberration of the Bush administration. The World Health Organization, the health ministries of China, Japan and other Asian countries, and the health commissioner of the European Union have all called for bird flu preparedness plans that include the stockpiling of Tamiflu.
Sorting fact from error
The forwarded text advancing these claims was paraphrased from an editorial that appeared in the April 2006 issue of the Spanish health magazine Discovery DSalud. Albeit in much briefer form, the email captures the spirit and message of the orginal column. There are factual errors, however, some of which can be found in the original, some of which may be due to mistranslation, and some of which probably crept into the text during transmission:
* CLAIM: Bird flu was discovered in Vietnam nine years ago.
NOT EXACTLY. Avian flu strain H5N1 was first isolated in human beings nine years ago - in Hong Kong, not Vietnam. The first reported cases in Vietnam occurred in 2003.
NOT EXACTLY. Avian flu strain H5N1 was first isolated in human beings nine years ago - in Hong Kong, not Vietnam. The first reported cases in Vietnam occurred in 2003.
* CLAIM: Barely 100 people have died in the whole world in all that time.
TRUE. As of this writing, the official human death toll from bird flu since 2003 is 115. Counting the six who died in Hong Kong in 1997, the nine-year total is 121.
TRUE. As of this writing, the official human death toll from bird flu since 2003 is 115. Counting the six who died in Hong Kong in 1997, the nine-year total is 121.
* CLAIM: "...it was the Americans who alerted us to the efficacy of the human antiviral Tamiflu as a preventative."
PROBABLY TRUE. The Georgia-based Centers for Disease Control and Prevention announced as early as 2004 that the antiviral drug oseltamivir phosphate (Tamiflu), already proven successful in the prevention and treatment of the common flu, was likely to prove similarly effective against the avian influenza virus.
PROBABLY TRUE. The Georgia-based Centers for Disease Control and Prevention announced as early as 2004 that the antiviral drug oseltamivir phosphate (Tamiflu), already proven successful in the prevention and treatment of the common flu, was likely to prove similarly effective against the avian influenza virus.
* CLAIM: Tamiflu barely alleviates some symptoms of the common flu.
MISLEADING. Antiviral medications like Tamiflu attack the flu virus itself, not specific symptoms. Even so, Tamiflu has been shown in clinical trials to reduce the severity of common flu symptoms, shorten the duration of the illness by an average of 37 percent, and reduce the number of complications in otherwise healthy individuals.
MISLEADING. Antiviral medications like Tamiflu attack the flu virus itself, not specific symptoms. Even so, Tamiflu has been shown in clinical trials to reduce the severity of common flu symptoms, shorten the duration of the illness by an average of 37 percent, and reduce the number of complications in otherwise healthy individuals.
* CLAIM: Tamiflu's efficacy against the common flu is questioned by a great part of the scientific community.
FALSE. A search of the available medical literature on Tamiflu yielded no evidence of significant controversy regarding its efficacy against the common flu.
FALSE. A search of the available medical literature on Tamiflu yielded no evidence of significant controversy regarding its efficacy against the common flu.
* CLAIM: "...against a SUPPOSED mutant virus such as H5N1, Tamiflu barely alleviates the illness."
UNSUBSTANTIATED. While the efficacy of Tamiflu against H5N1, the most pathogenic strain of bird flu, has yet to be assessed in clinical trials, its effectiveness has been sufficiently verified in animal and in vitro studies to earn the recommendation of the World Health Organization for the treatment and prevention of H5N1.
UNSUBSTANTIATED. While the efficacy of Tamiflu against H5N1, the most pathogenic strain of bird flu, has yet to be assessed in clinical trials, its effectiveness has been sufficiently verified in animal and in vitro studies to earn the recommendation of the World Health Organization for the treatment and prevention of H5N1.
* CLAIM: To date, avian flu affects birds only.
FALSE. Not to mention self-contradictory and nonsensical. As confirmed above, over 100 human beings worldwide have died of avian flu in the past three years. Clearly it doesn't affect birds only.
FALSE. Not to mention self-contradictory and nonsensical. As confirmed above, over 100 human beings worldwide have died of avian flu in the past three years. Clearly it doesn't affect birds only.
* CLAIM: "Do you know who markets Tamiflu? ROCHE LABORATORIES."
TRUE. Roche is a pharmaceutical manufacturer based in Switzerland.
TRUE. Roche is a pharmaceutical manufacturer based in Switzerland.
* CLAIM: "Do you know who bought the patent for Tamiflu from ROCHE LABORATORIES in 1996? GILEAD SCIENCES INC."
GARBLED. Gilead Sciences, Inc. discovered Tamiflu in the early 1990s and still holds the patent. Gilead licensed development and marketing rights to Roche in 1996.
GARBLED. Gilead Sciences, Inc. discovered Tamiflu in the early 1990s and still holds the patent. Gilead licensed development and marketing rights to Roche in 1996.
* CLAIM: "Do you know who was the then president of GILEAD SCIENCES INC. and remains a major shareholder? DONALD RUMSFELD, the present Secretary of Defence of the USA."
TRUE. According to Fortune magazine, Rumsfeld was Gilead's chairman from 1997 to 2001. It's unknown exactly how many shares he still owns in the company, but the value of his holdings is estimated at between $5 million and $25 million.
TRUE. According to Fortune magazine, Rumsfeld was Gilead's chairman from 1997 to 2001. It's unknown exactly how many shares he still owns in the company, but the value of his holdings is estimated at between $5 million and $25 million.
* CLAIM: the "base" of Tamiflu is crushed aniseed.
TRUE. One of the basic ingredients of Tamiflu is shikimic acid, the main source of which is currently star anise, a spice grown in China. However, there are r methods of making shikimic acid,nd Roche is already looking at ways to reduce its dependence on the star anise supply.
TRUE. One of the basic ingredients of Tamiflu is shikimic acid, the main source of which is currently star anise, a spice grown in China. However, there are r methods of making shikimic acid,nd Roche is already looking at ways to reduce its dependence on the star anise supply.
* CLAIM: "Do you know who controls 90% of the world's production of this tree? ROCHE."
FALSE. According to a November 2005 report in the Washington Post, only about half of China's entire stock of star anise goes to pharmaceutical manufacturers, including Roche.
FALSE. According to a November 2005 report in the Washington Post, only about half of China's entire stock of star anise goes to pharmaceutical manufacturers, including Roche.
* CLAIM: Sales of Tamiflu were over $254 million in 2004 and more than $1 billion in 2005?
ROUGHLY ACCURATE. According to Forbes magazine, Tamiflu sales totalled $258 million in 2004 and were projected to exceed $1 billion in 2005.
ROUGHLY ACCURATE. According to Forbes magazine, Tamiflu sales totalled $258 million in 2004 and were projected to exceed $1 billion in 2005.
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9.) Donald Rumsfeld's controversial links to drug company behind Tamiflu
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By Mail on Sunday Reporter
UPDATED: 22:04 BST, 2 May 2009
Source:http://www.dailymail.co.uk/news/article-1176743/Donald-Rumsfelds-controversial-links-drug-company-Tamiflu.html#ixzz4sFKpQKxu
9.) Donald Rumsfeld's controversial links to drug company behind Tamiflu
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By Mail on Sunday Reporter
UPDATED: 22:04 BST, 2 May 2009
Source:http://www.dailymail.co.uk/news/article-1176743/Donald-Rumsfelds-controversial-links-drug-company-Tamiflu.html#ixzz4sFKpQKxu
The drug company behind the swine flu medicine Tamiflu is at the centre of controversy over its links to former US Defence Secretary Donald Rumsfeld.
Mr Rumsfeld, a former chairman of the company, has refused to comment on whether he still holds shares in Californian firm Gilead Sciences, which developed the drug now being desperately stockpiled by governments around the world to combat the threatened pandemic.
Last night an associate of Mr Rumsfeld said: ‘He does not publicly discuss his private finances.’
However, should Mr Rumsfeld have held on to shares in the company, he would be a major beneficiary of the surge in the global demand for the drug. The NHS alone has already purchased enough Tamiflu to treat three-quarters of the population in the UK.
However, should Mr Rumsfeld have held on to shares in the company, he would be a major beneficiary of the surge in the global demand for the drug. The NHS alone has already purchased enough Tamiflu to treat three-quarters of the population in the UK.
Mr Rumsfeld has previously been accused of a potential conflict of interest over his links to Gilead Sciences, which sold the licensing rights for the medicine to Swiss giant Hoffman-La Roche in 1996.
Under the terms of the deal Gilead, headed by Mr Rumsfeld between 1997 and 2001, still receives between 14 and 22 per cent of the income from the wholesale trade in the drug, depending on the volume of sales.
Under the terms of the deal Gilead, headed by Mr Rumsfeld between 1997 and 2001, still receives between 14 and 22 per cent of the income from the wholesale trade in the drug, depending on the volume of sales.
Four years ago the value of Mr Rumsfeld’s shares in Gilead Sciences saw a huge hike from an estimated £3million to an estimated £17million over the avian flu scare.
It was partially sparked by a warning from President Bush’s top health adviser Mike Leavitt that a pandemic could cause nearly two million deaths in the US alone.
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When details of Mr Rumsfeld’s shareholding became public he consulted a lawyer who advised him to keep the stock but excuse himself from any government decisions involving the flu drug.
When details of Mr Rumsfeld’s shareholding became public he consulted a lawyer who advised him to keep the stock but excuse himself from any government decisions involving the flu drug.
He issued a document explaining the situation. Some months later the Pentagon ordered £39million worth of the Tamiflu drug for US troops.
tamiflu
When details of Mr Rumsfeld's shareholding became public he was advised to keep the stock but excuse himself from government decisions
tamiflu
When details of Mr Rumsfeld's shareholding became public he was advised to keep the stock but excuse himself from government decisions
Dr Joseph Mercola, author of The Great Bird Flu Hoax, said yesterday: ‘The only thing all this talk of swine flu does is spread fear. President Bush sought to instil panic by telling us a minimum of 200,000 people will die from avian flu but it could be as bad as two million deaths in the US alone. This hoax was justified by the immediate purchase of 80million doses of Tamiflu.’
As well as Mr Rumsfeld, Gilead has links with a number of other Republican figures. The largest shareholder is FMR Corporation, owned by Grover Glenn Norquist, a Republican activist.
And George Schultz, President Ronald Reagan’s former Secretary of State, was a major shareholder until he sold his stake in 2005, netting around £5million.
And George Schultz, President Ronald Reagan’s former Secretary of State, was a major shareholder until he sold his stake in 2005, netting around £5million.
Gilead has announced record first-quarter results, with revenues of £1billion, although a lot of revenue came from their AIDS drugs.
Michael Riordan, 51, the founder of Gilead who retired in 1997, said yesterday: ‘If the company has been successful, it’s not because of any political affiliations.’
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10.) China anuncia primera vacuna contra Gripe Porcina H1N1
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jueves, 03 de septiembre de 2009
Michael Riordan, 51, the founder of Gilead who retired in 1997, said yesterday: ‘If the company has been successful, it’s not because of any political affiliations.’
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10.) China anuncia primera vacuna contra Gripe Porcina H1N1
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jueves, 03 de septiembre de 2009
Source:http://hunnapuh.blogcindario.com/2009/09/03271-china-anuncia-primera-vacuna-contra-gripe-porcina-h1n1.html
La agencia oficial de comunicaciones Chinas XINHUA, anunció que china logró hoy la licencia de producción de la primera vacuna específica contra la gripe Porcina o H1N1, la empresa farmacéutica China Sinovac Biotech, fue la responsable de este avance, el nombre que han dado a dicha vacuna es "Panflu.1".
"La vacuna H1N1 de Sinovac está aprobada oficialmente", declaró en conferencia de prensa el jefe de la SFDA (Autoridad Estatal de Alimentos y Medicamentos), Zhang Wei, luego añadió, "El conjunto de pruebas de la vacuna de Sinovac muestra que la vacuna es muy segura".
"China ha avanzado muy rápidamente en este tema y podemos felicitarlos por haber compartido con nosotros los resultados de las pruebas", declaró la directora del servicio de vacunas de la OMS, Marie-Paule Kieny
"China ha avanzado muy rápidamente en este tema y podemos felicitarlos por haber compartido con nosotros los resultados de las pruebas", declaró la directora del servicio de vacunas de la OMS, Marie-Paule Kieny
Existe otra vacuna China que está en espera de los resultados de las pruebas y que aspira a convertirse en la segunda vacuna contra la gripe porcina, se trata de la empresa farmacéutica Hualan Biological Engineering Inc. tambióen de China.
En todo el mundo hay como 8 vacunas mas que están en la etapa de pruebas para poder recibir la autorización, pero esta vez los gigantes farmaceuticos se quedaron atras y los Chinos toman la delantera científica y tecnológica.
El laboratorio Sinovac espera alcanzar una meta de producción de 2 millones de dosis mensuales.
En europa se han recibido ya las primeras dosis pero aún no se tiene la autorización para comercializarlas.
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11.) Baxter, los virus de la gripe extraviados y el plasma sanguíneo contaminado.
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Source:http://www.migueljara.com/2009/10/13/baxter-los-virus-de-la-gripe-extraviados-y-el-plasma-sanguineo-contaminado/
En europa se han recibido ya las primeras dosis pero aún no se tiene la autorización para comercializarlas.
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11.) Baxter, los virus de la gripe extraviados y el plasma sanguíneo contaminado.
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Source:http://www.migueljara.com/2009/10/13/baxter-los-virus-de-la-gripe-extraviados-y-el-plasma-sanguineo-contaminado/
Publicado por Miguel Jara el 13 de Octubre de 2009.
Quisiera en esta información tratar sobre una de las cosas que más llama la atención del video ya famoso de la monja benedictina y médica Teresa Forcades:
Cuenta que a finales de enero de 2009, la filial austríaca de la farmacéutica norteamericana Baxter, especializada en la fabricación de vacunas, entre otros preparados, distribuyó a 16 laboratorios de Austria, Alemania, la República Checa y Eslovenia, 72 kilogramos de material para preparar miles de vacunas contra el virus de la gripe estacional. Las vacunas tenían que ser administradas a la población de estos países durante los meses de febrero y marzo. Antes de que ninguna de estas vacunas fuese administrada, un técnico de laboratorio de la empresa BioTest de la República Checa decidió por su cuenta probar las vacunas en hurones, que son los animales que desde 1918 se utilizan para estudiar las vacunas de la gripe. Todos los hurones vacunados murieron. Se investigó entonces en qué consistía exactamente el material enviado por la casa Baxter y se descubrió que contenía virus vivos de la gripe aviar (virus A/H5N1) combinados con virus vivos de la gripe de cada año (virus A/H3N2). Si esta contaminación no se hubiese descubierto a tiempo -prosigue Forcades-, la pandemia que “sin base real están anunciando las autoridades sanitarias globales y nacionales”, ahora sería una “espantosa realidad”. Esta combinación de virus vivos puede ser especialmente letal porque combina un virus que tiene un 60 de mortalidad pero es poco contagioso (el virus de la gripe aviar) con otro que tiene una mortalidad muy baja pero con una gran capacidad de contagio (un virus de los de la gripe de cada año).
A menudo nos llegan informaciones de este tipo que podemos pensar que pertenecen más bien al campo de la ciencia ficción. Pero ¿y si el laboratorio del que tratamos, Baxter, ya se hubiera visto implicado en el pasado en hechos cuando menos similares? Muchos de ustedes han leído mi primer libro, Traficantes de salud: Cómo nos venden medicamentos peligrosos y juegan con la enfermedad.
Recordarán que en el primer capítulo de todos trato el caso de las personas muertas en España tras el contagio de su sangre con los virus de la hepatitis C y de sida (al menos unas 1.600). Estos sucesos se desarrollaron en los años ochenta y se prolongaron durante los noventa e incluso ya entrados en la década de 2000 había personas que fallecían por los problemas que les habían causado lustros antes. Había varios laboratorios implicados y uno de ellos era Baxter que había comercializado su hemoderivado Hemofil contaminado. Como me contaría Josefa Lorenzo, uno de los pocos padres que se atrevieron a denunciar a los laboratorios y a la administración tras la muerte de sus hijos:
“Los laboratorios no tomaron las medidas oportunas para evitar la exclusión como donantes de personas que podían transmitir la nueva enfermedad y no se avisó a los hemofílicos del riesgo que suponía la administración de dichos preparados. Todo esto a pesar de que en los años ochenta los científicos conocieron el riesgo que suponía administrar derivados sanguíneos a los hemofílicos”.
Pero hubo más. Nuestro país no fue el único donde ocurrieron estos hechos. En Francia el escándalo fue mayúsculo. Se contagiaron unas 4.400 personas y varios ministros del gobierno galo fueron juzgados y el de Sanidad hallado culpable. En Canadá, entre los años 1986 y 1990, alrededor de 6.500 personas resultaron infectadas con Hepatitis C a través de transfusiones de sangre y derivados sanguíneos. Al menos 1.000 hemofílicos que padecieron sida y Hepatitis C y B en este país recibieron tratamiento con productos tóxicos procedentes de prisiones de EE.UU. Hasta 1983 las compañías farmacéuticas acudieron a estos centros penitenciarios para “recaudar” la sangre “donada” por los condenados de aquel país. Canadá dejó de utilizar este método en 1971 porque la mayoría de los presidiarios estaban infectados con Hepatitis. Pese a haber tardado doce años en adoptar la misma medida que su vecino del norte a los reclusos estadounidenses continuaron extrayéndoles sangre para satisfacer a la clientela farmacéutica. Michael Galster, que trabajó en el grupo de médicos del sistema penitenciario de Arkansas durante la época en la que ocurrieron los hechos, escribió un libro denunciando estos hechos vividos en su práctica cotidiana.
La sangre recogida de personas enfermas en las prisiones fue importada, entre otros países, por España. No cabe duda que en nuestro país entró plasma sanguíneo con muchas posibilidades, por mostrarme prudente, de estar contaminado con la Hepatitis B. Así lo advirtieron las autoridades canadienses a las españolas. Con todo lujo de detalles añadían los lotes concretos que habían llegado a la Península, como documento en el libro. El laboratorio implicado en este caso, el que importó el plasma de otra empresa fue Landerlan, ya desaparecido como tal
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12.) OMS a juicio por Bioterrorismo por la Gripe Porcina
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Source:Http://www.cherada.com/articulos/oms-a-juicio-por-bioterrorismo-por-la-gripe-porcina
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12.) OMS a juicio por Bioterrorismo por la Gripe Porcina
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Source:Http://www.cherada.com/articulos/oms-a-juicio-por-bioterrorismo-por-la-gripe-porcina
Publicado por: Sauron el 25 / 07 / 2009 a las 12:59 am.
Según la denuncia, los gobiernos y multitud de organismos internacionales implicados en una trama de reducir la población mundial. Una periodista de investigación de Austria alerta al mundo de que el mayor crimen en la historia de la humanidad está en marcha.
Por Trinity
Bárbara Minton, editora del popular sitio de información sobre la salud, Natural News, presenta una investigación efectuada por una periodista austríaca, Jane Bürgermeister, que denuncia a grandes laboratorios, la OMS y hasta al presidente de USA, Barack Obama, de ser parte de un plan de vacunación masiva contra la gripe porcina que tendría como fin real reducir la población mundial significativamente
Jane Bürgermeister ha presentado al FBI cargos criminales contra de la Organización Mundial de la Salud (OMS), las Naciones Unidas (ONU), y funcionarios de Gobiernos y empresas en relación con el bioterrorismo e intentos de cometer asesinatos en masa. En julio del 2009 se espera que esté lista la vacuna de Baxter contra la gripe A/H1N1 que piensa ser empleada como "arma de destrucción masiva".
La denunciante también ha preparado un mandamiento judicial contra la vacunación que se está presentado en América. Se presentan cargos contra Baxter AG y Avir Green Hills Biotechnology de Austria por producir vacunas contra la gripe empleando para ello aves contaminadas, alegando que se trataba de un acto deliberado de provocar y sacar provecho de una pandemia.
Resumen de las reclamaciones y denuncias presentadas ante el FBI en Austria el 10 de junio, 2009
Resumen de las reclamaciones y denuncias presentadas ante el FBI en Austria el 10 de junio, 2009
En su acusación, Bürgermeister presenta pruebas de los actos de bioterrorismo en violación de la ley de EE.UU, por un grupo que opera en los EE.UU bajo la dirección de los banqueros internacionales que controlan la Reserva Federal, así como la OMS, la ONU y la OTAN con el fin de llevar a cabo un genocidio en masa contra la población de los EE.UU. mediante el uso de la ingeniería genética una pandemia de gripe de virus con la intención de causar la muerte. Este grupo ha elevado anexo de las oficinas gubernamentales en los EE.UU.
Cargos penales relativos a actos Bioterrorismo y el asesinato en masa.
Enviado a: FBI OFICIAL
EMBAJADA DE LOS ESTADOS UNIDOS
Boltzmanngasse 16 A-1090 Viena Austria
Fecha: 10 de junio de 2009
Índice
I. Introducción: Resumen de las reivindicaciones
II. Antecedentes de hecho
III. Prueba de la gripe porcina, las vacunas son armas biológicas
IV. Pruebas científicas el virus de la gripe porcina es artificial (ingeniería genética) del virus.
V. Las pruebas científicas de que la gripe porcina se asemeja genéticamente al de la gripe española de 1918, el virus asesino.
VI. Secuencia del genoma de la gripe porcina
VII. Pruebas de liberación del virus de la gripe porcina en México
VIII. Pruebas de la participación del Presidente Obama
IX. Pruebas de la función de Baxter y la OMS en la producción y liberación de la pandemia del virus de material en Austria.
X. Prueba de que Baxter es un elemento encubierto de armas biológicas que opera en una red.
XI. Prueba de que Baxter ha contaminado deliberadamente las drogas.
XII. Prueba de que las vacunas de Novartis están siendo utilizadas como armas biológicas.
XIII. Pruebas de la función de la OMS en el programa de armas biológicas: proveedor de los virus de la gripe aviar a Baxter
XIV. Pruebas de que la OMS está manipulando los datos de la enfermedad con el fin de justificar la declaración de una pandemia Nivel 6 con el fin de tomar el control de los EE.UU..
XV. Pruebas de la función de la FDA en la cobertura de programa de armas biológicas
XVI. Pruebas de la Nacional de Microbiología de Canadá de los laboratorios en el programa de armas biológicas
XVI. Pruebas de la participación de los científicos que trabajan para el Reino Unido de NIBSC, y el CDC en la ingeniería de la gripe porcina.
XVII. Prueba de que las vacunas asesinas causaron la gripe española de 1918.
XVIII. Precedentes: la gripe porcina y el programa de vacunación masiva de 1976
XIX. Resultados insuficientes del gobierno para detener la propagación de la gripe porcina como cobertura para la difusión de una pandemia
XX. Pruebas de la manipulación del marco jurídico para permitir el asesinato en masa con total impunidad
XXII. Cuestiones constitucionales: la necesidad de actuar desde la legalidad para poner punto y final a la ilegalidad de poner en peligro la vida, la salud y el bien público en un sistema de vacunaciones en masa
XXI. El tema de la inmunidad y la indemnización como prueba de la intención de cometer un delito
XXII. Pruebas de la utilización de la reducción de la población por medio de Chemtrails
XXIII. Pruebas de la existencia de un sindicato internacional de delincuencia empresarial a nivel global.
XXIV. Pruebas de la existencia de la organización llamada Illuminati
XXV. Pruebas de la participación de los Illuminati en el actual colapso del sistema financiero mundial
XXVI. Pruebas del objetivo en la agenda Illuminati de depoblación a nivel mundial; El Club Bilderberg y su participación en la ingeniería y la liberación de virus artificial de la gripe porcina.
XXVII. Pruebas de la Agenda de genocidio por medio de la gripe en armas que se debate en la reunión anual de Bilderberg en Atenas a partir de mayo (en los días del 14 al 17) de 2009
XXXVIII. Conclusión
XXX Acusados. Adjuntos ? Cargos penales presentadas contra Baxter y la OMS, entre otras cosas, en Austria ? Cargos penales presentados contra Baxter y la OMS, entre otras cosas, en Suiza ? respuestas de Baxter al incidente- Extracto: sobre las armas biológicas, la Ley contra terrorismo de 1989
I. Introducción:
I. Introducción:
Presento las pruebas de las alegaciones de los actos de bioterrorismo en violación de la legislación penal de los Estados Unidos, llevados a cabo por un grupo que opera en los Estados Unidos, bajo la dirección de un grupo de banqueros internacionales que controlan, entre otras cosas, las instituciones financieras, la Reserva Federal, así como las organizaciones gubernamentales internacionales, en particular la Organización Mundial de la Salud, las Naciones Unidas y la OTAN.
Aquí se presentan las pruebas con objeto de demostrar que un sindicato internacional dedicado al crimen, que opera por medio de estas empresas, tiene la intención de llevar a cabo un genocidio en masa contra la población de los Estados Unidos mediante el uso de un producto biológico creado por medio de ingeniería genética.
Específicamente, se presentan pruebas contra los siguientes Demandados :
Presidente Barack Obama, Presidente de los Estados Unidos,
David Nabarro, Coordinador del Sistema de las Naciones Unidas para la Gripe,
Margaret Chan, Directora General de la Organización Mundial de la Salud,
Kathleen Sibelius, Secretario del Departamento de Salud y Servicios Humanos (HHS ), Secretario,
Janet Napolitano, el Departamento de Seguridad Interior,
David de Rothschild, banquero,
David Rockefeller, banquero,
George Soros, el banquero,
Werner Faymann, Canciller de Austria,
Alois Stöger, Ministro de Salud de Austria
David Nabarro, Coordinador del Sistema de las Naciones Unidas para la Gripe,
Margaret Chan, Directora General de la Organización Mundial de la Salud,
Kathleen Sibelius, Secretario del Departamento de Salud y Servicios Humanos (HHS ), Secretario,
Janet Napolitano, el Departamento de Seguridad Interior,
David de Rothschild, banquero,
David Rockefeller, banquero,
George Soros, el banquero,
Werner Faymann, Canciller de Austria,
Alois Stöger, Ministro de Salud de Austria
Todas estas personas son parte de una organización criminal de empresas que ha desarrollado, producido, almacenado y empleado armas biológicas para eliminar la población de los Estados Unidos y de otros países con objeto de obtener beneficios políticos y financieros.
Se presentan pruebas de que los acusados conspiran entre sí , y con otros para diseñar, financiar y participar en la fase final de la ejecución de un programa encubierto de armas biológicas a nivel internacional que implica, entre otras entidades, a las empresas farmacéuticas Baxter y Novartis, quienes, por medio de bioingeniería y posterior liberación de agentes biológicos letales, en primer lugar, el llamado virus de la gripe aviar y, en segundo lugar, el llamado virus de la gripe porcina, pretenden poner en marcha un programa de vacunación masiva forzada, que será el medio para la administración de un agente biológico tóxico.
Dicho agente causará muerte y lesiones a la población de los Estados Unidos al entrar en el organismo por medio de inyecciones; todo ello en un acto de violación de las Armas Biológicas Ley Antiterrorista de 1989 (BWATA), aprobada en 1990, que amplió el ámbito de los bio- materiales de guerra a fin de incluir en dicha regulación a particulares y organizaciones no estatales, incluidas las empresas del sector farmacéutico.
El expediente aportado presenta pruebas de que Baxter AG, filial austriaca de Baxter Internacional, con sede en Deerfield, Ill, deliberadamente, a sabiendas y voluntariamente, envió 72 kilos de virus de la gripe de aves vivas, suministrados por la Organización Mundial de la Salud, Ginebra, Suiza en el invierno de 2009 a 16 laboratorios en cuatro países. Estas pruebas ofrecen una prueba clara de que las empresas farmacéuticas internacionales y los organismos gubernamentales están participando activamente en la elaboración, desarrollo, fabricación y distribución de agentes biológicos como el más mortal arma biológica en el planeta con el fin de desencadenar una pandemia y causar muertes en masa.
El Anexo (A) es una copia de los cargos penales presentados contra Baxter y otros acusados en la ciudad de Viena Fiscalía 8t de abril de 2009. La policía austríaca están investigando el incidente de la liberación de 72 kilos de aves vivas del virus de la gripe de Baxter laboratorio Orth an der Donau este invierno.
La pandemia de la gripe porcina se basa en una gran mentira que asegura que el virus es de origen natural y que representa una amenaza para la población. Se ofrece clara prueba y evidencia científica de que el virus de la gripe aviar y el virus de la gripe porcina, de hecho, han sido diseñados por bioingeniería en laboratorios, utilizando fondos suministrados por la OMS y otros organismos gubernamentales, entre otros. Este virus de la gripe porcina es un híbrido, de gripe porcina, y de de gripe aviar, algo que sólo puede provenir de un laboratorio, según los propios expertos.
La OMS afirma que la gripe porcina se está extendiendo y declara una pandemia haciendo caso omiso de las causas que la producen. Los virus que fueron puestos en libertad fueron creados y puestos en libertad con la ayuda de la OMS y la OMS es responsable de la abrumadora pandemia, en primer lugar, por no introducir medidas para limitar la propagación del virus con rapidez. Por otro lado, los síntomas de la gripe porcina son indistinguibles de los periódicos de la gripe o resfriado común.
El virus, que se supone causante de la gripe, no causa muerte con mayor intensidad que la gripe ordinaria. Las cifras de muertes registradas por la gripe porcina son incompatibles con la alarma levantada y no hay claridad en cuanto a la forma en que el número de muertes se está documentando.
Sin embargo, hay motivos razonables para creer que en las vacunas obligatorias se introducen sustancias contaminadas que están específicamente diseñadas para causar la muerte. Una licencia de vacuna de la empresa farmacéutica Novartis contra la gripe aviar mató, al menos, a 21 personas sin techo en Polonia durante el verano de 2008 y tuvo como principal resultado una alta tasa de efectos adversos, cumpliendo así con la propia definición de arma biológica (una agente biológico destinado a causar una alta tasa de eventos adversos, es decir, la muerte o lesiones), mediante un sistema de prestación de servicios (inyecciones de vacunas).
La misma red de compañías farmacéuticas internacionales y los organismos gubernamentales que han desarrollado y liberado los materiales relacionados con esta pandemia se han posicionado en el mercado para beneficiarse económicamente tras desencadenar la pandemia, sellando previamente contratos de suministro de dicha vacuna y su financiación. La pandemia traerá enormes beneficios económicos para la industria farmacéutica, relacionados con la posible venta de vacunas contra la gripe porcina, por medio de subvenciones y financiación.
Los diferentes grupos de medios de comunicación están controlados por el mismo grupo que se encarga de esta gripe porcina alimentando por medio de desinformación a los ciudadanos con objeto de que sean destinatarios de la peligrosa vacuna.
En resumen, el expediente presenta pruebas de que el pueblo de los Estados Unidos va a sufrir un perjuicio considerable e irreparable si los ciudadanos se ven obligados a recibir esta vacuna sin su consentimiento informado de acuerdo con el modelo de Estado de Emergencia de Salud Ley de poderes, la Ley de Emergencia Nacional, la seguridad nacional la Directiva Presidencial / NSPD 51 y SEGURIDAD PRESIDENCIAL DIRECTIVE/HSPD-20, y la Alianza Internacional sobre la Gripe Aviar y Pandémica.
Los acusados han planeado el asesinato en masa de la población de los EE.UU por medio de la administración de vacunas, pero también mediante la instalación de una amplia red de campos de concentración del FEMA y la identificación de fosas comunes. Los acusados han participado en la elaboración y aplicación de un plan de golpe de Estado contra los Estados Unidos de América, utilizando la peste porcina o la gripe pandémica como pretexto. Dicho sindicato del crimen emplea la delincuencia internacional, utilizando a las Naciones Unidas y la Organización Mundial de la Salud como frente, en violación de todas las leyes sobre alta traición.
Se presentan pruebas de que el complejo de las empresas farmacéuticas de Baxter, Novartis y Sanofi
Aventis, son parte de una organización que opera de fuera de Estados Unidos en base a un doble propósito de armas biológicas, programa financiado por el sindicato penal internacional y diseñado para la aplicación de los asesinatos en masa para reducir la población del mundo en los próximos diez años, a sembrar el terror, para justificar la obligación de que los ciudadanos renuncien voluntariamente a sus derechos y se sometan a las normas de cuarentena en los campos de FEMA.
Asimismo, los activos patrimoniales, las casas, empresas, granjas, de los que morirán por culpa de este plan de este sindicato de la delincuencia internacional quedarán a la disposición de ellos. Al eliminar la población de América del Norte, la élite internacional tendrá acceso a los recursos naturales de la región y mediante la eliminación de los Estados Unidos y su constitución democrática al unificar, bajo la entidad de un superestado en America del Norte, con una moneda internacional, el grupo de delincuencia tendrá el control total de América del Norte.
La pandemia también ha sido diseñada por el mismo grupo de delincuencia internacional con objeto de distraer la atención del mundo de la devastadora crisis económica mundial, marcada por la pobreza, el colapso económico, la guerra, la pérdida de los derechos civiles y la desaparición de programas sociales del Estado.
En la denuncia se presentan:
En la denuncia se presentan:
El modelo de Estado de Emergencia de Salud Ley de poderes, el Consejo Nacional de Seguridad DIRECTIVA PRESIDENCIAL / NSPD 51 y SEGURIDAD PRESIDENCIAL DIRECTIVE/HSPD-20 y otras leyes de emergencia, cuarentena, indemnizaciones en caso de muerte o lesiones por vacuna, vacunación de emergencia, obligatoriedad de vacunas, ley marcial, emergencia nacional, suspensión de gobierno, obligatoriedad de los médicos de vacunar, eliminación de obligación de indemnización de los Estados en caso de muerte o lesión por vacuna, militarización de la gestión de emergencias sanitarias, se priman las decisiones de las organizaciones mundiales en la salud (como la OMS) frente a las del Gobierno de los Estados Unidos, ejercicios de preparación de Northcom frente a la pandemia, aprobación de legislación para facultar el estado de vigilancia y control de sus ciudadanos en caso de pandemia, aprobación de directivas que otorgan plenos poderes para el presidente en caso de evento catastrófico, entre otras leyes aprobadas.
Source:http://www.pandemicflu.gov/plan/states/stateplans.html
Otros hechos presentados
Otros hechos presentados
En septiembre de 2005, el Dr. David Nabarro fue nombrado el primer coordinador de la gripe del sistema de la ONU. El 29 de septiembre de 2005, en una conferencia de prensa en las Naciones Unidas, Nabarro dejó claro que su trabajo consistía en preparar para el virus H5N1, conocido como la gripe aviar. Se cuantificó la mortalidad que se esperaba de la siguiente manera:
"No estoy, en el momento, en la libertad de darle una predicción sobre el número, pero sólo quiero hacer hincapié en que, digamos, la serie de muertes podría ser cualquier cosa desde 5 a 150 millones de personas. "
Varios organismos dentro del Departamento de Salud y Servicios Humanos (DHHS), entre ellas la Oficina del Secretario, la Food and Drug Administration (FDA), los CDC y el Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID), están en el proceso de trabajo con los fabricantes de vacunas a fin de facilitar la producción de los lotes de vacunas experimentales para los dos cepas H5N1 y H9N2, así como la contratación de la fabricación de 2 millones de dosis de una vacuna contra el H5N1.
El 27 de octubre de 2005, el Departamento de Salud y Servicios Humanos otorgó un contrato de $ 62.5 millones a Chiron Corporation para la fabricación de una vacuna contra la gripe aviar destinada a proteger contra la cepa H5N1 del virus de la gripe. Esto siguió a una anterior otorgó $ 100 millones del contrato-a Sanofi Pasteur, el negocio de las vacunas Sanofi-Aventis Group, para la vacuna contra la gripe aviar.
Según The New York Times en marzo de 2006, "los gobiernos de todo el mundo han gastado miles de millones de planificación para una posible pandemia de influenza: la compra de medicamentos, ejecutando simulacros de desastres, [y] el desarrollo de estrategias para reforzar los controles en las fronteras", debido a la amenaza que el virus H5N1. [83]
El 1 de noviembre de 2005 el Presidente Bush presentó una solicitud al Congreso por valor de:
$ 7.1 millones para iniciar la aplicación de la Estrategia Nacional de salvaguardia contra el peligro de pandemia de gripe. La solicitud incluye $ 251 millones para detectar y contener brotes antes de que se extiendan en todo el mundo;
$ 2,8 millones para acelerar el desarrollo de la cultura de la tecnología celular, $ 800 millones para el desarrollo de nuevos tratamientos y vacunas,
$ 1,519 millones para los departamentos de Salud y Servicios Humanos (HHS ) y de Defensa para la compra de las vacunas contra la gripe,
$ 1.029 millones para almacenar medicamentos antivirales, y
$ 644 millones para garantizar que todos los niveles de gobierno están preparados para responder a un brote pandémico. [96]
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13.) Farmacéuticas, las ganadoras frente a la influenza
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Source:http://eleconomista.com.mx/negocios/2009/09/01/farmaceuticas-las-ganadoras-frente-influenza
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13.) Farmacéuticas, las ganadoras frente a la influenza
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Source:http://eleconomista.com.mx/negocios/2009/09/01/farmaceuticas-las-ganadoras-frente-influenza
1 Septiembre, 2009 - 16:55
FUENTE: Notimex
Los laboratorios farmacéuticos son por ahora los grandes beneficiarios de la pandemia de la influenza, ya que los antivirales les están redituando enormes sumas, al menos hasta que las vacunas estén listas para su comercialización.
Desde abril pasado, cuando apareció el virus de influenza A H1N1, los gobiernos han desbloqueado fondos masivos para proteger a sus poblaciones con antivirales, ya que son el único tratamiento efectivo, refirió un reporte especial del diario francés Le Monde.
Apenas la semana pasada, España declaró que invertiría 333 millones de euros (U$473 millones) para luchar contra la influenza humana, mientras Francia estimó su plan en 1,000 millones de euros(U$1,400 millones) entre vacunas y antivirales.
El laboratorio británico GlaxoSmithKline (GSK), el francés Sanofi Pasteur y los suizos Novartis y Roche 'aparecen, por ahora, como los principales beneficiarios de la pandemia por los antivirales', dijo el analista Jean-Jacques Le Fur, de la sociedad Bourse Oddo.
Más de 200 millones de dosis del Tamiflu han sido solicitados por 85 países desde abril pasado, 'la venta de esta droga se multiplicó por 12 respecto al mismo periodo del 2008', indicó Thierry Verrecchia, analista de la Sociedad de Inversión Raymond James Euro Equities.
Aunque Roche -que tiene la patente de este antiviral- ha hecho descuentos en ventas a los gobiernos, la rentabilidad de Tamiflu sigue siendo cómoda. 'Su margen bruto es del 40%, mientras la de la vacuna contra la influenza A se aproxima a 15 por ciento'.
Ante tal panorama, se prevé que las ventas del antiviral deberán generar un volumen de negocios de más de 1,300 millones de euros (U$1,800 millones) en el 2009, es decir 4.2% de las ventas de Roche.
Sin embargo, este éxito tiene un impacto limitado en las cuentas del grupo suizo, porque debe pagar una parte de los beneficios de Tamiflu al estadunidense Gilead, descubridor de la molécula.
Sin embargo, este éxito tiene un impacto limitado en las cuentas del grupo suizo, porque debe pagar una parte de los beneficios de Tamiflu al estadunidense Gilead, descubridor de la molécula.
Respecto a las ventas del antiviral Relenza, el impacto a las cuentas de GSK será aún más diluida, ya que este medicamento había sido prácticamente abandonado y apenas se comenzó su lanzamiento comercial.
Ahora, para los fabricantes de vacunas la pandemia 'no será un muy buen negocio', indicó Le Monde.
'La creación de una vacuna en tan poco tiempo es una tarea más difícil -y mucho menos rentable- que producir antivirales', agregó.
Desde el brote del virus A H1N1, más de mil millones de dosis de vacunas han sido ordenados por el hemisferio norte por cerca de 10 millones de euros, pero la competencia entre los productores pesan sobre los márgenes.
El laboratorio Sinovac China, uno de los pocos en desarrollar un tratamiento contra la influenza humana en una sola inyección, anunció que su producto sería 30% más barato que sus competidores.
RDS/doch
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14.) Big Pharma: Baxter Files Swine Flu Vaccine Patent a Year Ahead of Outbreak
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Source:Http:///www.globalresearch.ca/index.php?context=va&aid=14430/
RDS/doch
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14.) Big Pharma: Baxter Files Swine Flu Vaccine Patent a Year Ahead of Outbreak
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Source:Http:///www.globalresearch.ca/index.php?context=va&aid=14430/
by Lori Price
Barack Opharma issues the ultimate bad news during his weekly Friday night bad news dump: Legal immunity set for swine flu vaccine makers 17 Jul 2009 The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects [paralysis, death] from the shots. This time, the government has already taken steps to head that off. Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday. The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies.
Baxter Files Swine Flu Vaccine Patent a Year Ahead of Outbreak --US20090060950A1 to Baxter International filed 28th August 2008 By Lara 10 Jul 2009 Baxter Vaccine Patent Application US 2009/0060950 A1 --'In particular preferred embodiments the composition or vaccine comprises more than one antigen.....such as influenza A and influenza B in particular selected from of one or more of the human H1N1, H2N2, H3N2, H5N1, H7N7, H1N2, H9N2, H7N2, H7N3, H10N7 subtypes, of the pig flu H1N1, H1N2, H3N1 and H3N2 subtypes, of the dog or horse flu H7N7, H3N8 subtypes or of the avian H5N1, H7N2, H1N7, H7N3, H13N6, H5N9, H11N6, H3N8, H9N2, H5N2, H4N8, H10N7, H2N2, H8N4, H14N5, H6N5, H12N5 subtypes.'
Baxter can take no more H1N1 flu vaccine orders 16 Jul 2009 While at least 50 governments have placed orders or are negotiating with drug companies for supplies of flu vaccine against the [their] fast spreading H1N1 strain, the lone U.S.-based maker has already taken on as much as it can handle.
Baxter International Inc said on Thursday it has taken orders from five countries, including Britain, Ireland and New Zealand, for a total of 80 million doses of H1N1 vaccine and will not take any more.
'Clearly we believe this demand has the potential to translate into a significant opportunity.' Baxter 2Q Profit Up 7.9%; Full-Year Guidance Raised 16 Jul 2009 Baxter International Inc. posted a stronger-than-expected 7.9% rise in second-quarter profit with help from improved margins and product sales that continued to avoid any hits from the economic downturn. The medical-products maker boosted its 2009 earnings guidance while saying the increase doesn't reflect at this point any contribution from making a vaccine for the H1N1 flu strain. Baxter reported a second-quarter profit of $587 million, or 96 cents a share, up from $544 million, or 85 cents a share, a year earlier.
'Clearly we believe this demand has the potential to translate into a significant opportunity.' Baxter 2Q Profit Up 7.9%; Full-Year Guidance Raised 16 Jul 2009 Baxter International Inc. posted a stronger-than-expected 7.9% rise in second-quarter profit with help from improved margins and product sales that continued to avoid any hits from the economic downturn. The medical-products maker boosted its 2009 earnings guidance while saying the increase doesn't reflect at this point any contribution from making a vaccine for the H1N1 flu strain. Baxter reported a second-quarter profit of $587 million, or 96 cents a share, up from $544 million, or 85 cents a share, a year earlier.
Baxter working on vaccine to stop swine flu, though admitted sending live pandemic flu viruses to subcontractor By Lori Price 26 Apr 2009 The OMFG moment of the century: Illinois-based Baxter working on vaccine to 'stop' swine flu outbreak in Mexico 25 Apr 2009 Specialty drug maker Baxter International Inc. will work with the World Health Organization to develop a vaccine that could stem [foment] an outbreak of a deadly swine flu strain in Mexico. Baxter spokesman Christopher Bona said Saturday that the Deerfield, Ill.-based company has asked the WHO for a sample of the flu strain. He says Baxter has patented technology that allows the company to develop vaccines in half the time it usually takes -- about 13 weeks instead of 26.
Baxter admits sending live avian flu viruses to subcontractor --Baxter admits contaminated seasonal flu product contained live bird flu virus 27 Feb 2009 The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses. And an official of the World Health Organization's European operation said the body is closely monitoring the investigation into the events that took place at Baxter International's research facility in Orth-Donau, Austria.
Human trial of swine flu vaccine 'soon' 15 Jul 2009 The federal government has defended its policy of not following the United Kingdom's lead and rushing out a swine flu vaccine. Biopharmaceutical company CSL will start clinical vaccine trials on 240 healthy adults in Adelaide next week. The vaccine is due to be rolled out in October.
CLG Pandemic Action Alerts 12 Jul 2009 Petition against mandatory vaccines; contact the White House, US Congress --More flu news here
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15.) AstraZeneca compra la estadounidense Medimmune por mas de 11.000 millones de euros
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Source:www.eleconomista.es/empresas-finanzas/noticias/201934/04/07/Astra-Zeneca-compra-estadounidense-Medimmune-por-mas-11000-millones-euros.html
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15.) AstraZeneca compra la estadounidense Medimmune por mas de 11.000 millones de euros
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Source:www.eleconomista.es/empresas-finanzas/noticias/201934/04/07/Astra-Zeneca-compra-estadounidense-Medimmune-por-mas-11000-millones-euros.html
Copenhague, 23 abr (EFECOM).- La farmacéutica sueco-británica Astra Zeneca anunció hoy que ha cerrado un acuerdo con la estadounidense Medimmune para adquirir la totalidad de sus acciones por 15.600 millones de dólares, lo que supone un pago de 58 dólares por acción.
La operación, que se espera esté completada en junio, cuenta con el apoyo de la dirección de
La operación, que se espera esté completada en junio, cuenta con el apoyo de la dirección de
Medimmune, que ha recomendado a sus accionistas que acepten la oferta, según un comunicado de Astra Zeneca.
La compañía estadounidense obtuvo en 2006 unos ingresos de 1.300 millones dólares y unas ganancias antes de impuestos de 75 millones, cuenta con 2.500 empleados y tiene su sede central en Maryland (Estados Unidos).
Medimmune trabaja fundamentalmente en tres áreas de investigación: enfermedades infecciosas, cáncer y enfermedades inflamatorias.
El director general de la firma sueco-británica, David Brennan, señaló en el comunicado que la compra permitiría a la compañía diversificar su capacidad de investigación y aumentar sus posibilidades de crecimiento.
Astra Zeneca anunció hoy también unos beneficios brutos de 2.267 millones de dólares en el primer trimestre, un 2,5 por ciento más que en el mismo período de 2006.EFECOM
Copenhague, 23 abr (EFECOM).- La farmacéutica sueco-británica Astra Zeneca anunció hoy que ha cerrado un acuerdo con la estadounidense Medimmune para adquirir la totalidad de sus acciones por 15.600 millones de dólares, lo que supone un pago de 58 dólares por acción.
La operación, que se espera esté completada en junio, cuenta con el apoyo de la dirección de
Medimmune, que ha recomendado a sus accionistas que acepten la oferta, según un comunicado de Astra Zeneca.
Medimmune, que ha recomendado a sus accionistas que acepten la oferta, según un comunicado de Astra Zeneca.
La compañía estadounidense obtuvo en 2006 unos ingresos de 1.300 millones dólares y unas ganancias antes de impuestos de 75 millones, cuenta con 2.500 empleados y tiene su sede central en Maryland (Estados Unidos).
Medimmune trabaja fundamentalmente en tres áreas de investigación: enfermedades infecciosas, cáncer y enfermedades inflamatorias.
El director general de la firma sueco-británica, David Brennan, señaló en el comunicado que la compra permitiría a la compañía diversificar su capacidad de investigación y aumentar sus posibilidades de crecimiento.
Astra Zeneca anunció hoy también unos beneficios brutos de 2.267 millones de dólares en el primer trimestre, un 2,5 por ciento más que en el mismo período de 2006.EFECOM
alc/rz/jj
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16.) Dos mutaciones hacen letal al H5N1
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Source:http://axxon.com.ar/not/168/c-1680102.htm
alc/rz/jj
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16.) Dos mutaciones hacen letal al H5N1
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Source:http://axxon.com.ar/not/168/c-1680102.htm
Dos mutaciones bastan para que el relativamente inocuo virus H5N1, el causante de la gripe aviar, se convierta en un agente letal en más del 50% de los casos de las infecciones en personas.
Ésta es la conclusión a la que han llegado los investigadores de la Universidad de Tokio al comparar las proteínas de la cubierta del virus en muestras tomadas de aves silvestres y de enfermos por la enfermedad. El descubrimiento fue publicado en la revista Nature.
Ésta es la conclusión a la que han llegado los investigadores de la Universidad de Tokio al comparar las proteínas de la cubierta del virus en muestras tomadas de aves silvestres y de enfermos por la enfermedad. El descubrimiento fue publicado en la revista Nature.
Dos cambios en una proteína
Los dos cambios se dan en la proteína hemaglutinina (la "H" del nombre del virus). Gracias a ellos, el virus adquiere la propiedad de unirse más fácilmente a las células que forman las paredes internas del sistema respiratorio.
Así es como comienza el proceso de infección, que acaba con un deterioro que puede llevar a la muerte.
Los investigadores, dirigidos por Yoshihiro Kawaoka, han detectado los cambios (una sencilla alteración en un aminoácido, el eslabón que forma la cadena que es toda proteína) por separado. Es decir, no tienen que coincidir los dos para que el virus sea más peligroso para las personas.
La siguiente pregunta es qué pasará si ambos cambios coincidieran.
153 víctimas mortales
Hasta ahora, por culpa de estos cambios y probablemente otros factores todavía no descubiertos, la gripe aviar se ha cobrado 153 víctimas mortales, y ha hecho enfermar a otras 105 personas, según el último recuento de la Organización Mundial de Salud (OMS).
La última de ellas, una mujer indonesia que falleció el pasado 13 de noviembre.
El hallazgo no se refiere a estos casos, pero indica el camino que debe recorrer el virus hasta llegar a ser la pandemia que temen los expertos.
El hallazgo no se refiere a estos casos, pero indica el camino que debe recorrer el virus hasta llegar a ser la pandemia que temen los expertos.
Fuente: Univisión. Aportado por Eduardo J. Carletti
</!C
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17.) VACUNA H1N1: Múltiples efectos secundarios en Suecia por Pandemrix (GSK) y en Suiza entran grandes dudas
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Source:http://notemaslaverdad.wordpress.com/2009/10/22/vacuna-h1n1-multiples-efectos-secundarios-en-suecia-por-pandemrix-gsk-y-en-suiza-entran-grandes-dudas/
</!C
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17.) VACUNA H1N1: Múltiples efectos secundarios en Suecia por Pandemrix (GSK) y en Suiza entran grandes dudas
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Source:http://notemaslaverdad.wordpress.com/2009/10/22/vacuna-h1n1-multiples-efectos-secundarios-en-suecia-por-pandemrix-gsk-y-en-suiza-entran-grandes-dudas/
Publicado por notemaslaverdad en 22 Octubre 2009
Las autoridades gubernamentales de Suiza han cambiado sus directrices para la vacunación de mujeres embarazadas y niños pequeños y se recomienda una vacuna sin adyuvantes, según informaciones en el diario Tages-Anzeiger.
Joachim Gross, de la reglamentación farmacéutica suiza, Swissmedic, dijo: “Porque no hay suficientes datos clínicos de las vacunas, especialmente para los niños y las mujeres embarazadas, daremos recomendaciones de vacunación concretas.”
Jefe médico Pietro Vernazza del Cantón Hospital St. Gallen se inyectó con el adyuvante AS03 de GSK como parte de un estudio, dijo: “Se puede sentir eso. El brazo me duele. Es difícil dormir por la noche. En algunos casos puede haber fiebre. Algunas personas pueden tener dificultades de movilidad durante algunos días. “
La decisión del gobierno suizo a abandonar los adyuvantes en vacunas de la gripe porcina para las mujeres embarazadas y niños pequeños, se produce en medio de una tormenta de protestas en Alemania en el uso de los ingredientes probados y tóxicos, con el pretexto de una emergencia pandémica.
Por otro lado, después de iniciar la vacunación contra el H1N1 en Suecia, se han dado casi 200 casos con efectos secundarios reseñables.
Oficialmente a día de ayer habían sido reportados 140 casos de efectos secundarios a las autoridades sanitarias Suecas. Entre ellas la Muerte de una persona debida a un ataque cardiaco, aunque dichas autoridades aseguran que no está demostrado que haya sido debida a la vacuna.
Aun así, Annika Linde, director del Instituto Sueco para el Control de Enfermedades Infecciosas (SMI) se las arregla para darle a esto giro en algo positivo al afirmar que “La vacuna tiene más efectos secundarios de la vacuna contra la gripe normal. Es una señal que demuestra que se da una protección efectiva”. Digo yo que la que tenía que haber muerto era ella.
Miles de suecos han sido vacunados hasta la fecha y los informes de los efectos secundarios están inundando al Instituto Sueco para el Control de Enfermedades Infecciosas (SMI). Annika Linde: “Es obvio que la vacuna contra la gripe porcina en los resultados tienen más efectos secundarios que las vacunas contra la gripe normal. Eso es porque la vacuna contra la gripe porcina contiene adyuvantes, aceite de hígado de tiburón, lo que provoca la respuesta de defensa del sistema inmunitario. También resultados en la protección contra el virus se vuelve mejor “.
Varios casos graves de reacciones alérgicas son reportados a la unidad para la seguridad de medicamentos. “Hasta ahora los efectos secundarios observados no son inesperados”, dice Gunilla Sjölin Forsberg. Esta unidad ya ha solicitado a algunas de las muchas unidades de vacunación que informen sobre efectos secundarios para conseguir un mejor control sobre la situación. Esta afirmación es sorprendente ya que, según la práctica habitual, todos los efectos secundarios deben ser automáticamente notificados – ¿verdad?
“Enfermé con la vacuna”- Hälsa – Expressen.se
Una enfermera a la que le fue administrada la vacuna la semana pasada hoy miércoles se siente todavía enferma. Se levantó con fiebre alta y escalofríos al día siguiente de tomar la vacuna de influenza porcina. “Estaba temblando en mi cuerpo. Sin fuerzas, hasta el punto de que ni siquiera podía sostener un vaso de agua en la mano.”, Lotta Lindström, dice.”- Ahora estoy pensando en qué es lo que nos han inyectado. Realmente estoy muy afectada. Es una sensación muy desagradable”.
María, 27: “Me hizo un terrible daño” – Hälsa – Expressen.se
María Strindlund no está segura de haber hecho la elección correcta al decidir tomar la vacuna. Ella también tiene una fiebre alta y escalofríos. “- Desde que trabajo como enfermera, decidí que era la mejor cosa que podía hacer.”, Dice ella. “Al principio no sentía nada, pero unas horas después los efectos secundarios comenzaron a afectarme”. “- Tengo un dolor extremo en el brazo. Ya no lo puedo levantar”. Le vino la fiebre y los escalofríos. “_ Yo estaba acostada en la cama temblando y sentía mucho frío y estaba en una ducha de agua caliente para entrar en calor.” Ella dice que muchos colegas suyos de los que también tomaron la vacuna ha tenido reacciones similares. Ella ha estado tomando muchas vacunas en el pasado sin ninguna reacción de ningún tipo.
Rebecka, 32: “me siento decrépita” – Hälsa – Expressen.se
Rebecka Andersson fue la primera persona que recibió la vacuna en Suecia. Ella se le sobrevino la fiebre y se sentía mal del estómago después de tomar la vacuna. “- He perdido toda la energía”, dice ella. “Nunca estoy enferma, por lo que normalmente se entiende que debe ser la vacuna”. Sus compañeros de clase fueron vacunados, al mismo tiempo y se afirma que cinco de los diecinueve también se enfermaron con la vacuna contra la gripe porcina.
Lotta, 49: “No puedo dormir” – Hälsa – Expressen.se
Lotta Lindström, una enfermera, afirma que recibió la vacuna hace una semana y aún no está bien. “- Esto es muy preocupante”, dice ella. “- No he dormido nada la noche después de la inyección ya que el dolor en mi brazo era muy grave.” El día después, en el trabajo, la fiebre del vino. Más tarde tuvo dolores de cabeza. Todavía hoy, una semana después de la inyección se siente enferma.
Otra enfermera, Jennely, casi no podía caminar cinco metros después de que ella se enfermó con la vacuna de la gripe porcina. Estaba completamente sana cuando se puso la vacuna, pero el día después tenía 39 grados de fiebre (102,2 F). “- Yo casi no podía caminar los cinco metros que tenía al baño”, dice ella. La fiebre duró tres días. Varios de sus compañeros en el trabajo han tenido experiencias similares. “- Yo sé de al menos diez que tienen fiebre, estamos cerca de 80 personas en mi lugar de trabajo.”
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Other Sources: Autism prevention. blogspot.com
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It is very possible that PATERNAL AGE is the major predictor of(non-familial) autism." Harry Fisch, M.D., author "The Male Biological Clock". Sperm DNA mutates and autism, schizophrenia bipolar etc. results. What is the connection with autoimmune disorders? Having Type 1 diabetes, SLE,etc. in the family, also if mother had older father. NW Cryobank will not accept a sperm donor past 35th BD to minimize genetic abnormalities.VACCINATIONS also cause autism.
Fuente: http://autism-prevention.blogspot.com/
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18.) Fort Detrick Inventory Turns Up 9,220 More Vials of Pathogens
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Source:http://www.washingtonpost.com/wp-dyn/content/article/2009/06/17/AR2009061703271.html
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Other Sources: Autism prevention. blogspot.com
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It is very possible that PATERNAL AGE is the major predictor of(non-familial) autism." Harry Fisch, M.D., author "The Male Biological Clock". Sperm DNA mutates and autism, schizophrenia bipolar etc. results. What is the connection with autoimmune disorders? Having Type 1 diabetes, SLE,etc. in the family, also if mother had older father. NW Cryobank will not accept a sperm donor past 35th BD to minimize genetic abnormalities.VACCINATIONS also cause autism.
Fuente: http://autism-prevention.blogspot.com/
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18.) Fort Detrick Inventory Turns Up 9,220 More Vials of Pathogens
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Source:http://www.washingtonpost.com/wp-dyn/content/article/2009/06/17/AR2009061703271.html
By Nelson Hernandez
Washington Post Staff Writer
Thursday, June 18, 2009
An inventory of potentially deadly pathogens at Fort Detrick's infectious disease laboratory found more than 9,000 vials that had not been accounted for, Army officials said yesterday, raising concerns that officials wouldn't know whether dangerous toxins were missing.
After four months of searching about 335 freezers and refrigerators at the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, investigators found 9,220 samples that hadn't been included in a database of about 66,000 items listed as of February, said Col. Mark Kortepeter, the institute's deputy commander.
The vials contained some dangerous pathogens, among them the Ebola virus, anthrax bacteria and botulinum toxin, and less lethal agents such as Venezuelan equine encephalitis virus and the bacterium that causes tularemia. Most of them, forgotten inside freezer drawers, hadn't been used in years or even decades. Officials said some serum samples from hemorrhagic fever patients dated to the Korean War.
Kortepeter likened the inventory to cleaning out the attic and said he knew of no plans for an investigation into how the vials had been left out of the database. "The vast majority of these samples were working stock that were accumulated over decades," he said, left there by scientists who had retired or left the institute.
"I can't say that nothing did [leave the lab], but I can say that we think it's extremely unlikely," Kortepeter said.
Still, the overstock and the previous inaccuracy of the database raised the possibility that someone could have taken a sample outside the lab with no way for officials to know something was missing.
"Nine thousand, two hundred undocumented samples is an extraordinarily serious breach," said Richard H. Ebright, a professor at Rutgers University who follows biosecurity. "A small number would be a concern; 9,200 . . . at an institution that has been the focus of intense scrutiny on this issue, that's deeply worrisome. Unacceptable."
The institute has been under pressure to tighten security in the wake of the 2001 anthrax attacks, which killed five people and sickened 17. FBI investigators say they think the anthrax strain used in the attacks originated at the Army lab, and its prime suspect, Bruce E. Ivins, researched anthrax there. Ivins committed suicide last year during an investigation into his activities.
Kortepeter noted that since 2001 the lab has imposed multiple layers of security to check people entering and leaving, that there are now cameras in the labs, and that employees are subjected to a reliability program and random inspections.
"The bottom line is, we have a lot of buffers to prevent anybody who shouldn't be getting into the laboratory," Kortepeter said.
Sam Edwin, the institute's inventory control officer, said most of the samples found were vials with tiny amounts of pathogens that would thaw quickly and die once they were taken out of a freezer, making smuggling something off the base difficult.
The probe began in February, when a problem accounting for Venezuelan equine encephalitis virus triggered the suspension of most research at the lab. A spot check in January found 20 samples of the virus in a box of vials instead of the 16 listed in the institute's database. Most work was stopped until the institute could take a thorough inventory of its stock of viruses and bacteria.
Edwin said about 50 percent of the samples that had been found were destroyed. The rest were added to the catalog. Because the lab will now conduct an inventory every year, "it's really less likely that we will be in a situation like this again," he said.
Procedures have changed, too. Scientists who have worked at the lab said that in the past, departing scientists turned over their logbooks to their successors, but records were sometimes incomplete or complex. As generations of scientists passed through, the knowledge of what was in the freezers was lost. With a comprehensive database, every sample is now tracked until it is destroyed or transferred.
But some scientists are skeptical. Unlike uranium or chemical weapons, pathogens are living materials that can replicate and die. A small amount can easily be turned into a large amount. They said the strict inventories slow their work without guaranteeing security.
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19.) French scientists sound the alarm about aluminum in vaccines — crickets from media and health authorities
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Source:https://medium.com/@jbhandley/french-scientists-sound-the-alarm-about-aluminum-in-vaccines-crickets-from-media-and-health-d3fc0fe23079
BY J.B. HANDLEY September 9, 2017
“In the context of massive development of vaccine-based strategies worldwide, the present study may suggest that aluminium adjuvant toxicokinetics and safety require reevaluation.”
Maybe it will just go away?
PARIS, France — Roman K. Gherardi and his colleagues from the Université Paris Est Créteil (“UPEC”)in France issued a worldwide warning in late 2016 about the aluminum adjuvant used in childhood vaccines. Their paper, published in the highly-respected journal Toxicology, is deeply distrubing for any parent contemplating vaccinating their child according to the present schedule recommended by the American Centers for Disease Control (“CDC”). And, it’s highly likely that this is the first time you’ve ever heard about it.
It’s safe to say that this study’s conclusions have revolutionized our understanding of aluminum adjuvant, the kind used in most children’s vaccines.
The French study authors were very concerned about the widespread use of aluminum adjuvant:
“Concerns about its [aluminum adjuvant’s] safety emerged following recognition of its unexpectedly long-lasting biopersistence within immune cells in some individuals, and reports of chronic fatigue syndrome, cognitive dysfunction, myalgia, dysautonomia and autoimmune/inflammatory features temporally linked to multiple Al-containing vaccine administrations.”
The scientists also discovered, through mouse-models, a deeply alarming unique characteristic of aluminum adjuvant: low, consistent doses (the kind given to babies through their vaccines) were MORE neurotoxic than a single bolus dose:
“We conclude that Alhydrogel [aluminum adjuvant] injected at low dose in mouse muscle may selectively induce long-term Al cerebral accumulation and neurotoxic effects. To explain this unexpected result, an avenue that could be explored in the future relates to the adjuvant size since the injected suspensions corresponding to the lowest dose, but not to the highest doses, exclusively contained small agglomerates in the bacteria-size range known to favour capture and, presumably, transportation by monocyte-lineage cells. In any event, the view that Alhydrogel neurotoxicity obeys ‘the dose makes the poison’ rule of classical chemical toxicity appears overly simplistic.”
This is a confusing conclusion, but profoundly important, here’s a further explanation from the excellent website, Vaccine Papers.org:
A new paper (Crepeaux et al.) by the Gherardi research group in France reports important results on the toxicity and transport of aluminum (Al) adjuvant in mice. This single study is especially valuable because it looked at many outcomes: behavioral effects, immune (microglial) activation in the brain, and Al transport into the brain. The study tested dosages of 200 , 400 and 800 mcg/Kg, injected intramuscularly (IM). The Al adjuvant used was AlOH (brand name Alhydrogel), the most common vaccine adjuvant in use today. It is used in the tetanus, Hep A, Hep B, HiB, pneumococcal, meningococcal, and anthrax vaccines.
Remarkably, the study found that the lowest dosage (200 mcg/Kg) was the most toxic! For many outcomes, the 400 and 800 mcg/Kg dosages had no observable adverse effects, but the 200 mcg/Kg dosage did.
The low toxicity of the higher dosages appears to be a consequence of dosage-dependent inflammation at the injection site. The high dosages caused intense inflammation at the injection site, forming “granulomas”. The 200 mcg/Kg dosage did not produce granulomas. Granulomas are hard nodules in tissue produced in response to injury, infection or foreign substances. Its a way the body “walls off” injured tissue and prevents the spread of infection or toxins. The granuloma appears to provide protection from Al adjuvant toxicity; apparently the granuloma prevented Al adjuvant particles from leaving the injection site. This explains why the 200 mcg/Kg dosage affected the brain and behavior, while the higher dosages did not. This suggests that it is more dangerous and harmful to administer numerous small injections of Al adjuvant, compared to a large single injection capable of inducing a granuloma.
The study authors also disputed the way the FDA and CDC currently think about aluminum adjuvant toxicity, basically saying that the current research approach is wrong:
“As a possible consequence, comparing vaccine adjuvant exposure to other non- relevant aluminium exposures, e.g. soluble aluminium and other routes of exposure, may not represent valid approaches.”
And, the French scientists finish with a conclusion that all parents should find very troubling:
“In the context of massive development of vaccine-based strategies worldwide, the present study may suggest that aluminium adjuvant toxicokinetics and safety require reevaluation.”
Radio Silence
Where’s the media? Where’s the CDC? Where are the other member of our public health authorities? Where are the elected officials? Where’s the American Academy of Pediatrics? Why is no one willing to discuss a highly credible study raising grave concerns about something being injected into American babies? Moreover, the scientists directly challenge the CDC’s approach to assessing the safety of injected aluminum adjuvant, basically saying it’s being done incorrectly.
For further reading on this complex topic, I hope you’ll consider reading a more extensive exploration of the complex relationship between aluminum adjuvant and autism, which has so far has more than 250,000 reads:
“Scientists appear to be far closer to explaining the mechanisms of action within the body that cause autism. Most of the research that has created this understanding has been published in the last 36 months, and largely from international scientists in Canada, France, Israel, and China. Four clear, replicable, and related discoveries explaining how autism is triggered are forming an undeniably clear picture of autism’s causation, and possibly ways to alleviate the symptoms, too.”
Did Chinese scientists find autism’s missing puzzle piece?
BY J.B. HANDLEY February 22, 2017
healthcareinamerica.us
J.B. Handley is the father of a child with Autism. He and his wife co-founded Generation Rescue, Jenny McCarthy’s autism charity. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. He is also the author of “The Only Vaccine Guide a New Parent Will Ever Need” , “An Angry Father’s Guide to Vaccine-Autism Science”, and “7 reasons CDC employees should be “crying in the hallways” Mr. Handley has started a podcast called “How to End the Autism Epidemic” — you might enjoy his first six interviews:
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20.) Influenza vaccination and Guillain Barre syndrome small star, filled.
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Geier MR, Geier DA, Zahalsky AC.
The Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905, USA. mgeier@erols.com <mgeier@erols.com>
Comment in:
· Clin Immunol. 2003 Dec;109(3):359; author reply 360-1.
Acute and severe Guillain Barre Syndrome (GBS) cases reported following influenza vaccine to the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1999 were examined. Endotoxin concentrations were measured using the Limulus amebocyte lysate assay in influenza vaccines. There were a total of 382 cases of GBS reported to the VAERS database following influenza vaccination (male/female ratio, 1.2). The median onset of GBS following influenza vaccine was 12 days (interquartile range, 7 days to 21 days). There was an increased risk of acute GBS (relative risk, 4.3; 95% confidence interval, 3.0 to 6.4) and severe GBS (relative risk, 8.5; 95% confidence interval, 3.7 to 18.9) in comparison to an adult tetanus-diphtheria (Td) vaccine control group. There were maximums in the incidence of GBS following influenza vaccine that occurred approximately every third year (1993, 1996, and 1998) and statistically significant variation in the incidence of GBS among different influenza manufacturers. Influenza vaccines contained from a 125- to a 1250-fold increase in endotoxin concentrations in comparison to an adult Td vaccine control and endotoxin concentrations varied up to 10-fold among different lots and manufacturers of influenza vaccine. The biologic mechanism for GBS following influenza vaccine may involve the synergistic effects of endotoxin and vaccine-induced autoimmunity. There were minimal potential reporting biases in the data reported to the VAERS database in this study. Patients should make an informed consent decision on whether to take this optional vaccine based upon its safety and efficacy and physicians should vigilantly report GBS following influenza vaccination to the VAERS in the United States so that continued evaluation of the safety of influenza vaccine may be undertaken.
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21.) Guillain-Barré syndrome following influenza vaccination.
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JAMA. 2004 Nov 24;292(20):2478-81
Haber P, DeStefano F, Angulo FJ, Iskander J, Shadomy SV, Weintraub E, Chen RT.
Immunization Safety Branch, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga 30333, USA. PHaber@cdc.gov
CONTEXT: An unexplained increase in the risk of Guillain-Barre syndrome (GBS) occurred among recipients of the swine influenza vaccine in 1976-1977. Guillain-Barre syndrome remains the most frequent neurological condition reported after influenza vaccination to the Vaccine Adverse Events Reporting System (VAERS) since its inception in 1990. OBJECTIVE: To evaluate trends of reports to VAERS of GBS following influenza vaccination in adults. DESIGN, SETTING, AND PARTICIPANTS: VAERS is the US national spontaneous reporting system for adverse events following vaccination. Reports of GBS in persons 18 years or older following influenza vaccination were evaluated for each influenza season from July 1, 1990, through June 30, 2003. The number of people vaccinated was estimated from the National Health Interview Survey and US census data. Beginning in 1994, active follow-up was conducted to verify GBS diagnosis and obtain other clinical details. MAIN OUTCOME MEASURE: Reporting rates of GBS following influenza vaccination over time. RESULTS: From July 1990 through June 2003, VAERS received 501 reports of GBS following influenza vaccination in adults. The median onset interval (13 days) was longer than that of non-GBS reports of adverse events after influenza vaccine (1 day) (P<.001). The annual reporting rate decreased 4-fold from a high of 0.17 per 100,000 vaccinees in 1993-1994 to 0.04 in 2002-2003 (P<.001). A GBS diagnosis was confirmed in 82% of reports. Preceding illness within 4 weeks of vaccination was identified in 24% of reported cases. CONCLUSIONS: From 1990 to 2003, VAERS reporting rates of GBS after influenza vaccination decreased. The long onset interval and low prevalence of other preexisting illnesses are consistent with a possible causal association between GBS and influenza vaccine. These findings require additional research, which can lead to a fuller understanding of the causes of GBS and its possible relationship with influenza vaccine.
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22.) Clinical implications of endotoxin concentrations in vaccines.
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Ann Pharmacother. 2002 May;36(5):776-80.
Geier DA, Geier MR.
Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905-5726, USA.
Comment in:
· Ann Pharmacother. 2002 Oct;36(10):1650; author reply 1650-1.
BACKGROUND: A previous study suggested that high concentrations of endotoxin may be present in whole-cell diphtheria/tetanus/pertussis (DTP) vaccine, and the scientific literature contains many studies examining the reactivity of whole-cell DTP vaccine. The medical and scientific communities have previously reported that the presence of endotoxin in commercial vaccines may have negative effects on vaccine recipients. OBJECTIVE: To determine the endotoxin concentrations in whole-cell DTP, acellular DTP(DTaP), and DT vaccines and determine the clinical experience with each vaccine. METHODS: To study the endotoxin concentrations in vaccines, the Limulus amebocyte lysate (LAL) assay was used. The vaccines analyzed with the LAL assay were whole-cell DTP vaccine lots manufactured by Connaught, Lederle, the Michigan and Massachusetts Departments of Health, and Wyeth; DTaP vaccine lots manufactured by Merieux and Takeda; and DT vaccine lots manufactured by Wyeth and Lederle. The incidence of adverse reactions following whole-cell DTP, DTaP, and DT vaccines were determined based on analysis of the Vaccine Adverse Events Reporting System (VAERS) database. RESULTS: The results of the LAL assay showed that whole-cell DTP vaccines contained considerably more endotoxin than either DTaP or DT vaccines. The VAERS showed that statistically significantly more adverse reactions were associated with whole-cell DTP vaccine than DTaP or DT vaccines. CONCLUSIONS: This analysis confirmed higher concentrations of endotoxin in whole-cell DTP vaccines compared with DTaP or DT vaccines. As high concentrations of endotoxin may be correlated with a higher incidence of adverse events, the switch from whole-cell DTP to DTaP for routine vaccinations in the US seems well justified.
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23.) Guillain-Barré syndrome after influenza vaccination in adults: a population-based study.
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Arch Intern Med. 2006 Nov 13;166(20):2217-21.
Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, Upshur RE, Manuel DG, Moineddin R, Wilson K.
Institute of Clinical Evaluative Sciences, Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario.
BACKGROUND: Whether influenza vaccination is associated with Guillain-Barré syndrome (GBS) remains uncertain. METHODS: We conducted 2 studies using population-based health care data from the province of Ontario, Canada. In the first study, we used the self-matched case-series method to explore the temporal association between probable influenza vaccination (adults vaccinated during October and November) and subsequent hospitalization because of GBS. In the second study, we used time-series analysis to determine whether the institution of a universal influenza immunization program in October 2000 was associated with a subsequent increase in hospital admissions because of GBS at the population level. RESULTS: From April 1, 1992, to March 31, 2004, we identified 1601 incident hospital admissions because of GBS in Ontario. In 269 patients, GBS was diagnosed within 43 weeks of vaccination against influenza. The estimated relative incidence of GBS during the primary risk interval (weeks 2 through 7) compared with the control interval (weeks 20 through 43) was 1.45 (95% confidence interval, 1.05-1.99; P = .02). This association persisted in several sensitivity analyses using risk and control intervals of different durations. However, a separate time-series analysis demonstrated no evidence of seasonality and revealed no statistically significant increase in hospital admissions because of GBS after the introduction of the universal influenza immunization program. CONCLUSION: Influenza vaccination is associated with a small but significantly increased risk for hospitalization because of GBS.
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24.) Novel Pandemic Influenza A(H1N1) Viruses Are Potently Inhibited by DAS181, a Sialidase Fusion Protein
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Gallen B. Triana-Baltzer,1 Larisa V. Gubareva,2 John M. Nicholls,3 Melissa B. Pearce,2 Vasiliy P. Mishin,2 Jessica A. Belser,2 Li-Mei Chen,2 Renee W. Y. Chan,3 Michael C. W. Chan,3 Maria Hedlund,1 Jeffrey L. Larson,1 Ronald B. Moss,1 Jacqueline M. Katz,2 Terrence M. Tumpey,2 and Fang Fang1*
1NexBio, Inc., San Diego, California, United States of America
2Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for
Disease Control and Prevention, Atlanta, Georgia, United States of America
3Departments of Pathology and Microbiology, University of Hong Kong, Pok Fu Lam, Hong Kong Special Administrative Region, People's Republic of China
Cheryl A. Stoddart, Editor
University of California San Francisco, United States of America
* E-mail: ffang@nexbio.com
Conceived and designed the experiments: GBTB LG JMN VPM JAB MH JLL RBm TMT FF. Performed the experiments: LG JMN MBP VPM JAB LMC RWYC MCC. Analyzed the data: GBTB LG JMN VPM LMC RWYC MH RBm JMK TMT FF. Contributed reagents/materials/analysis tools: GBTB LG JMN VPM RWYC JMK TMT FF. Wrote the paper: GBTB JLL.
Received June 10, 2009; Accepted October 13, 2009.
Abstract
Background
The recent emergence of a novel pandemic influenza A(H1N1) strain in humans exemplifies the rapid and unpredictable nature of influenza virus evolution and the need for effective therapeutics and vaccines to control such outbreaks. However, resistance to antivirals can be a formidable problem as evidenced by the currently widespread oseltamivir- and adamantane-resistant seasonal influenza A viruses (IFV). Additional antiviral approaches with novel mechanisms of action are needed to combat novel and resistant influenza strains. DAS181 (Fludase™) is a sialidase fusion protein in early clinical development with in vitro and in vivo preclinical activity against a variety of seasonal influenza strains and highly pathogenic avian influenza strains (A/H5N1). Here, we use in vitro, ex vivo, and in vivo models to evaluate the activity of DAS181 against several pandemic influenza A(H1N1) viruses.
Methods and Findings
The activity of DAS181 against several pandemic influenza A(H1N1) virus isolates was examined in MDCK cells, differentiated primary human respiratory tract culture, ex-vivo human bronchi tissue and mice. DAS181 efficiently inhibited viral replication in each of these models and against all tested pandemic influenza A(H1N1) strains. DAS181 treatment also protected mice from pandemic influenza A(H1N1)-induced pathogenesis. Furthermore, DAS181 antiviral activity against pandemic influenza A(H1N1) strains was comparable to that observed against seasonal influenza virus including the H274Y oseltamivir-resistant influenza virus.
Conclusions
The sialidase fusion protein DAS181 exhibits potent inhibitory activity against pandemic influenza A(H1N1) viruses. As inhibition was also observed with oseltamivir-resistant IFV (H274Y), DAS181 may be active against the antigenically novel pandemic influenza
A(H1N1) virus should it acquire the H274Y mutation. Based on these and previous results demonstrating DAS181 broad-spectrum anti-IFV activity, DAS181 represents a potential therapeutic agent for prevention and treatment of infections by both emerging and seasonal strains of IFV.
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25.)A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
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Geier DA, Geier MR.
MedCon, Inc., Silver Spring, Maryland, USA. mgeier@erols.com
OBJECTIVES: This analysis examined the incidence rate of chronic arthritis adverse reactions reported following adult rubella and hepatitis B vaccinations. In this analysis, etiologic mechanisms for chronic arthritis following adult rubella and hepatitis B vaccines were also explored. METHODS: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence rate of reported cases of chronic arthritis in comparison to Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups. RESULTS: Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females (female/male ratio = 3.0), at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females(female/male ratio = 3.5), at about 33 years-old, and with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased, by chi 2 analysis, in comparison to the adult vaccine control groups. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms. Furthermore, potential biases in the reporting rates of adverse reactions to VAERS were not observed.
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26.) Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database.
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Am J Epidemiol. 2009 Feb 1;169(3):382-8. Epub 2008 Nov 24
Stowe J, Andrews N, Wise L, Miller E.
Immunisation Department, Health Protection Agency Centre for Infections, London, UK. julia.stowe@hpa.org.uk
In 1976, the national swine influenza vaccination program in the United States was suspended because of an increased risk of Guillain-Barré syndrome. Subsequent studies of seasonal influenza vaccine have given conflicting results. The authors used the self-controlled case series method to investigate the relation of Guillain-Barré syndrome with influenza vaccine and influenzalike illness using cases recorded in the General Practice Research Database from 1990 to 2005 in the United Kingdom. The relative incidence of Guillain-Barré syndrome within 90 days of vaccination was 0.76 (95% confidence interval: 0.41, 1.40). In contrast, the relative incidence of Guillain-Barré syndrome within 90 days of an influenzalike illness was 7.35 (95% confidence interval: 4.36, 12.38), with the greatest relative incidence (16.64, 95% confidence interval: 9.37, 29.54) within 30 days. The relative incidence was similar (0.89, 95% confidence interval: 0.42, 1.89) when the analysis was restricted to a subset of validated cases. The authors found no evidence of an increased risk of Guillain-Barré syndrome after seasonal influenza vaccine. The finding of a greatly increased risk after influenzalike illness is consistent with anecdotal reports of a preceding respiratory illness in Guillain-Barré syndrome and has important implications for the risk/benefit assessment that would be carried out should pandemic vaccines be deployed in the future.
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27.) Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-September 2006.
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MMWR Morb Mortal Wkly Rep. 2006 Oct 20;55(41):1120-4.
Centers for Disease Control and Prevention (CDC).
Erratum in:
· MMWR Morb Mortal Wkly Rep. 2006 Nov 3;55(43):1177.
In October 2005, reports indicating a possible association between Guillain-Barré Syndrome (GBS) and receipt of meningococcal conjugate vaccine (MCV4) (Menactra, Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) were made to the Vaccine Adverse Event Reporting System (VAERS). GBS is a serious neurologic disorder involving inflammatory demyelination of the peripheral nerves. During March 2005-February 2006, eight confirmed cases had occurred within 6 weeks (i.e., the time window of elevated risk noted for GBS after administration of other vaccines) after MCV4 vaccination. This report summarizes nine additional GBS cases reported to VAERS during March-September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.
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28.) Guillain-Barre syndrome following vaccination in the National Influenza Immunization
Program, United States, 1976--1977.
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Am J Epidemiol. 1979 Aug;110(2):105-23
Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, Retailliau HF, Eddins DL, Bryan JA.
Because of an increase in the number of reports of Guillian-Barre syndrome (GBS) following A/New Jersey influenza vaccination, the National Influenza Immunization Program was suspended December 16, 1976 and nationwide surveillance for GBS was begun. This surveillance uncovered a total of 1098 patients with onset of GBS from October 1, 1976, to January 31, 1977, from all 50 states, District of Columbia, and Puerto Rico. A total of 532 patients had recently received an A/New Jersey influenza vaccination prior to their onset of GBS (vaccinated cases), and 15 patients received a vaccination after their onset of GBS. Five hundred forty-three patients had not been recently vaccinated with A/New Jersey influenza vaccine and the vaccination status for 8 was unknown. Epidemiologic evidence indicated that many cases of GBS were related to vaccination. When compared to the unvaccinated population, the vaccinated population had a significantly elevated attack rate in every adult age group. The estimated attributable risk of vaccine-related GBS in the adult population was just under one case per 100,000 vaccinations. The period of increased risk was concentrated primarily within the 5-week period after vaccination, although it lasted for approximately 9 or 10 weeks.
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29.) Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.
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Pediatrics. 2005 Feb;115(2):453-60.
McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, Ball R.
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville,
Maryland 20852, USA. mcmahon@cber.fda.gov
BACKGROUND: In April 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and children with trivalent influenza vaccine (TIV). OBJECTIVES: To describe adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV vaccination among children <2 years of age and to compare reports before the ACIP guideline (January 1990 to June 2002) and after the ACIP guideline (July 2002 to June 2003). METHODS: VAERS is a passive vaccine safety surveillance system begun by the Food and Drug Administration and the Centers for Disease Control and Prevention in 1990. We reviewed reports to VAERS for children <2 years of age who received TIV, alone or in combination with other vaccines. Influenza seasons were defined as the period from July 1 of one year to June 30 of the following year. RESULTS: Between 1990 and 2003, VAERS received 166 TIV reports for children <2 years of age. There were 62 reports (37%) after administration of TIV alone and 104 reports (63%) after administration of TIV and > or =1 other vaccine. Approximately one third of reports (N = 61) were in the post-ACIP guideline period. The 4 most frequent AE coding terms were fever (N = 59, 35%), unspecified or urticarial rash (42, 25%), seizure (28, 17%), and injection site reaction (28, 17%). The median number of days from vaccination to symptom onset, the percentage of reports that represented serious AEs, and the gender distribution were similar in the pre-ACIP guideline and post-ACIP guideline periods. The percentage of reports describing an underlying medical condition for the subject decreased from 58% before the ACIP guideline to 37% after the ACIP guideline. Nineteen of 28 seizure reports (68%) described fever with the seizure within 2 days after vaccination. Seizure was the most frequent coding term (N = 10, 7 with fever) among 23 serious reports. The annual number of TIV-related VAERS reports for children <2 years of age increased in the post-ACIP guideline period, probably at least in part because of an increase in the number of vaccinees after the ACIP announcement. The safety profiles in the pre-ACIP guideline and post-ACIP guideline periods were similar. CONCLUSIONS: In October 2003, the ACIP recommended that all healthy children 6 to 23 months of age be vaccinated with TIV, starting in the 2004-2005 influenza season. This study provides generally reassuring, although limited, data regarding the safety of TIV among children in this age range. Continued surveillance for seizures and other clinically significant AEs is warranted and will continue.
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30.)Vaccines and Guillain-Barré syndrome.
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Haber P, Sejvar J, Mikaeloff Y, DeStefano F.
Drug Saf. 2009;32(4):309-23. doi: 10.2165/00002018-200932040-00005.
Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. PHaber@cdc.gov
Guillain-Barré syndrome (GBS) is the leading cause of acute flaccid paralysis in developed countries and is characterized by various degrees of weakness, sensory abnormalities and autonomic dysfunction. Although the underlying aetiology and pathophysiology of GBS are not completely understood, it is broadly believed that immune stimulation plays a role in its pathogenesis. Thus, since vaccines have an effect on the immune system it is biologically plausible that immunizations may be associated with subsequent GBS. The objective of this article is to review the current body of evidence that either supports or does not support a causal, rather than just temporal, association between various vaccines and GBS, and to provide an evidence-based review of this issue. The scope of the article includes published reports that, regardless of method of case ascertainment, appeared in peer-reviewed literature between 1950 and 2008. Our review indicates that, with rare exceptions, associations between vaccines and GBS have been only temporal. There is little evidence to support a causal association with most vaccines. The evidence for a causal association is strongest for the swine influenza vaccine that was used in 1976-77. Studies of influenza vaccines used in subsequent years, however, have found small or no increased risk of GBS. Older formulations of rabies vaccine cultured in mammalian brain tissues have been found to have an increased risk of GBS, but newer formulations of rabies vaccine, derived from chick embryo cells, do not appear to be associated with GBS at a greater than expected rate. In an earlier review, the Institute of Medicine concluded that the evidence favoured a causal association between oral polio vaccine and tetanus toxoid-containing vaccines and GBS. However, recent evidence from large epidemiological studies and mass immunization campaigns in different countries found no correlation between oral polio vaccine or tetanus toxoid-containing vaccines and GBS. Spontaneous reports to the US Vaccine Adverse Events Reporting System shortly after the introduction of quadrivalent conjugated meningococcal vaccine (MCV4) raised concerns of a possible association with GBS. Comparisons with expected rates of GBS, however, were inconclusive for an increased risk, and lack of controlled epidemiological studies makes it difficult to draw conclusions about a causal association. For other vaccines, available data are based on isolated case reports or very small clusters temporally related to immunizations, and no conclusion about causality can be drawn. There are certain circumstances in which immunizing individuals, particularly those with a prior history of GBS, may require caution. However, the benefit of vaccines in preventing disease and decreasing morbidity and mortality, particularly for influenza, needs to be weighed against the potential risk of GBS.
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31.) potential signal of Bell's palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.
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Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):505-10.
Zhou W, Pool V, DeStefano F, Iskander JK, Haber P, Chen RT; VAERS Working Group.
Epidemic Intelligence Service, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Comment in:
· Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):501-2.
· Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):511-3; discussion 515-7.
PURPOSE: Post-licensure experience with a new intranasal inactivated influenza vaccine in Switzerland recently identified an increased risk for Bell's palsy. We reviewed reports in the Vaccine Adverse Event Reporting System (VAERS) to assess if parenteral inactivated influenza vaccines (influenza vaccines) may also increase the risk for Bell's palsy. METHODS: Reports of Bell's palsy after influenza vaccines in VAERS from 1/1/1991 to 12/31/2001 were identified by searching the Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) for 'paralysis facial' and by text string search in the automated database. The text descriptions on each report were reviewed to verify the diagnosis. The proportional reporting ratio (PRR) was calculated to aid signal detection. RESULTS: We found a total of 197 reports of Bell's palsy after receipt of influenza vaccines. The diagnosis was verified for 154 (78.2%), of which 145 (94.2%) had received influenza vaccines alone. The verified reports were submitted from 35 states; 58% of the reports involved persons living in states where the risk of Lyme disease, which can also cause facial paralysis, was low, minimal or none. The PRRs in all age groups exceeded the criteria for a signal of possible association. The highest PRR was 3.91 in the > or = 65 years age group. CONCLUSIONS: Our findings revealed a signal of possible association between influenza vaccines and an increased risk of Bell's palsy. A population-based controlled study is needed to determine whether this association could be causal and to quantify the risk. 2004 by John Wiley & Sons, Ltd.
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32.) Adverse events reported following live, cold-adapted, intranasal influenza vaccine.
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JAMA. 2005 Dec 7;294(21):2720-5.
Izurieta HS, Haber P, Wise RP, Iskander J, Pratt D, Mink C, Chang S, Braun MM, Ball R.
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md
20852-1448, USA. hector.izurieta@fda.hhs.gov
Erratum in:
· JAMA. 2005 Dec 28;294(24):3092.
Comment in:
· JAMA. 2005 Dec 7;294(21):2763-5.
CONTEXT: In June 2003, the US Food and Drug Administration licensed a trivalent live, attenuated influenza vaccine (LAIV-T) for intranasal administration to healthy persons 5 to 49 years of age. Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably. OBJECTIVE: To identify adverse events reported following LAIV-T administration after licensure. DESIGN, SETTING, AND PARTICIPANTS: All adverse events reported to the US Vaccine Adverse Event Reporting System (VAERS) during the 2003-2004 and the 2004-2005 influenza seasons. MAIN OUTCOME MEASURES: Numbers and proportions of reported adverse events and reporting rates of adverse events per 100,000 vaccinees. RESULTS: Approximately 2,500,000 persons received LAIV-T during the first 2 postlicensure seasons. As of August 16, 2005, VAERS received 460 adverse event reports for vaccinations received from August 2003 through July 2005. No fatalities were reported. There were 7 reports of possible anaphylaxis, 2 reports of Guillain-Barré syndrome, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history. Events in individuals for whom the vaccine was not indicated accounted for 73 reports (16%). CONCLUSIONS: Reports to VAERS in the first 2 seasons of LAIV-T use did not identify any unexpected serious risks with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis. Secondary transmission of the vaccine virus merits further investigation. Reports of asthma exacerbations in vaccinees with prior asthma history highlight the risks of vaccine use inconsistent with approved labeling.
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33.) Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience.
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Expert Rev Vaccines. 2008 Feb;7(1):75-82.
Iskander J, Broder K.
US Public Health Service, Immunization Safety Office, Office of Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, MS D-26, Atlanta, GA 30333, USA. jxi0@cdc.gov
Annual use of influenza vaccines represents the largest vaccine campaign conducted in the USA. Recent expansions in influenza vaccine recommendations suggest a move toward 'universal' vaccination strategies. Although a great deal of safety data has been accumulated, concerns remain regarding rare, serious adverse events following immunization. A proven association between the 1976-1977 swine influenza vaccine and Guillain-Barré syndrome halted that particular national vaccination campaign. Recently, annual influenza vaccines have been associated with novel adverse events, for example, oculorespiratory syndrome in Canada. Any vaccine used against an influenza strain of pandemic potential will have an incompletely described safety profile. Thus, the challenge of influenza vaccine safety is to detect new safety concerns that may arise during seasonal campaigns, while preparing vaccine safety systems for the timely detection of adverse events in the setting of a pandemic.
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34.) Are toxic biometals destroying your children's future?
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Biometals. 2009 Oct;22(5):697-700. Epub 2009 Feb 11
Drum DA.
poohpadon@wowway.com
Cadmium, arsenic, lead, and mercury have been linked to autism, attention deficit disorder, mental retardation and death of children. Mercury in thimerosal found in many vaccines and flu shots contributes significantly to these problems. Decomposition of the thimerosal can produce more toxic compounds, either methylethylmercury or diethylmercury, in the body. These compounds have a toxicity level similar to dimethylmercury. Within the human body, a mitochondrial disorder may release the more toxic form of mercury internally. Young children and pregnant women must minimize internal exposure to the vaccines and flu shots containing mercury.
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35.) Surveillance for safety after immunization: Vaccine Adverse Event Reporting System
(VAERS)--United States, 1991-2001.
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MMWR Surveill Summ. 2003 Jan 24;52(1):1-24
Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.
Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA.
Erratum in:
· MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.
PROBLEM/CONDITION: Vaccines are usually administered to healthy persons who have substantial expectations for the safety of the vaccines. Adverse events after vaccinations occur but are generally rare. Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations. Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events. REPORTING PERIOD COVERED: This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from January 1, 1991, through December 31, 2001. DESCRIPTION OF SYSTEMS: VAERS was established in 1990 under the joint administration of CDC and the Food and Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed in the United States. VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who experience them, their caregivers, or others. Passive surveillance systems (e.g., VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. Reports may be submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted by mail or fax. A web-based electronic reporting system has recently become available. Information from the reports is entered into the VAERS database, and new reports are analyzed weekly. VAERS data stripped of personal identifiers can be reviewed by the public by accessing http://www.vaers.org. The objectives of VAERS are to 1) detect new, unusual, or rare vaccine adverse events; 2) monitor increases in known adverse events; 3) determine patient risk factors for particular types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5) assess the safety of newly licensed vaccines. RESULTS: During 1991-2001, VAERS received 128,717 reports, whereas >1.9 billion net doses of human vaccines were distributed. The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per 100,000 net doses distributed. The proportions of reports in the age groups <1 year, 1-6 years, 7-17 years, 18-64 years, and >/= years were 18.1%, 26.7%, 8.0%, 32.6%, and 4.9%, respectively. In all of the adult age groups, a predominance among the number of women reporting was observed, but the difference in sex was minimal among children. Overall, the most commonly reported adverse event was fever, which appeared in 25.8% of all reports, followed by injection-site hypersensitivity (15.8%), rash (unspecified) (11.0%), injection-site edema (10.8%), and vasodilatation (10.8%). A total of 14.2% of all reports described serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability. Examples of the uses of VAERS data for vaccine safety surveillance are included in this report. INTERPRETATION: As a national public health surveillance system, VAERS is a key component in ensuring the safety of vaccines. VAERS data are used by CDC, FDA, and other organizations to monitor and study vaccine safety. CDC and FDA use VAERS data to respond to public inquiries regarding vaccine safety, and both organizations have published and presented vaccine safety studies based on VAERS data. VAERS data are also used by the Advisory Committee on Immunization Practices and the Vaccine and Related Biological Products Advisory Committee to evaluate possible adverse events after vaccinations and to develop recommendations for precautions and contraindications to vaccinations. Reviews of VAERS reports and the studies based on VAERS reports during 1991-2001 have demonstrated that vaccines are usually safe and that serious adverse events occur but are rare. PUBLIC HEALTH ACTIONS: Through continued reporting of adverse events after vaccination to VAERS by health-care providers, public health professionals, and the public and monitoring of reported events by the VAERS working group, the public health system will continue to be able to detect rare but potentially serious consequences of vaccination. This knowledge facilitates improvement in the safety of vaccines and the vaccination process.
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36.) Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States.
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Pediatrics. 2008 Apr;121(4):e836-43.
Smith MJ, Ellenberg SS, Bell LM, Rubin DM.
Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. mjsmit22@louisville.edu
Comment in:
· Pediatrics. 2008 Sep;122(3):684-5; author reply 685-6.
OBJECTIVE: The purpose of this work was to assess the association between media coverage of the MMR-autism controversy and MMR immunization in the United States. METHODS: The public-use files of the National Immunization Survey were used to estimate annual MMR coverage from 1995 to 2004. The primary outcome was selective measles-mumps-rubella nonreceipt, that is, those children who received all childhood immunizations except MMR. Media coverage was measured by using LexisNexis, a comprehensive database of national and local news media. Factors associated with MMR nonreceipt were identified by using a logistic regression model. RESULTS: Selective MMR nonreceipt, occurring in as few as 0.77% of children in the 1995 cohort, rose to 2.1% in the 2000 National Immunization Survey. Children included in the 2000 National Immunization Survey were born when the putative link between MMR and autism surfaced in the medical literature but before any significant media attention occurred. Selective nonreceipt was more prevalent in private practices and unrelated to family characteristics. MMR nonreceipt returned to baseline before sustained media coverage of the MMR-autism story began. CONCLUSIONS: There was a significant increase in selective MMR nonreceipt that was temporally associated with the publication of the original scientific literature, suggesting a link between MMR and autism, which preceded media coverage of the MMR-autism controversy. This finding suggests a limited influence of mainstream media on MMR immunization in the United States.
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37.) A meta-analysis epidemiological assessment of neurodevelopmental disorders following vaccines administered from 1994 through 2000 in the United States.
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Neuro Endocrinol Lett. 2006 Aug;27(4):401-13.
Geier DA, Geier MR.
The Institute for Chronic Illnesses, Inc., Silver Spring, MD 20905, USA. mgeier@comcast.net
BACKGROUND: Thimerosal is an ethylmercury-containing compound (49.6% mercury by weight) used as at the preservative level in vaccines (0.005% to 0.01%). METHODS: Statistical modeling in a meta-analysis epidemiological assessment of the Vaccine Adverse Event Reporting System (VAERS) for neurodevelopment disorders (NDs) reported following Diphtheria-Tetanus-whole-cell-Pertussis (DTP) vaccines in comparison to Diphtheria-Tetanus-whole-cell-Pertussis-Haemophilus Influenzae Type b (DTPH) vaccines (administered: 1994-1997) and following Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis (DTaP), vaccines in comparison to Thimerosal-free DTaP vaccines (administered: 1997-2000), was undertaken. RESULTS: Significantly increased adjusted (sex, age, vaccine type, vaccine manufacturer) risks of autism, speech disorders, mental retardation, personality disorders, thinking abnormalities, ataxia, and NDs in general, with minimal systematic error or confounding, were associated with TCV exposure. CONCLUSION: It is clear from the results of the present epidemiological study and other recently published data associating mercury exposure with childhood NDs, additional ND research should be undertaken in the context of evaluating mercury-associated exposures, especially from Thimerosal-containing vaccines.
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38.) An evaluation of the effects of thimerosal on neurodevelopmental disorders reported following DTP and Hib vaccines in comparison to DTPH vaccine in the United States.
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J Toxicol Environ Health A. 2006 Aug;69(15):1481-95.
Geier DA, Geier MR.
The Genetic Centers of America, Silver Spring, Maryland 20905, USA. mgeier@comcast.net
Thimerosal is an ethylmercury (49.55% mercury by weight) preservative historically added to some vaccines. Toxicokinetic studies showed children in the United States received doses of mercury from Thimerosal-containing vaccines (TCVs) in excess of safety guidelines. In the United States during the 1990s, diphtheria-tetanus-pertussis (DTP) and Haemophilus influenzae type b (Hib) vaccines (maximally, 50 mug mercury per joint administration) and diphtheria-tetanus-pertussis-Haemophilus influenzae type b (DTPH) vaccines (25 mug mercury per administration) were given to children in the same childhood vaccination schedule at 2, 4, 6, and 15-18 mo, so that children receiving DTP and Hib vaccines may have maximally received an additional 100 mug more mercury exposure from TCVs than children administered DTPH vaccines. A case-control epidemiological study of neurodevelopmental disorders (NDs) reported to the Vaccine Adverse Event Reporting System (VAERS) (online public access version; updated 31 August 2004) following administration of DTP vaccines in comparison DTPH vaccines manufactured by Lederle Laboratories (Pearl River, NY) from 1994 through 1998 was undertaken. Significantly increased odds ratios for autism, speech disorders, mental retardation, infantile spasms, and thinking abnormalities reported to VAERS were found following DTP vaccines in comparison to DTPH vaccines with minimal bias or systematic error. Additional ND research should be undertaken in the context of evaluating mercury-associated exposures, especially since in 2005 the Institute of Medicine issued a report calling into question handling of vaccine safety data by the National Immunization Program of the Centers for Disease Control and Prevention
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39.) Neurodevelopmental disorders following thimerosal-containing childhood immunizations: a follow-up analysis.
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Int J Toxicol. 2004 Nov-Dec;23(6):369-76.
Geier D, Geier MR.
MedCon, Inc., Maryland, USA.
The authors previously published the first epidemiological study from the United States associating thimerosal from childhood vaccines with neurodevelopmental disorders (NDs) based upon assessment of the Vaccine Adverse Event Reporting System (VAERS). A number of years have gone by since their previous analysis of the VAERS. The present study was undertaken to determine whether the previously observed effect between thimerosal-containing childhood vaccines and NDs are still apparent in the VAERS as children have had a chance to further mature and potentially be diagnosed with additional NDs. In the present study, a cohort of children receiving thimerosal-containing diphtheria-tetanus-acellular pertussis (DTaP) vaccines in comparison to a cohort of children receiving thimerosal-free DTaP vaccines administered from 1997 through 2000 based upon an assessment of adverse events reported to the VAERS were evaluated. It was determined that there were significantly increased odds ratios (ORs) for autism (OR = 1.8, p < .05), mental retardation (OR = 2.6, p < .002), speech disorder (OR = 2.1, p < .02), personality disorders (OR = 2.6, p < .01), and thinking abnormality (OR = 8.2, p < .01) adverse events reported to the VAERS following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. Potential confounders and reporting biases were found to be minimal in this assessment of the VAERS. It was observed, even though the media has reported a potential association between autism and thimerosal exposure, that the other NDs analyzed in this assessment of the VAERS had significantly higher ORs than autism following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. The present study provides additional epidemiological evidence supporting previous epidemiological, clinical and experimental evidence that administration of thimerosal-containing vaccines in the United States resulted in a significant number of children developing NDs.
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40.) Neurodevelopmental disorders after thimerosal-containing vaccines: a brief communication.
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Exp Biol Med (Maywood). 2003 Jun;228(6):660-4.
Geier MR, Geier DA.
The Genetic Centers of America, Silver Spring, Maryland 20905, USA. mgeier@erols.com
Comment in:
· Exp Biol Med (Maywood). 2003 Oct;228(9):991-2; discussion 993-4.
We were initially highly skeptical that differences in the concentrations of thimerosal in vaccines would have any effect on the incidence rate of neurodevelopmental disorders after childhood immunization. This study presents the first epidemiologic evidence, based upon tens of millions of doses of vaccine administered in the United States, that associates increasing thimerosal from vaccines with neurodevelopmental disorders. Specifically, an analysis of the Vaccine Adverse Events Reporting System (VAERS) database showed statistical increases in the incidence rate of autism (relative risk [RR] = 6.0), mental retardation (RR = 6.1), and speech disorders (RR = 2.2) after thimerosal-containing diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in comparison with thimerosal-free DTaP vaccines. The male/female ratio indicated that autism (17) and speech disorders (2.3) were reported more in males than females after thimerosal-containing DTaP vaccines, whereas mental retardation (1.2) was more evenly reported among male and female vaccine recipients. Controls were employed to determine if biases were present in the data, but none were found. It was determined that overall adverse reactions were reported in similar-aged populations after thimerosal-containing DTaP (2.4 +/- 3.2 years old) and thimerosal-free DTaP (2.1 +/- 2.8 years old) vaccinations. Acute control adverse reactions such as deaths (RR = 1.0), vasculitis (RR = 1.2), seizures (RR = 1.6), ED visits (RR = 1.4), total adverse reactions (RR = 1.4), and gastroenteritis (RR = 1.1) were reported similarly after thimerosal-containing and thimerosal-free DTaP vaccines. An association between neurodevelopmental disorders and thimerosal-containing DTaP vaccines was found, but additional studies should be conducted to confirm and extend this study.
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41.) A comparative evaluation of the effects of MMR immunization and mercury doses from thimerosal-containing childhood vaccines on the population prevalence of autism.
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Med Sci Monit. 2004 Mar;10(3):PI33-9. Epub 2004 Mar 1.
Geier DA, Geier MR.=
President, MedCon, Inc, Silver Spring, MD, USA.
Comment in:
· Med Sci Monit. 2005 Oct;11(10):LE13-4.
BACKGROUND: The purpose of the study was to evaluate the effects of MMR immunization and mercury from thimerosal-containing childhood vaccines on the prevalence of autism. MATERIAL/METHODS: Evaluations of the Biological Surveillance Summaries of the Centers for Disease Control and Prevention (CDC), the U.S. Department of Education datasets, and the CDC's yearly live birth estimates were undertaken RESULTS: It was determined that there was a close correlation between mercury doses from thimerosal--containing childhood vaccines and the prevalence of autism from the late 1980s through the mid-1990s. In contrast, there was a potential correlation between the number of primary pediatric measles-containing vaccines administered and the prevalence of autism during the 1980s. In addition, it was found that there were statistically significant odds ratios for the development of autism following increasing doses of mercury from thimerosal-containing vaccines (birth cohorts: 1985 and 1990-1995) in comparison to a baseline measurement (birth cohort: 1984). The contribution of thimerosal from childhood vaccines (>50% effect) was greater than MMR vaccine on the prevalence of autism observed in this study. CONCLUSIONS: The results of this study agree with a number of previously published studies. These studies have shown that there is biological plausibility and epidemiological evidence showing a direct relationship between increasing doses of mercury from thimerosal-containing vaccines and neurodevelopmental disorders, and measles-containing vaccines and serious neurological disorders. It is recommended that thimerosal be removed from all vaccines, and additional research be undertaken to produce a MMR vaccine with an improved safety profile
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42.) Aluminum adjuvant linked to Gulf War illness induces motor neuron death in mice.
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Neuromolecular Med. 2007;9(1):83-100.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.
Department of Ophthalmology and Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada. mspetrik@interchange.ubc.ca
Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants
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43.) Influenza vaccine with squalene adjuvant: new preparation. No better than available products.
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Prescrire Int. 2004 Dec;13(74):206-8.
[No authors listed]
(1) Injectable influenza vaccines reduce morbidity and mortality in people over 65 years. (2) A new influenza vaccine, with an adjuvant (MF59C.1) based on squalene, is now marketed in France for people over 65, and especially those with chronic conditions at risk of influenza complications. (3) The clinical evaluation dossier contains data from about twenty immunogenicity studies in more than 4000 elderly subjects. According to a meta-analysis of these studies, there is no firm evidence that the MF59C.1 adjuvant vaccine is any better than other vaccines at inducing immunity in elderly people with chronic conditions. (4) A retrospective analysis of mortality among subjects enrolled in immunogenicity studies showed no significant difference between groups receiving the squalene adjuvant vaccine and groups receiving another influenza vaccine, either in the general population or in subsets of patients with relevant chronic conditions. (5) Local adverse effects (pain, rash, induration) and systemic adverse effects (malaise, myalgia, headache) were significantly more common after the squalene adjuvant vaccine than after other influenza vaccines. Pharmacovigilance data collected by the company show no unexpected adverse events. (6) In practice, there is no reason to prefer the squalene adjuvant vaccine to existing vaccines for elderly people, whether or not they have underlying chronic conditions.
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44.) Antibodies to squalene in recipients of anthrax vaccine.
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Exp Mol Pathol. 2002 Aug;73(1):19-27.
Asa PB, Wilson RB, Garry RF.
Department of Microbiology, Tulane University Medical School, New Orleans, Louisiana 70112, USA.
We previously reported that antibodies to squalene, an experimental vaccine adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000). The United States Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP) in 1997 to immunize 2.4 million military personnel. Because adverse reactions in vaccinated personnel were similar to symptoms of GWS, we tested AVIP participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were positive for ASA. In a larger blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of controls were positive (P > 0.05). Further analysis revealed that ASA were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P < 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional personnel revealed that in all but one case (19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine known to contain squalene. Except for one symptomatic individual, positive clinical findings in 17 ASA-negative personnel were restricted to 4 individuals receiving vaccine from lots containing squalene. ASA were not present prior to vaccination in preimmunization sera available from 4 AVIP personnel. Three of these individuals became ASA positive after vaccination. These results suggest that the production of ASA in GWS patients is linked to the presence of squalene in certain lots of anthrax vaccine.
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45.)Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration.
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J Inorg Biochem. 2009 Nov;103(11):1555-62. Epub 2009 Aug 20.
Shaw CA, Petrik MS.
Departments of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada. cashawlab@gmail.com
Gulf War Syndrome is a multi-system disorder afflicting many veterans of Western armies in the 1990-1991 Gulf War. A number of those afflicted may show neurological deficits including various cognitive dysfunctions and motor neuron disease, the latter expression virtually indistinguishable from classical amyotrophic lateral sclerosis (ALS) except for the age of onset. This ALS "cluster" represents the second such ALS cluster described in the literature to date. Possible causes of GWS include several of the adjuvants in the anthrax vaccine and others. The most likely culprit appears to be aluminum hydroxide. In an initial series of experiments, we examined the potential toxicity of aluminum hydroxide in male, outbred CD-1 mice injected subcutaneously in two equivalent-to-human doses. After sacrifice, spinal cord and motor cortex samples were examined by immunohistochemistry. Aluminum-treated mice showed significantly increased apoptosis of motor neurons and increases in reactive astrocytes and microglial proliferation within the spinal cord and cortex. Morin stain detected the presence of aluminum in the cytoplasm of motor neurons with some neurons also testing positive for the presence of hyper-phosphorylated tau protein, a pathological hallmark of various neurological diseases, including Alzheimer's disease and frontotemporal dementia. A second series of experiments was conducted on mice injected with six doses of aluminum hydroxide. Behavioural analyses in these mice revealed significant impairments in a number of motor functions as well as diminished spatial memory capacity. The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant suggest that greater scrutiny by the scientific community is warranted.
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46.) Aluminum-induced model of motor neuron degeneration: subperineurial injection of aluminum in rabbits.
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Neurotoxicology. 1995 Fall;16(3):413-24.\
Kihira T, Yoshida S, Komoto J, Wakayama I, Yase Y.
Division of Neurological Diseases, Wakayama Medical College, Japan.
Environmental factors, particularly chronic exposure to aluminum (Al) and manganese (Mn) with dietary deficiency of calcium (Ca) and magnesium (Mg), are speculated to be contributory in the pathogenesis of amyotrophic lateral sclerosis (ALS). However, the mechanisms by which these elements accumulate in the CNS tissues and induce neuronal death are not known. In the present study, we investigated the retrograde transport of Al as a possible mechanism of pathogenesis. Al (as aluminum chloride or maltol) was injected into the subepineurial space of the sciatic nerve with subsequent morphological evaluation of the neurotoxic effect on spinal motor neurons in rabbits. Spheroid/globules, central and peripheral chromatolysis, and neuronal degeneration were observed in the spinal anterior horn in Al-maltol, Al chloride, and maltol treated rabbits to more marked extent than those in uninjected or saline controls. By electron microscopy, the soma and dendrites of neurons in the anterior horn at the fifth lumbar spinal cord in the Al-treated rabbit showed marked edematous change, fragmentation of granular endoplasmic reticulum, increased accumulation of neurofilament, and accumulation of free ribosomes and lipid-droplet-like structures. Horseradish peroxidase (HRP) reactive product was seen in the axons and cytoplasm of Schwann cells of the sciatic nerve in Al-maltol treated rabbits, suggesting that the permeability of the blood-nerve-barrier was increased by injection of Al-maltol. We suggest that Al, subperineurially injected, was absorbed into the spinal cord and induced degeneration of spinal motor neurons in these rabbits. These findings indicate that the retrograde transport of Al into spinal motor neurons via the peripheral nervous system may exacerbate neuronal degeneration in ALS.
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47.) Vaccines as a trigger for myopathies.
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Lupus. 2009 Nov;18(13):1213-6.
Orbach H, Tanay A.
Department of Medicine B, Wolfson Medical Center, Holon, Israel. orbach@wolfson.health.gov.il
Vaccines are considered to be among the greatest medical discoveries, credited with the virtual eradication of some diseases and the consequent improved survival and quality of life of the at-risk population. With that, vaccines are among the environmental factors implicated as triggers for the development of inflammatory myopathies. The sporadic reports on vaccine-induced inflammatory myopathies include cases of hepatitis B virus, bacillus Calmette-Guérin, tetanus, influenza, smallpox, polio, diphtheria, diphtheria-pertussis-tetanus, combination of diphtheria with scarlet fever and diphtheria-pertussis-tetanus with polio vaccines. However, a significant increase in the incidence of dermatomyositis or polymyositis after any massive vaccination campaign has not been reported in the literature. In study patients with inflammatory myopathies, no recent immunization was recorded in any of the patients. Moreover, after the 1976 mass flu vaccination, no increase in the incidence of inflammatory myopathies was observed. Although rare, macrophagic myofasciitis has been reported following vaccination and is attributed to the aluminium hydroxide used as an adjuvant in some vaccines. Prospective multicenter studies are needed to identify potential environmental factors, including vaccines, as potential triggers for inflammatory myopathies.
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48.) Induction of metallothionein in mouse cerebellum and cerebrum with low-dose thimerosal injection.
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Cell Biol Toxicol. 2009 Apr 9. [Epub ahead of print]
Minami T, Miyata E, Sakamoto Y, Yamazaki H, Ichida S.
Department of Life Sciences, School of Science & Engineering, Kinki University, 3-4-1
Kowakae, Higashi-osaka, Osaka, 577-8502, Japan, minamita@life.kindai.ac.jp.
Thimerosal, an ethyl mercury compound, is used worldwide as a vaccine preservative. We previously observed that the mercury concentration in mouse brains did not increase with the clinical dose of thimerosal injection, but the concentration increased in the brain after the injection of thimerosal with lipopolysaccharide, even if a low dose of thimerosal was administered. Thimerosal may penetrate the brain, but is undetectable when a clinical dose of thimerosal is injected; therefore, the induction of metallothionein (MT) messenger RNA (mRNA) and protein was observed in the cerebellum and cerebrum of mice after thimerosal injection, as MT is an inducible protein. MT-1 mRNA was expressed at 6 and 9 h in both the cerebrum and cerebellum, but MT-1 mRNA expression in the cerebellum was three times higher than that in the cerebrum after the injection of 12 microg/kg thimerosal. MT-2 mRNA was not expressed until 24 h in both organs. MT-3 mRNA was expressed in the cerebellum from 6 to 15 h after the injection, but not in the cerebrum until 24 h. MT-1 and MT-3 mRNAs were expressed in the cerebellum in a dose-dependent manner. Furthermore, MT-1 protein was detected from 6 to 72 h in the cerebellum after 12 microg/kg of thimerosal was injected and peaked at 10 h. MT-2 was detected in the cerebellum only at 10 h. In the cerebrum, little MT-1 protein was detected at 10 and 24 h, and there were no peaks of MT-2 protein in the cerebrum. In conclusion, MT-1 and MT-3 mRNAs but not MT-2 mRNA are easily expressed in the cerebellum rather than in the cerebrum by the injection of low-dose thimerosal. It is thought that the cerebellum is a sensitive organ against thimerosal. As a result of the present findings, in combination with the brain pathology observed in patients diagnosed with autism, the present study helps to support the possible biological plausibility for how low-dose exposure to mercury from thimerosal-containing vaccines may be associated with autism.
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49.) Neonate exposure to thimerosal mercury from hepatitis B vaccines.
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Am J Perinatol. 2009 Aug;26(7):523-7. Epub 2009 Mar 12.=
Dórea JG, Marques RC, Brandão KG.
Universidade de Brasília, DF, Brazil. dorea@rudah.com.br
Infant exposure to ethylmercury (EtHg) has not only increased but is starting earlier as a result of the current immunization schedule that uses thimerosal-containing vaccines (TCVs). Although vaccination schedule varies considerably between countries, infants in less-developed countries continue to be exposed to EtHg derived from more affordable TCVs. We studied the exposure of newborns to EtHg from hepatitis B vaccines; hospital records (21,685) were summarized for the years 2001 to 2005 regarding date of birth, vaccination date, and birth weight. Most of the vaccinations occurred in the first 24 hours postdelivery; over the 5 years, there was an increase in vaccinations within hours of birth (same day), from 7.4% (2001) to 87.8% (2005). Nearly 94.6% of infants are now being vaccinated within the first 24 hours. Range of mercury exposure spread from 4.2 to 21.1 microg mercury/kg body weight for those receiving TCVs with the highest thimerosal concentration; these exposure levels are conservative for 2% of children receiving vaccines within 2 to 3 postnatal days, when they are still going through physiological postnatal weight loss. Because of the particular timing (transitioning from in utero to ex utero metabolism) and specific aspects of exposure (i.e., parenteral mode, bypassing gastroenteric barriers) and dose (related to vaccine manufacturer and with variation in birth weight), this study reveals critical issues that can modulate toxicokinetics and toxicodynamics of organomercurials in neonates.
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50.) Secret CDC vaccine study Thimerosal an autism risk
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Sources: www.whale.to
AUTISM FIRST STEPS
AUTISM DAILY NEWSLETTER
Thursday January 3, 2002
SPECIAL EDITION
An unreleased confidential report by Center's for Disease Control (CDC) scientists reveals that
exposure to significant amounts of mercury during the first months of life significantly increases a
child's risk of developing autism, according to an attorney with the law firm of Walters & Kraus. The
firm is a part of a coalition of law firms, representing families in at least 25 states, that has filed
lawsuits in an attempt to force drug companies to investigate the possible link between mercury and developmental disorders.
Attorney Andy Walters says that the unreleased CDC report, obtained by the SAFEMINDS
advocacy group, found a 2.48 times increased risk of autism in children exposed to more then 62.5
micrograms of mercury before they were 3 months of age. In a press release, Walters and Kraus
notes that "in the United States, courts of law have generally held that a relative increased risk of 2.0 or higher is sufficient to substantiate that a given exposure causes disease." Walters says that in many of the cases that his firm has evaluated, autistic children have received more than 62.5 micrograms of mercury through pediatric vaccines.
A report made public by the CDC in the fall claimed that the thimerosal, the mercury containing
preservative used in many vaccines, could not be linked to autism, while calling on Physicians to
avoid thimerosal containing vaccines when possible. However, according to Walters & Kraus, the
confidential CDC report states: "As for the exposure evaluated at 3 months of age, we found
increasing risks of "neurological developmental disorders" with increasing cumulative exposure to
thimerosal... within the group of "developmental disorders"... for the subgroup called "specific
delays," and within the this subgroup for the specific disorder "developmental speech disorder," and
for "autism" "stuttering" and "attention deficit disorder".
Walters says the report's contents, and the fact that it was kept secret, are "shocking, but
unfortunately not surprising, given the political influence of pharmaceutical companies and the
tremendous liability they face if they are forced to compensate thousands of families for the costs of
care that these children require".
Press Release, Walters & Kraus, 2001
******************************
PRESS RELEASE
An announcement was made today by the law firm of Waters & Kraus, the firm that filed the first
known lawsuit alleging that a mercury preservative in children's vaccines caused neurological damage to an infant ultimately diagnosed with autism. Waters & Kraus is leading a consortium of ten firms in as many states that are actively prosecuting cases of this nature (firms listed below). Andy Waters, the lead attorney in the cases, announced that his firm is now in possession of a previously unreleased confidential report authored by Centers for Disease Control scientists which studied autism as a potential neurological injury caused by mercury in children's vaccines. A different version of the report was made public and has been cited by the recent Institute of Medicine study as inconclusive on the issue of whether the mercury-based vaccine preservative known as Thimerosal has contributed to cause a nationwide epidemic of regressive autism and other neurological disorders in small children. The confidential version of the study, however, clearly demonstrated that an exposure to more than 62.5 micrograms of mercury within the first three months of life significantly increased a child's risk of developing autism. Specifically, the study found a 2.48 times increased risk of autism _ that is to say, children with the exposure were more than twice as likely to develop autism as children not exposed. Click here to view the full report. (27 pages formatted in TIFF) In the United States, courts of law have generally held that a relative increased risk of 2.0 or higher is sufficient to substantiate that a given exposure causes disease. As but one example, in the case of Cook v. United States, 545 F.Supp. 306, at 308 (Northern District _ California 1982) the Court stated that, "in a vaccine case, a relative risk greater than 2.0 establishes that there is a greater than 50% chance that the injury was caused by the vaccine." Waters indicated that, in many of the cases his firm has evaluated, including the case filed in a Texas state court on behalf of the Counter family, the affected child received more than 62.5 micrograms of mercury through pediatric vaccines in the first three months of life. The confidential report, which was obtained by the SAFEMINDS support and advocacy group, states: "As for the exposure evaluated at 3 months of age, we found increasing
risks of 'neurological developmental disorders' with increasing cumulative exposure to thimerosal ...
within the group of 'developmental disorders'... for the sub_group called 'specific delays,' and within this sub_group for the specific disorder 'developmental speech disorder,' and for 'autism,' 'stuttering' and 'attention deficit disorder.'" The report also contained the graph depicted below which illustrated the report's findings of a child's increasing risk of developing the neurological symptoms of autism after receiving increasing amounts of thimerosal.Graph 3: Relative risk 95 % CI of Autism after different exposure levels of thimerosal at 3 months of age, NCK & GHCWaters pointed out that the confidential study's lead author, Thomas Verstraeten, has since left the Centers for Disease Control and is now employed by GlaxoSmithKline, a manufacturer of thimerosal_containing vaccines for many years that is a defendant in numerous suits pending nationwide. "We have asked GlaxoSmithKline to provide Mr. Verstraeten's deposition in order to understand if conflict of interest issues may have played a role in the CDC's decision to keep this report confidential, and specifically, their failure to reveal it to the Institute of Medicine."Waters called the report's contents and the fact that it was kept from the public as "shocking, but unfortunately not surprising, given the political influence of pharmaceutical companies and the tremendous liability they face if they are forced to compensate thousands of families for the costs of care that these children require." Waters added that "no amount of money can give these children back the potential that they were born with, and no amount of money will comfort the parents that watched helplessly as their children literally just slipped away." The purpose of the lawsuits his firm is currently prosecuting, said Waters, is "to bring
to the surface the truth on this issue, a truth that government agencies seem unwilling to admit,
perhaps for fear that parents will stop vaccinating their children, and to force the companies that profited from this disastrous mistake to shoulder the responsibility that so many families now bear on their own, often without even the aid of health insurance benefits." Media inquiries should be directed to Melissa Miles at 214-357-6244.Client inquiries should be directed to Victoria Gibson, toll-free at 1-866-829-7529, or to the firms listed below.Other firms working with Waters & Kraus to prosecute individual cases involving thimerosal exposure are:ANDERSON & KRIGER,
APLC40925 County Center Drive, Suite 210Temecula, California 92591Telephone:
909.296.5090DOGAN & WILKINSON726 Delmas AvenuePascagoula, Mississippi
39567Telephone: 228.762.2272 DORAN & MURPHY, LLP1234 Delaware AvenueBuffalo, New
York 14209Telephone: 716.884.2000EVERT & WEATHERSBY, L.L.C.3405 Piedmont Road,
Suite 225Atlanta, Georgia 30305-1764Telephone : 404.233.8718HENDRICKSON & LONG214
Capital StreetP.O. Box 11070Charleston, W. VA 25339Telephone: 304.346.5500JONES,
MARTIN, PARRIS, &TESSENER LAW OFFICES, PLLC410 Glenwood Ave., Suite
200Raleigh, North Carolina 27603Telephone: 919.821.0005LEACH, SCHWARZ
&STRASSBERG11 Bala Ave.Bala Cynwyd, Pennsylvania 19004Telephone:
610.668.7964MARTZELL & BICKFORD338 Lafayette StreetNew Orleans, Louisianna
70130Telephone: 504.581.90653555 College AvenueWISE & JULIAN, PC3555 College
AvenueAlton, Illinois 62002Telephone: 618.462.2600
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51.) Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed?
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Med Microbiol Immunol. 2009 Oct 23. [Epub ahead of print]
Bhakdi S, Lackner K, Doerr HW.
Institute of Medical Microbiology and Hygiene, University Medical Center, Augustusplatz, 55101, Mainz, Germany, sbhakdi@uni-mainz.de.
Programs for vaccination against the new influenza A/H1N1 targeting many hundred million citizens in Europe and the USA are to be launched in the fall of this year. The USA is planning to employ a non-adjuvanted vaccine, whereas European nations are opting for inclusion of MF59, the adjuvant contained in an alternative seasonal flu vaccine, or the related adjuvant AS03 that is contained in a recently developed H5N1 vaccine. We draw attention to unappreciated hazards of using adjuvanted vaccine in Europe. Evidence from animal experiments in conjunction with clinical epidemiological data indicates that, quite irrespective of cause, stimulation of the immune system may accelerate atherogenesis. Application of adjuvanted flu vaccines to individuals at risk may therefore aggravate the course of underlying atherosclerotic vessel disease with all the clinical consequences. The same may hold true for other widespread diseases that are propelled by deregulated immune mechanisms. Safety trials conducted to date have not specifically taken these possible side effects into account, and unexpected serious adverse effects thus may follow in the wake of a general vaccination program. A prudent consequence would be to establish careful survey systems alongside with mass application of new adjuvanted vaccines, or to hold mass vaccination in reserve for use only in situations of true need, such as would arise with the emergence of a more virulent new H1N1 virus strain, or to use non-adjuvanted vaccines in individuals who are potentially at risk for adverse side effects.
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52.) Adjuvants and autoimmunity.
================================================
Lupus. 2009 Nov;18(13):1217-25
Israeli E, Agmon-Levin N, Blank M, Shoenfeld Y.
Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel.
Some adjuvants may exert adverse effects upon injection or, on the other hand, may not trigger a full immunological reaction. The mechanisms underlying adjuvant adverse effects are under renewed scrutiny because of the enormous implications for vaccine development. In the search for new and safer adjuvants, several new adjuvants were developed by pharmaceutical companies utilizing new immunological and chemical innovations. The ability of the immune system to recognize molecules that are broadly shared by pathogens is, in part, due to the presence of special immune receptors called toll-like receptors (TLRs) that are expressed on leukocyte membranes. The very fact that TLR activation leads to adaptive immune responses to foreign entities explains why so many adjuvants used today in vaccinations are developed to mimic TLR ligands. Alongside their supportive role, adjuvants were found to inflict by themselves an illness of autoimmune nature, defined as 'the adjuvant diseases'. The debatable question of silicone as an adjuvant and connective tissue diseases, as well as the Gulf War syndrome and macrophagic myofaciitis which followed multiple injections of aluminium-based vaccines, are presented here. Owing to the adverse effects exerted by adjuvants, there is no doubt that safer adjuvants need to be developed and incorporated into future vaccines. Other needs in light of new vaccine technologies are adjuvants suitable for use with mucosally delivered vaccines, DNA vaccines, cancer and autoimmunity vaccines. In particular, there is demand for safe and non-toxic adjuvants able to stimulate cellular (Th1) immunity. More adjuvants were approved to date besides alum for human vaccines, including MF59 in some viral vaccines, MPL, AS04, AS01B and AS02A against viral and parasitic infections, virosomes for HBV, HPV and HAV, and cholera toxin for cholera. Perhaps future adjuvants occupying other putative receptors will be employed to bypass the TLR signaling pathway completely in order to circumvent common side effects of adjuvant-activated TLRs such as local inflammation and the general malaise felt because of the costly whole-body immune response to antigen.
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53.)Oseltamivir-Resistant Influenza Virus A (H1N1), Europe, 2007–08 Season
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Adam Meijer, Angie Lackenby, Olav Hungnes, Bruno Lina, Sylvie van der Werf, Brunhilde Schweiger, Matthias Opp, John Paget, Jan van de Kassteele, Alan Hay, Maria Zambon, and on behalf of the European Influenza Surveillance Scheme1
Netherlands Institute for Health Services Research, Utrecht, the Netherlands (A. Meijer, J. Paget)
National Institute for Public Health and the Environment, Bilthoven, the Netherlands (A. Meijer,
J. van de Kassteele)
European Surveillance Network for Vigilance against Viral Resistance (A. Lackenby, B. Lina, S. van der Werf, A. Hay, M. Zambon)
Health Protection Agency, London, UK (A. Lackenby, M. Zambon)
Norwegian Institute of Public Health, Oslo, Norway (O. Hungnes); Centre National de Référence des Virus Influenza (Région Sud), Lyon, France (B. Lina)
Centre National de Référence des Virus Influenza (Région Nord), Paris, France (S. van der Werf)
Robert Koch Institute, Berlin, Germany (B. Schweiger)
Laboratoire National de Santé, Luxembourg, Luxembourg (M. Opp)
World Health Organization Collaborating Centre Medical Research Council/National Institute of Medical Research, London (A. Hay)
Corresponding author.
Address for correspondence: Adam Meijer, Centre for Infectious Disease Control, National Institute for Public Health and the Environment, PO Box 1, 3720 BA Bilthoven, the Netherlands; email: adam.meijer@rivm.nl
This article has been cited by other articles in PMC.
Abstract
In Europe, the 2007–08 winter season was dominated by influenza virus A (H1N1) circulation through week 7, followed by influenza B virus from week 8 onward. Oseltamivir-resistant influenza viruses A (H1N1) (ORVs) with H275Y mutation in the neuraminidase emerged independently of drug use. By country, the proportion of ORVs ranged from 0% to 68%, with the highest proportion in Norway. The average weighted prevalence of ORVs across Europe increased gradually over time, from near 0 in week 40 of 2007 to 56% in week 19 of 2008 (mean 20%). Neuraminidase genes of ORVs possessing the H275Y substitution formed a homogeneous subgroup closely related to, but distinguishable from, those of oseltamivir-sensitive influenza viruses A (H1N1). Minor variants of ORVs emerged independently, indicating multiclonal ORVs. Overall, the clinical effect of ORVs in Europe, measured by influenza-like illness or acute respiratory infection, was unremarkable and consistent with normal seasonal activity.
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54.) Oseltamivir-Resistant Influenza Viruses A (H1N1), Norway, 2007–08
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Siri H. Hauge, Susanne Dudman, Katrine Borgen, Angie Lackenby, and Olav Hungnes
Norwegian Institute of Public Health, Oslo, Norway (S.H. Hauge, S. Dudman, K. Borgen, O. Hungnes)
Health Protection Agency, London, UK (A. Lackenby)
Corresponding author.
Address for correspondence: Olav Hungnes, Norwegian Institute of Public Health, Department of Virology, PO Box 4404, Nydalen Oslo N-0403, Norway; email: olav.hungnes@fhi.no
Abstract
In Norway in January 2008, unprecedented levels of oseltamivir resistance were found in 12 of 16 influenza viruses A (H1N1) tested. To investigate the epidemiologic and clinical characteristics of these viruses, we used sequence analysis to test all available subtype H1N1 viruses from the 2007–08 season for resistance. Questionnaires from physicians provided information on predisposing diseases, oseltamivir use, symptoms, and complications. Clinical data were obtained for 265 patients. In total, 183 (67.3%) of 272 viruses were oseltamivir resistant. Resistance was not associated with prior use of antiviral drugs. Symptoms and hospitalization rates did not differ for patients infected with a resistant or a susceptible virus. Oseltamivir-resistant influenza viruses A (H1N1) did not show diminished capability to spread in the absence of selective pressure. The ability of these viruses to sustain their fitness and spread among persons should be considered when shaping future strategies for treating and preventing seasonal and pandemic influenza.
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19.) French scientists sound the alarm about aluminum in vaccines — crickets from media and health authorities
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Source:https://medium.com/@jbhandley/french-scientists-sound-the-alarm-about-aluminum-in-vaccines-crickets-from-media-and-health-d3fc0fe23079
BY J.B. HANDLEY September 9, 2017
“In the context of massive development of vaccine-based strategies worldwide, the present study may suggest that aluminium adjuvant toxicokinetics and safety require reevaluation.”
Maybe it will just go away?
PARIS, France — Roman K. Gherardi and his colleagues from the Université Paris Est Créteil (“UPEC”)in France issued a worldwide warning in late 2016 about the aluminum adjuvant used in childhood vaccines. Their paper, published in the highly-respected journal Toxicology, is deeply distrubing for any parent contemplating vaccinating their child according to the present schedule recommended by the American Centers for Disease Control (“CDC”). And, it’s highly likely that this is the first time you’ve ever heard about it.
It’s safe to say that this study’s conclusions have revolutionized our understanding of aluminum adjuvant, the kind used in most children’s vaccines.
The French study authors were very concerned about the widespread use of aluminum adjuvant:
“Concerns about its [aluminum adjuvant’s] safety emerged following recognition of its unexpectedly long-lasting biopersistence within immune cells in some individuals, and reports of chronic fatigue syndrome, cognitive dysfunction, myalgia, dysautonomia and autoimmune/inflammatory features temporally linked to multiple Al-containing vaccine administrations.”
The scientists also discovered, through mouse-models, a deeply alarming unique characteristic of aluminum adjuvant: low, consistent doses (the kind given to babies through their vaccines) were MORE neurotoxic than a single bolus dose:
“We conclude that Alhydrogel [aluminum adjuvant] injected at low dose in mouse muscle may selectively induce long-term Al cerebral accumulation and neurotoxic effects. To explain this unexpected result, an avenue that could be explored in the future relates to the adjuvant size since the injected suspensions corresponding to the lowest dose, but not to the highest doses, exclusively contained small agglomerates in the bacteria-size range known to favour capture and, presumably, transportation by monocyte-lineage cells. In any event, the view that Alhydrogel neurotoxicity obeys ‘the dose makes the poison’ rule of classical chemical toxicity appears overly simplistic.”
This is a confusing conclusion, but profoundly important, here’s a further explanation from the excellent website, Vaccine Papers.org:
A new paper (Crepeaux et al.) by the Gherardi research group in France reports important results on the toxicity and transport of aluminum (Al) adjuvant in mice. This single study is especially valuable because it looked at many outcomes: behavioral effects, immune (microglial) activation in the brain, and Al transport into the brain. The study tested dosages of 200 , 400 and 800 mcg/Kg, injected intramuscularly (IM). The Al adjuvant used was AlOH (brand name Alhydrogel), the most common vaccine adjuvant in use today. It is used in the tetanus, Hep A, Hep B, HiB, pneumococcal, meningococcal, and anthrax vaccines.
Remarkably, the study found that the lowest dosage (200 mcg/Kg) was the most toxic! For many outcomes, the 400 and 800 mcg/Kg dosages had no observable adverse effects, but the 200 mcg/Kg dosage did.
The low toxicity of the higher dosages appears to be a consequence of dosage-dependent inflammation at the injection site. The high dosages caused intense inflammation at the injection site, forming “granulomas”. The 200 mcg/Kg dosage did not produce granulomas. Granulomas are hard nodules in tissue produced in response to injury, infection or foreign substances. Its a way the body “walls off” injured tissue and prevents the spread of infection or toxins. The granuloma appears to provide protection from Al adjuvant toxicity; apparently the granuloma prevented Al adjuvant particles from leaving the injection site. This explains why the 200 mcg/Kg dosage affected the brain and behavior, while the higher dosages did not. This suggests that it is more dangerous and harmful to administer numerous small injections of Al adjuvant, compared to a large single injection capable of inducing a granuloma.
The study authors also disputed the way the FDA and CDC currently think about aluminum adjuvant toxicity, basically saying that the current research approach is wrong:
“As a possible consequence, comparing vaccine adjuvant exposure to other non- relevant aluminium exposures, e.g. soluble aluminium and other routes of exposure, may not represent valid approaches.”
And, the French scientists finish with a conclusion that all parents should find very troubling:
“In the context of massive development of vaccine-based strategies worldwide, the present study may suggest that aluminium adjuvant toxicokinetics and safety require reevaluation.”
Radio Silence
Where’s the media? Where’s the CDC? Where are the other member of our public health authorities? Where are the elected officials? Where’s the American Academy of Pediatrics? Why is no one willing to discuss a highly credible study raising grave concerns about something being injected into American babies? Moreover, the scientists directly challenge the CDC’s approach to assessing the safety of injected aluminum adjuvant, basically saying it’s being done incorrectly.
For further reading on this complex topic, I hope you’ll consider reading a more extensive exploration of the complex relationship between aluminum adjuvant and autism, which has so far has more than 250,000 reads:
“Scientists appear to be far closer to explaining the mechanisms of action within the body that cause autism. Most of the research that has created this understanding has been published in the last 36 months, and largely from international scientists in Canada, France, Israel, and China. Four clear, replicable, and related discoveries explaining how autism is triggered are forming an undeniably clear picture of autism’s causation, and possibly ways to alleviate the symptoms, too.”
Did Chinese scientists find autism’s missing puzzle piece?
BY J.B. HANDLEY February 22, 2017
healthcareinamerica.us
J.B. Handley is the father of a child with Autism. He and his wife co-founded Generation Rescue, Jenny McCarthy’s autism charity. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. He is also the author of “The Only Vaccine Guide a New Parent Will Ever Need” , “An Angry Father’s Guide to Vaccine-Autism Science”, and “7 reasons CDC employees should be “crying in the hallways” Mr. Handley has started a podcast called “How to End the Autism Epidemic” — you might enjoy his first six interviews:
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20.) Influenza vaccination and Guillain Barre syndrome small star, filled.
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Geier MR, Geier DA, Zahalsky AC.
The Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905, USA. mgeier@erols.com <mgeier@erols.com>
Comment in:
· Clin Immunol. 2003 Dec;109(3):359; author reply 360-1.
Acute and severe Guillain Barre Syndrome (GBS) cases reported following influenza vaccine to the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1999 were examined. Endotoxin concentrations were measured using the Limulus amebocyte lysate assay in influenza vaccines. There were a total of 382 cases of GBS reported to the VAERS database following influenza vaccination (male/female ratio, 1.2). The median onset of GBS following influenza vaccine was 12 days (interquartile range, 7 days to 21 days). There was an increased risk of acute GBS (relative risk, 4.3; 95% confidence interval, 3.0 to 6.4) and severe GBS (relative risk, 8.5; 95% confidence interval, 3.7 to 18.9) in comparison to an adult tetanus-diphtheria (Td) vaccine control group. There were maximums in the incidence of GBS following influenza vaccine that occurred approximately every third year (1993, 1996, and 1998) and statistically significant variation in the incidence of GBS among different influenza manufacturers. Influenza vaccines contained from a 125- to a 1250-fold increase in endotoxin concentrations in comparison to an adult Td vaccine control and endotoxin concentrations varied up to 10-fold among different lots and manufacturers of influenza vaccine. The biologic mechanism for GBS following influenza vaccine may involve the synergistic effects of endotoxin and vaccine-induced autoimmunity. There were minimal potential reporting biases in the data reported to the VAERS database in this study. Patients should make an informed consent decision on whether to take this optional vaccine based upon its safety and efficacy and physicians should vigilantly report GBS following influenza vaccination to the VAERS in the United States so that continued evaluation of the safety of influenza vaccine may be undertaken.
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21.) Guillain-Barré syndrome following influenza vaccination.
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JAMA. 2004 Nov 24;292(20):2478-81
Haber P, DeStefano F, Angulo FJ, Iskander J, Shadomy SV, Weintraub E, Chen RT.
Immunization Safety Branch, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga 30333, USA. PHaber@cdc.gov
CONTEXT: An unexplained increase in the risk of Guillain-Barre syndrome (GBS) occurred among recipients of the swine influenza vaccine in 1976-1977. Guillain-Barre syndrome remains the most frequent neurological condition reported after influenza vaccination to the Vaccine Adverse Events Reporting System (VAERS) since its inception in 1990. OBJECTIVE: To evaluate trends of reports to VAERS of GBS following influenza vaccination in adults. DESIGN, SETTING, AND PARTICIPANTS: VAERS is the US national spontaneous reporting system for adverse events following vaccination. Reports of GBS in persons 18 years or older following influenza vaccination were evaluated for each influenza season from July 1, 1990, through June 30, 2003. The number of people vaccinated was estimated from the National Health Interview Survey and US census data. Beginning in 1994, active follow-up was conducted to verify GBS diagnosis and obtain other clinical details. MAIN OUTCOME MEASURE: Reporting rates of GBS following influenza vaccination over time. RESULTS: From July 1990 through June 2003, VAERS received 501 reports of GBS following influenza vaccination in adults. The median onset interval (13 days) was longer than that of non-GBS reports of adverse events after influenza vaccine (1 day) (P<.001). The annual reporting rate decreased 4-fold from a high of 0.17 per 100,000 vaccinees in 1993-1994 to 0.04 in 2002-2003 (P<.001). A GBS diagnosis was confirmed in 82% of reports. Preceding illness within 4 weeks of vaccination was identified in 24% of reported cases. CONCLUSIONS: From 1990 to 2003, VAERS reporting rates of GBS after influenza vaccination decreased. The long onset interval and low prevalence of other preexisting illnesses are consistent with a possible causal association between GBS and influenza vaccine. These findings require additional research, which can lead to a fuller understanding of the causes of GBS and its possible relationship with influenza vaccine.
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22.) Clinical implications of endotoxin concentrations in vaccines.
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Ann Pharmacother. 2002 May;36(5):776-80.
Geier DA, Geier MR.
Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905-5726, USA.
Comment in:
· Ann Pharmacother. 2002 Oct;36(10):1650; author reply 1650-1.
BACKGROUND: A previous study suggested that high concentrations of endotoxin may be present in whole-cell diphtheria/tetanus/pertussis (DTP) vaccine, and the scientific literature contains many studies examining the reactivity of whole-cell DTP vaccine. The medical and scientific communities have previously reported that the presence of endotoxin in commercial vaccines may have negative effects on vaccine recipients. OBJECTIVE: To determine the endotoxin concentrations in whole-cell DTP, acellular DTP(DTaP), and DT vaccines and determine the clinical experience with each vaccine. METHODS: To study the endotoxin concentrations in vaccines, the Limulus amebocyte lysate (LAL) assay was used. The vaccines analyzed with the LAL assay were whole-cell DTP vaccine lots manufactured by Connaught, Lederle, the Michigan and Massachusetts Departments of Health, and Wyeth; DTaP vaccine lots manufactured by Merieux and Takeda; and DT vaccine lots manufactured by Wyeth and Lederle. The incidence of adverse reactions following whole-cell DTP, DTaP, and DT vaccines were determined based on analysis of the Vaccine Adverse Events Reporting System (VAERS) database. RESULTS: The results of the LAL assay showed that whole-cell DTP vaccines contained considerably more endotoxin than either DTaP or DT vaccines. The VAERS showed that statistically significantly more adverse reactions were associated with whole-cell DTP vaccine than DTaP or DT vaccines. CONCLUSIONS: This analysis confirmed higher concentrations of endotoxin in whole-cell DTP vaccines compared with DTaP or DT vaccines. As high concentrations of endotoxin may be correlated with a higher incidence of adverse events, the switch from whole-cell DTP to DTaP for routine vaccinations in the US seems well justified.
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23.) Guillain-Barré syndrome after influenza vaccination in adults: a population-based study.
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Arch Intern Med. 2006 Nov 13;166(20):2217-21.
Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, Upshur RE, Manuel DG, Moineddin R, Wilson K.
Institute of Clinical Evaluative Sciences, Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario.
BACKGROUND: Whether influenza vaccination is associated with Guillain-Barré syndrome (GBS) remains uncertain. METHODS: We conducted 2 studies using population-based health care data from the province of Ontario, Canada. In the first study, we used the self-matched case-series method to explore the temporal association between probable influenza vaccination (adults vaccinated during October and November) and subsequent hospitalization because of GBS. In the second study, we used time-series analysis to determine whether the institution of a universal influenza immunization program in October 2000 was associated with a subsequent increase in hospital admissions because of GBS at the population level. RESULTS: From April 1, 1992, to March 31, 2004, we identified 1601 incident hospital admissions because of GBS in Ontario. In 269 patients, GBS was diagnosed within 43 weeks of vaccination against influenza. The estimated relative incidence of GBS during the primary risk interval (weeks 2 through 7) compared with the control interval (weeks 20 through 43) was 1.45 (95% confidence interval, 1.05-1.99; P = .02). This association persisted in several sensitivity analyses using risk and control intervals of different durations. However, a separate time-series analysis demonstrated no evidence of seasonality and revealed no statistically significant increase in hospital admissions because of GBS after the introduction of the universal influenza immunization program. CONCLUSION: Influenza vaccination is associated with a small but significantly increased risk for hospitalization because of GBS.
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24.) Novel Pandemic Influenza A(H1N1) Viruses Are Potently Inhibited by DAS181, a Sialidase Fusion Protein
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Gallen B. Triana-Baltzer,1 Larisa V. Gubareva,2 John M. Nicholls,3 Melissa B. Pearce,2 Vasiliy P. Mishin,2 Jessica A. Belser,2 Li-Mei Chen,2 Renee W. Y. Chan,3 Michael C. W. Chan,3 Maria Hedlund,1 Jeffrey L. Larson,1 Ronald B. Moss,1 Jacqueline M. Katz,2 Terrence M. Tumpey,2 and Fang Fang1*
1NexBio, Inc., San Diego, California, United States of America
2Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for
Disease Control and Prevention, Atlanta, Georgia, United States of America
3Departments of Pathology and Microbiology, University of Hong Kong, Pok Fu Lam, Hong Kong Special Administrative Region, People's Republic of China
Cheryl A. Stoddart, Editor
University of California San Francisco, United States of America
* E-mail: ffang@nexbio.com
Conceived and designed the experiments: GBTB LG JMN VPM JAB MH JLL RBm TMT FF. Performed the experiments: LG JMN MBP VPM JAB LMC RWYC MCC. Analyzed the data: GBTB LG JMN VPM LMC RWYC MH RBm JMK TMT FF. Contributed reagents/materials/analysis tools: GBTB LG JMN VPM RWYC JMK TMT FF. Wrote the paper: GBTB JLL.
Received June 10, 2009; Accepted October 13, 2009.
Abstract
Background
The recent emergence of a novel pandemic influenza A(H1N1) strain in humans exemplifies the rapid and unpredictable nature of influenza virus evolution and the need for effective therapeutics and vaccines to control such outbreaks. However, resistance to antivirals can be a formidable problem as evidenced by the currently widespread oseltamivir- and adamantane-resistant seasonal influenza A viruses (IFV). Additional antiviral approaches with novel mechanisms of action are needed to combat novel and resistant influenza strains. DAS181 (Fludase™) is a sialidase fusion protein in early clinical development with in vitro and in vivo preclinical activity against a variety of seasonal influenza strains and highly pathogenic avian influenza strains (A/H5N1). Here, we use in vitro, ex vivo, and in vivo models to evaluate the activity of DAS181 against several pandemic influenza A(H1N1) viruses.
Methods and Findings
The activity of DAS181 against several pandemic influenza A(H1N1) virus isolates was examined in MDCK cells, differentiated primary human respiratory tract culture, ex-vivo human bronchi tissue and mice. DAS181 efficiently inhibited viral replication in each of these models and against all tested pandemic influenza A(H1N1) strains. DAS181 treatment also protected mice from pandemic influenza A(H1N1)-induced pathogenesis. Furthermore, DAS181 antiviral activity against pandemic influenza A(H1N1) strains was comparable to that observed against seasonal influenza virus including the H274Y oseltamivir-resistant influenza virus.
Conclusions
The sialidase fusion protein DAS181 exhibits potent inhibitory activity against pandemic influenza A(H1N1) viruses. As inhibition was also observed with oseltamivir-resistant IFV (H274Y), DAS181 may be active against the antigenically novel pandemic influenza
A(H1N1) virus should it acquire the H274Y mutation. Based on these and previous results demonstrating DAS181 broad-spectrum anti-IFV activity, DAS181 represents a potential therapeutic agent for prevention and treatment of infections by both emerging and seasonal strains of IFV.
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25.)A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
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Geier DA, Geier MR.
MedCon, Inc., Silver Spring, Maryland, USA. mgeier@erols.com
OBJECTIVES: This analysis examined the incidence rate of chronic arthritis adverse reactions reported following adult rubella and hepatitis B vaccinations. In this analysis, etiologic mechanisms for chronic arthritis following adult rubella and hepatitis B vaccines were also explored. METHODS: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence rate of reported cases of chronic arthritis in comparison to Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups. RESULTS: Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females (female/male ratio = 3.0), at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females(female/male ratio = 3.5), at about 33 years-old, and with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased, by chi 2 analysis, in comparison to the adult vaccine control groups. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms. Furthermore, potential biases in the reporting rates of adverse reactions to VAERS were not observed.
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26.) Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database.
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Am J Epidemiol. 2009 Feb 1;169(3):382-8. Epub 2008 Nov 24
Stowe J, Andrews N, Wise L, Miller E.
Immunisation Department, Health Protection Agency Centre for Infections, London, UK. julia.stowe@hpa.org.uk
In 1976, the national swine influenza vaccination program in the United States was suspended because of an increased risk of Guillain-Barré syndrome. Subsequent studies of seasonal influenza vaccine have given conflicting results. The authors used the self-controlled case series method to investigate the relation of Guillain-Barré syndrome with influenza vaccine and influenzalike illness using cases recorded in the General Practice Research Database from 1990 to 2005 in the United Kingdom. The relative incidence of Guillain-Barré syndrome within 90 days of vaccination was 0.76 (95% confidence interval: 0.41, 1.40). In contrast, the relative incidence of Guillain-Barré syndrome within 90 days of an influenzalike illness was 7.35 (95% confidence interval: 4.36, 12.38), with the greatest relative incidence (16.64, 95% confidence interval: 9.37, 29.54) within 30 days. The relative incidence was similar (0.89, 95% confidence interval: 0.42, 1.89) when the analysis was restricted to a subset of validated cases. The authors found no evidence of an increased risk of Guillain-Barré syndrome after seasonal influenza vaccine. The finding of a greatly increased risk after influenzalike illness is consistent with anecdotal reports of a preceding respiratory illness in Guillain-Barré syndrome and has important implications for the risk/benefit assessment that would be carried out should pandemic vaccines be deployed in the future.
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27.) Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-September 2006.
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MMWR Morb Mortal Wkly Rep. 2006 Oct 20;55(41):1120-4.
Centers for Disease Control and Prevention (CDC).
Erratum in:
· MMWR Morb Mortal Wkly Rep. 2006 Nov 3;55(43):1177.
In October 2005, reports indicating a possible association between Guillain-Barré Syndrome (GBS) and receipt of meningococcal conjugate vaccine (MCV4) (Menactra, Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) were made to the Vaccine Adverse Event Reporting System (VAERS). GBS is a serious neurologic disorder involving inflammatory demyelination of the peripheral nerves. During March 2005-February 2006, eight confirmed cases had occurred within 6 weeks (i.e., the time window of elevated risk noted for GBS after administration of other vaccines) after MCV4 vaccination. This report summarizes nine additional GBS cases reported to VAERS during March-September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.
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28.) Guillain-Barre syndrome following vaccination in the National Influenza Immunization
Program, United States, 1976--1977.
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Am J Epidemiol. 1979 Aug;110(2):105-23
Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, Retailliau HF, Eddins DL, Bryan JA.
Because of an increase in the number of reports of Guillian-Barre syndrome (GBS) following A/New Jersey influenza vaccination, the National Influenza Immunization Program was suspended December 16, 1976 and nationwide surveillance for GBS was begun. This surveillance uncovered a total of 1098 patients with onset of GBS from October 1, 1976, to January 31, 1977, from all 50 states, District of Columbia, and Puerto Rico. A total of 532 patients had recently received an A/New Jersey influenza vaccination prior to their onset of GBS (vaccinated cases), and 15 patients received a vaccination after their onset of GBS. Five hundred forty-three patients had not been recently vaccinated with A/New Jersey influenza vaccine and the vaccination status for 8 was unknown. Epidemiologic evidence indicated that many cases of GBS were related to vaccination. When compared to the unvaccinated population, the vaccinated population had a significantly elevated attack rate in every adult age group. The estimated attributable risk of vaccine-related GBS in the adult population was just under one case per 100,000 vaccinations. The period of increased risk was concentrated primarily within the 5-week period after vaccination, although it lasted for approximately 9 or 10 weeks.
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29.) Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.
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Pediatrics. 2005 Feb;115(2):453-60.
McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, Ball R.
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville,
Maryland 20852, USA. mcmahon@cber.fda.gov
BACKGROUND: In April 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and children with trivalent influenza vaccine (TIV). OBJECTIVES: To describe adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV vaccination among children <2 years of age and to compare reports before the ACIP guideline (January 1990 to June 2002) and after the ACIP guideline (July 2002 to June 2003). METHODS: VAERS is a passive vaccine safety surveillance system begun by the Food and Drug Administration and the Centers for Disease Control and Prevention in 1990. We reviewed reports to VAERS for children <2 years of age who received TIV, alone or in combination with other vaccines. Influenza seasons were defined as the period from July 1 of one year to June 30 of the following year. RESULTS: Between 1990 and 2003, VAERS received 166 TIV reports for children <2 years of age. There were 62 reports (37%) after administration of TIV alone and 104 reports (63%) after administration of TIV and > or =1 other vaccine. Approximately one third of reports (N = 61) were in the post-ACIP guideline period. The 4 most frequent AE coding terms were fever (N = 59, 35%), unspecified or urticarial rash (42, 25%), seizure (28, 17%), and injection site reaction (28, 17%). The median number of days from vaccination to symptom onset, the percentage of reports that represented serious AEs, and the gender distribution were similar in the pre-ACIP guideline and post-ACIP guideline periods. The percentage of reports describing an underlying medical condition for the subject decreased from 58% before the ACIP guideline to 37% after the ACIP guideline. Nineteen of 28 seizure reports (68%) described fever with the seizure within 2 days after vaccination. Seizure was the most frequent coding term (N = 10, 7 with fever) among 23 serious reports. The annual number of TIV-related VAERS reports for children <2 years of age increased in the post-ACIP guideline period, probably at least in part because of an increase in the number of vaccinees after the ACIP announcement. The safety profiles in the pre-ACIP guideline and post-ACIP guideline periods were similar. CONCLUSIONS: In October 2003, the ACIP recommended that all healthy children 6 to 23 months of age be vaccinated with TIV, starting in the 2004-2005 influenza season. This study provides generally reassuring, although limited, data regarding the safety of TIV among children in this age range. Continued surveillance for seizures and other clinically significant AEs is warranted and will continue.
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30.)Vaccines and Guillain-Barré syndrome.
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Haber P, Sejvar J, Mikaeloff Y, DeStefano F.
Drug Saf. 2009;32(4):309-23. doi: 10.2165/00002018-200932040-00005.
Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. PHaber@cdc.gov
Guillain-Barré syndrome (GBS) is the leading cause of acute flaccid paralysis in developed countries and is characterized by various degrees of weakness, sensory abnormalities and autonomic dysfunction. Although the underlying aetiology and pathophysiology of GBS are not completely understood, it is broadly believed that immune stimulation plays a role in its pathogenesis. Thus, since vaccines have an effect on the immune system it is biologically plausible that immunizations may be associated with subsequent GBS. The objective of this article is to review the current body of evidence that either supports or does not support a causal, rather than just temporal, association between various vaccines and GBS, and to provide an evidence-based review of this issue. The scope of the article includes published reports that, regardless of method of case ascertainment, appeared in peer-reviewed literature between 1950 and 2008. Our review indicates that, with rare exceptions, associations between vaccines and GBS have been only temporal. There is little evidence to support a causal association with most vaccines. The evidence for a causal association is strongest for the swine influenza vaccine that was used in 1976-77. Studies of influenza vaccines used in subsequent years, however, have found small or no increased risk of GBS. Older formulations of rabies vaccine cultured in mammalian brain tissues have been found to have an increased risk of GBS, but newer formulations of rabies vaccine, derived from chick embryo cells, do not appear to be associated with GBS at a greater than expected rate. In an earlier review, the Institute of Medicine concluded that the evidence favoured a causal association between oral polio vaccine and tetanus toxoid-containing vaccines and GBS. However, recent evidence from large epidemiological studies and mass immunization campaigns in different countries found no correlation between oral polio vaccine or tetanus toxoid-containing vaccines and GBS. Spontaneous reports to the US Vaccine Adverse Events Reporting System shortly after the introduction of quadrivalent conjugated meningococcal vaccine (MCV4) raised concerns of a possible association with GBS. Comparisons with expected rates of GBS, however, were inconclusive for an increased risk, and lack of controlled epidemiological studies makes it difficult to draw conclusions about a causal association. For other vaccines, available data are based on isolated case reports or very small clusters temporally related to immunizations, and no conclusion about causality can be drawn. There are certain circumstances in which immunizing individuals, particularly those with a prior history of GBS, may require caution. However, the benefit of vaccines in preventing disease and decreasing morbidity and mortality, particularly for influenza, needs to be weighed against the potential risk of GBS.
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31.) potential signal of Bell's palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.
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Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):505-10.
Zhou W, Pool V, DeStefano F, Iskander JK, Haber P, Chen RT; VAERS Working Group.
Epidemic Intelligence Service, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Comment in:
· Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):501-2.
· Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):511-3; discussion 515-7.
PURPOSE: Post-licensure experience with a new intranasal inactivated influenza vaccine in Switzerland recently identified an increased risk for Bell's palsy. We reviewed reports in the Vaccine Adverse Event Reporting System (VAERS) to assess if parenteral inactivated influenza vaccines (influenza vaccines) may also increase the risk for Bell's palsy. METHODS: Reports of Bell's palsy after influenza vaccines in VAERS from 1/1/1991 to 12/31/2001 were identified by searching the Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) for 'paralysis facial' and by text string search in the automated database. The text descriptions on each report were reviewed to verify the diagnosis. The proportional reporting ratio (PRR) was calculated to aid signal detection. RESULTS: We found a total of 197 reports of Bell's palsy after receipt of influenza vaccines. The diagnosis was verified for 154 (78.2%), of which 145 (94.2%) had received influenza vaccines alone. The verified reports were submitted from 35 states; 58% of the reports involved persons living in states where the risk of Lyme disease, which can also cause facial paralysis, was low, minimal or none. The PRRs in all age groups exceeded the criteria for a signal of possible association. The highest PRR was 3.91 in the > or = 65 years age group. CONCLUSIONS: Our findings revealed a signal of possible association between influenza vaccines and an increased risk of Bell's palsy. A population-based controlled study is needed to determine whether this association could be causal and to quantify the risk. 2004 by John Wiley & Sons, Ltd.
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32.) Adverse events reported following live, cold-adapted, intranasal influenza vaccine.
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JAMA. 2005 Dec 7;294(21):2720-5.
Izurieta HS, Haber P, Wise RP, Iskander J, Pratt D, Mink C, Chang S, Braun MM, Ball R.
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md
20852-1448, USA. hector.izurieta@fda.hhs.gov
Erratum in:
· JAMA. 2005 Dec 28;294(24):3092.
Comment in:
· JAMA. 2005 Dec 7;294(21):2763-5.
CONTEXT: In June 2003, the US Food and Drug Administration licensed a trivalent live, attenuated influenza vaccine (LAIV-T) for intranasal administration to healthy persons 5 to 49 years of age. Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably. OBJECTIVE: To identify adverse events reported following LAIV-T administration after licensure. DESIGN, SETTING, AND PARTICIPANTS: All adverse events reported to the US Vaccine Adverse Event Reporting System (VAERS) during the 2003-2004 and the 2004-2005 influenza seasons. MAIN OUTCOME MEASURES: Numbers and proportions of reported adverse events and reporting rates of adverse events per 100,000 vaccinees. RESULTS: Approximately 2,500,000 persons received LAIV-T during the first 2 postlicensure seasons. As of August 16, 2005, VAERS received 460 adverse event reports for vaccinations received from August 2003 through July 2005. No fatalities were reported. There were 7 reports of possible anaphylaxis, 2 reports of Guillain-Barré syndrome, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history. Events in individuals for whom the vaccine was not indicated accounted for 73 reports (16%). CONCLUSIONS: Reports to VAERS in the first 2 seasons of LAIV-T use did not identify any unexpected serious risks with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis. Secondary transmission of the vaccine virus merits further investigation. Reports of asthma exacerbations in vaccinees with prior asthma history highlight the risks of vaccine use inconsistent with approved labeling.
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33.) Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience.
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Expert Rev Vaccines. 2008 Feb;7(1):75-82.
Iskander J, Broder K.
US Public Health Service, Immunization Safety Office, Office of Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, MS D-26, Atlanta, GA 30333, USA. jxi0@cdc.gov
Annual use of influenza vaccines represents the largest vaccine campaign conducted in the USA. Recent expansions in influenza vaccine recommendations suggest a move toward 'universal' vaccination strategies. Although a great deal of safety data has been accumulated, concerns remain regarding rare, serious adverse events following immunization. A proven association between the 1976-1977 swine influenza vaccine and Guillain-Barré syndrome halted that particular national vaccination campaign. Recently, annual influenza vaccines have been associated with novel adverse events, for example, oculorespiratory syndrome in Canada. Any vaccine used against an influenza strain of pandemic potential will have an incompletely described safety profile. Thus, the challenge of influenza vaccine safety is to detect new safety concerns that may arise during seasonal campaigns, while preparing vaccine safety systems for the timely detection of adverse events in the setting of a pandemic.
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34.) Are toxic biometals destroying your children's future?
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Biometals. 2009 Oct;22(5):697-700. Epub 2009 Feb 11
Drum DA.
poohpadon@wowway.com
Cadmium, arsenic, lead, and mercury have been linked to autism, attention deficit disorder, mental retardation and death of children. Mercury in thimerosal found in many vaccines and flu shots contributes significantly to these problems. Decomposition of the thimerosal can produce more toxic compounds, either methylethylmercury or diethylmercury, in the body. These compounds have a toxicity level similar to dimethylmercury. Within the human body, a mitochondrial disorder may release the more toxic form of mercury internally. Young children and pregnant women must minimize internal exposure to the vaccines and flu shots containing mercury.
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35.) Surveillance for safety after immunization: Vaccine Adverse Event Reporting System
(VAERS)--United States, 1991-2001.
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MMWR Surveill Summ. 2003 Jan 24;52(1):1-24
Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.
Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA.
Erratum in:
· MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.
PROBLEM/CONDITION: Vaccines are usually administered to healthy persons who have substantial expectations for the safety of the vaccines. Adverse events after vaccinations occur but are generally rare. Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations. Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events. REPORTING PERIOD COVERED: This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from January 1, 1991, through December 31, 2001. DESCRIPTION OF SYSTEMS: VAERS was established in 1990 under the joint administration of CDC and the Food and Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed in the United States. VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who experience them, their caregivers, or others. Passive surveillance systems (e.g., VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. Reports may be submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted by mail or fax. A web-based electronic reporting system has recently become available. Information from the reports is entered into the VAERS database, and new reports are analyzed weekly. VAERS data stripped of personal identifiers can be reviewed by the public by accessing http://www.vaers.org. The objectives of VAERS are to 1) detect new, unusual, or rare vaccine adverse events; 2) monitor increases in known adverse events; 3) determine patient risk factors for particular types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5) assess the safety of newly licensed vaccines. RESULTS: During 1991-2001, VAERS received 128,717 reports, whereas >1.9 billion net doses of human vaccines were distributed. The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per 100,000 net doses distributed. The proportions of reports in the age groups <1 year, 1-6 years, 7-17 years, 18-64 years, and >/= years were 18.1%, 26.7%, 8.0%, 32.6%, and 4.9%, respectively. In all of the adult age groups, a predominance among the number of women reporting was observed, but the difference in sex was minimal among children. Overall, the most commonly reported adverse event was fever, which appeared in 25.8% of all reports, followed by injection-site hypersensitivity (15.8%), rash (unspecified) (11.0%), injection-site edema (10.8%), and vasodilatation (10.8%). A total of 14.2% of all reports described serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability. Examples of the uses of VAERS data for vaccine safety surveillance are included in this report. INTERPRETATION: As a national public health surveillance system, VAERS is a key component in ensuring the safety of vaccines. VAERS data are used by CDC, FDA, and other organizations to monitor and study vaccine safety. CDC and FDA use VAERS data to respond to public inquiries regarding vaccine safety, and both organizations have published and presented vaccine safety studies based on VAERS data. VAERS data are also used by the Advisory Committee on Immunization Practices and the Vaccine and Related Biological Products Advisory Committee to evaluate possible adverse events after vaccinations and to develop recommendations for precautions and contraindications to vaccinations. Reviews of VAERS reports and the studies based on VAERS reports during 1991-2001 have demonstrated that vaccines are usually safe and that serious adverse events occur but are rare. PUBLIC HEALTH ACTIONS: Through continued reporting of adverse events after vaccination to VAERS by health-care providers, public health professionals, and the public and monitoring of reported events by the VAERS working group, the public health system will continue to be able to detect rare but potentially serious consequences of vaccination. This knowledge facilitates improvement in the safety of vaccines and the vaccination process.
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36.) Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States.
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Pediatrics. 2008 Apr;121(4):e836-43.
Smith MJ, Ellenberg SS, Bell LM, Rubin DM.
Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. mjsmit22@louisville.edu
Comment in:
· Pediatrics. 2008 Sep;122(3):684-5; author reply 685-6.
OBJECTIVE: The purpose of this work was to assess the association between media coverage of the MMR-autism controversy and MMR immunization in the United States. METHODS: The public-use files of the National Immunization Survey were used to estimate annual MMR coverage from 1995 to 2004. The primary outcome was selective measles-mumps-rubella nonreceipt, that is, those children who received all childhood immunizations except MMR. Media coverage was measured by using LexisNexis, a comprehensive database of national and local news media. Factors associated with MMR nonreceipt were identified by using a logistic regression model. RESULTS: Selective MMR nonreceipt, occurring in as few as 0.77% of children in the 1995 cohort, rose to 2.1% in the 2000 National Immunization Survey. Children included in the 2000 National Immunization Survey were born when the putative link between MMR and autism surfaced in the medical literature but before any significant media attention occurred. Selective nonreceipt was more prevalent in private practices and unrelated to family characteristics. MMR nonreceipt returned to baseline before sustained media coverage of the MMR-autism story began. CONCLUSIONS: There was a significant increase in selective MMR nonreceipt that was temporally associated with the publication of the original scientific literature, suggesting a link between MMR and autism, which preceded media coverage of the MMR-autism controversy. This finding suggests a limited influence of mainstream media on MMR immunization in the United States.
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37.) A meta-analysis epidemiological assessment of neurodevelopmental disorders following vaccines administered from 1994 through 2000 in the United States.
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Neuro Endocrinol Lett. 2006 Aug;27(4):401-13.
Geier DA, Geier MR.
The Institute for Chronic Illnesses, Inc., Silver Spring, MD 20905, USA. mgeier@comcast.net
BACKGROUND: Thimerosal is an ethylmercury-containing compound (49.6% mercury by weight) used as at the preservative level in vaccines (0.005% to 0.01%). METHODS: Statistical modeling in a meta-analysis epidemiological assessment of the Vaccine Adverse Event Reporting System (VAERS) for neurodevelopment disorders (NDs) reported following Diphtheria-Tetanus-whole-cell-Pertussis (DTP) vaccines in comparison to Diphtheria-Tetanus-whole-cell-Pertussis-Haemophilus Influenzae Type b (DTPH) vaccines (administered: 1994-1997) and following Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis (DTaP), vaccines in comparison to Thimerosal-free DTaP vaccines (administered: 1997-2000), was undertaken. RESULTS: Significantly increased adjusted (sex, age, vaccine type, vaccine manufacturer) risks of autism, speech disorders, mental retardation, personality disorders, thinking abnormalities, ataxia, and NDs in general, with minimal systematic error or confounding, were associated with TCV exposure. CONCLUSION: It is clear from the results of the present epidemiological study and other recently published data associating mercury exposure with childhood NDs, additional ND research should be undertaken in the context of evaluating mercury-associated exposures, especially from Thimerosal-containing vaccines.
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38.) An evaluation of the effects of thimerosal on neurodevelopmental disorders reported following DTP and Hib vaccines in comparison to DTPH vaccine in the United States.
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J Toxicol Environ Health A. 2006 Aug;69(15):1481-95.
Geier DA, Geier MR.
The Genetic Centers of America, Silver Spring, Maryland 20905, USA. mgeier@comcast.net
Thimerosal is an ethylmercury (49.55% mercury by weight) preservative historically added to some vaccines. Toxicokinetic studies showed children in the United States received doses of mercury from Thimerosal-containing vaccines (TCVs) in excess of safety guidelines. In the United States during the 1990s, diphtheria-tetanus-pertussis (DTP) and Haemophilus influenzae type b (Hib) vaccines (maximally, 50 mug mercury per joint administration) and diphtheria-tetanus-pertussis-Haemophilus influenzae type b (DTPH) vaccines (25 mug mercury per administration) were given to children in the same childhood vaccination schedule at 2, 4, 6, and 15-18 mo, so that children receiving DTP and Hib vaccines may have maximally received an additional 100 mug more mercury exposure from TCVs than children administered DTPH vaccines. A case-control epidemiological study of neurodevelopmental disorders (NDs) reported to the Vaccine Adverse Event Reporting System (VAERS) (online public access version; updated 31 August 2004) following administration of DTP vaccines in comparison DTPH vaccines manufactured by Lederle Laboratories (Pearl River, NY) from 1994 through 1998 was undertaken. Significantly increased odds ratios for autism, speech disorders, mental retardation, infantile spasms, and thinking abnormalities reported to VAERS were found following DTP vaccines in comparison to DTPH vaccines with minimal bias or systematic error. Additional ND research should be undertaken in the context of evaluating mercury-associated exposures, especially since in 2005 the Institute of Medicine issued a report calling into question handling of vaccine safety data by the National Immunization Program of the Centers for Disease Control and Prevention
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39.) Neurodevelopmental disorders following thimerosal-containing childhood immunizations: a follow-up analysis.
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Int J Toxicol. 2004 Nov-Dec;23(6):369-76.
Geier D, Geier MR.
MedCon, Inc., Maryland, USA.
The authors previously published the first epidemiological study from the United States associating thimerosal from childhood vaccines with neurodevelopmental disorders (NDs) based upon assessment of the Vaccine Adverse Event Reporting System (VAERS). A number of years have gone by since their previous analysis of the VAERS. The present study was undertaken to determine whether the previously observed effect between thimerosal-containing childhood vaccines and NDs are still apparent in the VAERS as children have had a chance to further mature and potentially be diagnosed with additional NDs. In the present study, a cohort of children receiving thimerosal-containing diphtheria-tetanus-acellular pertussis (DTaP) vaccines in comparison to a cohort of children receiving thimerosal-free DTaP vaccines administered from 1997 through 2000 based upon an assessment of adverse events reported to the VAERS were evaluated. It was determined that there were significantly increased odds ratios (ORs) for autism (OR = 1.8, p < .05), mental retardation (OR = 2.6, p < .002), speech disorder (OR = 2.1, p < .02), personality disorders (OR = 2.6, p < .01), and thinking abnormality (OR = 8.2, p < .01) adverse events reported to the VAERS following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. Potential confounders and reporting biases were found to be minimal in this assessment of the VAERS. It was observed, even though the media has reported a potential association between autism and thimerosal exposure, that the other NDs analyzed in this assessment of the VAERS had significantly higher ORs than autism following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. The present study provides additional epidemiological evidence supporting previous epidemiological, clinical and experimental evidence that administration of thimerosal-containing vaccines in the United States resulted in a significant number of children developing NDs.
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40.) Neurodevelopmental disorders after thimerosal-containing vaccines: a brief communication.
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Exp Biol Med (Maywood). 2003 Jun;228(6):660-4.
Geier MR, Geier DA.
The Genetic Centers of America, Silver Spring, Maryland 20905, USA. mgeier@erols.com
Comment in:
· Exp Biol Med (Maywood). 2003 Oct;228(9):991-2; discussion 993-4.
We were initially highly skeptical that differences in the concentrations of thimerosal in vaccines would have any effect on the incidence rate of neurodevelopmental disorders after childhood immunization. This study presents the first epidemiologic evidence, based upon tens of millions of doses of vaccine administered in the United States, that associates increasing thimerosal from vaccines with neurodevelopmental disorders. Specifically, an analysis of the Vaccine Adverse Events Reporting System (VAERS) database showed statistical increases in the incidence rate of autism (relative risk [RR] = 6.0), mental retardation (RR = 6.1), and speech disorders (RR = 2.2) after thimerosal-containing diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in comparison with thimerosal-free DTaP vaccines. The male/female ratio indicated that autism (17) and speech disorders (2.3) were reported more in males than females after thimerosal-containing DTaP vaccines, whereas mental retardation (1.2) was more evenly reported among male and female vaccine recipients. Controls were employed to determine if biases were present in the data, but none were found. It was determined that overall adverse reactions were reported in similar-aged populations after thimerosal-containing DTaP (2.4 +/- 3.2 years old) and thimerosal-free DTaP (2.1 +/- 2.8 years old) vaccinations. Acute control adverse reactions such as deaths (RR = 1.0), vasculitis (RR = 1.2), seizures (RR = 1.6), ED visits (RR = 1.4), total adverse reactions (RR = 1.4), and gastroenteritis (RR = 1.1) were reported similarly after thimerosal-containing and thimerosal-free DTaP vaccines. An association between neurodevelopmental disorders and thimerosal-containing DTaP vaccines was found, but additional studies should be conducted to confirm and extend this study.
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41.) A comparative evaluation of the effects of MMR immunization and mercury doses from thimerosal-containing childhood vaccines on the population prevalence of autism.
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Med Sci Monit. 2004 Mar;10(3):PI33-9. Epub 2004 Mar 1.
Geier DA, Geier MR.=
President, MedCon, Inc, Silver Spring, MD, USA.
Comment in:
· Med Sci Monit. 2005 Oct;11(10):LE13-4.
BACKGROUND: The purpose of the study was to evaluate the effects of MMR immunization and mercury from thimerosal-containing childhood vaccines on the prevalence of autism. MATERIAL/METHODS: Evaluations of the Biological Surveillance Summaries of the Centers for Disease Control and Prevention (CDC), the U.S. Department of Education datasets, and the CDC's yearly live birth estimates were undertaken RESULTS: It was determined that there was a close correlation between mercury doses from thimerosal--containing childhood vaccines and the prevalence of autism from the late 1980s through the mid-1990s. In contrast, there was a potential correlation between the number of primary pediatric measles-containing vaccines administered and the prevalence of autism during the 1980s. In addition, it was found that there were statistically significant odds ratios for the development of autism following increasing doses of mercury from thimerosal-containing vaccines (birth cohorts: 1985 and 1990-1995) in comparison to a baseline measurement (birth cohort: 1984). The contribution of thimerosal from childhood vaccines (>50% effect) was greater than MMR vaccine on the prevalence of autism observed in this study. CONCLUSIONS: The results of this study agree with a number of previously published studies. These studies have shown that there is biological plausibility and epidemiological evidence showing a direct relationship between increasing doses of mercury from thimerosal-containing vaccines and neurodevelopmental disorders, and measles-containing vaccines and serious neurological disorders. It is recommended that thimerosal be removed from all vaccines, and additional research be undertaken to produce a MMR vaccine with an improved safety profile
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42.) Aluminum adjuvant linked to Gulf War illness induces motor neuron death in mice.
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Neuromolecular Med. 2007;9(1):83-100.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.
Department of Ophthalmology and Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada. mspetrik@interchange.ubc.ca
Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants
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43.) Influenza vaccine with squalene adjuvant: new preparation. No better than available products.
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Prescrire Int. 2004 Dec;13(74):206-8.
[No authors listed]
(1) Injectable influenza vaccines reduce morbidity and mortality in people over 65 years. (2) A new influenza vaccine, with an adjuvant (MF59C.1) based on squalene, is now marketed in France for people over 65, and especially those with chronic conditions at risk of influenza complications. (3) The clinical evaluation dossier contains data from about twenty immunogenicity studies in more than 4000 elderly subjects. According to a meta-analysis of these studies, there is no firm evidence that the MF59C.1 adjuvant vaccine is any better than other vaccines at inducing immunity in elderly people with chronic conditions. (4) A retrospective analysis of mortality among subjects enrolled in immunogenicity studies showed no significant difference between groups receiving the squalene adjuvant vaccine and groups receiving another influenza vaccine, either in the general population or in subsets of patients with relevant chronic conditions. (5) Local adverse effects (pain, rash, induration) and systemic adverse effects (malaise, myalgia, headache) were significantly more common after the squalene adjuvant vaccine than after other influenza vaccines. Pharmacovigilance data collected by the company show no unexpected adverse events. (6) In practice, there is no reason to prefer the squalene adjuvant vaccine to existing vaccines for elderly people, whether or not they have underlying chronic conditions.
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44.) Antibodies to squalene in recipients of anthrax vaccine.
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Exp Mol Pathol. 2002 Aug;73(1):19-27.
Asa PB, Wilson RB, Garry RF.
Department of Microbiology, Tulane University Medical School, New Orleans, Louisiana 70112, USA.
We previously reported that antibodies to squalene, an experimental vaccine adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000). The United States Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP) in 1997 to immunize 2.4 million military personnel. Because adverse reactions in vaccinated personnel were similar to symptoms of GWS, we tested AVIP participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were positive for ASA. In a larger blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of controls were positive (P > 0.05). Further analysis revealed that ASA were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P < 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional personnel revealed that in all but one case (19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine known to contain squalene. Except for one symptomatic individual, positive clinical findings in 17 ASA-negative personnel were restricted to 4 individuals receiving vaccine from lots containing squalene. ASA were not present prior to vaccination in preimmunization sera available from 4 AVIP personnel. Three of these individuals became ASA positive after vaccination. These results suggest that the production of ASA in GWS patients is linked to the presence of squalene in certain lots of anthrax vaccine.
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45.)Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration.
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J Inorg Biochem. 2009 Nov;103(11):1555-62. Epub 2009 Aug 20.
Shaw CA, Petrik MS.
Departments of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada. cashawlab@gmail.com
Gulf War Syndrome is a multi-system disorder afflicting many veterans of Western armies in the 1990-1991 Gulf War. A number of those afflicted may show neurological deficits including various cognitive dysfunctions and motor neuron disease, the latter expression virtually indistinguishable from classical amyotrophic lateral sclerosis (ALS) except for the age of onset. This ALS "cluster" represents the second such ALS cluster described in the literature to date. Possible causes of GWS include several of the adjuvants in the anthrax vaccine and others. The most likely culprit appears to be aluminum hydroxide. In an initial series of experiments, we examined the potential toxicity of aluminum hydroxide in male, outbred CD-1 mice injected subcutaneously in two equivalent-to-human doses. After sacrifice, spinal cord and motor cortex samples were examined by immunohistochemistry. Aluminum-treated mice showed significantly increased apoptosis of motor neurons and increases in reactive astrocytes and microglial proliferation within the spinal cord and cortex. Morin stain detected the presence of aluminum in the cytoplasm of motor neurons with some neurons also testing positive for the presence of hyper-phosphorylated tau protein, a pathological hallmark of various neurological diseases, including Alzheimer's disease and frontotemporal dementia. A second series of experiments was conducted on mice injected with six doses of aluminum hydroxide. Behavioural analyses in these mice revealed significant impairments in a number of motor functions as well as diminished spatial memory capacity. The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant suggest that greater scrutiny by the scientific community is warranted.
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46.) Aluminum-induced model of motor neuron degeneration: subperineurial injection of aluminum in rabbits.
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Neurotoxicology. 1995 Fall;16(3):413-24.\
Kihira T, Yoshida S, Komoto J, Wakayama I, Yase Y.
Division of Neurological Diseases, Wakayama Medical College, Japan.
Environmental factors, particularly chronic exposure to aluminum (Al) and manganese (Mn) with dietary deficiency of calcium (Ca) and magnesium (Mg), are speculated to be contributory in the pathogenesis of amyotrophic lateral sclerosis (ALS). However, the mechanisms by which these elements accumulate in the CNS tissues and induce neuronal death are not known. In the present study, we investigated the retrograde transport of Al as a possible mechanism of pathogenesis. Al (as aluminum chloride or maltol) was injected into the subepineurial space of the sciatic nerve with subsequent morphological evaluation of the neurotoxic effect on spinal motor neurons in rabbits. Spheroid/globules, central and peripheral chromatolysis, and neuronal degeneration were observed in the spinal anterior horn in Al-maltol, Al chloride, and maltol treated rabbits to more marked extent than those in uninjected or saline controls. By electron microscopy, the soma and dendrites of neurons in the anterior horn at the fifth lumbar spinal cord in the Al-treated rabbit showed marked edematous change, fragmentation of granular endoplasmic reticulum, increased accumulation of neurofilament, and accumulation of free ribosomes and lipid-droplet-like structures. Horseradish peroxidase (HRP) reactive product was seen in the axons and cytoplasm of Schwann cells of the sciatic nerve in Al-maltol treated rabbits, suggesting that the permeability of the blood-nerve-barrier was increased by injection of Al-maltol. We suggest that Al, subperineurially injected, was absorbed into the spinal cord and induced degeneration of spinal motor neurons in these rabbits. These findings indicate that the retrograde transport of Al into spinal motor neurons via the peripheral nervous system may exacerbate neuronal degeneration in ALS.
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47.) Vaccines as a trigger for myopathies.
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Lupus. 2009 Nov;18(13):1213-6.
Orbach H, Tanay A.
Department of Medicine B, Wolfson Medical Center, Holon, Israel. orbach@wolfson.health.gov.il
Vaccines are considered to be among the greatest medical discoveries, credited with the virtual eradication of some diseases and the consequent improved survival and quality of life of the at-risk population. With that, vaccines are among the environmental factors implicated as triggers for the development of inflammatory myopathies. The sporadic reports on vaccine-induced inflammatory myopathies include cases of hepatitis B virus, bacillus Calmette-Guérin, tetanus, influenza, smallpox, polio, diphtheria, diphtheria-pertussis-tetanus, combination of diphtheria with scarlet fever and diphtheria-pertussis-tetanus with polio vaccines. However, a significant increase in the incidence of dermatomyositis or polymyositis after any massive vaccination campaign has not been reported in the literature. In study patients with inflammatory myopathies, no recent immunization was recorded in any of the patients. Moreover, after the 1976 mass flu vaccination, no increase in the incidence of inflammatory myopathies was observed. Although rare, macrophagic myofasciitis has been reported following vaccination and is attributed to the aluminium hydroxide used as an adjuvant in some vaccines. Prospective multicenter studies are needed to identify potential environmental factors, including vaccines, as potential triggers for inflammatory myopathies.
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48.) Induction of metallothionein in mouse cerebellum and cerebrum with low-dose thimerosal injection.
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Cell Biol Toxicol. 2009 Apr 9. [Epub ahead of print]
Minami T, Miyata E, Sakamoto Y, Yamazaki H, Ichida S.
Department of Life Sciences, School of Science & Engineering, Kinki University, 3-4-1
Kowakae, Higashi-osaka, Osaka, 577-8502, Japan, minamita@life.kindai.ac.jp.
Thimerosal, an ethyl mercury compound, is used worldwide as a vaccine preservative. We previously observed that the mercury concentration in mouse brains did not increase with the clinical dose of thimerosal injection, but the concentration increased in the brain after the injection of thimerosal with lipopolysaccharide, even if a low dose of thimerosal was administered. Thimerosal may penetrate the brain, but is undetectable when a clinical dose of thimerosal is injected; therefore, the induction of metallothionein (MT) messenger RNA (mRNA) and protein was observed in the cerebellum and cerebrum of mice after thimerosal injection, as MT is an inducible protein. MT-1 mRNA was expressed at 6 and 9 h in both the cerebrum and cerebellum, but MT-1 mRNA expression in the cerebellum was three times higher than that in the cerebrum after the injection of 12 microg/kg thimerosal. MT-2 mRNA was not expressed until 24 h in both organs. MT-3 mRNA was expressed in the cerebellum from 6 to 15 h after the injection, but not in the cerebrum until 24 h. MT-1 and MT-3 mRNAs were expressed in the cerebellum in a dose-dependent manner. Furthermore, MT-1 protein was detected from 6 to 72 h in the cerebellum after 12 microg/kg of thimerosal was injected and peaked at 10 h. MT-2 was detected in the cerebellum only at 10 h. In the cerebrum, little MT-1 protein was detected at 10 and 24 h, and there were no peaks of MT-2 protein in the cerebrum. In conclusion, MT-1 and MT-3 mRNAs but not MT-2 mRNA are easily expressed in the cerebellum rather than in the cerebrum by the injection of low-dose thimerosal. It is thought that the cerebellum is a sensitive organ against thimerosal. As a result of the present findings, in combination with the brain pathology observed in patients diagnosed with autism, the present study helps to support the possible biological plausibility for how low-dose exposure to mercury from thimerosal-containing vaccines may be associated with autism.
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49.) Neonate exposure to thimerosal mercury from hepatitis B vaccines.
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Am J Perinatol. 2009 Aug;26(7):523-7. Epub 2009 Mar 12.=
Dórea JG, Marques RC, Brandão KG.
Universidade de Brasília, DF, Brazil. dorea@rudah.com.br
Infant exposure to ethylmercury (EtHg) has not only increased but is starting earlier as a result of the current immunization schedule that uses thimerosal-containing vaccines (TCVs). Although vaccination schedule varies considerably between countries, infants in less-developed countries continue to be exposed to EtHg derived from more affordable TCVs. We studied the exposure of newborns to EtHg from hepatitis B vaccines; hospital records (21,685) were summarized for the years 2001 to 2005 regarding date of birth, vaccination date, and birth weight. Most of the vaccinations occurred in the first 24 hours postdelivery; over the 5 years, there was an increase in vaccinations within hours of birth (same day), from 7.4% (2001) to 87.8% (2005). Nearly 94.6% of infants are now being vaccinated within the first 24 hours. Range of mercury exposure spread from 4.2 to 21.1 microg mercury/kg body weight for those receiving TCVs with the highest thimerosal concentration; these exposure levels are conservative for 2% of children receiving vaccines within 2 to 3 postnatal days, when they are still going through physiological postnatal weight loss. Because of the particular timing (transitioning from in utero to ex utero metabolism) and specific aspects of exposure (i.e., parenteral mode, bypassing gastroenteric barriers) and dose (related to vaccine manufacturer and with variation in birth weight), this study reveals critical issues that can modulate toxicokinetics and toxicodynamics of organomercurials in neonates.
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50.) Secret CDC vaccine study Thimerosal an autism risk
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Sources: www.whale.to
AUTISM FIRST STEPS
AUTISM DAILY NEWSLETTER
Thursday January 3, 2002
SPECIAL EDITION
An unreleased confidential report by Center's for Disease Control (CDC) scientists reveals that
exposure to significant amounts of mercury during the first months of life significantly increases a
child's risk of developing autism, according to an attorney with the law firm of Walters & Kraus. The
firm is a part of a coalition of law firms, representing families in at least 25 states, that has filed
lawsuits in an attempt to force drug companies to investigate the possible link between mercury and developmental disorders.
Attorney Andy Walters says that the unreleased CDC report, obtained by the SAFEMINDS
advocacy group, found a 2.48 times increased risk of autism in children exposed to more then 62.5
micrograms of mercury before they were 3 months of age. In a press release, Walters and Kraus
notes that "in the United States, courts of law have generally held that a relative increased risk of 2.0 or higher is sufficient to substantiate that a given exposure causes disease." Walters says that in many of the cases that his firm has evaluated, autistic children have received more than 62.5 micrograms of mercury through pediatric vaccines.
A report made public by the CDC in the fall claimed that the thimerosal, the mercury containing
preservative used in many vaccines, could not be linked to autism, while calling on Physicians to
avoid thimerosal containing vaccines when possible. However, according to Walters & Kraus, the
confidential CDC report states: "As for the exposure evaluated at 3 months of age, we found
increasing risks of "neurological developmental disorders" with increasing cumulative exposure to
thimerosal... within the group of "developmental disorders"... for the subgroup called "specific
delays," and within the this subgroup for the specific disorder "developmental speech disorder," and
for "autism" "stuttering" and "attention deficit disorder".
Walters says the report's contents, and the fact that it was kept secret, are "shocking, but
unfortunately not surprising, given the political influence of pharmaceutical companies and the
tremendous liability they face if they are forced to compensate thousands of families for the costs of
care that these children require".
Press Release, Walters & Kraus, 2001
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PRESS RELEASE
An announcement was made today by the law firm of Waters & Kraus, the firm that filed the first
known lawsuit alleging that a mercury preservative in children's vaccines caused neurological damage to an infant ultimately diagnosed with autism. Waters & Kraus is leading a consortium of ten firms in as many states that are actively prosecuting cases of this nature (firms listed below). Andy Waters, the lead attorney in the cases, announced that his firm is now in possession of a previously unreleased confidential report authored by Centers for Disease Control scientists which studied autism as a potential neurological injury caused by mercury in children's vaccines. A different version of the report was made public and has been cited by the recent Institute of Medicine study as inconclusive on the issue of whether the mercury-based vaccine preservative known as Thimerosal has contributed to cause a nationwide epidemic of regressive autism and other neurological disorders in small children. The confidential version of the study, however, clearly demonstrated that an exposure to more than 62.5 micrograms of mercury within the first three months of life significantly increased a child's risk of developing autism. Specifically, the study found a 2.48 times increased risk of autism _ that is to say, children with the exposure were more than twice as likely to develop autism as children not exposed. Click here to view the full report. (27 pages formatted in TIFF) In the United States, courts of law have generally held that a relative increased risk of 2.0 or higher is sufficient to substantiate that a given exposure causes disease. As but one example, in the case of Cook v. United States, 545 F.Supp. 306, at 308 (Northern District _ California 1982) the Court stated that, "in a vaccine case, a relative risk greater than 2.0 establishes that there is a greater than 50% chance that the injury was caused by the vaccine." Waters indicated that, in many of the cases his firm has evaluated, including the case filed in a Texas state court on behalf of the Counter family, the affected child received more than 62.5 micrograms of mercury through pediatric vaccines in the first three months of life. The confidential report, which was obtained by the SAFEMINDS support and advocacy group, states: "As for the exposure evaluated at 3 months of age, we found increasing
risks of 'neurological developmental disorders' with increasing cumulative exposure to thimerosal ...
within the group of 'developmental disorders'... for the sub_group called 'specific delays,' and within this sub_group for the specific disorder 'developmental speech disorder,' and for 'autism,' 'stuttering' and 'attention deficit disorder.'" The report also contained the graph depicted below which illustrated the report's findings of a child's increasing risk of developing the neurological symptoms of autism after receiving increasing amounts of thimerosal.Graph 3: Relative risk 95 % CI of Autism after different exposure levels of thimerosal at 3 months of age, NCK & GHCWaters pointed out that the confidential study's lead author, Thomas Verstraeten, has since left the Centers for Disease Control and is now employed by GlaxoSmithKline, a manufacturer of thimerosal_containing vaccines for many years that is a defendant in numerous suits pending nationwide. "We have asked GlaxoSmithKline to provide Mr. Verstraeten's deposition in order to understand if conflict of interest issues may have played a role in the CDC's decision to keep this report confidential, and specifically, their failure to reveal it to the Institute of Medicine."Waters called the report's contents and the fact that it was kept from the public as "shocking, but unfortunately not surprising, given the political influence of pharmaceutical companies and the tremendous liability they face if they are forced to compensate thousands of families for the costs of care that these children require." Waters added that "no amount of money can give these children back the potential that they were born with, and no amount of money will comfort the parents that watched helplessly as their children literally just slipped away." The purpose of the lawsuits his firm is currently prosecuting, said Waters, is "to bring
to the surface the truth on this issue, a truth that government agencies seem unwilling to admit,
perhaps for fear that parents will stop vaccinating their children, and to force the companies that profited from this disastrous mistake to shoulder the responsibility that so many families now bear on their own, often without even the aid of health insurance benefits." Media inquiries should be directed to Melissa Miles at 214-357-6244.Client inquiries should be directed to Victoria Gibson, toll-free at 1-866-829-7529, or to the firms listed below.Other firms working with Waters & Kraus to prosecute individual cases involving thimerosal exposure are:ANDERSON & KRIGER,
APLC40925 County Center Drive, Suite 210Temecula, California 92591Telephone:
909.296.5090DOGAN & WILKINSON726 Delmas AvenuePascagoula, Mississippi
39567Telephone: 228.762.2272 DORAN & MURPHY, LLP1234 Delaware AvenueBuffalo, New
York 14209Telephone: 716.884.2000EVERT & WEATHERSBY, L.L.C.3405 Piedmont Road,
Suite 225Atlanta, Georgia 30305-1764Telephone : 404.233.8718HENDRICKSON & LONG214
Capital StreetP.O. Box 11070Charleston, W. VA 25339Telephone: 304.346.5500JONES,
MARTIN, PARRIS, &TESSENER LAW OFFICES, PLLC410 Glenwood Ave., Suite
200Raleigh, North Carolina 27603Telephone: 919.821.0005LEACH, SCHWARZ
&STRASSBERG11 Bala Ave.Bala Cynwyd, Pennsylvania 19004Telephone:
610.668.7964MARTZELL & BICKFORD338 Lafayette StreetNew Orleans, Louisianna
70130Telephone: 504.581.90653555 College AvenueWISE & JULIAN, PC3555 College
AvenueAlton, Illinois 62002Telephone: 618.462.2600
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51.) Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed?
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Med Microbiol Immunol. 2009 Oct 23. [Epub ahead of print]
Bhakdi S, Lackner K, Doerr HW.
Institute of Medical Microbiology and Hygiene, University Medical Center, Augustusplatz, 55101, Mainz, Germany, sbhakdi@uni-mainz.de.
Programs for vaccination against the new influenza A/H1N1 targeting many hundred million citizens in Europe and the USA are to be launched in the fall of this year. The USA is planning to employ a non-adjuvanted vaccine, whereas European nations are opting for inclusion of MF59, the adjuvant contained in an alternative seasonal flu vaccine, or the related adjuvant AS03 that is contained in a recently developed H5N1 vaccine. We draw attention to unappreciated hazards of using adjuvanted vaccine in Europe. Evidence from animal experiments in conjunction with clinical epidemiological data indicates that, quite irrespective of cause, stimulation of the immune system may accelerate atherogenesis. Application of adjuvanted flu vaccines to individuals at risk may therefore aggravate the course of underlying atherosclerotic vessel disease with all the clinical consequences. The same may hold true for other widespread diseases that are propelled by deregulated immune mechanisms. Safety trials conducted to date have not specifically taken these possible side effects into account, and unexpected serious adverse effects thus may follow in the wake of a general vaccination program. A prudent consequence would be to establish careful survey systems alongside with mass application of new adjuvanted vaccines, or to hold mass vaccination in reserve for use only in situations of true need, such as would arise with the emergence of a more virulent new H1N1 virus strain, or to use non-adjuvanted vaccines in individuals who are potentially at risk for adverse side effects.
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52.) Adjuvants and autoimmunity.
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Lupus. 2009 Nov;18(13):1217-25
Israeli E, Agmon-Levin N, Blank M, Shoenfeld Y.
Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel.
Some adjuvants may exert adverse effects upon injection or, on the other hand, may not trigger a full immunological reaction. The mechanisms underlying adjuvant adverse effects are under renewed scrutiny because of the enormous implications for vaccine development. In the search for new and safer adjuvants, several new adjuvants were developed by pharmaceutical companies utilizing new immunological and chemical innovations. The ability of the immune system to recognize molecules that are broadly shared by pathogens is, in part, due to the presence of special immune receptors called toll-like receptors (TLRs) that are expressed on leukocyte membranes. The very fact that TLR activation leads to adaptive immune responses to foreign entities explains why so many adjuvants used today in vaccinations are developed to mimic TLR ligands. Alongside their supportive role, adjuvants were found to inflict by themselves an illness of autoimmune nature, defined as 'the adjuvant diseases'. The debatable question of silicone as an adjuvant and connective tissue diseases, as well as the Gulf War syndrome and macrophagic myofaciitis which followed multiple injections of aluminium-based vaccines, are presented here. Owing to the adverse effects exerted by adjuvants, there is no doubt that safer adjuvants need to be developed and incorporated into future vaccines. Other needs in light of new vaccine technologies are adjuvants suitable for use with mucosally delivered vaccines, DNA vaccines, cancer and autoimmunity vaccines. In particular, there is demand for safe and non-toxic adjuvants able to stimulate cellular (Th1) immunity. More adjuvants were approved to date besides alum for human vaccines, including MF59 in some viral vaccines, MPL, AS04, AS01B and AS02A against viral and parasitic infections, virosomes for HBV, HPV and HAV, and cholera toxin for cholera. Perhaps future adjuvants occupying other putative receptors will be employed to bypass the TLR signaling pathway completely in order to circumvent common side effects of adjuvant-activated TLRs such as local inflammation and the general malaise felt because of the costly whole-body immune response to antigen.
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53.)Oseltamivir-Resistant Influenza Virus A (H1N1), Europe, 2007–08 Season
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Adam Meijer, Angie Lackenby, Olav Hungnes, Bruno Lina, Sylvie van der Werf, Brunhilde Schweiger, Matthias Opp, John Paget, Jan van de Kassteele, Alan Hay, Maria Zambon, and on behalf of the European Influenza Surveillance Scheme1
Netherlands Institute for Health Services Research, Utrecht, the Netherlands (A. Meijer, J. Paget)
National Institute for Public Health and the Environment, Bilthoven, the Netherlands (A. Meijer,
J. van de Kassteele)
European Surveillance Network for Vigilance against Viral Resistance (A. Lackenby, B. Lina, S. van der Werf, A. Hay, M. Zambon)
Health Protection Agency, London, UK (A. Lackenby, M. Zambon)
Norwegian Institute of Public Health, Oslo, Norway (O. Hungnes); Centre National de Référence des Virus Influenza (Région Sud), Lyon, France (B. Lina)
Centre National de Référence des Virus Influenza (Région Nord), Paris, France (S. van der Werf)
Robert Koch Institute, Berlin, Germany (B. Schweiger)
Laboratoire National de Santé, Luxembourg, Luxembourg (M. Opp)
World Health Organization Collaborating Centre Medical Research Council/National Institute of Medical Research, London (A. Hay)
Corresponding author.
Address for correspondence: Adam Meijer, Centre for Infectious Disease Control, National Institute for Public Health and the Environment, PO Box 1, 3720 BA Bilthoven, the Netherlands; email: adam.meijer@rivm.nl
This article has been cited by other articles in PMC.
Abstract
In Europe, the 2007–08 winter season was dominated by influenza virus A (H1N1) circulation through week 7, followed by influenza B virus from week 8 onward. Oseltamivir-resistant influenza viruses A (H1N1) (ORVs) with H275Y mutation in the neuraminidase emerged independently of drug use. By country, the proportion of ORVs ranged from 0% to 68%, with the highest proportion in Norway. The average weighted prevalence of ORVs across Europe increased gradually over time, from near 0 in week 40 of 2007 to 56% in week 19 of 2008 (mean 20%). Neuraminidase genes of ORVs possessing the H275Y substitution formed a homogeneous subgroup closely related to, but distinguishable from, those of oseltamivir-sensitive influenza viruses A (H1N1). Minor variants of ORVs emerged independently, indicating multiclonal ORVs. Overall, the clinical effect of ORVs in Europe, measured by influenza-like illness or acute respiratory infection, was unremarkable and consistent with normal seasonal activity.
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54.) Oseltamivir-Resistant Influenza Viruses A (H1N1), Norway, 2007–08
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Siri H. Hauge, Susanne Dudman, Katrine Borgen, Angie Lackenby, and Olav Hungnes
Norwegian Institute of Public Health, Oslo, Norway (S.H. Hauge, S. Dudman, K. Borgen, O. Hungnes)
Health Protection Agency, London, UK (A. Lackenby)
Corresponding author.
Address for correspondence: Olav Hungnes, Norwegian Institute of Public Health, Department of Virology, PO Box 4404, Nydalen Oslo N-0403, Norway; email: olav.hungnes@fhi.no
Abstract
In Norway in January 2008, unprecedented levels of oseltamivir resistance were found in 12 of 16 influenza viruses A (H1N1) tested. To investigate the epidemiologic and clinical characteristics of these viruses, we used sequence analysis to test all available subtype H1N1 viruses from the 2007–08 season for resistance. Questionnaires from physicians provided information on predisposing diseases, oseltamivir use, symptoms, and complications. Clinical data were obtained for 265 patients. In total, 183 (67.3%) of 272 viruses were oseltamivir resistant. Resistance was not associated with prior use of antiviral drugs. Symptoms and hospitalization rates did not differ for patients infected with a resistant or a susceptible virus. Oseltamivir-resistant influenza viruses A (H1N1) did not show diminished capability to spread in the absence of selective pressure. The ability of these viruses to sustain their fitness and spread among persons should be considered when shaping future strategies for treating and preventing seasonal and pandemic influenza.
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