"Lo que vas a leer acá son los efectos adversos publicados POR LA MISMA
FDA ocasionados por la VACUNA LYMERIX aprobada para ser utilizada en la
ENFERMEDAD de LYME, provocada por la picadura de una garrapata que
transmite una ESPIROQUETA denominada Borrelia Burgdorferi, liberada
esta vacuna en 1.998 en eliminada del mercado 4 años después en 2.002. Los
testimoniales de los pacientes estaban PUBLICADOS EN LA FDA, y
fueron léase bien, fueron
BORRADOS de la misma
recientemente, afortunadamente yo tenía esos 12 testimoniales y en
base a ellos hice esta publicación, ESTOS testimoniales fueron publicados
por la FDA el 1 de enero del año 2.001"
"Repito una vez más: NO CREO que ningún LABORATORIO FARMACÉUTICO fabrique
VACUNAS para "matar personas", simplemente, aparecen los efectos adversos
y hay que retirarlas del mercado para evitar más daños colaterales"
EDITORIAL ESPAÑOL =================
Hola amigos de la red, DERMAGIC EXPRESS, te trae un tema bastante
polémico en estos EXPEDIENTES SECRETOS: LA HISTORIA NO CONTADA DE LAS VICTIMAS DE LA VACUNA LIMERIX PARA LA
ENFERMEDAD DE LYME.
Quizá lo primero que te estés preguntado es que hace un Dr.
que vive en el HEMISFERIO SUR donde esta enfermedad NO EXISTE, - pues las
garrapatas en este continente, por lo menos en este país NO SON PORTADORAS
DE LA BORRELIA BURGDORFERI,- dándole tanta importancia a la ENFERMEDAD DE
LYME.
Te voy a dar la respuesta: voy a recordarte que soy hijo
de un dermatólogo QUIEN FUE UN GRAN INVESTIGADOR EN EL CAMPO DE LA LEPRA:
lee LA LEPRA EN CABO BLANCO, y LA LEPRA EN LA ISLA DE PROVIDENCIA. Yo particularmente herede su LEGADO y estoy avocado en estos momentos a
dar mi ayuda y soporte tanto a investigadores como pacientes que sufren
esta terrible enfermedad.
Como dato inicial te diré que cuando
publique el articulo en Febrero 1, 2.017 BUSCANDO UNA VACUNA PARA LA ENFERMEDAD DE LYME, no me imagine que después de 4 meses de publicado siga en el primer
lugar de los mas leídos. Este hecho me llevo a pensar que algo está
sucediendo con esta enfermedad en el HEMISFERIO NORTE el cual es el más
afectado y me puse a investigar más a fondo la enfermedad y sus
consecuencias.
Posteriormente publique el 7 Mayo, 2.017 el
articulo LA ENFERMEDAD DE LYME, DEMENCIA Y ALZHEIMER, haciendo énfasis que la fase tardía de la enfermedad denominada
NEUROBORRELIOSIS puede estar involucrada en daños neurológicos que pueden
contribuir al desarrollo de ALZHEIMER Y DEMENCIA.
Recordemos
que la BORRELIA BURGDORFERI, cualquiera sea su tipo, es una ESPIROQUETA igual que el TREPONEMA PALLIDUM, agente causal de
la SIFILIS. Si comparamos ambas enfermedades tendremos que las
dos tienen 3 ETAPAS: PRIMARIA, SECUNDARIA Y TERCIARIA. En
la SIFILIS LA ETAPA TERCIARIA se denomina NEUROSIFILIS, en la BORRELIOSIS, SE DENOMINA NEUROBORRELIOSIS, ambas afectan el cerebro.
AHORA TE VOY A PONER LA LISTA DE LAS MANIFESTACIONES CLINICAS MAS
RELEVANTES DE LA NEUROSIFILIS:
1.) Marcha anormal.
2.) Ceguera.
3.) Confusión, desorientación.
4.) Cambios repentinos de personalidad.
5.) Cambios en la estabilidad mental.
6.) Demencia.
7.) Depresión.
8.) Dolor de cabeza.
9.) Incontinencia urinaria y fecal.
10.) Irritabilidad.
11.) Problemas de memoria.
12.) Alteraciones del estado de ánimo.
13.) Entumecimiento en los dedos de los pies, pies o piernas.
14.) Pobre concentración.
15.) Psicosis.
16.) Convulsiones.
17.) Rigidez en el cuello.
18.) Temblores.
19.) Alteraciones visuales, signo de las pupilas de Argyll
Robertson.
20.) Debilidad muscular.
21.) Reflejos anormales.
22.) Atrofia muscular.
23.) Contracciones musculares.
AHORA TE VOY A PONER LAS MANIFESTACIONES CLINICAS QUE EXPERIMENTARON
12 PACIENTES QUE SE COLOCARON LA VACUNA LYMERIX PARA LA ENFERMEDAD DE
LYME:
1.) Mielitis Transversa.
2.) Dolor en el tobillo.
3.) Síntomas similares a la gripe.
4.) Erupción.
5.) Ceguera periférica.
6.) Dolores musculares.
7.) Inflamación y dolor de la articulación.
8.) Positivo ANA (Anticuerpos AntiNucleares).
9.) Migrañas.
10.) Dolores de cabeza.
11.) Malestar general.
12.) Dolores óseos.
13.) Dolor en el cuerpo.
14.) Fatiga.
15.) Dolor severo en las articulaciones.
16.) Fibromialgia.
17.) Crisis de parálisis.
18.) Reacción autoinmune.
19.) Sensación de ardor en la piel.
20.) Pies hinchados.
21.) Las articulaciones: dolor migratorio.
22.) Incapacidad funcional de las manos con dolor.
23.) Dolor intenso: mano, muñeca, hombro, rodillas, tobillos,
cuello.
24.) Disminución del desempeño laboral.
25.) Enfermedad de Raynaud (manos).
26.) Fisura de las puntas de los dedos.
27.) Depresión.
28.) Síndrome de Guillan Barre.
29.) Poli neuropatía inflamatoria desmielinizante crónica.
30.) Debilidad de las piernas.
31.) Sensibilidad a la luz y al sonido.
32.) Dolor de cabeza, sinusal y presión.
33.) Hormigueo en manos, brazos, piernas y pies.
34.) Rigidez, debilidad y temblor en manos y brazos.
35.) Perdida de equilibrio.
36.) Mareo, y una incapacidad para enfocarse / concentrarse.
37.) Migrañas menstruales mensuales que comenzaron inmediatamente
después de la vacuna y continuaron durante 10 meses.
38.) Síndrome de fatiga crónica.
39.) Dolor neuropático.
40.) sinusitis severa.
41.) Insomnio severo.
42.) Llanto incontrolado.
43.) fallo de la memoria.
44.) Atrofia muscular y desmielinización de los nervios.
45.) Ateraciones visuales.
46.) Tendinitis.
47.) Artritis.
Si tu analizas ambos
conjuntos de SIGNOS Y SINTOMAS, son los mismos, a excepción de
CONVULSIONES e INCONTINENCIA URINARIA que se manifiestan en la NEUROSIFILIS.
Quiere decir esto que la vacuna LYMERix provoco en los
pacientes síntomas IGUALES A LA NEUROSIFILIS, o sífilis TERCIARIA, provoco auto anticuerpos ANA, ENFERMEDADES AUTOINMUNES y muchos
más, solo estoy hablando de 12 casos, prácticamente destruyo la vida en
muchos de ellos que era TOTALMENTE SANA. Es increíble!!
Otro dato que debes conocer es
que LOS PACIENTES QUE SON HLA-DR4, están mas propensos a
manifestar reacciones a la vacuna LYMERix, esto significa que en tu
composición inmunológica tienes un marcador antigénico o ALELO DENOMINADO
DR4, que se determina con un examen sanguíneo y si eres portador del mismo
la vacuna LYMERix manifestara más efectos secundarios, uno de los casos
que aquí expongo dijo que el laboratorio NUNCA LES DIJO ESO Y EL ERA HLA- DR4.
Esto se explica porque el LABORATORIO NO SABIA DE ESTE HECHO, TAMPOCO SABIA QUE LOS PACIENTES EXPUESTOS A LA
ENFERMEDAD DE LYME NO DEBIAN VACUNARSE POR SER UN FACTOR DE RIESGO, esto fue descubierto por el sistema VAERS (SISTEMA PARA REPORTAR EFECTOS ADVERSOS DE LAS VACUNAS) Y LO PUBLICO EL 31 DE ENERO DE 2.001, cuando ya se habían distribuido 1. Millón 44 mil dosis de LYMErix
Ahora te voy a mostrar lo que VAERS (SISTEMA PARA REPORTAR EFECTOS ADVERSOS DE LAS
VACUNAS), público para esa fecha en LA FDA SOBRE LA VACUNA LYMErix:
REPORTE DE EFECTOS ADVERSOS DE LA VACUNA LYMErix
EFECTOS ADVERSOS MAS FRECUENTES: (VER ADJUNTO), Entre paréntesis el
número de casos)
1.) ARTRALGIA (322).2.) MIALGIA (227).3.) DOLOR (196).4.) ASTENIA (167).5.) FIEBRE (126).6.) SINDROME GRIPAL (124)7.) DOLOR EN EL SITIO DE LA INYECCION (117).8.) RASH (85).AHORA TE VOY A COLOCAR LAS MUERTES OCASIONADAS POR LYMErix REPORTADAS
POR VAERS (SISTEMA PARA REPORTAR EFECTOS ADVERSOS DE LAS VACUNAS: publicado 31 Enero 2.001. Ver el adjunto1.) 54 JOVENES O ADULTOS MASCULINOS MURIERON POR ENFERMEDAD CARDIOVASCULAR HIPERTENSIVA, 1 DIA DESPUES DE LA SEGUNDA DOSIS.
2.) 63 JOVENES O ADULTOS MASCULINOS MURIERON POR ENFERMEDAD CARDIOVASCULAR HIPERTENSIVA O
ARTERIOESCLEROTICA 3 DIAS DESPUES DE LA 1ERA DOSIS.
3.) 43 JOVENES O ADULTOS MASCULINOS DESARROLLARON SINTOMAS DE ARTRITIS Y NEUROLOGICOS ATRIBUIDOS A LA VACUNA LYMErix Y SE SUICIDARON 7 MESES DESPUES DE LA 2DA DOSIS.
4.) 69 JOVENES O MUJERES ADULTAS DESARROLLARON ENFERMEDADES, INCLUYENDO ANEMIA Y TROMBOCITOPENIA, 7 MESES DESPUES DE LA PRIMERA DOSIS Y MURIERON 6 MESES DESPUES EN UN
TIEMPO QUE SE DESCONOCE DESPUES DE LA 3ERA DOSIS CON EL DISGNOSTICO DE MIELOFIBROSIS.
MUERTES REPORTADAS DESPUÉS DE COLOCARSE LA VACUNA LEMErix
RESUMIENDO: 229 personas FUERON prácticamente "MATADAS" por colocarse la VACUNA LYMErix, lo que significa: Buscando una solución encontraron la muerte.
DE PRONTO dirás, pero Dr., eso fue hace muchos
años entre 1.998-2.002, han pasado más de 15 años, pero traje este tema
hoy, porque ya está en marcha la producción de una NUEVA VACUNA para la enfermedad de LYME.
La vacuna LYMERix estaba basada en (Recombinat OspA) una
proteína de superficie A de la BORRELIA BURGDORFERI y lamentablemente fue
tremendo fracaso. Allí te pongo todos los estudios que encontré al
respecto. De manera que puedas sacar tus conclusiones.
Y finalizo este POST con algunas citas de los pacientes afectados por
la VACUNA LYMErix:
"......... Smithkline no debería ser capaz de destruir vidas de la
gente como ellos han destruido la mía ..."
"..... A partir del 8 de mayo de 2.000 hubo 467 reacciones
adversas reportadas a VAERS, y de ellas 144 se habían quejado de algún
tipo de dolor en las articulaciones. Por favor, no dejes que esta
vacuna haga daño a la gente. Ahora SmithKline quiere aprobarla para
niños, POR FAVOR NO LOS DEJEN HERIR MAS NIÑOS ... "
"..... La FDA puso esta (vacuna) en el mercado sin la prueba
completa. Cuanto más se deje en el mercado, más gente va a conseguir
lastimado, Sáquenla del mercado ... "
"..... Nadie más debería sufrir cambios de vida tan profundos
a través de la administración de una vacuna "segura". ¡Habría estado
mucho mejor en contraer la enfermedad de Lyme que estar incapacitado
por algo con lo que contamos para proteger la salud! ... "
"... Por favor, detengan esta vacuna de arruinar más vidas!
Respetuosamente enviado...."
Y LA PERLA FINAL: LA RESPUESTA DE UN MIEMBRO AVOCADO A LA LUCHA
CONTRA LA ENFERMEDAD DE LYME:
"..... 1. Los médicos no saben cómo manejar la erupción de los
efectos secundarios 2. Los médicos no quieren sentir su culpa por la vacuna que causa
efectos 3. Los pacientes están sufriendo porque los médicos no Quiere
tratar con la enfermedad de Lyme y mucho menos con la vacuna ...
"
Ni siquiera estaban preparados para lo que podía suceder....
Esta revision esta dedicada a todos los investigadores, medicos y
personas avocadas a la lucha contra la enfermedad de LYME, y a la vez es
un aviso a los LABORATORIOS y FABRICANTES, que antes de lanzar una nueva
vacuna contra esta enfermedad, se aseguren de probarla bien para
no ocasionar daño a los pacientes incluso la muerte. ! En las referencias y adjuntos los hechos.
Saludos a
todos.
Dr. José Lapenta.
=====================================================================
PUBLISHED IN 2.017 UPDATED IN 2.023
"What you are going to read here are the adverse effects published BY
THE FDA SAME caused by the LYMERIX VACCINE approved for use in LYME
DISEASE, caused by the bite of a tick that transmits a SPIROCHETE called
Borrelia Burgdorferi, this vaccine released in 1998 in eliminated from
the market 4 years later in 2002. The patient testimonials were
PUBLISHED IN THE FDA, and keep this in mind, they were
DELETED from it recently,
fortunately I had those 12 testimonials and based on them I made this
publication, THESE testimonials were published by the FDA on January 1,
2001"
"I repeat once again: I DO NOT BELIEVE that any PHARMACEUTICAL
LABORATORY manufactures VACCINES to "kill people", simply, the adverse
effects appear and they must be removed from the market to avoid more
collateral damage"
EDITORIAL ENGLISH
===================
Hello friends of the network, DERMAGIC EXPRESS, bring you a rather
controversial subject in these SECRET X- FILES:
THE UNTOLD HISTORY OF THE VICTIMS OF THE LIMERIX VACCINE FOR THE LYME
DISEASE.
Perhaps the first thing you are asked is why a Dr. who lives in the South
HEMISPHERE where this disease does not exist, - because the ticks in this
continent, at least in this country are NOT CARRIERS OF THE BORRELIA
BURGDORFERI, - giving him so much Importance to LYME DISEASE.
I'll give you the answer: I'll remind you that I'm the son of a
dermatologist WHO WAS A GREAT INVESTIGATOR IN THE LEPROSY FIELD: read
THE LEPROSY IN CAPE WHITE,
AND
THE LEPROSY IN THE ISLAND OF PROVIDENCIA. I particularly inherit his LEGACY and I am advocated at this time to give
my help and support to both investigators and patients suffering this
terrible disease.
As initial information I will tell you that when I publish the article on
February 1, 2.017
LOOKING FOR A VACCINE FOR THE LYME DISEASE
I do not imagine that after 4 months of published continue in the
first place of the most read. This fact led me to think that something is
happening with this disease in the NORTHERN HEMISPHERE which is the most
affected and I began to investigate more thoroughly the disease and its
consequences.
Later published on May 7, 2017 the article
THE LYME DISEASE, DEMENTIA AND ALZHEIMER, emphasizing that the late phase of the disease called NEUROBORRELIOSIS
may be involved in neurological damage that may contribute to the
development of ALZHEIMER AND DEMENTIA.
Remember that the BORRELIA BURGDORFERI, whatever its type, is a
SPIROCHETE
just like the TREPONEMA PALLIDUM, causal agent of the
SYPHILLIS. If we compare both diseases we will have both have
3 STAGES: PRIMARY, SECONDARY AND TERTIARY.
In
SYPHILLIS THE TERTIARY STAGE is called
NEUROSYPHILLIS, in
BORRELIOSIS, is called NEUROBORRELIOSIS,
both affect the brain.
NOW I'LL PUT THE LIST OF THE MOST RELEVANT CLINICAL MANIFESTATIONS OF
NEUROSYPHILLIS:
1.) Abnormal gait.
2.) Blindness.
3.) Confusion, disorientation.
4.) Sudden personality changes.
5.) Changes in mental stability.
6.) Dementia.
7.) Depression.
8.) Headache.
9.) Urinary and fecal incontinence.
10.) Irritability.
11.) Memory problems.
12.) Mood alterations.
13.) Numbness in toes, feet or legs.
14.) Poor concentration.
15.) Psychosis.
16.) Convulsions.
17.) Rigidity in the neck.
18.) Tremors.
19.) Visual disturbances, sign of the pupils of Argyll Robertson.
20.) Muscle weakness.
21.) Abnormal reflexes.
22.) Muscle atrophy.
23.) Muscle contractions.
I WILL NOW PUT THE CLINICAL MANIFESTATIONS THAT EXPERIENCED 12 PATIENTS
WHO WERE INJECTED THE LYMERIX VACCINE FOR LYME DISEASE:
1.) Transverse Myelitis.
2.) Ankle pain.
3.) Flu-like symptoms.
4.) Eruption.
5.) Peripheral blindness.
6.) Muscle aches.
7.) Inflammation and pain of the joint.
8.) ANA Positive (Anti-Nuclear Antibodies).
9.) Migraines.
10.) Headaches.
11.) General malaise.
12.) Bone pain.
13.) Pain in the body.
14.) Fatigue.
15.) Severe pain in the joints.
16.) Fibromyalgia.
17.) Crisis of paralysis.
18.) Autoimmune reaction.
19.) Burning sensation on the skin.
20.) Swollen feet.
21.) The joints: migratory pain.
22.) Functional incapacity of the hands with pain.
23.) Severe pain: hand, wrist, shoulder, knees, ankles, neck.
24.) Decreased work performance.
25.) Raynaud's disease (hands).
26.) Cracking of the tips of the fingers.
27.) Depression.
28.) Guillan Barre syndrome.
29.) Polymeric demyelinating chronic inflammatory neuropathy.
30.) Weakness of the legs.
31.) Sensitivity to light and sound.
32.) Headache, sinus and pressure.
33.) Tingling in hands, arms, legs and feet.
34.) Rigidity, weakness and trembling in hands and arms.
35.) Loss of balance.
36.) Dizziness, and an inability to focus / concentrate.
37.) Monthly menstrual migraines that began immediately after the vaccine
and continued for 10 months.
38.) Chronic fatigue syndrome.
39.) Neuropathic pain.
40.) Severe sinusitis.
41.) Severe insomnia.
42.) Uncontrolled crying.
43.) Memory failure.
44.) Muscular atrophy and demyelination of the nerves.
45.) Visual markings.
46.) Tendonitis.
47.) Arthritis.
If you analyze both sets of SIGNS AND SYMPTOMS, they are the same,
except for CONVULSIONS and URINARY INCONTINENCE that are manifested in
NEUROSYPHILLIS.
This means that the LYMERix vaccine causes symptoms similar to
NEUROSYPHILLIS, or tertiary syphilis, causes auto antibodies ANA, autoimmune diseases and
many more, I am only talking about 12 cases, practically destroyed life in
many of them that was
TOTALLY HEALTHY. Is
incredible!!
Another fact to know is the PATIENTS WHO ARE HLA-DR4, are more
likely to manifest reactions to the vaccine LYMERix, this means that in your
immunological composition you have an antigenic marker or ALLELE DENOMINATED
DR4, which is determined with a blood test and If you are a carrier, the
LYMERix vaccine will show more side effects, one of the cases I put here
said that the laboratory
NEVER SAID THAT ABOUT THE HLA-DR4, AND HE WAS.
This is because the LABORATORY
DOES NOT KNOW OF THIS FACT, IT ALSO DID NOT KNOW THAT PATIENTS EXPOSED TO
LYME DISEASE SHOULD NOT BE VACCINATED AS A RISK FACTOR,
this was discovered by the VAERS
system (SYSTEM FOR REPORTING ADVERSE EFFECTS OF VACCINES)
AND PUBLISHED ON JANUARY 31, 2.001, when
1. Million 44 thousand doses of LYMErix was released.
Now I'm going to show you what
VAERS (VACCINE ADVERSE EFFECTS REPORT SYSTEM), PUBLISHED by that date in the FDA ABOUT THE VACCINE LYMErix:
ADVERSE EFFECTS: (SEE ATTACHED), in parentheses the number of cases)
1.) ARTHRALGIA (322).
2.) MYALGIA (227).
3.) PAIN (196).
4.) ASTHENIA (167).
5.) FEVER (126).
6.) FLU SYNDROME (124)
7.) INJECTION SITE PAIN (117).
8.) RASH (85).
I AM GOING TO PLACE THE DEATHS OCCURRED BY LYMErix REPORTED BY VAERS
(VACCINE ADVERSE EFFECTS REPORT SYSTEM), published 31 January 2.001. See attached
1.) 54 YOUNG OR ADULT MALES DIED BY
HYPERTENSIVE CARDIOVASCULAR DISEASE, 1
DAY AFTER THE SECOND DOSE.
2.) 63 YOUNG OR MALE ADULTS DIED BY
HYPERTENSIVE AND CARDIOVASCULAR ARTERIOSCLEROTIC DISEASE
3 DAYS AFTER THE FIRST DOSE.
3.) 43 YOUNG OR ADULT MALE DEVELOPED
ARTHRITIS AND NEUROLOGICAL SYMPTOMS
ATTRIBUTED TO THE LYMErix VACCINE AND
SUICIDATED 7 MONTHS AFTER THE 2nd
DOSE.
4.) 69 YOUNG OR ADULT WOMEN DEVELOPED ILLNESSES, INCLUDING
ANEMIA AND TROMBOCYTOPENIA, 7 MONTHS
AFTER THE FIRST DOSE AND DIED 6 MONTHS
LATER AN UNKNOW TIME AFTER THE 3rd DOSE
WITH DIAGNOSIS OF MYELOFIBROSIS.
SUMMARIZING: 229 people WERE practically "KILLED"
by placing the LYMErix VACCINE, which means:
Looking for a solution they found the death.
SUDDENLY you will say, but Dr., that was many years ago between
1998-2.002, more than 15 years have passed, but I brought this subject
today because the production of a NEW VACCINE for LYME disease is already
underway.
The LYMERix vaccine was based on (Recombinat OspA) a surface protein A of
BORRELIA BURGDORFERI and unfortunately was a tremendous failure. There I
put all the studies that I found about it. So you can draw your
conclusions.
And I end this POST with some quotes from the patients affected by the
LYMErix VACCINE:
".....Smithkline should not be able to destroy people's lives as they
have destroyed mine ..."
"... As of May 8, 2000 there were 467 adverse reactions reported to
VAERS, and of them 144 had complained of some sort of joint pain.
Please do not let this vaccine hurt anymore people. I know SmithKline
is trying to get it approved for children, PLEASE DO NOT LET THEM HURT
ANYMORE KIDS..."
"..... The FDA let them put this on the market without fully testing
it. The longer that this is left on the market, the more people are
going to get hurt. Please stop this madness and take it off the market..."
"..... No one else should ever suffer such profound life changes
through the administration of a “safe” vaccine. He would have been far
better off to get Lyme Disease than to be incapacitated by something
we counted on to protect his health!..."
"....Please stop this vaccine from wrecking more lives! !Respectfully
submitted..."
AND THE FINAL PEARL: THE RESPONSE OF A MEMBER ADVOCATED FOR THE FIGHT
AGAINST LYME DISEASE:
"..... 1. Doctors don’t know how to handle the rash of side
effects. 2. Doctors don’t want to feel their at fault for the vaccine causing
effects. 3. Patients are suffering because doctors don’t want to deal with
Lyme let alone the vaccine..."
They were not even ready for what could happen ....
This review is dedicated to all researchers, doctors and people
advocated in the fight against LYME disease, and at the same time it
is a warning to LABORATORIES and MANUFACTURERS, that before launching
a new vaccine, they will be sure to test it well for not cause harm to patients including death. !!!
In the references and attach the facts.
Greetings to all.
Dr. José Lapenta.
REFERENCIAS BIBLIOGRAFICAS /
BIBLIOGRAPHICAL REFERENCES
======================================================================
FDA Vaccine Advisory Committee, January 8, 2001. LYMErix vaccine victim's
stories
1.) CASE No 1:
2.) CASE No 2:
3.) CASE No 3
4.) CASE No 4
5.) CASE No 5
6.) CASE No 6
7.) CASE No 7
8.) CASE No 8
9.) CASE No 9
10.) CASE No 10
11.) CASE No. 11
12.) CASE No 12
13.) LYME INFORMATION FROM A MEMBER OF ACTIONLYME, ADVOCATING LYME PATIENTES
RIGTHS AND THE LYE INFORMATION YEAR 2.001
14.) Identification of a defined linear epitope in the OspA protein of the
Lyme disease spirochetes
that elicits bactericidal antibody responses: Implications for vaccine
development.
15.) Borrelia burgdorferi OspA is an arthropod-specific
transmission-blocking Lyme disease vaccine.
16.) An effective second-generation outer surface protein A-derived Lyme
vaccine that eliminates a potentially autoreactive T cell epitope.
17.) Safety, immunogenicity, and efficacy of Borrelia burgdorferi outer
surface protein A (OspA) vaccine: A meta-analysis.
18.) Antibody profiling of canine IgG responses to the OspC protein of the
Lyme disease spirochetes supports a multivalent approach in vaccine and
diagnostic assay development.
19.) Enhanced Protective Immunogenicity of Homodimeric Borrelia burgdorferi
Outer Surface Protein C.
20.) Intentions to receive a potentially available Lyme disease vaccine in
an urban sample.
==============================================
==============================================
FDA Vaccine Advisory Committee, January 8, 2001.
==============================================
1.) CASE No 1:
==============================================
To Whom It May Concern:
I am unable to attend the January 3 1 FDA Vaccine Advisory Committee meeting
due to a
restrictive condition, , resulting from the Lymerix vaccine. In the spring
of
1999, I decided to get the series of Lymerix shots, after, viewing a verv
convincing TV
commercial touting the importance of protecting oneself from Lyme Dise:ase.
I felt this would be a good thing to take advantage of since I had had
numerous bites from the ticks which cause
Lyme Disease.
I was given the fust shot of the series on April 20, 1999. Thirteen days
later, I collapsed,
completely paralyzed. Many tests at the hospital confirmed the di&nosis
of Transverse Myelitis
- inflammation of the myelin sheath around the spinal cord. After days in
Intensive Care at the
hospital, I was transferred to the Rehabilitation Center where I spent six
months. After intensive
physical and occupational therapy, some mobility returned, but I am in a
wheelchair most of the
time. My life has been drastically changed for the past 21 months. Up to the
day I collapsed, I
was constantly on the go with meetings of historical societies and community
organizations,
church activities, house tours, dinner parties, exercise classes, bus trips,
theater outings, concerts, etc. I used to wear my daughters out, just
telling them about all of the running around I did. Iused to be a world
traveler, but now because of physical liitations, I stay close to home. I
amable to live at home onlv with sunport from family and friends, and a paid
nighttime caregiver.
For the first nine months after coming home from the Rehabilitation Center,
I required round-
the-clock caregivers.
Prior to the Lymerix vaccine, I was in excellent health and completely
independent. I
strongly urge you to take Lymerix off the market to spare others the pain
and suffering it can
cause.
Very truly yours,
.-
==========================================================
2.) CASE No 2:
==========================================================
My name is
and I have been asked to speak on behalf ofmy daughter,
‘. had a pretty normal childhood and
adolescence until the year 1999. Until that point in time, she had a very
active life. She had a horse that she used for exercise and enjoyment.
She
had competed on him in various venues. They enjoyed jumping and dressage.
She volunteered in a therapeutic riding barn and worked with multiply
handicapped children. Her plans were to get her degree in veterinary
medicine
and have a small animal practice. She held down a job at a vet’s office
and
loved going to work and facing the challenges there.ln the !spring of
that
year, I decided to get her the lyme vaccine. She was in contact with
various
animals daily and spent a lot of time in the woods with horses. It seemed
like
a good idea at the time. She had had a simple case of unconfirmed Lyme
Disease when she was around 12 years old and it seemed to respond to
antibiotics, so I thought Lymerix would be a good idea. My primary doctor
looked over the literature and agreed to give this series of injections.
Our
lives have never been the same.
After the 2nd injection, --complained of ankle pain. I took her to an
orthopedic
surgeon who couldn’t find anything wrong at the time. We sent her for
physical
therapy and gave her medication. She made the best of it and never really
got much better. She
had vague complaints of other joints bothering her, but again she kept
plugging along. She developed flulike symptoms, a rash, and woke up on
October 3 1 st, 1999 with peripheral blindness. She was having terrible
muscle
aches and joint swelling and pain. We went to many specialists. Finally,
we
decided to test her for HLA-dr4 ad lo and behold we had a positive. We
also
had a positive ANA. To this day, she continues to test negative for Lyme,
MS, Lupus, Crohn’s Disease and all of the other autoimmune illnesses that
our doctors assumed were the possible cause. Their is no history of
juvenile
arthritis in either side of the family. Her arthritis just kept getting
worse,
even with treatments of anti inflammatories
and all of the arthritis medications on the market. She spent her entire
senior year at home, too ill to even walk through the hallways and put in a
full
day at school. She missed her senior prom and any social activities that
a
.
normal senior in high school participates in. Her horse coulcl not be
exercised
or jumped by her for a very long period of time. We have taken -to
many specialists in the New York area. They have no explanations for this
sudden dramatic change in her health except the probability that she had
a
reaction to Lymerix which somehow caused an autoimmune reaction (because
of the bodies exposure to OspA). I am not as knowledgeable as this
distinguished panel of experts that I speak-to today, but I krnow one
thing
with all of my being. It was Lymerix which somehow had this devastating
affect on my 17 year-old child. I think you have all considered that
possibility
before today. Maybe after today you will think it is more than just a
possibility, you will see this drug can have some longlasting,dangerous
side
effects. Just remember, I have been told this by many a doctor in the
last
year and a half, they can treat and cure Lyme Disease but they cannot
cure
an autoimmune arthritis. This is an 18year old who will never again be able
to
run to catch a bus, or jump her horse with abandon. Her life will be
forever
changed by Lymerix. Please consider this very carefully when making your
decisions about giving this to children.
================================================================
3.) CASE No 3
================================================================
To Whom It May Concern,
January 23,200l
In 1999 I was a very healthy 40 year old. Very active with my 10 year
old son, skating, bowling and biking. My only health complaint was
migraines and daily headaches. On May 21 ,I 999 I received the Lymetix
vaccine. With 24 hours I had flu like symptoms, body aches and low
grade fever. I did not think much of it being a nurse and knowing that
this
is a common reaction to vaccines. Two weeks after the shot I woke up
and my right elbow was hurting and with a few days the body aches
returned. By the time I went for my second injection I had complained to
my doctor that I was hurting from head to toe and the fatigue was
unbearable.
He did not think it was related to the vaccine, because he had
heard nothing about any adverse reactions. I had the second injection
that day and my life has been a living hell since. Within 48 hours I was
in
severe joint and body pain, that has not stopped. I tried seeing doctors
and no one knew anything about this vaccine and the realctions it was
causing. I was diagnosed with CFS, fibromalagia, and was even told it
could be stress from my job. I am a Hospice nurse and love what I do.
For months I went through this pain without any help from1 the medical
field. I wake up in the mornings and my husband has to help me out of
bed because the pain is so severe.
Four times I have been paralyzed,three from my wrist down and once from
my neck down for up to 20 minutes. I am scared that I my wake up
one day and not be able to move ever again.
I have since seen a doctor that told me I have an auto-immune reaction to
the vaccine that is untreatable and incurable. I am presently under the
care of a pain management doctor. If it was not for the pa.in medicine I
.
would not be able to get through my day. I still wake in the mornings
with
severe, debilitating pain. I have to keep the pain medicine by my bed to
get up.
I have had very odd occurrences of unexplained symptoms. I have small
areas on my body that become red and feel as if they are burning, like
fire,
from the inside. The fatigue is unbearable at times, especially with having
a
10 year old. I am unable to enjoy being active with him like before.
I have been in contact with nearly 75 people that have been harmed by
this vaccine. It is destroying peoples life’s. It is hurting our most
healthy
population. The population that goes out doors for different activities,
they
are now bedridden or in such severe pain they are unable to move about
with daily activities without difficulty.
This reaction is not just hurting a certain age group. I have been
contacted
by people from the age of 17 and up. I ask the committee to recommend
that this vaccine be taken off the market before more people are hurt.
As of May 8, 2000 there were 467 adverse reactions reported to VAERS,
and of them 144 had complained of some sort of joint pain. Please do not
let this vaccine hurt anymore people. I know SmithKline is trying to get
it
approved for children, PLEASE DO NOT LET THEM HURT ANYMORE
KIDS.
Thank you,
=============================================================
4.) CASE No 4
=============================================================
Su bj:
Date:
From:
To:
cc:
Lymerix Vaccine
Wednesday, October 11, 2000 9:s 1:04 AM
stanisic@cber.fda.gov
I know that I am having a reaction to the lymerix vaccine. My nightmare
started with the second shot which I received sometime in 8/99. I had flu
like systems which turned into joint pain which has lasted around a year.
I
reiceived the last shot in 7/00 and have been sick ever since. I have
such
joint pain that it is hard to even get out of bed some days. I have had
every
kind of blood work done that you can imagine. 1 am being treated by a
Rheumatologist.
I have been on prednisone for the last six weeks. In four
weeks he will be starting me on Methotrexate. I was only 36 yrs old when
this whole thing started I just recently turned 37 yrs old and feel like I
am
80. I have to young children we live in a high tic area I will never allow
them
to have this vaccine. The FDA and my MD should have gave some sort of
warning that is could happen. Also,the adverse reaction form that you
have
to fill out is almost impossible to get the information for that. I thought
I
was protecting myself from getting
sick I didn’t realize that I was allowing the government and my doctor to
make me sick. 1 just hope some day 1 will feel better. Thank you
============================================================
5.) CASE No 5
============================================================
My name is
. and I am HLA-DM positive.
Eighteen months ago I ran five miles a week and worked
out at least an hour a day. I was very healthy and had no
health problems at all.
Within six months of getting the lymerix vaccine, I
couldn’t get out of bed by myself and was in constant
excruciating joint and muscle pain. My joints have started
making snapping sounds. I now get muscle aches in my
legs and I have a hard time walking. My feet feel like they
are on fire and get swollen. There are days when I all I can
do is stay in bed and cry because I am in so much pain.
Every week my body goes thru some other type of pain. It
moves from elbows to the knees to the hips to the leg
muscles. I also get cold spots that move around on my
body.
I have been tested for Lupus, Crohns Disease and MS
and they are negative. Smithkline should not be able to
destroy peoples lives as they have destroyed mine. The
FDA let them put this on the market without fully testing
it. The longer that this is left on the market, the more
people are going to get hurt. Please stop this madness and
take it offthe market.
Thank You,
====================================================
6.) CASE No 6
====================================================
January 9, 2001
To whom it may concern,
My name is :-
-My phone number is -
I was diagnosed with Lyme disease on October, 1991 by Doctor -
and was treated with oral antibiotics. In July of 1998, I was reinfected
and
was treated by Doctor -
with oral antibiotics. At his suggestion, I had the
LymeRex vaccine on April 23, 1999 (LY 10482 exp. 1 O/21 /99) and the booster
on May
24, 1999 (LY 123A9 exp. 2/l 7/00).
After several months, I was experiencing hand pains and a decrease in
function. X-rays
of my hands were ordered plus a blood test for HLA-DR4. I tested positive
for the auto
immune factor and my Doctor told me not to have the additional booster
shot.
I feel that the pains in my hands, wrists, shoulders, knees, ankles and neck
are directly
caused by reaction to the LymeRex vaccine. My hands are affected the most, I
can
hardly turn faucets, jar covers, door handles, etc. Since I am a realtor,
the pains in my
hands and feet are interfering with my job performance.
My Doctor was never notified by Smith Kline to test for the auto Immune
blood factor.
He also was unaware that the vaccine should not be administered to people
who were
already infected. Why weren’t the Doctors informed by Smith Kline of these
limitations?
I would not be experiencing the pain and diminished use of my hands if I had
been told
not to take the vaccine.
Sincerely yours,
======================================================================
7.) CASE No 7
======================================================================
January 1,200l
To Whom It May Concern:
I am a positive, determined 40-year old woman who has recently had an
extreme medical
setback. I have run three (3) marathons since 1995 and have been in
excellent condition ah
of my life. I have played sports in high school, in college, and have
continued
to run and bike tremendous distances up until the Fall of 1999.
Please be advised that after receiving my initial Lymerix vaccination in
April of 1999 and
my second Lymerix vaccination in May of 1999, I developed the following
adverse
reactions.
In October of 1999 while training for my fourth marathon, I suddeuly became
extremely
fatigue and sluggish. I could no longer physically run, as if my legs ‘were
knocked out from
under me. I then developed severe joint and muscle pain throughout my entire
body in
January of 2000.
.
My autoimmune system was also greatly affected. I developed full-blown
Raynaud’s
Disease in my hands in March of 2000. There has been a total lack of
circulation in my
hands and severe cracking in my finger tips. I can no longer tolerabe
temperatures below
50 degrees.
I then received my third Lymerix vaccination in May of 2000. I have never
felt so
discouraged and depressed over no longer being able to physically exercise!
There has been
no improvement with the fatigue and achy joints even though I have been on
anti-
inflammatories since May of 2000 and antibiotics since October of 2000.
This has been extremely difficult for me both physically and emotionally. I
have always
been healthy and active, and now I can no loner live my live with xest and
the way I know
how!. It is totally devastating!
======================================================================
8.) CASE No 8
======================================================================
January 4,2001
In April of 2000, after seeing LymeRix ads on television and a poster in
my doctor’s office, I decided to have the vaccine. Since my husband and I
love many outdoor activities including travelling, gardening, canoeing
and
walking in woods with our dogs, I thought the vaccine would protect him
as
well. We both had LymeRix in April and May.
In July, he began to have neurological symptoms and weakness, which
were diagnosed in August as Guillain-Barre Syndrome. He was hospitalized
following an electromyography, nerve conduction studies and a spinal tap.
Released to outpatient physical therapy 5 days later, he continued to
grow
weaker. In September, he was rediagnosed with Chronic Inflammatory
Demyelinating Polyneuropathy and hospitalized again for 9 days. Despite
continuing medical care and bi-weekly rounds of plasmapheresis
treatments,
his condition has continued to deteriorate. A recent repeat of the
electromyography and nerve conduction studies-showed “severe sensory,
motor, axonal and demyelinating neuropathy . . ..In comparison with the
August 2000 study, the neuropathy has increased substantially”.
The .neurologist has reported the disease to VAEXS as a vackine atdverse
event.
My husband was director of the training program at the -_.-.For 33 years, he
has
earned his living by walking 10 or more miles a day in the performance of
his
job responsibilities. His retirement was planned for 2001, so he could
have
more time to enjoy his family and hobbies, but he is so profoundly
disabled
that he is unable to walk independently, get into bed or the s:hower.
Personal
care is accomplished only through great effort. Our plans now revolve
solely
around medical appointments and physical therapy.
No one else should ever suffer such profound life changes through the
administration of a “safe” vaccine. He would have been far better off to
get
Lyme Disease than to be incapacitated by something we counted on to
protect
his health!
================================================================
9.) CASE No 9
================================================================
MY name is *
dndIlive~inNorfh f2entdbdima. I am 55
years old and for the last 27 years I have beenan
1 was always pretty healthy and very active with interests and
hobbies that included hunting, fishing, and golf mainly. I am 6 foot 1
and
weighed 210 Ibs. 1 stayed in reasonably good shape Erom activities and
In the spring of 1999 our Department decided to give us LYMErix vaccine
and told us it was safe and ef%ective. After my second shot in August of
1999 I experienced extreme rib soreness and went ‘for a chest X ray, then
developed tennis .elbow, a stiff knee, and sharp pain in my left hip,
along
with increasing~weakness in my legs.
By December my legs ached and Ifelt flu like sometimes and had
to rest more than usual. On Jarmary 30,2000 fny health nose-dived to
where I could not function at all. ‘I did-not know what was wrong
with me, but did not consider lyme disease, since we were told
you could .not get lyme disease from the vaccine. My life
fell into a black hole. 1 became super sensitive to light and sound and
was
living in a darkened bedroom with earplugs, with occasional blind folded
trips to various doctors to try and get a diagnoses. I thought that I
would
die and many times wished that I would because I felt so bad. Finally in
March the Doctors started looking at Lyme disease and I tested positive.
My current health is better Corn the neurological problems. I am still
unable to work, as I have no strength, especially in my legs. Sometimes
my knees hurt and burn like there is liquid fire in them My hips and
shoulders hurt and ache every day. My right index finger is too stiff to
bend and my left thumb hurts. It is obvious that I will suffer for a long
time because I let them inject a foreign substance called LYMErix into my
body If I had know about the HLA-DR4 theory of arthritis or that booster
shots would be needed, you would not be reading this, because I would
not have consented to the vaccine!! Even though my occupations is high
risk, my work area is low risk and not endemic.
Please stop this vaccine from wrecking more lives! !
Respectfully submitted
============================================================
10.) CASE No 10
===========================================================
January 12,200l
To Whom It May Concern,
This letter is to inform you of my symptoms, tests and treatments since
receiving the
Lymerix vaccine in 1999.
I was diagnosed with Lyme disease in October, 1998, after noticing a large
red rash on
my right hip in July, 1998. The rash eventually disappeared, but my hip
became very
sore and I developed a limp. Hip pain and fatigue were my only symptoms. A
western
blot in October, 1998, confirmed Lyme disease. I began taking oral
C’efuroxime -
500mg/twice a day for three weeks. At the end of this period, I still had
some hip pain so
I was placed on IV Rocephin - 2 grams/day for four weeks. At the end of this
time I was
almost pain-free and after several weeks of physical therapy had no pain
whatsoever. I
continued symptom free until May, 1999, after the second Lymerix vaccine.
The vaccine
was strongly recommended by the infectious disease physician who had treated
me for
lyme disease and felt I would be an excellent candidate for the vaccine.
I received the first vaccine on April 12, 1999, and the second on May ‘7,
1999. Due to the
onset of symptoms, I did not receive the third dose. Below are the symptoms
I have
experienced since the second vaccine. These symptoms began within :2 weeks
of the
second dose.
-Sinus headache and pressure.
-Tingling in my hands, arms, legs and feet. It is worse when I am lying down
and can be
so severe in my arms and hands that it wakes me up. It also occurs while
showerin&
sneezing yawning or coughing.
-Burning in my knees, legs, feet and arms.
-Pain in my knees and hips
-Stiffness, weakness and trembling in my right hands and arms. Pain in my
right wrist.
This is currently my worst symptom. I find activities such as reading,
writing, etc., can
cause soreness and burning to develop in my arm and wrist, and tremor as
well.
-Pain in the knuckles of my hands.
-A pulsating feeling in my head and arms. A feeling similar to a tremor, but
there is no
visible signs of a tremor.-Small exploding burst of pain/heat all over my
body. I know
this sounds odd, but it feels somewhat like a bee sting f?om the inside and
is very short-
lived. I have experienced this sensation in many areas of my body.
-Lightheadedness, and an inability to focus/concentrate. It almost feels
like my
equilibrium is off, however I do not feel dizzy, more like I’m in a fog.
-A slight jerking movement of my body or a part of my limbs as I lay down
and rest.
-Monthly menstrual migraines that began immediately after the vaccine and
continued for
10 months.
-The sensation of my stomach turning over, however, it is in my head. I know
this
sounds unusual, but someone described it that way and it seemed perfect!
This feeling
happens when I am lying down and can occur several times. It seems to occur
over
several days and then will subside for a few weeks.
I do not experience all of these symptoms simultaneously, they seem to come
and go
without any pattern or predictability. They all began after the second dose
of the vaccine.
Listed below are the antibiotics I have taken since receiving the second
vaccine.
1 l/22/99 - 0 l/28/00 Doxycycline 200mg/day
01/28/00 - 02/10/00 Doxycycline 3OOmg/day - Discontinued due to GI
intolerance
02/13/00 - 03/23/00 Keflex
1500 mg/day - Discontinued due: to yeast infections
03/23/00 - 04/12/00 Zithromax
250 mglday
04/12/00 - 04/23/00 Zithromax
500 mg - Twice a week
05/19/00 - 06/29/00 IV Rocephin 6 week IV therapy
At the end of the IV treatment, I still had no improvement. In September,
2000, I saw Dr.
~-
+ I. He is a physician who is treating chronic lyme
disease as a neurotoxin. I completed the treatment below, with’still no
improvement.
09/24/00 - 1 O/l 6/00 Cholestyramine
4 grams per scoop/4 times per day
1 O/l 7/00 - 1 O/30/00 Cholestyramine
4 grams per scoop/4 times per day
Chitosan
750 mg/3 times per day
The following tests have been performed:
06/29/99 - MRI of the brain without/with contrast - result: normal
0710 l/99 - Lyme, Western blot. Positive.
07/28/99 - MRI of the brain with attention to the pituitary - result: 2mm
microademoma
in the right side of the pituitary gland. This is something I have been
a.ware of for 10
years and has been followed on a regular basis by my endocronologist. This
finding does
not reveal any significant change in the microadenoma since my last MRI.
08199 - EKG - result:normal
09/20/99 - Median Nerve Evoked Potential - result: normal
09/20/99 - Posterior Tibial Evoked Response - result: normal
09/23/99 - MRI, cervical without contrast - result: normal
01/13/00 - Lumbar Puncture - result: borderline lyme serology. I t has been
brought to
my attention that since a serum sample was not taken at the same time, this
result is
irrelevant. I do not know why a serum sample was not ordered.
Thank you for your attention to this matter.
Sincerelv
===================================================================
11.) CASE No. 11
===================================================================
Hello,
12/30/00
I am a fifty-one year old woman who has survived Rheumatic Fever, Child
birth
complications, a hysterectomy at the age of 27, and a three year bout with
Lyme Disease
from 1987 to 1990. I have always been a fighter, and after each setback., I
battled
my way back to a useful life.
This time is different. At the prompting of my insurance company and my
doctor, I received my first Lyme Vaccine shot on 5/4/99 and the second on
6/4/99. No one even thought to test me for a gene that would say I was
allergic to the shots. Suffering additional and increased health problems
after the first two
shots, which included neuropathic pain in my legs and feet, migraines and
other
headaches, severe sinus problems, chronic fatigue syndrome, depression,
having to
double my medication (a Parkinsons drug called Mirapex) which was prescribed
to me
for Restless :Leg Syndrome which began during my first bout with Lymes, I
again took
the advice of my physician and got the third Lyme Vaccine shot in June of
2000.
From this point things went very wrong extremely fast, and I was able to
put it all together, placing the blame where it belonged, on the vaccine
shots for Lyme disease. My emotions went crazy, causing uncontrolled
crying
spells while I was in school where I am learning computers. I became
extremely co&.sed (Lyme victims call it brain fog) and had to drop two
of
my classes..My Restless Leg Syndrome, mostly, up to this point, medication
controlled
jerking of the legs when I relaxed, suddenly began causing severe insomnia,
jerking
of my head and left hand, and muscle spasms in my legs that my medication
would not stop. Fearing Parkinson’s, I was evaluated by two therapists
who
were concerned because of a noticeable facial tic as well as a neck
jerking.
My doctor suspected a late sequela of late treated Lyme’s disease and put
me
on Lorazepam to calm my nerves, which did help my nerves, but nothing
else.
Althougtl de&ed the possibility that the vaccine shots could have
caused
my problems, she did agree to give me 28 days of doxicycline on the chance
that
it might stop the irreversible neurological damage I was suffering. I
began
to feel much better, and have done quite well until the past month when.
my
left knee, my lower back, hips and neck have once again begun causing me
pain. (I had been pain free for at least two years before I got these shots)
Although I was
never able to recall many things from my first bout with Lymes, I have been
perfectly
able to relearn, as my two Scholarships and 3.868 Grade Point Average prove,
but now
my memory is beginning to fail me again. I am signed up for three classes
this neti
semester, and am so af?aid that I won’t be able to complete them. I want so
badly to be
independent, to get a job that I can do over the intemet where I could w,ork
around the
physical limitations I already had from Lyme Disease, but the additional
fatigue, physical
and mental limitations inflicted upon me from these Lyme vaccination shots
are &e last
straw. Unless I can receive some serious and immediate help, I fear I may
soon be of no
use to anyone. I beg you to stop these vaccines now! Don’t let anyone,
especially
children, suffer from them ever again.
====================================================================
12.) CASE No 12
===================================================================
fri 19 jan 2001
to whom it may concen
my name is
_
_
had the 3 shot series of the lyme
vaccine. june 13 th, 2000 was shot 3 of 3. six days later on 19 june
2000 i woke up with swollen , tender, and painfull knees and both
quadracept leg muscles hurt. the night before i had no prolblem at all.
it just came from nowhere without any warning symptoms.
during the following month my legs became weak and i noticed my leg
muscles getting smaller.after a quadracept biopsy and leg nerve
conduction tests i was diagnosed with muscle atophy and demyelination of
the nerves.
Approximately 1 aug 2000 i woke up with excruiating pain in my left hip.
i was first diagnosed with hip tendonitis then avascular necrosis and
then with an arthritic hip. this was all done with x-rays and mri”s.
in Sept. 2000 my left knee became so painfull i was told to use a cane,
which is the only way i can move now.
i was using oxyconyin 20 mg twice a day with no affect on the pain. i am
now on percocet S/325 about 5 times a day, just to take the extreme pain
away from my body, but it has no affect on my hip and knee pain.
my history is that in 1991 i had arthritis, scoliosis, hemochromatosis.
degenerative spine ,and degenerative lumbar area with stenosis of L3/L4
vertebrea causing sciatica. all the conditions starting with 199 1 have
been under control and stabilized with nsaids(feldene) for
arthritis,theraputic
phlebotomys for hemochromatosis, and gravity lumbar
traction for the sciatica. i have been on social security disability
since 1995. i am currently 62 years old.
when on S.S. disability i could not work ( i was an electronics teacher
for 30 years ),because of low back pain , sciatica, and constant
gravity lumbar traction. now , i have no quality of life. i get around
on the cane and my right leg with great pain. i am very depressed and
fear-full of what migth happen next to my body as i live alone. if my
right leg goes, im dead in the water.
-
thanks .-
=================================================================
13.) LYME INFORMATION FROM A MEMBER OF ACTIONLYME, ADVOCATING LYME PATIENTES
RIGTHS AND THE LYE INFORMATION YEAR 2.001
=================================================================
i/22/01
MON 14:29 c
i__ b_.-A
('
@loon
. . .
Good afternoon, my’ name is
I am from Wenham Massachusetts, one of the most Lyme-endemic areas in the
US. I am a
member of ActionLyme, advocating for Lyme patient rights and the
-
Lyme information
and support group in my community.
I work locally with schools, parents and Lyme patients to raise awareness
of Lyme disease in our area, and I have read through much of what has
been written on Lymerix, especially the material provided by the CDC and
FDA.
I come before you today as a mother of two, a consumer, and a patient
advocate, with issues that have occurred to others and me as we carefully
review the material on this vaccine.
1 pose these issues in the form of questions and hope this committee
sees fit to pursue answers to these important questions and concerns
before more aggressive marketing of the vaccine is allowed, especially to
our children.
I am a layperson --not a scientist. However others and myself have read
material published by the government and SmithKline Beecham and we
recognize the disparity between real- world experience and the reality of
the trials used to study the safety of‘Lymerix vaccine. I am sure my
questions are those that might be asked by any mother living in a Lyme-
endemic area, I pose them to you here, today with hope you will consider
the answers to these troubling questions before Lymerix is marketed to
our children.
I. The case definition of Lyme disease used for the vaccine is different
than the definition the CDC instructs our physicians to use when
diagnosing and treating Lyme. Given this disparity, how can we have
confidence that the vaccine trials reflect true patient situations?
2. Many individuals I know have claimed adverse events after receiving
the Lymerix vaccine, yet have been told their reports are ulnconnected to
the vaccine. How can so many people have the same type of reaction
directly after being vaccinated with Lymerix without it being vaccine
related?
3. My children and I have had Lyme disease. I have read literature
stating
the Lyme infection may persist, possibly hidden, in human cells after a
patient has been treated. What attentions have the Lymerix vaccine
makers taken to assure previously infected patients will not be harmed by
their vaccine?
4. The children playing in the forests and along the beaches of our
Massachusettstowns have been exposed to Lyme disease since they
could crawl. What of the children who have not been diagnosed with
VRBPAC
l/31/01
nJ ,‘zz/ol
YON 14: 30
Lyme but do indeed’harbor the infection? What effect would Lymerix
vaccination produce in these innocents?
With new reports of asymptomatic
Lyme disease now abounding, 1 would
like to ask SmithKline Beecham how this possibility has been accounted
for in the study of safety of Lymerix for pediatric use.
I urge the committee to be prudent while reviewing the safety of
thisvaccine.
Thank you for allowing me this opportunity.
Page 20
From -
o. Nancy Cherry
.
Date: l/21/01
Time: 1:45:48 PM
January 2 1, 200 1
Dear, Nancy Cherry
I’m writing this in reply to my concerns about Lymerix.
1. Doctors don’t know how to handle the rash of side effects.
2. Doctors don’t want to feel their at fault for the vaccine causing
effects.
3. Patients are suffering because doctors don’t want to deal with Lyme let
alone the vaccine
======================================================================
14.) Identification of a defined linear epitope in the OspA protein of the
Lyme disease spirochetes
that elicits bactericidal antibody responses: Implications for vaccine
development.
======================================================================
Vaccine. 2017 May 31;35(24):3178-3185. doi: 10.1016/j.vaccine.2017.04.079.
Epub 2017 May 4.
Izac JR1, Oliver LD Jr1, Earnhart CG1, Marconi RT2.
Author information
1
Dept. Microbiology and Immunology, Virginia Commonwealth University Medical
Center, Richmond, VA, United States.
2
Dept. Microbiology and Immunology, Virginia Commonwealth University Medical
Center, Richmond, VA, United States. Electronic address:
richard.marconi@vcuhealth.org.
Abstract
The lipoprotein OspA is produced by the Lyme disease spirochetes primarily
in unfed ticks. OspA production is down-regulated by the blood meal and it
is not produced in mammals except for possible transient production during
late stage infection in patients with Lyme arthritis. Vaccination with OspA
elicits antibody (Ab) that can target spirochetes in the tick midgut during
feeding and inhibit transmission to mammals. OspA was the primary component
of the human LYMErix™ vaccine. LYMErix™ was available from 1998 to 2002 but
then pulled from the market due to declining sales as a result of
unsubstantiated concerns about vaccination induced adverse events and poor
efficacy. It was postulated that a segment of OspA that shares sequence
similarity with a region in human LFA-1 and may trigger putative autoimmune
events. While evidence supporting such a link has not been demonstrated,
most efforts to move forward with OspA as a vaccine component have sought to
eliminate this region of concern. Here we identify an OspA linear epitope
localized within OspA amino acid residues 221-240 (OspA221-240) that lacks
the OspA region suggested to elicit autoimmunity. A peptide consisting of
residues 221-240 was immunogenic in mice. Ab raised against OspA221-240
peptide surface labeled B. burgdorferi in IFAs and displayed potent Ab
mediated-complement dependent bactericidal activity. BLAST analyses
identified several variants of OspA221-240 and a closely related sequence in
OspB. It is our hypothesis that integration of the OspA221-240 epitope into
a multivalent-OspC based chimeric epitope based vaccine antigen
(chimeritope) could result in a subunit vaccine that protects against Lyme
disease through synergistic mechanisms.
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15.) Borrelia burgdorferi OspA is an arthropod-specific
transmission-blocking Lyme disease vaccine.
=====================================================================
J Exp Med. 1996 Jan 1;183(1):271-5.
de Silva AM1, Telford SR 3rd, Brunet LR, Barthold SW, Fikrig E.
Author information
1
Department of Internal Medicine, Yale University School of Medicine, New
Haven, Connecticut 06520-8031, USA.
Abstract
Borrelia burgdorferi, the spirochetal agent of Lyme disease, is transmitted
by Ixodes ticks. A vaccine based on B. burgdorferi outer surface protein
(Osp) A protects mice from spirochete infection. Here we report on the
expression of OspA on spirochetes inside engorging ticks and relate OspA
expression to antispirochetal immunity. Spirochetes in the gut of unfed
nymphal ticks were stained by an OspA antibody, whereas in feeding ticks,
the majority of spirochetes in the gut and salivary glands did not stain
with the antibody. Thus, OspA was not expressed on most spirochetes during
transmission from the vector to the vertebrate host. To examine the
mechanism of protection afforded by OspA antibody, mice were passively
immunized with OspA antibody at different times relative to tick attachment.
When OspA antibody was administered to mice before or at the time of tick
attachment, spirochetal development events in the vector, such as growth and
salivary gland invasion, were blocked and the mice were protected from B.
burgdorferi infection. When OspA antibody was administered to mice 48 h
after tick attachment, spirochetes persisted in the nymphs and the mice were
not protected despite the presence of circulating antibodies in the host as
well as in the tick blood meal. Thus, OspA immunity appears to be effective
only during a narrow window time at the beginning of the blood meal when
antibodies bind to OspA-expressing spirochetes in the tick gut and block
transmission from the vector to the host.
======================================================================
16.) An effective second-generation outer surface protein A-derived Lyme
vaccine that eliminates a potentially autoreactive T cell epitope.
======================================================================
Proc Natl Acad Sci U S A. 2004 Feb 3;101(5):1303-8. Epub 2004 Jan 23.
Willett TA1, Meyer AL, Brown EL, Huber BT.
Author information
1
Department of Pathology, Tufts University School of Medicine, 150 Harrison
Avenue, Boston, MA 02111, USA.
Abstract
The antigenic component of a common Lyme disease vaccine is recombinant
outer surface protein A (rOspA) of Borrelia burgdorferi (Bb), the causative
agent of Lyme disease. Coincidentally, patients with chronic,
treatment-resistant Lyme arthritis develop an immune response against OspA,
whereas those with acute Lyme disease usually do not. Treatment-resistant
Lyme arthritis occurs in a subset of Lyme arthritis patients and is linked
to HLA.DRB1*0401 (DR4) and related alleles. Recent work from our laboratory
identified T cell crossreactivity between epitopes of OspA and lymphocyte
function-associated antigen 1alpha(L) chain (LFA-1alpha(L)) in these
patients. We generated a form of rOspA, FTK-OspA, in which the
LFA-1alpha(L)/rOspA crossreactive T cell epitope was mutated to reduce the
possible risk of autoimmunity in genetically susceptible individuals.
FTK-OspA did not stimulate human or mouse DR4-restricted, WT-OspA-specific T
cells, whereas it did stimulate antibody responses specific for WT-OspA that
were similar to mice vaccinated WT-OspA. We show here that the protective
efficacy of FTK-OspA is indistinguishable from that of WT-OspA in
vaccination trials, as both C3H/HeJ and BALB/c FTK-OspA-vaccinated mice were
protected from Bb infection. These data demonstrate that this rOspA-derived
vaccine lacking the predicted cross-reactive T cell epitope, but retaining
the capacity to elicit antibodies against infection, is effective in
generating protective immunity.
======================================================================
17.) Safety, immunogenicity, and efficacy of Borrelia burgdorferi outer
surface protein A (OspA) vaccine: A meta-analysis.
======================================================================
J Infect Dev Ctries. 2017 Jan 30;11(1):1-9. doi: 10.3855/jidc.7999.
Zhao H1, Bao FF, Liu A.
Author information
1
Kunming Medical University, Kunming, China. 379740844@qq.com.
Abstract
INTRODUCTION:
Lyme borreliosis, caused by Borrelia burgdorferi sensu stricto in the United
States and by several Borrelia species in Europe and Asia, has a great
impact on the health of the global population. There are human vaccines
available, such as the outer surface protein A (OspA) vaccine, but still
more evidence is needed to verify its function. We investigated the safety,
immunogenicity, and efficacy of adjuvanted or non-adjuvanted vaccines
containing protective epitopes from Borrelia species OspA serotypes in
healthy adults.
METHODOLOGY:
Seven electronic databases were searched for clinical trials involving
vaccine of OspA, with outcome data on safety, immunogenicity, and efficacy.
The meta-analysis method was used to compare all vaccination strategies at
the same time.
RESULTS:
Three relevant studies were identified. All were randomized controlled
trials (RCTs) or quasi-RCTs. Meta-analysis shows that, compared with low
dose, high dose comes with a higher IgG titer with overall effect size of
6.39. For the 30 µg dose, the geometric mean titer was 6918.31, which is
statistically significant when compared with 0. With respect to safety, only
soreness showed a relatively high incidence of 40% (p < 0.05 when
compared with 0, while the other side effects were no difference compared
with 0).
CONCLUSIONS:
The OspA vaccine against Lyme disease is safe and its immunogenicity and
efficacy have been verified. Instead of stagnating or giving up, further
research on improving the vaccine is needed. On the foundation of
preliminary studies, we can attempt to develop new vaccines for human
use.
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18.) Antibody profiling of canine IgG responses to the OspC protein of the
Lyme disease spirochetes supports a multivalent approach in vaccine and
diagnostic assay development.
======================================================================
Vet J. 2016 Dec;218:27-33. doi: 10.1016/j.tvjl.2016.11.001. Epub 2016 Nov
9.
Oliver LD Jr1, Earnhart CG1, Virginia-Rhodes D1, Theisen M2, Marconi RT3.
Author information
1
Department of Microbiology and Immunology, Virginia Commonwealth University
Medical Center, 1112 East Clay Street, McGuire Hall Room 101, Richmond, VA
23298-0678, USA.
2
Department of Congenital Disorders, Statens Serum Institute, Copenhagen,
Denmark.
3
Department of Microbiology and Immunology, Virginia Commonwealth University
Medical Center, 1112 East Clay Street, McGuire Hall Room 101, Richmond, VA
23298-0678, USA. Electronic address: richard.marconi@vcuhealth.org.
Abstract
OspC performs essential functions during the enzootic cycle of the Lyme
disease (LD) spirochetes. In this study, the specificity of antibody (Ab)
responses to OspC was profiled to define the antigenic determinants during
infection and after vaccination. Several OspC variants or 'types' were
screened with serum from SNAP4Dx C6 positive dogs and with serum from
rabbits hyperimmunized with OspC proteins. The OspC type-specific nature of
the Ab response revealed that variable domains of OspC are immunodominant
during infection and upon vaccination. To assess the potential of OspC to
elicit Ab in the context of a bacterin vaccine, OspC production in strains
cultivated in vitro was assessed. Immunoblot and indirect immunofluorescent
antibody analyses demonstrated that production is low and that only a subset
of cells actively produces OspC in vitro, raising questions about the
potential of bacterin vaccines to stimulate significant anti-OspC Ab
responses. The specificity of the OspC Ab response in experimentally
infected mice over time was assessed to determine if domains shielded in the
OspC homodimer become accessible and stimulate Ab production as infection
progresses. The results demonstrate that the OspC Ab response remains
focused on surface exposed variable regions of the protein throughout
infection. In contrast to some earlier studies, it is concluded that
conserved domains of OspC, including the C7 or C10 domain, do not elicit
significant Ab responses during infection or upon vaccination. Collectively,
the results indicate that OspC diversity must be considered in vaccine
design and in the interpretation of diagnostic assays that employ OspC as a
diagnostic antigen.
=================================================================
19.) Enhanced Protective Immunogenicity of Homodimeric Borrelia burgdorferi
Outer Surface Protein C.
=================================================================
Clin Vaccine Immunol. 2017 Jan 5;24(1). pii: e00306-16. doi:
10.1128/CVI.00306-16. Print 2017 Jan.
Edmondson DG1, Prabhakaran S1, Norris SJ1, Ullmann AJ2, Piesman J2, Dolan
M2, Probst C3, Radzimski C3, Stöcker W3, Komorowski L4.
Author information
1
Department of Pathology & Laboratory Medicine, Medical School,
University of Texas, Houston, Texas, USA.
2
Centers for Disease Control and Prevention, Division of Vector-Borne
Disease, Fort Collins, Colorado, USA.
3
Institute of Experimental Immunology, Euroimmun AG, Lübeck, Germany.
4
Institute of Experimental Immunology, Euroimmun AG, Lübeck, Germany
l.komorowski@euroimmun.de.
Abstract
Lyme borreliosis is caused by tick-transmitted spirochetes of the Borrelia
burgdorferi sensu lato group and is the most common vector-borne disease in
the United States and Europe. Outer surface protein C (OspC) is a 23-kDa
outer surface lipoprotein expressed during spirochete transmission from the
tick to the vertebrate host. In a previous study, we found that immunization
with a recombinant disulfide-bridged dimeric form of OspC (D-OspC)
stimulates increased antibody responses relative to immunization with
commonly employed monomeric OspC. Here, we report that mice immunized with
dimeric OspC proteins also exhibited enhanced protection against infection
with the cognate B. burgdorferi strain. Mice were protected by four
immunizations containing as little as 100 ng of dimeric OspC, suggesting
that this form of the protein can induce protective immunity within a dose
range reasonable for a human or veterinary vaccine. In contrast, monomeric
OspC was only partially protective at much higher doses. IgG subclass
analysis revealed that D-OspC-immunized animals mainly possessed
anti-OspC-IgG1. In contrast, infected animals develop anti-OspC restricted
to the IgG3 isotype. A subset of antibodies generated by dimeric OspC
immunization did not recognize the monomeric variant, indicating that unique
epitopes exist on the dimeric form. Moreover, monoclonal antibodies that
recognized only dimeric OspC protected mice from B. burgdorferi challenge,
whereas another monoclonal that recognized both immunogens was not
protective. These studies suggest that this dimeric OspC presents
distinctive epitopes that generate antibodies protective against B.
burgdorferi infection and could be a useful vaccine component.
=================================================================
20.) Intentions to receive a potentially available Lyme disease vaccine in
an urban sample.
==================================================================
Ther Adv Vaccines. 2016 Jan;4(1-2):3-14. doi: 10.1177/2051013616629881. Epub
2016 Jan 1.
Fogel J1, Kusz M2.
Author information
1
Department of Business Management, Brooklyn College of the City University
of New York, 218A, 2900 Bedford Avenue, Brooklyn, NY 11210, USA.
2
Department of Biology, Brooklyn College, Brooklyn, NY, USA.
Abstract
OBJECTIVES:
The only human Lyme disease vaccine of LYMErix was voluntarily removed from
the market in the United States in 2002 for a number of reasons. A new human
Lyme disease vaccine is currently being developed. We would like any future
approved human Lyme disease vaccine to be of interest and marketable to
consumers.
METHODS:
We surveyed 714 participants to determine variables associated with
intentions to receive a Lyme disease vaccine. Predictor variables included
demographics, protection motivational theory, Lyme disease knowledge, Lyme
disease preventive behaviors, beliefs and perceived health.
RESULTS:
We found in multivariate linear regression analyses that Asian/Asian
American race/ethnicity (p < 0.001), South Asian race/ethnicity (p =
0.01) and coping appraisal variables of response efficacy (p < 0.001) and
self-efficacy (p < 0.001) were each significantly associated with
increased intentions. The belief that vaccines are typically not safe was
significantly associated with decreased intentions (p = 0.03).
CONCLUSIONS:
Asian/Asian American and South Asian race/ethnicities have a strong interest
in receiving a Lyme disease vaccine. Although pharmaceutical companies may
benefit by advertising a Lyme disease vaccine to Asian/Asian Americans and
South Asians, marketers need to address and use approaches to interest those
from other race/ethnicities. Also, marketers need to address the erroneous
belief that vaccines are typically not safe in order to interest those with
such beliefs to use a Lyme disease vaccine.
