H1N1, INFLUENZE, The RESIDENT EVIL III, The path
to death...!!!! H1N1
INFLUENZA, EL HUESPED DIABOLICO III, camino a la muerte...!!!!
Data-Medicos
Dermagic/Express No.10-(X-19)
05 December 2.009 /05 Diciembre 2.009
EDITORIAL ESPAÑOL
=============== H1N1
INFLUENZA, El Huesped Diabolico III, CAMINO A LA MUERTE... !!!
Usted se recuerda la fecha 15 de mayo del 2.002 ??? cuando yo fui la primera
persona en TODO EL PLANETA TIERRA QUE hizo la PRIMERA publicacion formal de que
el mercurio en las vacunas estaba ocasionando una generacion de niños autistas
???, con el nombre de TIMEROSAL, AUTISMO Y VACUNAS ????
TIMEROSAL AUTISMO Y VACUNAS Se te olvido eso,?? Se te
olvido que yo fui la primera persona en el globo terraqueo que alerto a la
poblacion mundial de lo que estaba pasando con las vacunas ???? Conocias tu
que mi nombre figura como una de las grandes referencias en la CARTA PETITORIA
QUE LA SOCIEDAD ESTA HACIENDO EN CONTRA DE LA VACUNACION MASIVA ????, por el
temor a los efectos secundarios que puede oacasionarte una vacuna y que denuncie
hace mas de 7 AÑOS !!!!!
-
22 Jul 2009 ... El bioquímico líder en el
mundo,
Dr. Boyd Haley, Profesor y Jefe del ....
el
Dr. José
Lapenta R. de Venezuela en el Boletín
Dermagic del 15 ...
www.concienciaradio.com/declaracion_resistencia_vacunas.htm
-
En caché
!!!!!
TE PUEDO DAR UN PUÑADO DE DOLARES Y APOSTAR QUE
NO LO SABIAS....!!!!!
Y Ahora te voy a decir por ULTIMA VEZ, en este
tercer capitulo que hago sobre la influenza H1N1 y H5N1, que todo es
una danza millonaria, que la FDA Y LA OMS son entes corruptos que se
venden al dinero de los laboratorios y gobiernos.
Y Quien es el que ha
dado las grandes batallas y las ha ganado, contra
aquellas malas moleculas que estaban matando gente y
fueron sacadas del mercado: nimesulide, vioxx,
bextra, celebrex y alertado sobre los peligros de
otras mas ????
La caperucita roja ?????,esperando que el lobo venga a comersela ????
Que te paso ???? acaso creias que te estaba mintiendo ??? que era simple
publicidad ??? que estaba buscando el protagonismo,???? como muchos lo hacen
ahorita.... neofitos que no saben nada de lo que esta ocurriendo con las
medicinas y vacunas. Que han abierto sitios donde piden "donaciones" para
sacarte dinero !!! con la excusa, ayudame que yo soy tu salvador !!!!
Todos pueden comprar un ticket para viajar en un tren, y seguir viajando en el
tren de mentiras y falsedades que las farmaceuticas les venden, pero el DERMAGIC
EXPRESS, es y seguira siendo el UNICO EN EL MUNDO QUE les dijo la verdad.
Y a quien van a entrevistar cuando el asunto de las vacunas se ponga peor,
A jason Bourne ???
Lean estas 36 referencias sobre la H1N1 y H5N1 para que agarren un poquito de
minimo y se den cuenta desde cuando este juego de guerra comenzo.
DR. JOSE LAPENTA Diciembre 5/ 2.009/
ENGLISH EDITORIAL
================
H1N1, INFLUENZE, The Resident Evil III, THE path to death...!!!!
Are you reminded the date May 15 the 2.002 ??? when I was the first person in
THE whole PLANET EARTH THAT made the FIRST formal publication that the mercury
in the vaccines was causing a generation of autistic children???, with the
name:THIMEROSAL, AUTISM AND VACCINES ????
THIMEROSAL AUTISM AND VACCINES
Do you forget that??
Do you forget that I was the first person in the terraqueous globe that I alert
the world population of what was happening with the vaccines????
did you know that my name figures like one of the big references in the
PETITION LETTER THAT THE SOCIETY IS MAKING AGAINST OF THE MASSIVE
VACCINATION????, for the fear to the secondary effects that it can cause you a
vaccine, and that it denounces ago but of 7 YEARS !!!!!
-
22 Jul 2009 ... El bioquímico líder en el mundo,
Dr.
Boyd Haley, Profesor y Jefe del .... el
Dr.
José
Lapenta R. de Venezuela en el Boletín
Dermagic
del 15 ...
www.concienciaradio.com/declaracion_resistencia_vacunas.htm
-
En caché
!!!!!I CAN GIVE YOU A HANDFUL OF DOLLARS AND TO BET THAT YOU DIDN'T KNOW IT !!!!
And Now I will tell you for THE LAST TIME, in this third edition that I make on
the influenze H1N1 and H5N1, that everything is millionaire dance, that the FDA
AND THE OMS are corrupt entities that are sold to the money of the laboratories
and governments.
And Who it is the one that has given the big battles and it has won them,
against those bad molecules that were killing people and they were taken out of
the market: nimesulide, vioxx, bextra, celebrex??? and alerted about the danger
of other but???
The Little Ret Riding Hood ????, hoping the wolf comes to eat her ????
What I happen to you???? did you maybe believe that I was lying to you??? that
it was simple publicity??? that I was looking for the protagonism???? as many
they do make it right now.... neophytes that don't know anything about what is
happening with the medicines and vaccines. That they have opened places where
they request "donations" to take out you money!!! with the excuse, help me that
I am your savior!!!!
All can buy a ticket to travel in a train, and to continue traveling in the
train of lies and falsehoods that the pharmacists sell to you, but the DERMAGIC
EXPRESS, is and it will continue being the ONLY one IN THE WORLD THAT he told
all the truth.
And who they will interview when the matter of the vaccines becomes worse, ???
To jason Bourne???
Read these 36 references on the H1N1 and H5N1 so that you grab a minimum little
bit and realize from when this game of war began.
DR. JOSE LAPENTA December 5/ 2.009/
==============================================================
REFERENCIAS BIBLIOGRAFICAS
/BIBLIOGRAPHICAL REFERENCES
==============================================================
1.) Novel Pandemic Influenza A(H1N1) Viruses Are
Potently Inhibited by DAS181, a Sialidase Fusion Protein
2.) The evolution of human influenza A viruses from 1999 to 2006: A complete
genome study
3.)Oseltamivir-Resistant Influenza Virus A (H1N1), Europe, 2007–08 Season
4.) Oseltamivir-Resistant Influenza Viruses A (H1N1), Norway, 2007–08
5.) Influenza vaccination and Guillain Barre syndrome small star, filled.
6.) Guillain-Barré syndrome following influenza vaccination.
7.) Clinical implications of endotoxin concentrations in vaccines.
8.) Guillain-Barré syndrome after influenza vaccination in adults: a
population-based study.
9.)A one year followup of chronic arthritis following rubella and hepatitis B
vaccination based upon analysis of the Vaccine Adverse 10.) Investigation of the
temporal association of Guillain-Barre syndrome with influenza vaccine and
influenzalike illness using the
11.) Update: Guillain-Barré syndrome among recipients of Menactra meningococcal
conjugate vaccine--United States, June 2005-September
12.) Guillain-Barre syndrome following vaccination in the National Influenza
Immunization Program, United States, 1976--1977.
13.) 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.
14.)Vaccines and Guillain-Barré syndrome.
15.) potential signal of Bell's palsy after parenteral inactivated influenza
vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United
States, 1991-2001.
16.) Adverse events reported following live, cold-adapted, intranasal influenza
vaccine.
17.) Monitoring the safety of annual and pandemic influenza vaccines: lessons
from the US experience.
18.) Are toxic biometals destroying your children's future?
19.) Surveillance for safety after immunization: Vaccine Adverse Event Reporting
System (VAERS)--United States, 1991-2001.
20.) Media coverage of the measles-mumps-rubella vaccine and autism controversy
and its relationship to MMR immunization rates in the United States.
21.) A meta-analysis epidemiological assessment of neurodevelopmental disorders
following vaccines administered from 1994 through 22.) 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.
23.) Neurodevelopmental disorders following thimerosal-containing childhood
immunizations: a follow-up analysis.
24.) Neurodevelopmental disorders after thimerosal-containing vaccines: a brief
communication.
25.) A comparative evaluation of the effects of MMR immunization and mercury
doses from thimerosal-containing childhood vaccines on
26.) Aluminum adjuvant linked to Gulf War illness induces motor neuron death in
mice.
27.) Influenza vaccine with squalene adjuvant: new preparation. No better than
available products.
28.) Antibodies to squalene in recipients of anthrax vaccine.
29.)Aluminum hydroxide injections lead to motor deficits and motor neuron
degeneration.
30.) Aluminum-induced model of motor neuron degeneration: subperineurial
injection of aluminum in rabbits.
31.) Vaccines as a trigger for myopathies.
32.) Induction of metallothionein in mouse cerebellum and cerebrum with low-dose
thimerosal injection.
33.) Neonate exposure to thimerosal mercury from hepatitis B vaccines.
34.) Secret CDC vaccine study Thimerosal an autism risk
35.) Possible hidden hazards of mass vaccination against new influenza A/H1N1:
have the cardiovascular risks been adequately weighed?
36.) Adjuvants and autoimmunity.
=================================================================
1.) Novel Pandemic Influenza A(H1N1) Viruses Are Potently Inhibited by DAS181, a
Sialidase Fusion Protein
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:
[email protected]
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.
2.) The evolution of human influenza A viruses from 1999 to 2006: A complete
genome study
Karoline Bragstad,1 Lars P Nielsen,2 and Anders Fomsgaard1Laboratory
of Virus Research and Development, Statens Serum Institut, DK 2300 Copenhagen,
Denmark
2WHO
National Influenza Centre, Statens Serum Institut, DK-2300 Copenhagen, Denmark
Corresponding author.
Karoline Bragstad:
[email protected];
Lars P Nielsen:
[email protected];
Anders Fomsgaard:
[email protected]
Received January 9, 2008; Accepted March 7, 2008.
This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
, which
permits unrestricted use, distribution, and reproduction in any medium, provided
the original work is properly cited.
This article has been
cited by
other articles in PMC.
Abstract
Background
Knowledge about the complete genome constellation of seasonal influenza A
viruses from different countries is valuable for monitoring and understanding of
the evolution and migration of strains. Few complete genome sequences of
influenza A viruses from Europe are publicly available at the present time and
there have been few longitudinal genome studies of human influenza A viruses. We
have studied the evolution of circulating human H3N2, H1N1 and H1N2 influenza A
viruses from 1999 to 2006, we analysed 234 Danish human influenza A viruses and
characterised 24 complete genomes.
Results
H3N2 was the prevalent strain in Denmark during the study period, but H1N1
dominated the 2000–2001 season. H1N2 viruses were first observed in Denmark in
2002–2003. After years of little genetic change in the H1N1 viruses the
2005–2006 season presented H1N1 of greater variability than before. This
indicates that H1N1 viruses are evolving and that H1N1 soon is likely to be the
prevalent strain again. Generally, the influenza A haemagglutinin (HA) of H3N2
viruses formed seasonal phylogenetic clusters. Different lineages co-circulating
within the same season were also observed. The evolution has been stochastic,
influenced by small "jumps" in genetic distance rather than constant drift,
especially with the introduction of the Fujian-like viruses in 2002–2003. Also
evolutionary stasis-periods were observed which might indicate well fit viruses.
The evolution of H3N2 viruses have also been influenced by gene reassortments
between lineages from different seasons. None of the influenza genes were
influenced by strong positive selection pressure. The antigenic site B in H3N2
HA was the preferred site for genetic change during the study period probably
because the site A has been masked by glycosylations. Substitutions at
CTL-epitopes in the genes coding for the neuraminidase (NA), polymerase acidic
protein (PA), matrix protein 1 (M1), non-structural protein 1 (NS1) and
especially the nucleoprotein (NP) were observed. The N-linked glycosylation
pattern varied during the study period and the H3N2 isolates from 2004 to 2006
were highly glycosylated with ten predicted sequons in HA, the highest amount of
glycosylations observed in this study period.
Conclusion
The present study is the first to our knowledge to characterise the evolution of
complete genomes of influenza A H3N2, H1N1 and H1N2 isolates from Europe over a
time period of seven years from 1999 to 2006. More precise knowledge about the
circulating strains may have implications for predicting the following season
strains and thereby better matching the vaccine composition.
3.)Oseltamivir-Resistant Influenza Virus A (H1N1), Europe, 2007–08 Season
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:
[email protected]
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.
4.) Oseltamivir-Resistant Influenza Viruses A (H1N1), Norway, 2007–08
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:
[email protected]
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.
5.) Influenza vaccination and Guillain Barre syndrome small star, filled.
Geier MR,
Geier DA,
Zahalsky AC.
The Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905, USA.
[email protected] <[email protected]>
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.
6.)
Guillain-Barré syndrome following influenza vaccination.
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. [email protected]
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.
7.) Clinical
implications of endotoxin concentrations in vaccines.
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.
8.)
Guillain-Barré syndrome after influenza vaccination in adults: a
population-based study.
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.
9.)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.
Geier DA,
Geier MR.
MedCon, Inc., Silver Spring, Maryland, USA.
[email protected]
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.
10.)
Investigation of
the temporal association of Guillain-Barre syndrome with influenza vaccine and
influenzalike illness using the United Kingdom General Practice Research
Database.
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. [email protected]
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.
11.)
Update:
Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate
vaccine--United States, June 2005-September 2006.
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.
12.) Guillain-Barre syndrome following vaccination in the National Influenza
Immunization Program, United States, 1976--1977.
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.
13.) 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.
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.
[email protected]
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.
14.)Vaccines and Guillain-Barré syndrome.
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. [email protected]
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.
15.) potential signal of Bell's palsy after parenteral inactivated influenza
vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United
States, 1991-2001.
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.
16.)
Adverse events reported following live, cold-adapted, intranasal influenza
vaccine.
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.
[email protected]
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.
17.)
Monitoring the safety of annual and pandemic influenza vaccines: lessons from
the US experience.
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. [email protected]
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.
18.) Are
toxic biometals destroying your children's future?
Biometals. 2009 Oct;22(5):697-700. Epub 2009 Feb
11
Drum DA.
[email protected]
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.
19.)
Surveillance for safety after immunization: Vaccine Adverse Event Reporting
System (VAERS)--United States, 1991-2001.
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.
20.) Media coverage
of the measles-mumps-rubella vaccine and autism controversy and its relationship
to MMR immunization rates in the United States.
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. [email protected]
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.
21.) A
meta-analysis epidemiological assessment of neurodevelopmental disorders
following vaccines administered from 1994 through 2000 in the United States.
Neuro Endocrinol Lett. 2006 Aug;27(4):401-13.
Geier DA, Geier MR.
The Institute for Chronic Illnesses, Inc., Silver Spring, MD 20905, USA.
[email protected]
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.
22.) 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.
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.
[email protected]
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
23.)
Neurodevelopmental disorders following thimerosal-containing childhood
immunizations: a follow-up analysis.
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.
24.)
Neurodevelopmental disorders after thimerosal-containing vaccines: a brief
communication.
Exp Biol Med (Maywood). 2003 Jun;228(6):660-4.
Geier MR, Geier DA.
The Genetic Centers of America, Silver Spring, Maryland 20905, USA.
[email protected]
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.
25.) A
comparative evaluation of the effects of MMR immunization and mercury doses from
thimerosal-containing childhood vaccines on the population prevalence of autism.
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
26.) Aluminum
adjuvant linked to Gulf War illness induces motor neuron death in mice.
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.
[email protected]
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
27.)
Influenza vaccine with squalene adjuvant: new preparation. No better than
available products.
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.
28.) Antibodies
to squalene in recipients of anthrax vaccine.
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.
29.)Aluminum hydroxide injections lead to motor deficits and motor neuron
degeneration.
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.
[email protected]
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.
30.)
Aluminum-induced model of motor neuron degeneration: subperineurial injection of
aluminum in rabbits.
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.
31.) Vaccines as
a trigger for myopathies.
Lupus. 2009 Nov;18(13):1213-6.
Orbach H, Tanay A.
Department of Medicine B, Wolfson Medical Center, Holon, Israel.
[email protected]
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.
32.) Induction
of metallothionein in mouse cerebellum and cerebrum with low-dose thimerosal
injection.
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,
[email protected].
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.
33.) Neonate
exposure to thimerosal mercury from hepatitis B vaccines.
Am J Perinatol. 2009 Aug;26(7):523-7. Epub 2009
Mar 12.
Dórea JG, Marques RC, Brandão KG.
Universidade de Brasília, DF, Brazil.
[email protected]
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.
34.) Secret CDC vaccine study
Thimerosal an autism risk
Sources: www.whale.to
The Thimerosal Secret X FILE !!!
http://www.dermagic.i8.com/xfile1.html
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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