ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com
FYI
Judicial Watch and the National Vaccine Information Center (NVIC) have
separately issued updates involving serious adverse event reports about
Merck's HPV (Gardasil) vaccine.
Most serious are a statistically significant risk linking Gardasil when
co-administered with other vaccines, in particular, meningococcal vaccine
(Menactral).
NVIC reports: "as of May 31, there have been 2,227 Gardasil adverse events
filed with VAERS, including 13 suspected or confirmed cases of GBS (two more
GBS reports were made in June for a total of 15) and 239 cases of syncope
(fainting with temporary loss of consciousness), many of which resulted in
head injuries and fractures. Seven deaths have been reported after receipt
of Gardasil."
A total of 1,930 reported Gardasil adverse events involved administration of
Gardasil alone, and 135 adverse events involved co-administration of
Gardasil with Menactra.
ABC News reports that Earlier this year, the CDC did say there wasn't enough
evidence to prove Gardasil could be used safely with other vaccines.
http://abclocal.go.com/wls/story?section=health&id=5572168
What justification do officials of the Center for Disease Control and
Prevention offer for their encouragement to physicians to co- administer
Menactra and other vaccines with Gardasil when severe adverse event reports
should raise alarms about safety ?
CDC officials' record of massive waste and inappropriate perks---as
documented in a report by Sen. Tom Coburn, a practicing physician and
ranking member of the Senate Subcommittee on Federal Financial Management
Gov't Information and International Security--give one little trust in CDC
policies.
Contact: Vera Hassner Sharav
212-595-8974
veracare%40ahrp.org">veracare
ahrp.org <mailto: veracare%40ahrp.org">veracare
ahrp.org>
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National Vaccine Information Center <http://www.nvic.org/>
Press Release August 15, 2006
NVIC Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given
with Meningococcal and Other Vaccines
Washington, August 15, 2007 - The National Vaccine Information Center (NVIC)
today issued a new report on HPV vaccine (GardasilR) safety analyzing
adverse event reports to the federal Vaccine Adverse Event Reporting System
(VAERS). The analysis gives evidence for a reported association in VAERS
between Gardasil and Guillain-Barre Syndrome (GBS), with a statistically
significant increased risk of GBS and other serious adverse event reports
when Gardasil is co- administered with other vaccines, especially
meningococcal vaccine (MenactraR).
NVIC is calling on the Centers for Disease Control (CDC) to issue an
Advisory and amend its March 12 policy by alerting the public that Gardasil
has been associated with 15 cases of GBS and an increased risk of GBS and
other serious adverse event reports made to VAERS when the vaccine is
administered simultaneously with Menactra and other vaccines. "The
precautionary principle dictates that good science should precede CDC
vaccine policy recommendations," said Barbara Loe Fisher, NVIC co-founder
and president. "Parents have a right to expect proof of safety and not
assumption of safety before new vaccines, like Gardasil, are given
simultaneously with other vaccines to their children.
GBS is a disorder in which the body's immune system attacks part of the
peripheral nervous system, and can cause total paralysis. "Our analysis of
Gardasil reports to VAERS indicates there was a two to 12 times greater
likelihood that serious adverse events, such as GBS, were reported when
Gardasil was given in combination with Menactra rather than given alone,"
said Vicky Debold, PhD, RN, NVIC director of patient safety. "Accepted
scientific standards indicate that these findings are statistically
significant and cannot be dismissed as coincidence. In particular, the
available VAERS data show there was a more than 1,000 percent increased risk
of GBS reports following Gardasil administration when Menactra was given at
the same time."
Reported GBS and Other Serious Adverse Events
NVIC found that, as of May 31, there have been 2,227 Gardasil adverse events
filed with VAERS, including 13 suspected or confirmed cases of GBS (two more
GBS reports were made in June for a total of 15) and 239 cases of syncope
(fainting with temporary loss of consciousness), many of which resulted in
head injuries and fractures. Seven deaths have been reported after receipt
of Gardasil. Nearly 10 percent of all Gardasil adverse event reports to
VAERS involved avoidable medical errors.
A total of 1,930 reported Gardasil adverse events involved administration of
Gardasil alone, and 135 adverse events involved co-administration of
Gardasil with Menactra. NVIC's comparative analysis of those two categories
of VAERS reports indicates that when Gardasil was given simultaneously with
Menactra rather than alone, there was a statistically significant increased
risk of reported adverse events:
-respiratory problem reports increased by 114 percent;
-cardiac problems reports increased by 118 percent;
-neuromuscular and coordination problem reports increased by 234 percent;
-convulsions and central nervous system problem reports increased by 301
percent;
-reports of injuries from falls after unconsciousness increased by 674
percent; and
-GBS reports increased by 1,130 percent.
On February 21, NVIC expressed concern about the safety of administering
Gardasil simultaneously with other vaccines because the manufacturer
(Merck), the FDA and the CDC had not provided evidence to the public that
co-administration was safe. (1) On March 12, the CDC published
recommendations for Gardasil use in MMWR that acknowledged there is a lack
of evidence that Gardasil can be safely administered with other vaccines,
while encouraging physicians to co- administer Menactra and other vaccines
with Gardasil based on assumption of safety. (2)
Adverse Event Reports to NVIC: Shannon Nelson
Nineteen Gardasil adverse event reports from 12 states have been made to
NVIC's Vaccine Reaction Registry involving unconsciousness and injury,
convulsions, numbness, weakness and other neuromuscular and coordination
problems and GBS.
Shannon Nelson, 18, a Chicago area athlete, musician and artist entering
college reported to NVIC that she received HPV vaccine (Gardasil),
meningococcal vaccine (Menactra) and chicken pox vaccine (Varivax R)
simultaneously on June 21. Symptoms of tingling, numbness and muscle
weakness began within a week and progressively got worse. By July 3 she
could barely walk or raise her arms. She was hospitalized, paralyzed with
GBS on July 5, and spent 22 days in the hospital.
"Before the shots, I ran six miles a day," said Nelson. "The doctors told me
that I might have been put on a respirator if I hadn't been in such good
shape," she said. "I am out of the hospital now and getting a lot of
physical therapy. I just want to go to college and do the things I did
before, like play the guitar and draw or even just be able to smile. My Mom
and I wish we had known about HPV vaccine risks, especially what could
happen if I got other vaccines at the same time."
To view a copy of NVIC's report on HPV vaccine (Gardasil) safety, go here
<http://www.nvic.org/Diseases/HPV/HPVHOME.htm>
To report a vaccine reaction, go here
<http://www.nvic.org/report/reaction.htm>
References:
1) Vaccine Safety Group Releases Gardasil Report
<http://www.nvic.org/Diseases/HPV/pr022107HPV.htm> : Calls on FDA and CDC to
Warn Doctors and Parents to Report to VAERS, February 21, 2007.
2) Centers for Disease Control and Prevention. Quadrivalent Human
Papillomavirus Vaccine: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). Morbidity and Mortality Weekly Report (MMWR)
Early Release 2007 <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm>
; 56 March 12, 2007:1-24.
Learn more about vaccines, diseases and how to protect your informed consent
rights at www.nvic.org <http://www.nvic.org/>
National Vaccine Information Center
204 Mill Street
Vienna, VA 22180
phone: 703-938-0342
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