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 (Gardasil®)
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 (Menactra®).
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 ®)
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 to
http://www.nvic.org/Diseases/HPV/HPVHOME.htm
To report a vaccine
reaction, go to
https://w
ww.nvic.org/report/reaction.htm.
Founded in 1982, the
National Vaccine
Information Center (NVIC)
is a non-profit
(501C3) organization
working for child
health, public
education and
consumer
empowerment. NVIC is
dedicated to
preventing vaccine
injuries and deaths
through public
education and
defending the right
to informed consent
to vaccination. NVIC
has operated a
private Vaccine
Reaction Registry
for 25 years.
References:
1) Vaccine Safety
Group Releases
Gardasil Report:
Calls on FDA and CDC
to Warn Doctors and
Parents to Report to
VAERS, February 21,
2007
http://www.nvic.org/Diseases/HPV/pr022107HPV.
htm.
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; 56
March 12, 2007:1-24.
http://www.cdc.gov/mmwr/preview/mmwr
html/rr56e312a1.htm.
About National
Vaccine Information
Center
NVIC E-News is a
free service of the
National Vaccine
Information Center
and is supported
through membership
donations.
NVIC is funded
through the
financial support of
its members and does
not receive any
government
subsidies. Barbara
Loe Fisher,
President and Co-
founder.
Learn more about
vaccines, diseases
and how to protect
your informed
consent rights at
www.nvic.org
National
Vaccine
Information
Center
204 Mill
Street
Vienna,
VA 22180
phone:
703-938-0342
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