Vaccine Safety Group Releases GARDASIL Reaction Report
Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS
WASHINGTON, Feb. 21 /PRNewswire-USNewswire/ -- The National Vaccine
Information Center (NVIC) today released a new analysis of the federal
Vaccine Adverse Event Reporting System (VAERS) reports of serious health
problems following HPV vaccination (Merck's GARDASIL) during the last six
months of 2006. Out of the 385 individual GARDASIL adverse event reports
made to VAERS, two-thirds required additional medical care and about
one-third of all reports were for children 16-years-old and under, with
nearly 25 percent of those children having received simultaneously one or
more of the 18 vaccines that Merck did not study in combination with
GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors
that GARDASIL should not be combined with other vaccines and that young
girls should be monitored for at least 24 hours for syncopal
(collapse/fainting) episodes that can be accompanied by seizure activity, as
well as symptoms of tingling, numbness and loss of sensation in the
fingers and limbs, all of which should be reported to VAERS immediately.
"Because Merck only studied GARDASIL in fewer than 1200 girls under age
16 in pre-licensure trials, it is critical that doctors and parents be made
aware of the nature of the initial adverse event reports coming into VAERS
and that they report serious health problems after vaccination when they
occur," said NVIC President Barbara Loe Fisher. "There are twice as many
children collapsing and four times as many children experiencing tingling,
numbness and loss of sensation after getting a GARDASIL vaccination compared
to those getting a Tdap (tetanus-diphtheria-acellular pertussis)
vaccination. There have been reports of facial paralysis and Guillain-Barre
Syndrome. And doctors who give GARDASIL in combination with other vaccines
are basically conducting an experiment on their young patients because Merck
has not published any safety data for simultaneous vaccination with
any vaccine except hepatitis B vaccine."
According to NVIC's report, a majority of GARDASIL adverse event reports
to VAERS involved those who suffered fever, nausea, headache or
pain; 14 percent were for syncopal episodes with or without neurological
signs; and 8 percent experienced tingling, numbness and loss of sensation,
facial paralysis or Guillain-Barre Syndrome. Although adverse event reports
to VAERS do not prove causation, they can provide an early warning sign
that a new vaccine may be causing health problems that could be important.
For example, reports to VAERS of bowel blockage (intussusception) in babies
following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA
to issue a public warning to doctors and consumers on Feb. 13.
"About 4 reports per day were filed with VAERS in December 2006 for the
HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some
of these girls are being injured when they collapse after getting the
vaccine and others are complaining of neurological symptoms that should not
be ignored. Doctors and nurses should take note of the patient safety issues
related to giving this vaccine. Giving GARDASIL simultaneously with
any of the 18 vaccines Merck did not study in combination is not an
evidence-based guideline and should involve informed consent and a signed
patient release. To avoid unnecessary injuries, teenage girls should be
vaccinated laying down, not be left unattended and probably should not walk
or drive themselves home from the doctor's office after they get
NVIC also found that there were several VAERS reports of HPV infection,
genital warts and cervical lesions after GARDASIL vaccination. It is
unknown if the girls were infected with HPV before being vaccinated or if
GARDASIL failed to protect them. One case of HPV infection occurred in a
22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when
she had shown "strong conversion to all 4 vaccine types" but "tested
positive for high risk HPV" in 2006, according to the VAERS report.
In a May 18, 2006 Background Document for the FDA Vaccines and Related
Biological Products Advisory Committee (VRPBAC), the FDA staff stated that
Merck clinical trial data indicated there may be "the potential for GARDASIL
to enhance cervical disease in subjects who had evidence of persistent
infection with vaccine-relevant HPV types prior to vaccination."
Girls and women now being vaccinated with GARDASIL are not routinely being
tested for active HPV infection before vaccination.
The FDA staff also questioned whether the "HPV types not contained in
the vaccine might offset the overall clinical effectiveness of the
vaccine." There are more than 15 types of HPV associated with cervical
cancer but GARDASIL only contains HPV types 16 and 18. It is unknown
whether non-vaccine HPV types will become more dominant in the future.
However, there are indications this could occur because some of the seven
strains of pneumococcal contained in Wyeth's PREVNAR vaccine, which was
recommended by the CDC for universal use in all babies in 2000, have been
replaced by some of the more than 80 other pneumococcal strains not
contained in the vaccine.
VAERS is a passive surveillance system and depends upon voluntary
reporting of serious health problems following vaccination, even though
safety provisions in the National Childhood Vaccine Injury Act of 1986
mandated that health care providers report vaccine adverse events. There
have been estimates that fewer than 10 percent, even as low as 1 to 4
percent, of adverse events which occur after prescription drug or vaccine
use are ever reported to government adverse event reporting systems.
"If only 1 to 4 percent of all adverse events associated with GARDASIL
vaccination are being reported to VAERS, there could have been up to 38,000
health problems after GARDASIL vaccination in 2006 which were never
reported," said Fisher. "How many girls are really having short-term health
problems associated with getting this vaccine that could turn into long-term
neurological or immune system disorders? And how many will go on
to develop fertility problems, cancer or damage to their genes, all of which
Merck admits in its product insert that it has not studied at all? We
just don't know enough to be mandating GARDASIL for anyone, much less
vulnerable 11 to 12 year old girls entering puberty."
For a copy of NVIC's Report on VAERS and GARDASIL, references for this
statement and information about how to report a vaccine reaction to VAERS,
go to http://www.nvic.org.