[PROVE] HPV Vaccine Reaction Report by NVIC

[Guest guest]

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 vaccinated. "

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.

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Dawn

PROVE(Parents Requesting Open Vaccine Education)

prove@... (email)

http://vaccineinfo.net/ (web site)

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