[NVIC] HPV Vaccine Mandates Risky, Expensive

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February 02, 2007

National Vaccine Information Center

e-news

HPV Vaccine Mandates Risky and Expensive

Vaccine Safety Group Finds Serious Reactions, High Costs

SOURCE: National Vaccine Information Center

PRNewswire

February 31, 2007

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VIENNA, Va., Feb. 1 /PRNewswire-USNewswire/ -- The National Vaccine

Information Center (NVIC), the nation's leading vaccine safety and informed

consent advocacy organization, is urging state legislatures to investigate

the safety and cost of mandating Merck's HPV vaccine (GARDASIL) for all

pre- adolescent girls before introducing legislation amending state vaccine

laws. In an analysis of reports made to the federal Vaccine Adverse Event

Reporting System (VAERS) since the CDC's July 2006 universal use

recommendation for all young girls, NVIC found reports of loss of

consciousness, seizures, joint pain and Guillain-Barre Syndrome. In a

separate evaluation of costs for young girls being vaccinated in private

pediatrician offices, NVIC discovered that parents living in the

Washington, D.C. area will be paying between $500 and $900 to have their

daughters receive three doses of GARDASIL.

" GARDASIL safety appears to have been studied in fewer than 2,000 girls

aged 9 to 15 years pre-licensure clinical trials and it is unclear how long

they were followed up. VAERS is now receiving reports of loss of

consciousness, seizures, arthritis and other neurological problems in young

girls who have received the shot, " said NVIC President Barbara Loe Fisher.

" At the same time, parents who take their daughters to private

pediatricians are going to be shocked to find that they will be paying two

to three times the widely publicized $360 cost for the three-dose series.

The cost is going to break the pocketbooks of parents and break the banks

of both insurance companies and taxpayers, when the reality is that almost

all cases of HPV- associated cervical cancer can be prevented with annual

pap screening of girls who are sexually active. "

Between July 2006 and January 2007, there have been 82 reports of adverse

events filed with VAERS following receipt of GARDASIL by girls and boys

ranging in age from 11 to 27 years. Reaction reports have come from 21

states, including Virginia and the District of Columbia. All but three of

the reports were for adverse events which occurred within one week of

vaccination and more than 60 percent occurred within 24 hours of vaccination.

" The most frequent serious health events after GARDASIL shots are

neurological symptoms, " said NVIC Health Policy Analyst Vicky Debold, RN,

Ph.D. " These young girls are experiencing severe headaches, dizziness,

temporary loss of vision, slurred speech, fainting, involuntary contraction

of limbs (seizures), muscle weakness, tingling and numbness in the hands

and feet and joint pain. Some of the girls have lost consciousness during

what appears to be seizures. " Debold added " The manufacturer product insert

should include mention of syncopal episodes, seizures and Guillain-Barre

Syndrome so doctors and parents are aware these vaccine adverse responses

have been associated with the vaccine. "

VAERS reports also indicate the doctors are administering GARDASIL to

girls and women at the same with Tdap, DT, meningococcal (Menactra),

hepatitis A, and other vaccines, even though the Merck product insert

states that, with the exception of hepatitis B vaccine, " Co-administration

of GARDASIL with other vaccines has not been studied. " There is no publicly

available information about how many of the 9 to 15 year old girls in

Merck's pre- licensure clinical trials received GARDASIL simultaneously

with hepatitis B vaccine.

Although approximately half of all families in the U.S. select a

pediatrician in private practice to provide their children routine care,

including vaccinations, children can receive government subsidized reduced

cost or free vaccinations in public health clinics through the Vaccines for

Children program if they cannot afford to pay for vaccinations administered

by private pediatricians. NVIC's survey of four private pediatric practices

in the Virginia suburbs of Washington, D.C. found that parents could be

charged anywhere from $525 to $930 for three GARDASIL shots depending upon

whether the child was a first-time or current patient. Costs for the

vaccine plus an administration fee ranged from $140 to $275 per shot with

an additional office visit charge that fluctuated between $35 and $185

depending upon whether a nurse or doctor saw the child.

HPV is the most common sexually transmitted infection in the U.S. and most

persons naturally clear the infection from the body without symptoms.

However, many years of chronic HPV infection is associated with a higher

risk of pre- cancerous changes in the cervix that can lead to cancer unless

diagnosed and treated promptly. High risk factors for chronic HPV infection

include smoking, long-term use of oral contraceptives and co-infection with

HIV, herpes and chlamydia. There has been a more than 70 percent drop in

cervical cancer deaths in American women since the 1950's due to routine

pap smears and nearly all cervical cancers can be prevented with regular

pap smear screening and treatment.

In its product manufacturer insert, Merck states that " Vaccination does

not substitute for routine cervical cancer screening. Women who receive

GARDASIL should continue to undergo cervical cancer screening per standard

of care. " Merck also states that " The duration of immunity following a

complete schedule of immunization with GARDASIL has not been established. "

For more information about HPV infection and GARDASIL safety, including

NVIC's five-page report on GARDASIL adverse event reports to VAERS as well

as a direct link to VAERS reports, go to NVIC's website at

http://www.nvic.org

*************************************************************

National Vaccine Information Center

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NVIC E-News is a free service of the National Vaccine Information Center

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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

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