Gardasil and HPV Infection

"Protecting the health and informed consent rights of children since 1982."

for immediate release
February 1, 2007

HPV Vaccine Mandates Risky and Expensive
Vaccine Safety Group Finds Serious Reactions, High Costs

Vienna, Virginia - 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 and it is unclear how long they were followed up. [1] 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."[2] 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. [3] 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. [4] 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. [5]

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 www.NVIC.org.

[1] Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccine and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine. Study 016: Studies in Younger Age Groups, page 19. Study 018: Safety and immune response younger children, page 20.

[2] Merck & Co., Inc.2006. [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. www.merck.com/product.usa/pi_circulars/g/GARDASIL/GARDASIL_pi.pdf

[3] Food and Drug Administration. Product Approval Information - Licensing Action: GARDASIL Questions and Answers. http://www.fda.gov/cber/products/hpvmer060806qa.htm

[4] American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society; 2005. Pages 27-29. http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf

[5] Saslow D., Runowicz DC et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J. Clin 2002; 52:342-352. http://caonline.amcancersoc.org/cgi/content/full/52/6/342.