Gardasil safety questioned, CDC urged to back up statement with data

Oct 26 2008

The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects.

NVIC will also be calling on the newly elected President and members of Congress to remove the nation's vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation's public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority - if not all - of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO's participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

"Transparency in government is essential to trust in government and replication is the hallmark of good science," said NVIC co-founder and president Barbara Loe Fisher. "Parents of young girls and women cut down in their prime - some of them paralyzed or dead within hours or days of getting Gardasil vaccine - deserve better answers than a whitewashing of this vaccine's very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible."

• In June 2006 NVIC questioned the quality and quantity of Merck's pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;
• In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;
• During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;
• Last week, reports that Merck's Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVI was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.