cervical cancer vaccine is safe
The Centers for Disease Control and Prevention (CDC) has announced that results from two-years of data on Merck’s HPV vaccine indicate that the vaccine continues to be safe.

In June of 2006, the Food and Drug Administration (FDA) approved Gardasil® as the first vaccine for the prevention of cervical cancer. Licensed for females ages 9-26, the vaccine’s indication was recently expanded to include the prevention of vulvar and vaginal cancers. CDC recommends routine vaccination with Gardasil for females ages 11-12, with “catch up” for women ages 13-26.

Questions about almost every new vaccine’s safety begin shortly after they hit the market, and Gardasil proved no exception. Concerns seemed to peak over the summer amid media reports of side effects - including paralysis, seizures, and death- occurring in patients who received the vaccine. No evidence linked these conditions with Gardasil, and the Federal agencies responsible for monitoring vaccine safety, CDC and FDA, steadfastly maintained that Gardasil is safe.

The FDA and CDC have multiple mechanisms in place to monitor vaccine safety, including the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) Project, and the newly formed Clinical Immunization Safety Assessment (CISA) Network. VAERS is a passive safety surveillance program that collects reports of side effects, both minor and major, that occur in people who receive vaccines that are approved in the U.S. The system depends on the general public, health care professionals, and manufacturers to file reports about adverse events.

VSD, by contrast, is an active surveillance system where CDC works with large managed care organizations to actively collect information on vaccines, including reports of potential vaccine-related side effects. With Gardasil, VSD looked specifically at several preset conditions that included seizures and Guillain Barre Syndrome (a neurological disease that usually begins as tingling in the extremities and in some cases leads to paralysis). Established in 2001, CISA is a network of six academic centers with expertise in vaccine safety that investigates the biologic basis of adverse events following immunization and provides clinical consultation and review on specific cases. Their HPV related activities to date include detailed clinic review on rare serious adverse event following Guardasil.

At the October meeting of the Advisory Committee on Immunization Practices (ACIP), the expert group run by CDC that provides guidance of vaccines, researchers reported that analysis based on 375,000 doses of the vaccine given over nearly two years showed no elevated risk of any serious side effects among those vaccinated with Gardasil. To date, CDC says that 94% of the side effects reported in those who received Gardasil are minor and include fainting, discomfort at the injection site, nausea and headache, all of which are common with vaccines. For more information, read CDC’s updated HPV Vaccine Safety fact sheet.