Information from CDC and FDA on the Safety of Gardasil® Vaccine
Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil® is a safe and effective vaccine. FDA and CDC continue to monitor the safety of this vaccine, with the public's health and safety our top priority.
Consumers, parents, health care professionals and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil®. FDA and CDC take all concerns about vaccine safety seriously, and have been closely monitoring the safety of Gardasil.
Full text of the CDC-FDA information is available; see Information from FDA and CDC on Gardasil and Its Safety.
This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.
Monitoring Vaccine Safety
FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects).
CDC has two other systems in place to monitor the safety of all licensed vaccines. The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and addresses the gaps in scientific knowledge about rare and serious side effects following immunization. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events.
Adverse Event Reports following Gardasil
To date, over 16 million doses of Gardasil have been distributed in the United States. As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events. To report an adverse event to VAERS, call 1-800-822-7967 or submit a report through the VAERS Web site.
Continued Monitoring of Gardasil
Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women.
CDC has not changed its recommendations for use of Gardasil. FDA has not made any changes to the prescribing information for how the vaccine is used or to the vaccine's Precautions. In addition, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity and potency of Gardasil.
More Information on Vaccine Safety and HPV
- Information from CDC and FDA on the Safety of Gardasil Vaccine
- CDC HPV Disease Information
- CDC General HPV Vaccine Information
- CDC General Vaccine Safety Information
- FDA Center for Biologics Evaluation and Research
- CDC HPV Questions and Answers
Listen to the CDC podcast on the HPV vaccine
*Links to non-federal organizations are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the federal government, and none should be inferred. CDC is not responsible for the content of the individual organization Web pages found at these links.
