This drug is marketed as the only cervical cancer vaccine to help protect against four kinds of HPY; however, since its introduction, there have been over 15,000 reports of adverse effects, including 44 deaths possibly linked to it.

Consumers, parents, health care professionals and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil. FDA and the U.S. Centers for Disease Control and Prevention (CDC) take all concerns about vaccine safety seriously, and have been closely monitoring the safety of Gardasil.

Below is a summary of Gardasil vaccine safety monitoring activities and findings. 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.

History of Gardasil

FDA approved Gardasil on June 8, 2006. It is approved for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. CDC’s Advisory Committee on Immunization Practices (ACIP) recommended a routine 3-dose vaccination series for girls 11 and 12 years of age. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. Approximately half of the study participants received the vaccine, and the other half received a control. These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types.

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.

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