FDA, CDC reiterate safety of HPV vaccine

ATLANTA Based on ongoing assessments of vaccine safety information, the Food and Drug Administration and the Centers for Disease Control and Prevention continue to find that the human papillomavirus vaccine Gardasil is a safe and effective vaccine, the two agencies stated jointly last week.

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. 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.

FDA approved Gardasil June 8, 2006 for females between the ages of 9 and 26 to protect against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.  CDC’s Advisory Committee on Immunization Practices 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.

FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority.

Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die 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.