FDA Approves Gardasil to Prevent Cervical Cancer, Precancers

ROCKVILLE, Maryland—The FDA has approved Merck's Gardasil (quadrivalent human papillomavirus recombinant vaccine) for the prevention of cervical cancer and cervical, vulvar, and vaginal precancers caused by human papillomarvirus (HPV). The decision came after the agency's Vaccines and Related Biological Products Advisory Committee unanimously recommended the approval.

Gardasil is designed to protect against HPV types 6, 11, 16, and 18. HPV 16 and 18 cause an estimated 70% of cervical cancer cases, and HPV 6 and 11 account for some 90% of cases of genital warts, which can lead to abnormal Pap tests and low-grade cervical abnormalities.

Merck estimates the vaccine could reduce deaths worldwide from cervical cancer by two-thirds. The expected price (about $300 to $500 for three shots over 6 months), however, could limit its use.

The company presented data from trials conducted in 33 countries. The key randomized, placebo-controlled studies involved 20,887 women ages 16 to 26. (Efficacy trials have not been completed in males.) "Gardasil prevented 100% of cervical, vaginal, and vulvar precancers caused by HPV types 16 and 18; prevented 95.2% of cervical lesions caused by types 6, 11, 16, and 18; and prevented 99.1% of external genital lesions, including genital warts, caused by HPV types 6, 11, 16, and 18," the company said.

The CDC's Advisory Committee on Immunization Practices has recommended that 11- and 12-year-old girls be routinely vaccinated with Gardasil and that girls as young as 9 can receive the shots, at their physician's discretion.