Cervical-cancer vaccine approved

WASHINGTON — Women for the first time have a vaccine to protect themselves against cervical cancer.

The Food and Drug Administration on Thursday licensed the vaccine, Gardasil, for use in girls and women ages 9 to 26. The vaccine works by preventing infection by four of the dozens of strains of the human papillomavirus, or HPV, the most prevalent sexually transmitted disease.

By age 50, some 80 percent of women have been infected.

Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. The vaccine will be available by the end of the month, with a three-shot series costing $360.

Its manufacturer, Merck & Co. Inc., seeks similar approval elsewhere around the world. Each year, cervical cancer kills an estimated 240,000 women worldwide, including 3,700 in the United States.

"FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women's health in recent years," said Dr. Carolyn Runowicz, president of the American Cancer Society. The vaccine developed for hepatitis B has been shown to protect against liver cancer.

Clinical trials showed Gardasil prevented 100 percent of cervical cancer related to the two HPV strains in women who had not been previously infected, Merck said. It also prevented 99 percent of the cases of genital warts caused by the two other strains.

"Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again," said Alex Azar, deputy Health and Human Services secretary.

Research presented earlier suggests an added bonus to Gardasil: It also protects against vaginal and vulvar cancers linked to the four types of HPV.

Gardasil works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine does not protect those already infected.

The FDA said that Gardasil appeared very safe. It remains unclear if its effect is long-lasting or if women will need booster shots later in life. Merck will monitor its long-term effectiveness. The company also continues to study whether the vaccine is safe and effective in males.

Merck intends to market Gardasil as a cancer, rather than an STD, vaccine. Its cost, along with conservative opposition to making the vaccine mandatory for school attendance, may curb its widespread use.