Score One For Reality-Based Science

FDA Approves Cervical Cancer Vaccine

By Jennifer Couzin
ScienceNOW Daily News
8 June 2006
The U.S. Food and Drug Administration (FDA) today approved the first vaccine that can prevent cervical cancer. The vaccine targets human papillomavirus (HPV), which is widespread in the population. Roughly 500,000 women worldwide develop cervical cancer each year, and supporters hope the preventative will make a dent in the cancer's prevalence.

FDA was under pressure from women's groups to green-light the vaccine, made by Merck and sold under the brand name Gardasil. Last summer, the agency declined to allow Plan B, the morning-after pill, to be sold over the counter, a decision conservative groups endorsed but one that outraged reproductive rights organizations (ScienceNOW, 15 March).

Gardasil targets four strains of HPV, two of which cause about 70% of cervical cancer cases, and two of which cause roughly 90% of genital warts. The vaccine was tested in more than 30,000 women worldwide, most between 16 and 26 years of age. Among those free of HPV, it kept the virus at bay in nearly all of them. Merck has done some studies testing the immune response of males to the vaccine, says Janet Skidmore, a Merck spokesperson, and trials to test the vaccine's ability to prevent genital warts in boys are ongoing.

FDA approved Merck's vaccine for girls and young women aged 9 to 26, with the goal of reaching youngsters before they risk exposure to the virus during sex. Three doses are recommended over six months. Gardisil, which has also been approved in Mexico, doesn't come cheap; according to the company, it costs roughly $120 per dose. "It's low-income women who don't have good access to [HPV] screening and treatment who need this the most, but they may have the most difficulty getting it," says Susan Wood, the former head of FDA's Office of Women's Health. She resigned last year in protest over the agency's handling of Plan B and is pleased with today's approval.

The real test now, says Wood, is how the Advisory Committee on Immunization Practices will rule. The committee sets recommendations for vaccinations, such as whether schools should require children to receive particular vaccines before enrollment, and is used as a guide by many states. "We should turn attention to ensuring that states take this up as part of a public health strategy to really eliminate cervical cancer in this country, which we now have the ability to do," says Wood. The committee meets next on 29 June.

Glaxo-Smith Kline is also developing a cervical cancer vaccine and has applied for approval in Europe, Australia, and parts of Asia and Latin America. It plans to submit an FDA application late this year. Last week, Glaxo presented data at the American Society for Clinical Oncology meeting in Atlanta, Georgia, suggesting that its vaccine might be effective in women over 25, based on their immune responses.

Related sites

# Information on Gardasil from FDA
# Questions and answers on HPV
# More on HPV from CDC