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NEWS IN CONTEXT

Cervical Cancer Vaccine Approved by FDA

June 8, 2006

On June 8, the U.S. Food and Drug Administration (FDA) approved the cervical cancer vaccine Gardasil as safe and effective for use among girls and women ages 9–26. The vaccine, developed by Merck & Company, prevents infection with the types of human papillomavirus (HPV) most likely to lead to cervical cancer.

Cervical cancer is the second most common cancer among women worldwide, causing at least 250,000 deaths each year, including 3,700 in the United States. The vast majority of these deaths occur in Sub-Saharan Africa, South Asia and Latin America, where early detection (notably the Pap test) is rare. The vaccine promises huge benefits to women in developing countries, but reaching adolescents with the required three injections over a six-month period before they become sexually active will pose considerable logistical and financial challenges.

In the United States, cervical cancer is relatively uncommon, thanks to early detection. Still, the vaccine will provide an additional layer of protection, and is most critical for those disadvantaged women who do not get regular Pap tests and are most at risk for cervical cancer. The Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention will now examine Gardasil and make recommendations that will guide immunization practices and policies at the federal, state and local levels in the United States. Among other questions, ACIP will determine the optimal age of vaccination.

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The logistical and ideological hurdles faced by the cervical cancer vaccine.

The potential for integrating cervical cancer vaccines into schools and health care systems in Sub-Saharan Africa.

Arguments that risk reduction strategies can lead to “disinhibition”.