FDA Panel: Cervarix Safe and Effective for Preventing Cervical Cancer

An advisory panel to the Food and Drug Administration said today that a proposed new vaccine from GlaxoSmithKline for preventing cervical cancer is safe and effective for use in girls and women between the ages of 10 and 25.

The FDA will now take the advice of its panel and decide in the coming weeks or months whether to grant the vaccine, called Cervarix, approvals for use in the United States. While the FDA is not required to follow the recommendations of its advisory panels, most of the time, the agency does.

Gardasil Problems Reported

Cervarix is being watched closely in part because it would directly compete with Gardasil, the controversial Merck & Co. cervical cancer vaccine. Gardasil has been associated with severe allergic reactions, development of a rare but serious nervous system disorder called Guillain-Barre syndrome, and other complications in some girls and women who receive the series of three shots.

In June, the FDA ordered Gardasil to carry stronger warnings about the risks of fainting spells after receiving the vaccinations. Despite reports linking Gardasil to dozens of user deaths, U.S. drug-safety officials recently said that in their opinion, Gardasil remains safe for use in women and girls to prevent cervical cancer.

Both Cervarix and Gardasil are designed to prevent infection from the human papillomavirus (HPV), a virus that causes cervical cancer and genital warts. The vaccines prevent transmission of the strains of HPV responsible for most cases of cervical cancer.

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