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Glaxo Cervical Cancer Vaccine Up for Approval

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A panel of experts for the U.S. Food and Drug Administration could recommend approval next week of a cervical cancer vaccine from GlaxoSmithKline, the Associated Press reported Friday.

Called Cervarix, the vaccine blocked the human papilloma virus (HPV), which is responsible for most cases of cervical cancer, nearly 93 percent of the time, the FDA said in documents filed online.

Cervarix already is permitted in close to 100 other countries. The FDA delayed a decision on its use in the United States in 2007, saying it needed additional information, the AP said.

Side effects from the vaccine, such as soreness near the injection site, were mild, the data showed.

When an expert panel convenes on Wednesday, the FDA will ask if Cervarix should be approved for women and girls ages 10 to 25. The FDA usually follows the experts' advice.

In related news, the FDA says Gardasil, the Merck vaccine used to prevent cervical cancer in women, also blocks the viruses responsible for genital warts in men.

Gardasil prevented genital warts in patients 90 percent of the time, the FDA said in documents presented online, the AP reported. The vaccine apparently blocks two strains of HPV that cause genital growths on males.

Merck is seeking FDA approval of Gardasil for boys and men ages 16 to 26, and a panel of advisers will consider the request next week.

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