FDA Advisory Panel To Meet To Examine Merck Application For HPV Vaccine Gardasil

Main Category: Sexual Health / STDs
Also Included In: Cervical Cancer / HPV Vaccine;  Immune System / Vaccines
Article Date: 17 May 2006 - 14:00 PDT

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An FDA advisory panel on Thursday is scheduled to meet in Gaithersburg, Md., to discuss Merck's application for approval of its experimental human papillomavirus vaccine Gardasil and to make recommendations to the agency about the safety and efficacy of the vaccine, the Wall Street Journal reports. Although FDA is not required to agree with the advisory panel's recommendations, it often follows them, the Journal reports (Loftus, Wall Street Journal, 5/17). Merck in October 2005 announced that Gardasil in clinical trials was 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. The company in February announced that FDA had granted priority review for Gardasil (Kaiser Daily Women's Health Policy Report, 5/12). Some analysts and physicians believe FDA will approve Gardasil because of its success in clinical trials, but "questions linger about the vaccine's social implications," the Journal reports (Wall Street Journal, 5/17). Some research shows that physicians and parents support giving minors the vaccine, but at what age still is under debate (Johnson, AP/Forbes, 5/16). According to the Journal, Merck in clinical trials has given the vaccine to girls and women between ages nine and 26 and to boys ages nine to 15, which led some organizations to oppose the vaccine because they say it could encourage promiscuity among girls (Wall Street Journal, 5/17). Merck has said it expects FDA to act on the application by June 8 (Kaiser Daily Women's Health Policy Report, 5/12).

Next Steps
If Merck's application for Gardasil receives FDA approval, it also must be examined by CDC's Advisory Committee on Immunization Practices, which drafts recommendations and schedules for the administration of vaccines in the U.S. (Wall Street Journal, 5/17). The committee will consider recommendations for females ages 13 to 26, Lauri Markowitz, who heads the workgroup's CDC body, said. She added that vaccinations for older women and males will be considered if current studies lead to FDA approval (AP/Forbes, 5/17).

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