Merck & Co. seeks FDA approval for its Gardasil vaccine against four types of human papilloma virus, or HPV. Two of those four types are believed responsible for about 70 percent of cervical cancer cases. The cancer kills roughly 3,500 U.S. women a year; the other two types cause 90 percent of genital wart cases.
An FDA panel of outside experts is to meet Thursday and discuss whether to recommend that the agency approve the vaccine. The FDA isn't required to follow the advice of its expert panels but usually does, the AP reports.
According to briefing documents released ahead of the meeting, the panel should discuss various items of concern only if its members first agree that studies show the vaccine is safe and effective. That suggests the FDA favors its approval, the AP reports.
Merck said the vaccine has the potential to reduce the annual number of new cervical cancers worldwide to roughly 150,000, from the current 500,000, and cut global deaths from the cancer by more than two-thirds, to an estimated 90,000.
An FDA review of the results of studies on the vaccine found two important concerns, according to the documents released ahead of Thursday's meeting of the Vaccines and Related Biological Products advisory committee.
Merck developed the vaccine and tested it in both women and men, but Thursday's discussion is expected to focus on its use in preventing HPV-related disease in women.
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