Saturday, May 20, 2006

FDA Committee Recommends Approval of HPV Vaccine

The FDA's Vaccines and Related Biological Products Advisory Committe voted unanimously on Thursday that Merck's Gardasil vaccine to protect against certain types of HPV infection (and, by extension, cervical cancer) is safe and effective for women ages 9-26. The targeted HPV strains are thought to be responsible for about 70% of cervical cancers worldwide. The disease kills 290,000 women worldwide each year (3,500 in the U.S.), and it is estimated that approximately $1.7 billion is spent in the U.S. each year on cervical cancer treatment. The advisory document is not yet up on the FDA website - see the resources below for additional information. A final FDA approval decision is expected by June 8. One hurdle to vaccination is the anticipated cost of the vaccine, which may be in the $300-$500 range.

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MeSH Tags: Papillomavirus, Human; United States Food and Drug Administration; Uterine Cervical Neoplasms/prevention and control; Vaccines


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