New Products: HPV vaccine

October 1, 2008

The vaccine Gardasil, has been approved by the FDA.

The Food and Drug Administration has announced its approval of the vaccine Gardasil, for the prevention of two rare cancers: vaginal and vulvar cancers caused by types 16 and 18 of the human papillomavirus (HPV) in girls and women ages 9 to 26. In 2006, the federal agency had originally approved the vaccine to prevent cervical cancer caused by types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18, and genital warts caused by types 6 and 11.

The FDA based its approval of the two additional indications on research done by Gardasil's manufacturer, Merck & Co. Inc. (Whitehouse Station, NJ). Investigators followed over 15,000 participants from the original studies for roughly 2 extra years. About half had received the vaccine as part of the original study, while the other half served as a control group. They found that among females who tested negative for HPV types 16 or 18 at the beginning of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions.