The human papilloma virus vaccine, Gardasil, has been approved for a new claim: preventing vaginal and vulvar cancer caused by HPV types 16 and 18, in females aged 926, the Food and Drug Administration announced.
The approval is based on follow-up of more than 15,000 participants in the original studies of Gardasil, which found that about 2 years after vaccination, the vaccine was "highly effective" in preventing precancerous vulvar and vaginal lesions caused by HPV types 16 and 18 among females who tested negative for these two types when the study began. Among females in the control group who did not receive the vaccine, 10 developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, which were related to HPV types 16 or 18, according to the FDA statement announcing the approval.
However, there was no evidence that females who had already been infected with the HPV types in the vaccine derived any benefit from the vaccine.
"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.
Gardasil, manufactured by Merck & Co., was approved in 2006 in females aged 926 years for the prevention of cervical cancer caused by HPV type 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18, and genital warts caused by HPV types 6 and 11.
HPV types 16 and 18 cause an estimated 70% of cervical cancers and other cancers related to HPV.
More information on the approval is available at: www.fda.gov/cber/products/gardasil.htm