Many of my regular readers know that I post often about social issues, in particular teen pregnancy and the prevalence of human papillomavirus (HPV). HPV is a sexually transmitted disease. Two strains of it (16 & 18) cause virtually 100% of all cervical cancers. See National Cancer Institute Q & A.
The FDA announced on Friday that the HPV vaccine Gardasil has been approved for two
additional uses — prevention of vaginal and vulvar cancers caused by
HPV types 16 and 18.
The label expansion was based on follow-up of more than 15,000 female subjects who participated in placebo-controlled trials of the vaccine. Among subjects who tested negative for HPV-16 and -18 at study entry, precancerous vulvar or vaginal lesions (all related to the two HPV strains) developed in 19 placebo recipients — and none of the Gardasil recipients.
The vaccine was not effective in women who had previously been infected with either HPV strain.
FDA news release (Free)
Gardasil prescribing information (Free PDF)