FDA approves Gardasil as vulvar and vaginal cancer vaccine

Merck’s Gardasil (quadrivalent human papillomavirus [HPV] vaccine) has been approved for the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in females ages 9–26.

This approval is based on a 2 year follow-up of Gardasil’s original 15,000 study participants. None of the Gardasil-vaccinated patients developed precancerous vulvar or vaginal lesions due to HPV types 16 or 18 while 10 patients in the control group developed precancerous vulvar lesions and 9 developed precancerous vaginal lesions all related to HPV types 16 or 18.

Gardasil is already approved for females ages 9-26 to prevent cervical cancer, genital warts, cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), and cervical intraepithelial neoplasia (CIN) caused by HPV types 6, 11, 16, and 18.

For more information call (866) 822-0068 or visit www.gardasil.com.