FDA approves 9-valent HPV vaccine: active against types 6, 11, 16, 18, 31, 33, 45, 52 and 58
Simon Collins, HIV i-Base
On 26 February 2015, the FDA approved a new version of the Merck HPV vaccine that is active against a wider range of HPV subtypes. The new vaccine has a brand name Gardisil 9.
Approval is for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11.
It is also approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and to prevent precancerous or dysplastic lesions and genital warts caused by the same HPV types as for girls.
Approval was based on results from a randomised Phase 3 study in more than 14,000 girls and young women aged 16-26, and who completed the three vaccine course.
Efficacy rates ranged from 87 – 98% depending on the clinical endpoint, with activity well above 90% for most infections and complications.
The vaccine is a joint development with Sanofi Aventis who have marketing rights in Europe for the earlier quadrivalent version.
Merck press statement. FDA Approves Merck’s HPV Vaccine, GARDASIL®9, to Prevent Cancers and Other Diseases Caused by Nine HPV types – Including Types that Cause About 90% of Cervical Cancer Cases. (11 December 2014).