With this approval, the vaccine can effectively protect against 5 additional types of HPV than the parent Gardasil vaccine, thereby preventing the development of cervical, vulvar and vaginal cancers, based on a randomized clinical trial.
The FDA today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by 9 types of Human Papillomavirus (HPV). Covering 9 HPV types, 5 more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.
Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against 5 additional HPV types—31, 33, 45, 52 and 58—which cause approximately 20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
Read the FDA press release: http://1.usa.gov/1IBW8vi