Merck announced that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous 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. GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) includes the greatest number of HPV types in any available HPV vaccine. GARDASIL 9 adds protection against five additional HPV types -- 31, 33, 45, 52 and 58 -- in addition to the four original HPV types covered by GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Seven HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90-95 percent of HPV-related anal cancers, approximately 90 percent of cervical cancers, and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2 and CIN 3) worldwide. These seven HPV types also cause 90 percent of HPV-related vulvar cancers and 85 percent of HPV-related vaginal cancers. HPV types 6 and 11 cause approximately 90 percent of genital warts cases in males and females.
