Tradename: GARDASIL 9
Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant
Indication: To include clinical data from the long-term follow-up study V503-002-20 in support of modifications to the package insert.
Indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).
Cervical intraepithelial neoplasia (CIN) grade 1.
Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:
Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Approval Date: 04/28/2023
Manufacturer: Merck Sharp & Dohme LLC
More: https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9