Human Papillomavirus 9-valent Vaccine, Recombinant

1 INDICATIONS AND USAGE 1.1 Girls and Women GARDASIL ® 9 is a vaccine 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 1.2 Boys and Men GARDASIL 9 is 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 The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease [see Clinical Studies (14.5) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.3 Limitations of Use and Effectiveness • Vaccination with GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. • GARDASIL 9 has not been demonstrated to provide protection against disease caused by: • HPV types not covered by the vaccine [see Description (11) ], • HPV types to which a person has previously been exposed through sexual activity. • Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. • GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN; VIN; VaIN; or AIN. • Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.