Human Papillomavirus Vaccine
Class: Vaccines
ATC Class: J07BF01
VA Class: IM100
Brands: Gardasil 9
Introduction
Inactivated (recombinant) virus vaccine. Contains virus-like particles (VLPs) of the major capsid (L1) proteins of certain human papillomavirus (HPV) types; used to stimulated active immunity to the HPV serotypes represented in the vaccine. Commercially available in US as human papillomavirus 9-valent vaccine recombinant (9vHPV) containing VLPs of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Other HPV vaccines (human papillomavirus quadrivalent vaccine [4vHPV], human papillomavirus bivalent vaccine [2vHPV]) no longer available in US.
Uses for Human Papillomavirus Vaccine
Prevention of Disease Caused by HPV
Prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 in females 9 through 45 years of age. Also prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including cervical intraepithelial neoplasia (CIN) grades 1 and 2/3, cervical adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, in females 9 through 45 years of age.
Prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including AIN grades 1, 2, and 3, in males 9 through 45 years of age.
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11 in females and males 9 through 45 years of age.
Anogenital HPV is the most common sexually transmitted infection in US; approximately 79 million individuals already infected and 14 million more become infected each year (about 50% of cases are occurring in adolescents and young adults 15 through 24 years of age). Most HPV infections are asymptomatic and resolve spontaneously within 1–2 years, but some low-risk (nononcogenic) HPV types cause anogenital warts (condyloma acuminata) and some high-risk (oncogenic) HPV types are associated with persistent anogenital infections, dysplastic lesions, and development of cervical and other anogenital cancers (e.g., penile, vulvar, vaginal, anal). High-risk HPV types 16 and 18 cause about 70% of all cases of cervical and anogenital cancer in females and about 70% of all cases of anal cancer in males.
The 9-valent HPV vaccine (9vHPV) provides protection against disease caused by high-risk (oncogenic) HPV types 16, 18, 31, 33, 45, 52, and 58; also provides protection against disease caused by low-risk (nononcogenic) HPV types 6 and 11.
The CDC Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend that all females and males 9 through 26 years of age receive routine and catch-up vaccination with 9vHPV.
ACIP states that routine and catch-up vaccination with 9vHPV recommended for females and males 9 through 26 years of age w...