Officials with the Food and Drug Administration (FDA) have expanded the age indication for the human papillomavirus 9-valent vaccine (Gardasil 9, Merck) to include young men aged 16–26 for the prevention of anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 59; 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.
In a press release from Merck, officials stated Gardasil 9 adds protection against 5 additional HPV types in addition to the 4 original HPV types covered by Gardasil.
The vaccine was already approved for use in males aged 9–15 for the prevention of these diseases. It is also approved for use in females aged 9–26 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.
The efficacy of Gardasil 9 against persistent infection and disease was inferred from a non-inferiority comparison study (n=1,106). This detailed type-specific antibody geometric mean titers (GMTs) after vaccination with Gardasil 9 among heterosexual males aged 16–26 years, with those among females aged 16–26 years.
Results showed anti-HPV GMTs at month 7 among young aged 16–26 years were non-inferior to anti-HPV GMTs among the corresponding young women.
Gardasil 9 is available as 0.5mL single-dose vials in 1-, and 10-count cartons as well as 10-count single-dose prefilled syringes.