Gardasil 9 Indication Now Covers More Male Patients

Merck announced that the Food and Drug Administration (FDA) has expanded the age indication for Gardasil 9 (human papillomavirus 9-valent vaccine [recombinant]) in males. It now includes use in males aged 16–26 for the prevention of anal cancer caused by human papillomavirus (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 vaccine is already indicated 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. In addition, Gardasil 9 vaccine adds protection against 5 additional HPV types in addition to the 4 original HPV types covered by Gardasil.

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 males aged 16–26 years were non-inferior to anti-HPV GMTs among the corresponding females.

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.

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