Gardasil 9 Age Indication Expanded for Men

The FDA has expanded the age indication of Merck’s human papillomavirus (HPV) 9-valent vaccine (Gardasil 9) for men.

Gardasil 9 had already been approved for boys aged 9 to 15, but now the vaccine can be used in males aged 9 to 26.

The vaccine is designed to prevent anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

Additionally, it can reduce the chances of developing precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, plus genital warts caused by HPV types 6 and 11.

“This is an important approval that now aligns the indication for Gardasil 9 in males and females ages 9 through 26 to that of Gardasil, and also supports the CDC’s [US Centers for Disease Control and Prevention] HPV vaccine recommendations for use in males,” said Jacques Cholat, president of Merck Vaccines, in a press release. “We are pleased that males 16 through 26 years of age will now have access to Gardasil 9, which includes the most HPV types, to help further reduce the burden of HPV-related diseases.”

The vaccine was already approved for females aged 9 to 26 for the prevention of cervical, vulvar, vaginal, and anal cancers, precancerous or dysplastic lesions, and genital warts.

Adverse effects associated with Gardasil 9 include pain at the site of injection, headache, fever, and nausea.