FDA Approves Gardasil 9 for Prevention of Certain Cancers Caused by 5 More Types of HPV

The FDA today approved the human papillomavirus (HPV) 9-valent vaccine recombinant (Gardasil 9) for the prevention of 5 more types of HPV than the previously approved Gardasil, according to an FDA press release.

According to the FDA, Gardasil 9 can potentially prevent around 90% of cervical, vulvar, vaginal, and anal cancers.

The Gardasil 9 vaccine is approved for females aged 9 to 26 years and males aged 9 through 15 years, and it is approved to help prevent HPV types 16, 18, 31, 33, 45, 52, and 58, and for the prevention of genital warts caused by HPV types 6 or 11, the FDA stated. In addition, the vaccine protects against 5 more HPV types: 31, 33, 45, 52, and 58. These additional HPV types cause about 20% of cervical cancers and were not covered by previous vaccines approved by the FDA.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital, and anal cancers caused by HPV,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.

In a study of 14,000 females aged 16 through 26 years who tested negative for vaccine HPV types and received either Gardasil or Gardasil 9, the latter was 97% effective in preventing cervical, vulvar, and vaginal cancers caused by HPV types 31, 33, 45, 52, and 58. The study also showed Merck’s Gardasil 9 is as effective as the previously approved Gardasil for preventing disease caused by HPV types 6, 11, 16, and 18.