In October 2018, the U.S. Food and Drug Administration expanded the approved use of the human papillomavirus (HPV) 9-valent vaccine to include women and men aged 27–45 years. Previously, the vaccine had been approved for males and females aged 9–26 years, but the expanded approval was granted after the application had undergone priority review.
The approval is based on clinical trial data from an older version of the vaccine that covered four HPV types, but the 9-valent version has since replaced it. In the trial, 3,200 women aged 27–45 were followed for 3.5 years, and researchers found that the HPV 9-valent vaccine was 88% effective in preventing persistent HPV infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to the nine HPV types. Its effectiveness in men is inferred based on the same data.
Common reactions from the vaccine include injection site pain, swelling, redness, and headaches.