FDA Expands HPV Vaccine Indication

The FDA has approved the use of the human papillomavirus (HPV) 9-valent vaccine (Gardasil-9) for use in adults aged 27 to 45. The vaccine was previously only indicated for use in individuals aged 9 to 26 years old.

The approval is based upon the results of a study involving approximately 3200 women aged 27 through 45 years who were followed for an average of 3.5 years. Overall, the vaccine was 88% effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

The effectiveness in men was inferred from the data provided by the above study and its efficacy was inferred from data on the efficacy of the vaccine in younger men and immunogenicity data from a clinical trial of 150 men.

The most common adverse reactions are injection site pain, swelling, redness, and headaches.

—Michael Potts

Reference:

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old [press release]. October 5, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm.