FDA Approves HPV Vaccine for 27- to 45-Year-Old Men and Women

Merck’s Gardasil 9 human papillomavirus (HPV) vaccine has been approved by the U.S. Food and Drug Administration (FDA) for an expanded indication for men and women between the ages of 27 years and 45 years. Previously, the vaccine was approved for people only ages 9 years through 26 years. Approval is based on the expansion on results of a study of 3,200 women followed over three and a half years that found Gardasil 9 was 88 percent effective in the prevention of vulvar, vaginal and cervical precancerous lesions, cervical cancer and genital warts caused by the nine HPV strains. The vaccine’s effectiveness in men was “inferred” from the study’s data, as well as a clinical trial of 150 men ages 27 years to 45 years who received a three-dose vaccination regimen over a six-month period. FDA also looked at data from studies of younger men ages 16 years to 26 years.

Prior to this expanded indication, recommendations by the Centers for Disease Control and Prevention (CDC) were for HPV vaccination for boys and girls to begin between the ages of 11 years and 12 years, although the regimen could begin as early as age 9 years. If it is begun before age 15 years, boys and girls receive two doses of the vaccine, with the second vaccine given six months to 12 months after the first dose. If it’s not given by age 15 years, CDC recommends girls ages 15 years to 26 years and boys ages 15 years to 21 years receive three doses, with the second dose given one month or two months after the first and the third dose given six months after the first.