FDA Approves Age Expansion of HPV Vaccine

The Food and Drug Administration (FDA) approved an expanded age indication for Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), according to the FDA.

The approval allows Gardasil 9 — which protects nine kinds of human papillomaviruses (HPV) – to be used in men and women between the ages of 27 and 45 to prevent certain cancers and other diseases that are caused by HPV. Previously, the vaccine was only approved for women between the ages of 9 and 26 to prevent cervical, vulvar, vaginal and anal cancers, and for males in the same age range for the prevention of anal cancer. The expanded age indication was granted a priority review by the FDA in June of this year.

Seven different cancer types are associated with HPV: cervical, vaginal, vulvar, penile, anal and oropharynx cancers, as well as high-grade intraepithelial neoplasias. HPV is a sexually transmitted infection that affects both males and females, and can be attributed to about 91 percent of cervical cancers and the same amount of anal cancers, according to the Center for Disease Control and Prevention (CDC).

In a study of about 3,200 women who were between the ages of 27 and 45 and who were followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions and cervical precancerous lesions related to the HPV types that are covered by the vaccine.

Effectiveness of Gardasil 9 in men within the same age range is inferred from the women's data, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a three-dose regimen of Gardasil over six months.

Overall, Gardasil 9's safety was evaluated in about 13,000 indiviuals (both male and female), and the most commonly reported side effects were: injection site pain, swelling, redness and headaches.

"Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”