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FDA expands approval of Gardasil 9 for adults aged 27 to 45 years
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The FDA expanded the approval the HPV 9-valent vaccine, recombinant to include women and men aged 27 to 45 years for the prevention of certain cancers and diseases caused by HPV.
The HPV 9-valent vaccine (Gardasil 9, Merck) is now approved for males and females aged 9 through 45 years.
“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, MD, PhD, 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.”
The FDA based this expanded approval on a study of 3,200 women aged 27 to 45 years.
With a mean follow-up of 3.5 years, the vaccine had an effectiveness of 88% against prevention of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to nine HPV types covered by the vaccine.
The FDA based this approval for men using inferences from the data in adult women, efficacy data from adolescents and men aged 16 to 26 years, as well as immunogenicity from 150 men aged 27 to 45 years who received a three-dose regimen of the vaccine over 6 months.
The most commonly reported adverse events included injection site pain, swelling, redness and headaches.
The FDA granted this application priority review designation.