FDA Approves Expanded Use of HPV Vaccine Gardasil 9

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates


On October 5, 2018, the FDA approved the expanded use of the human papillomavirus (HPV) vaccine Gardasil 9 (9-valent vaccine, recombinant; Merck) to include men and women between the ages of 27 and 45 years. The FDA initially approved Gardasil 9 in 2006 for younger people (male and female) aged 9 years to 26 years. This HPV vaccine can prevent some types of cancers, including genital and oral cancer, as well as other diseases caused by 9 variants of HPV infection.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said 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% of these cancers, or 31,200 cases every year, from ever developing,” he added.

This approval is based on new results from a long-term follow-up study that included 3200 women aged 27 to 45 years. The results showed that Gardasil 9 was 88% effective in preventing persistent infections, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to the HPV variants that are covered by this vaccine. The approval in men of the same age was made based on an inference from the data in women, as well as on results from a clinical trial of 150 men aged 27 to 45 years who received 3 doses of Gardasil 9 during a 6-month period.

The most common adverse reactions reported with Gardasil 9 were injection-site pain, swelling, redness, and headaches.