Oct. 8, 2018 — The FDA has approved a supplemental application for Gardasil 9, Merck’s HPV vaccine for men and women ages 27-45.
“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, says in a news release.
“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,” Marks says.
About 14 million Americans become infected with HPV every year, the CDC says. About 12,000 women are diagnosed with cervical cancer and about 4,000 women die from cervical cancer caused by certain HPV viruses. HPV can also cause other forms of cancer in men and women.
Gardasil, which was first approved by the FDA in 2006 to prevent certain cancers and diseases caused by HPV, is no longer distributed in the United States.
In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as well as five additional kinds. It was first approved for anyone ages 9-26.
According to the FDA, a study followed roughly 3,200 women ages 27 to 45 for an average of 3.5 years. It found Gardasil was 88% effective in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.
“The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long-term follow-up from this study,” the FDA says.
The safety of Gardasil 9 was evaluated in about 13,000 men and women. The most common side effects were pain where the shot went in the skin, swelling, redness, and headaches.