FDA Approves Expanded Use of HPV Vaccine to Older Populations

The 9-valent, recombinant human papillomavirus (HPV) vaccine, Gardasil 9, was just granted expanded use to older populations by the US Food and Drug Administration (FDA). The approval expands the approved use of the vaccine to women and men age 27 to 45.

About 14 million Americans are infected with HPV each year, according to the US Centers for Disease Control and Prevention (CDC). Furthermore, about 12,000 women are diagnosed with cervical cancer caused by certain HPV viruses. About 4000 of those women will die.

In 2006, the FDA approved the Gardasil vaccine to prevent infection with 4 different strains of HPV in males and females age 9 through 26. In 2014, a new vaccine, Gardasil 9, was introduced in the United States to replace the original vaccine. Instead of only targeting 4 strains of HPV, Gardasil 9 targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Past research on the vaccine has shown that it is “highly effective” in the prevention of 9 different strains of cervical cancer-causing HPV. Study results revealed that Gardasil 9 has long-term activity against HPV infection and disease, and the vaccine decreased the risk of developing HPV 31/33/45/52/58-related cervical, vulvar, and vaginal disease by 97.7% when compared with Gardasil. Both Gardasil and Gardasil 9 showed similar activity at preventing HPV 6/11/16/18-associated disease. Gardasil 9 also proved effective at reducing the risk of developing cervical cell abnormalities, biopsies, and definitive therapies associated with HPV 31/33/45/52/58.

The approval of Gardasil 9 in expanded populations is based on new longer-term data of a study on about 3200 women, age 27 through 45, who were followed for an average of 3.5 years following vaccination. The study results revealed that the vaccine was 88% effective for the "prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine," according to a statement from the FDA.

The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.