HPV vaccine approved for larger age group

Henrietta Strickland
October 11, 2018

The U.S. Food and Drug Administration approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.

The approval was constructed from a study among women ages 27-45, showing that the previous version of the vaccine had great impact preventing the persistent infection of HPV, genital warts, vaginal and vulvar precancers, cervical cancer, and cervical precancers related to the types of virus covered by the vaccine.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range", Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. By increasing the age of who can receive the vaccine, and what insurance may cover, we could prevent more than 31,000 cases of cervical cancer every year. The vaccine had initially been rolled out to individuals ages 9 to 26. Just two shots can protect both boys and girls from the most unsafe HPV strains - and the cancers they cause. Each year, around 12,000 women are diagnosed with cervical cancer caused by certain HPV viruses, and about 4,000 women die from these cancers.

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A trial followed approximately 3,200 women 27 through 45 years of age for an average of 3.5 years.

Using these results, the FDA approved the newer formulation - Gardasil 9, which protects against five additional strains - for people ages 27 through 45. Most cases resolve spontaneously and without symptoms, but some variants of HPV - there are more than 170 - can lead to genital warts and are associated with cancer of the cervix, vulva, vagina, penis, anus, mouth and throat. But data also indicate that the vaccine can benefit the older group.

The vaccine has been available for "off-label" use in the older age ranges.

Women 30-65 years old can get pap smears every 3 years, or a pap smear plus HPV testing every 5 years. "At higher risk are people who have had multiple sexual partners in recent years and are still sexually active, or who are sexually active for the first time in many years, perhaps because of a relationship change". The FDA reports that the safety of Gardasil 9 was evaluated in roughly 13,000 individuals, with injection site pain, swelling, headaches, and redness being the most frequently reported adverse events. According to a report from the The New York Times, the FDA is now looking into making a recommendation for the use of the vaccine in older people for scenarios like these. That's because even though many adults have been exposed to some types of HPV, most have not been exposed to all nine types covered by the vaccine.

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