FDA widens age range OK'd to get HPV vaccine

Desiree Burns
October 11, 2018

While earlier vaccination targets the ages where exposure to HPV is most likely, a study of the original version of Gardasil in women aged between 27 and 45 showed the vaccine to be 88% effective in the prevention of a slate of infections, precancerous lesions and cervical cancer related to covered HPV types.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range", said Peter Marks, the director of the Center for Biologics Evaluation and Research.

The vaccine-previously approved for use in females and males aged 9 through 26 years-prevents certain cancers and diseases caused by 9 human papillomavirus (HPV) types, including cervical, vulvar, vaginal, and anal cancers in women, and anal cancer in men.

Gardasil-9 covers nine different subtypes of HPV and is now available for use in in the U.S.in males and females aged between nine and 26 years. Because HPV causes most cervical cancers, women can now not do the pap smear at all and just get HPV testing every 5 years as a new option. It also relied on immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

Gardasil, which was first approved by the FDA in 2006, contains a dead copy of the virus, which prompts the body to create its own antibodies against the virus. Adverse reactions that were most frequently reported included injection site pain, swelling, redness and headaches.

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All told, the vaccine prevents over 90 percent of possible HPV-caused cancers, said Gypsyamber D'Souza, an epidemiologist at the Bloomberg School of Public Health at Johns Hopkins University.

Regarding prevention and treatment, Brown recommends the HPV vaccine, widely provided to everyone-regardless of sex, gender, or sexual orientation-before sexual debut, and genital wart treatment. So, if you haven't yet gotten the HPV vaccine and are within the age range to do so, there's no time like the present. "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". Its effectiveness in preventing disease in men is based on previous research in younger men. Additionally, even if you already have HPV, the vaccine covers nine types of it, so it can offer protection against the one you don't have.

According to the American College of Gynecology and Obstetrics, women still should receive routine exams every three years if younger than 30.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The vaccine guards against the most common sexually transmitted HPV infections.

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