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FDA approves HPV vaccine for males ages 16-26 :

December 16, 2015

The Food and Drug Administration (FDA) has expanded its approval of 9-valent human papillomavirus (HPV) vaccine to include use in males ages 16-26.

Gardasil 9 already was licensed for males ages 9-15 and females ages 9-26.

The vaccine, manufactured Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., protects against anal, cervical, vulvar and vaginal cancer caused HPV types 16, 18, 31, 33, 45, 52 and 58, genital warts caused by types 6 and 11, and precancerous lesions caused by all nine of those types.

The FDA has expanded its approval of 9-valent HPV vaccine to include use in males ages 16-26. AAP News photo by Jeff KnoxThe FDA has expanded its approval of 9-valent HPV vaccine to include use in males ages 16-26. AAP News photo by Jeff KnoxNearly 80 million people in the U.S. are infected with HPV, and 14 million more contract the virus each year, according to the Centers for Disease Control and Prevention (CDC).

The Academy and CDC recommend HPV vaccine as part of routine immunization for males and females at age 11 or 12 years, although it can be started as early as 9 years, according to the AAP Red Book. The Academy and CDC also recommend catch-up vaccination for females ages 13 to 26 and males 13 through 21 who have not been vaccinated or did not complete the three-dose series. Males ages 22 to 26 also should be vaccinated if they have sex with other men or are immunocompromised.

If a patient started with another version of the vaccine, he or she still can be given the 9-valent vaccine to complete the series, according to the CDC.

The Academy says pediatricians should recommend the vaccine just as they do other vaccines, but rates have been lagging. In 2014, 60% of teen girls and 42% of teen boys had received at least one dose of HPV vaccine, according to the CDC.

“Research has demonstrated that parents often are influenced by the strong recommendations of their child’s pediatrician, and opportunities to prevent cervical cancer deaths are being missed by physicians focusing on the HPV vaccine as an STI vaccine rather than a cancer prevention vaccine,” according to the Red Book.

The most common adverse reactions to the vaccine in clinical studies were pain, swelling or redness at the injection site, according to Merck.

Gardasil 9 is contraindicated for people with a history of hypersensitivity to vaccine components and yeast. It also is not recommended during pregnancy.

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