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FDA Approves Nine-Valent HPV Vaccine for the Prevention of Certain HPV-Related Head and Neck Cancers

Gardasil 9 Now Approved for the Prevention of HPV-Related Cervical, Vaginal, Vulvar, Anal, Oropharyngeal, and Other Head and Neck Cancers


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On June 12, Merck announced that the U.S. Food and Drug Administration (FDA) had approved an expanded indication for Gardasil 9—a human papillomavirus (HPV) nine-valent vaccine—for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, which is currently underway.

Both men and women can be at risk for HPV-attributable oropharyngeal cancer; however, this cancer affects men more than women. For most people, HPV clears on its own, but for those who don't clear the virus, it can cause certain cancers.

Oropharyngeal cancer can arise as a result of HPV infection in the oropharynx, which includes the soft palate, side and back wall of the throat, tonsils, and back one-third of the tongue. According to a recent model published by the U.S. Centers for Disease Control and Prevention, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the United States.

More About Nine-Valent HPV Vaccine

The nine-valent HPV vaccine is indicated in females aged 9 through 45 years for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.

The vaccine is indicated in males aged 9 through 45 for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.

Dosage and Administration

The nine-valent HPV vaccine should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals aged 9 through 14 years, the vaccine can be administered using a two-dose or three-dose schedule. For the two-dose schedule, the second dose should be administered 6 to 12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the three-dose schedule, the vaccine should be administered at 2 months and 6 months after the first dose.
  • For individuals aged 15 through 45 years, the vaccine is administered using a three-dose schedule at first dose, 2 months, and 6 months.

The most common (≥ 10%) local and systemic adverse reactions in females were injection site pain, swelling, erythema, and headache. The most common (≥ 10%) local and systemic reactions in males were injection site pain, swelling, and erythema.


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