ACIP adds new vaccine to HPV recommendations

The Advisory Committee on Immunization Practices (ACIP) recommended the 9-valent human papillomavirus (HPV) vaccine (Gardasil 9) in last week's Morbidity and Mortality Weekly Report (MMWR).

The 9-valent vaccine is the third HPV vaccine to be recommended, after the bivalent and quadrivalent vaccines. It was approved by the FDA in December 2014 for use in females ages 9 to 26 and males ages 9 to 15. ACIP recommends that routine HPV vaccination be initiated at age 11 or 12, but the vaccination series can be started at age 9. Vaccination is also recommended for females 13 to 26 years and for males 13 to 21 years who have not been vaccinated previously or who have not completed the 3-dose series. Males aged 22 to 26 years may be vaccinated, ACIP said.

In addition to HPV types 6, 11, 16, and 18, the 9-valent vaccine protects against types 31, 33, 45, 52, and 58. According to the MMWR article, approximately 64% of invasive HPV-associated cancers in the U.S. are attributable to HPV 16 or 18 and 10% are attributable to the 5 additional types in the new vaccine. The 5 additional types also account for 15% of all cervical cancers and 25% of cervical intraepithelial neoplasia grade 2 or 3 and adenocarcinoma in situ in the U.S.

Safety of the new vaccine was evaluated in about 15,000 patients. It was well tolerated, and most adverse events were mild to moderate injection site-related pain, swelling, and erythema. Like the previous vaccines, it should be administered on a 3-dose schedule, although a clinical trial is ongoing to assess alternative dosing schedules for the 9-valent vaccine.