ACIP Updates Recommendations, Adds 9-Valent HPV Vaccine

Laurie Barclay, MD

March 27, 2015

The Advisory Committee on Immunization Practices (ACIP) recommends the 9-valent human papillomavirus vaccine (9vHPV; Gardasil 9, Merck) as one of three HPV vaccines that can be used for routine vaccination, according to a report published in the March 26 issue of Morbidity and Mortality Weekly Report.

The US Food and Drug Administration approved 9vHPV in December 2014, and, as reported by Medscape Medical News, the European Medicines Agency just recommended approval this week

"The evidence supporting 9vHPV vaccination was...determined to be type 2 (moderate level of evidence) among females and 3 (low level of evidence) among males; the recommendation was designated as a Category A recommendation (recommendation for all persons in an age- or risk-factor–based group)," write Emiko Petrosky, MD, from the Epidemic Intelligence Service, Centers for Disease Control and Prevention, and colleagues in the ACIP summary.

Nearly two thirds (64%) of invasive HPV-associated cancers are caused by HPV types 16 or 18, and about 10% are caused by types 31, 33, 45, 52, and 58. HPV types 6 and 11 cause anogenital warts. Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV protects against HPV 6, 11, 16, and 18; 9vHPV also protects against types 31, 33, 45, 52, and 58.

Specific ACIP recommendations are as follows:

  • For routine vaccination of females, 9vHPV, 4vHPV, or bivalent HPV vaccine can be administered.

  • For routine vaccination of males, 9vHPV or 4vHPV can be administered.

  • Routine HPV vaccination should begin at age 11 or 12 years, but the series may be started as early as age 9 years.

  • Females aged 13 through 26 years and males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series should also be vaccinated.

  • Males aged 22 through 26 years may also be vaccinated.

  • Men who have sex with men and immunocompromised persons through age 26 years, including those with HIV infection, should also be vaccinated with either 9vHPV or 4vHPV if they were not previously vaccinated.

The evidence underlying these recommendations included findings of a randomized trial enrolling approximately 14,000 females aged 16 through 26 years. This showed noninferior immunogenicity for the HPV types shared by 4vHPV and 9vHPV and high efficacy for the five additional types. Other trials in clinical development compared antibody responses across age groups and females and males.

"Introduction of 9vHPV in both males and females was cost-saving when compared with 4vHPV for both sexes in a cost-effectiveness model that assumed 9vHPV cost $13 more per dose than 4vHPV," the report authors conclude. "Because the additional five types in 9vHPV account for a higher proportion of HPV-associated cancers in females compared with males and cause cervical precancers, the additional protection from 9vHPV will mostly benefit females."

The authors have disclosed no relevant financial relationships.

Morb Mortal Wkly Rep. 2015:64:300-304. Full text

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