On October 25, 2011, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of quadrivalent human papillomavirus (HPV) vaccine (HPV4; Gardasil, Merck & Co. Inc.) in males aged 11 or 12 years. ACIP also recommended vaccination with HPV4 for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series; males aged 22 through 26 years may be vaccinated. These recommendations replace the October 2009 ACIP guidance that HPV4 may be given to males aged 9 through 26 years (1). For these recommendations, ACIP considered information on vaccine efficacy (including data available since October 2009, on prevention of grade 2 or 3 anal intraepithelial neoplasia [AIN2/3], a precursor of anal cancer), vaccine safety, estimates of disease and cancer resulting from HPV, cost-effectiveness, and programmatic considerations. The evidence for HPV4 vaccination of males was evaluated using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methods (2).
Background of HPV Vaccination Program in the United States
HPV4 is directed against HPV types 6, 11, 16, and 18, and was licensed by the Food and Drug Administration (FDA) for use in females in June 2006. Bivalent HPV vaccine (HPV2; Cervarix, GlaxoSmithKline) is directed against HPV 16 and 18, and was licensed for use in females in October 2009. ACIP recommends either vaccine for routine use in females aged 11 or 12 years (3). In 2009, HPV4 was licensed for use in males for prevention of genital warts; in December 2010, FDA added prevention of anal cancer in males and females as an indication for use (4). Since 2006, HPV vaccine coverage in females has increased but remains low. In 2010, coverage with at least 1 dose among females aged 13 through 17 years was 48.7%, and 3-dose coverage was 32.0% (5). Coverage with at least 1 dose among males aged 13 through 17 years was <2%.
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