ACIP Recommends HPV Vaccine for 11- to 12-Year-Old Boys

Emma Hitt, PhD

October 25, 2011

October 25, 2011 — The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) today recommended the routine use of the human papillomavirus quadrivalent vaccine (HPV4) in boys aged 11 to 12 years.

ACIP Working Group Chair Jon Temte, MD, PhD, from the University of Wisconsin School of Medicine and Public Health, Madison, and Larry Pickering, MD, from the CDC's National Center for Immunization and Respiratory Diseases, led the 14-member committee in the vote; 13 members voted yes, and 1 member abstained.

Existing guidance stated that the HPV4 vaccine may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts. The vote today approved the recommended draft language: "ACIP recommends routine vaccination of males aged 11-12 years with 3 doses of HPV4. The vaccination series can be started beginning at age 9 years."

Eileen Dunne, MD, medical epidemiologist from the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, noted in her presentation to ACIP that the new guideline would be the same as for girls, with the exception that the guideline for boys specifies use of only the quadrivalent vaccine.

Human papillomavirus quadrivalent vaccine (Gardasil).

At this time, 2 vaccines are available that protect against HPV. HPV4 (Gardasil, Merck) was approved in 2006 for administration to 9- to 26-year-old females and offers protection against HPV types 16 and 18, as well as against nononcogenic HPV types 6 and 11, which cause most genital warts. HPV4 was originally licensed in 2006 for administration to 9- to 26-year-old females, and in 2009 it received an expanded license for administration to 9- to 26-year-old males.

The other, bivalent vaccine (HPV2; Cervarix, GlaxoSmithKline) protects against the oncogenic HPV types 16 and 18 that cause 70% of cervical cancers. This vaccine was approved in 2009 for administration to females aged 10 to 25 years.

ACIP previously provided guidance on October 21, 2009, that HPV4 may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts, but did not recommend HPV4 for routine use among males until today. Unlike HPV4, HPV2 is not being recommended for routine use in males.

The committee also recommended today that boys aged 13 to 21 years who had not already received the HPV4 vaccine should also be vaccinated.

Speaking at a press conference held today, Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, noted that the new recommendation is based on data from clinical trials showing the vaccine to be highly effective in males, and that the vaccine is most effective when given before exposure to the virus.

The most common adverse effects associated with HPV vaccine include injection-site reactions, headache, and fever, all of which are generally mild to moderate in nature. "HPV vaccination of males offers the opportunity to decrease the burden of disease in both males and females," Dr. Schuchat said.

With respect to cost effectiveness, male vaccination is most cost-effective when coverage of females is low, which unfortunately is the case in the United States, she added.

"Some providers think that having a recommendation that's universal will enhance uptake in boys and girls, and we might even see better use of the vaccine in girls," Dr. Schuchat told Medscape Medical News during the call. "We don't expect quite as robust an uptake in boys as what we saw in girls," she added.

"Of course, we have a lot more room for improvement for uptake in girls, and part of our challenge is confusion over when to give the vaccine," she said. According to Dr. Schuchat, the age of 11 or 12 years, when the immune response is the strongest, but which is well before boys or girls would become sexually active, is the best time to give the vaccine. "We hope to improve this messaging (about the need to vaccinate at such a young age) going forward."

James C. Turner, MD, executive director of the American College Health Association, pointed out during the ACIP meeting that the recommendation to vaccinate boys only through age 21 years may be too limited. He estimated that about 70% of HPV vaccines given to men and women during the college years are given to students older than 21 years.

The next step will be for the CDC to develop written guidelines based on today's ACIP recommendation. These will be published in an upcoming issue of the CDC's Morbidity and Mortality Weekly Report.

The 2-day, twice-yearly ACIP meeting, which was held Tuesday and Wednesday of this week, will also include a vote today on the proposed recommendation for use of hepatitis B vaccination in patients with diabetes, as well as discussion on the use of meningococcal vaccines in infants.

Tomorrow, the committee will discuss updated information on various topics including 13-valent pneumococcal conjugate vaccine, vaccine-related febrile seizures, pertussis, immunization coverage of children/adolescents, measles, and influenza.


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