ACIP Expands HPV Vaccine Recommendation to Adolescent Boys

The CDC's Advisory Committee on Immunization Practices, or ACIP, voted to recommend major changes in the use of two vaccines during its Oct. 25-26 meeting in Atlanta. The committee agreed on a provisional recommendation to expand the routine use of quadrivalent human papillomavirus, or HPV, vaccine to adolescent boys, and it also voted to recommend the use of hepatitis B vaccine in all adults with diabetes who are younger than age 60 and who have not previously received the vaccine.

The ACIP recommendations must be evaluated and approved by the CDC before becoming official through publication in Morbidity and Mortality Weekly Report. Similarly, the AAFP Commission on Health of the Public and Science will review both recommendations.

Less than one-third of teenage girls in the United States have completed the three-dose series of HPV vaccine, according to the CDC's 2010 National Immunization Survey-Teen. Faced with such lackluster numbers in girls, the ACIP voted to recommend routine use of quadrivalent HPV vaccine in adolescent boys to, among other things, aid in halting spread of the infection to females.

"Uptake in girls has not been as good as (CDC officials and committee members) want it to be," said James Loehr, M.D., of Ithaca, N.Y., the AAFP's liaison to the ACIP. "The major risk of HPV is cervical cancer. Getting boys and men vaccinated will protect women from the infection," in addition to offering males protection against genital warts and certain rare cancers associated with HPV infection.

The ACIP also recommended routine use of the quadrivalent vaccine in men ages 22-26 who have HIV infection or who have sex with men.

Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases, said during an Oct. 25 media briefing that about 20 million Americans are infected with HPV, which is associated with cancers of the anus, cervix, head, neck, penis, vagina and vulva.

According to the CDC, 18,000 U.S. women are diagnosed with HPV-associated cancers each year, including 12,000 cases of cervical cancer. Some 4,000 women die of cervical cancer annually. About 7,000 men are diagnosed with HPV-associated cancers each year.

The CDC's 2010 teen immunization survey also found that less than half of U.S. adolescent girls had received even a single dose of the three-dose HPV vaccine series. Loehr said the ACIP expects that making the vaccine a routine immunization for boys and girls will increase uptake in girls.

"It should not be as much of a hard sell because now you're recommending it for all teenagers," he said. "There's no discrimination between boys or girls."

The quadrivalent HPV vaccine is covered for both girls and boys through the Vaccines for Children Program.

In 2009, the ACIP recommended against the routine use of quadrivalent HPV vaccine to prevent genital warts in boys and young men. Instead, the committee voted at that time to support the "permissive use" of Gardasil, Merck & Co. Inc.'s quadrivalent HPV vaccine, allowing males ages 9-26 years to decide, in collaboration with their health care professionals, whether they wished to be immunized.

Schuchat said in the briefing that the ACIP strengthened its recommendation based on a review of new data that were not available two years ago.

"In 2009, there were data about genital wart prevention, and there was an FDA label in support of that," she said. "Since that time, clinical efficacy data on prevention of the precursors of anal cancer have come out that were very striking, highly effective against that very severe type of cancer for which we don't have routine screening and for which we don′t have very effective treatment."

The new recommendation calls for routine HPV immunization of boys ages 11-12 years and a catch-up dose for males 13-21. The vaccine can be given to boys as young as 9. In addition, the ACIP supported permissive use of the vaccine in men ages 22-26.

The current recommendation applies specifically to Gardasil and does not include the use of Cervarix, GlaxoSmithKline's bivalent HPV vaccine, which -- like Gardasil -- is approved for the prevention of cervical cancer and precancerous lesions in females.

In other business, the ACIP voted to recommend routine hepatitis B immunization of unvaccinated adults with diabetes who are younger than age 60 and permissive use of the vaccine in adults 60 and older. The recommendation was based on evidence that patients with diabetes are at increased risk for hepatitis B because of shared testing equipment.

Loehr said patients 60 and older were relegated to a permissive use recommendation because the vaccine is more effective in younger patients.

Finally, the ACIP voted to approve the 2012 child, adolescent and adult immunization schedules, which are developed by the ACIP in collaboration with the AAFP, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American College of Physicians. Loehr said the schedules are expected to be published in February.