HPV vaccine proposed for teen boys
■ Some doctors are concerned that the qualified recommendation from a CDC advisory panel could create insurance coverage problems.
By Christine S. Moyer — Posted Nov. 13, 2009
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The Advisory Committee on Immunization Practices voted to recommend the use of a human papillomavirus vaccine for certain males to help prevent the transmission of genital warts caused by HPV types 6 and 11.
But doctors have expressed concern that the committee didn't go far enough, cautioning that the lack of a full recommendation could lead to a disparity in vaccination accessibility and add to challenges in inoculating adolescent boys.
During an Oct. 21 meeting, ACIP issued a recommendation for the use of Merck's quadrivalent HPV vaccine, Gardasil, for males ages 9 to 26. The action followed the Oct. 16 approval of the drug by the Food and Drug Administration for the prevention of genital warts in males.
ACIP, a committee of the Centers for Disease Control and Prevention, gave a permissive recommendation. That means the committee believes Gardasil is an effective vaccine, but it is waiting for data on cost effectiveness and efficacy in preventing precancer in males, said Lauri Markowitz, MD, a medical epidemiologist and HPV expert for the CDC.
Each year, approximately two in 1,000 males in the U.S. are diagnosed with genital warts. Merck studied Gardasil's effectiveness in a randomized trial of 4,055 males ages 16 to 26. Gardasil was nearly 90% effective in preventing genital warts caused by infection with HPV types 6 and 11 in men not infected at the start of the study, the FDA said.
The vaccine has been approved for use in females ages 9 to 26 since 2006.
"I am thrilled that the committee took the first step in assuring that males get vaccinated against this disease. It makes sense. They're vectors for the virus in terms of transmission to females," said Amy B. Middleman, MD, MPH, Society for Adolescent Medicine's liaison to ACIP and director of Adolescent and Young Adult Immunization at Texas Children's Hospital in Houston. "We're hoping that providers will be more proactive than this recommendation requires."
But there is uncertainty about whether private health insurers will cover the vaccine's use in males.
"If a male comes to me in my clinic and wants to get the vaccine, I can certainly give it to him. It's licensed. But I can be almost 100% certain that his insurance plan won't cover it," said James C. Turner, MD, president of the American College Health Assn. and executive director of the Dept. of Student Health at the University of Virginia. Turner is ACHA's liaison to ACIP.
The impact on physicians likely will be a hesitancy to promote the vaccine to their male patients, Dr. Turner said.
But Dr. Middleman is urging physicians to be proactive about the new inoculation. She suggested health care professionals educate adolescents' parents and young adults about the importance of the HPV vaccine, as well as other recommended inoculations, despite the potential cost to the patient.
"It's important to make it clear to parents of adolescents, just as it is to the parents of infants and children, that immunizations are an expectation for preventive health for this age group," she said.