Experts wrestle with vaccinating boys for HPV

CHICAGO (Reuters) - U.S. vaccine advisers are weighing whether boys and young men should be vaccinated against the human wart virus that causes a number of cancers, but some worry the vaccine is too costly to justify its use.

Merck & Co’s Gardasil vaccine is approved for boys, safe and it would be cost-effective, CDC researchers and vaccine experts told a meeting of the Advisory Committee on Immunization Practices on Thursday.

Some men would also benefit from the vaccine, including homosexuals and bisexuals, who are at risk of developing anal cancers and other conditions caused by the human papillomavirus, or HPV, the experts said.

HPV infection is best known as the primary cause of cervical cancer, but it can also lead to cancers of the anus, penis, head and neck. Vaccinating men and boys could prevent some of these cancers.

Currently, U.S. Centers for Disease Control and Prevention recommends Gardasil vaccinations for girls and women between the ages of 11 and 26.

And while doctors are free to use the vaccine for preventing genital warts in boys and men ages 9 through 26, U.S. vaccine advisers last year declined to recommend routine vaccination for males.

But they did make it available to boys in the Vaccines for Children Program, a government-funded system that provides vaccines to children eligible for the state-federal Medicaid health insurance plan and other uninsured children.

The main reason the vaccine was approved was to prevent cervical cancer, which kills 4,000 women a year in the United States. But various strains of HPV also cause disfiguring genital warts and anal, penile, head and neck cancers.

Last year, the advisory committee only considered its use based on its ability to prevent genital warts. In that case, the benefits did not seem to justify the vaccine’s $360 cost.

Now, the CDC is taking up the issue again.

Dr. Lauri Markowitz, who heads the committee’s HPV working group, told the meeting cases of anal cancers are increasing in the United States, especially among women, and men who have sex with men.

“Estimates from various studies indicate that the incidence of anal cancer in men who have sex with men may be as high as 37 cases per 100,000 men,” she said.

Markowitz said her panel is considering several options. They could make no change, or they could vote to recommend routine immunization of boys at age 11 or 12.

“With either of these options, there could be a specific recommendation of men who have sex with men,” she told the meeting.

Many also feel vaccinating adolescent males before they become sexually active is the best way to protect them without requiring them to disclose their sexual orientation, she said.

Cost appears to be a major concern for those who oppose routine vaccination, Markowitz said, but many members said they would reconsider their position if the vaccine were cheaper.

The Vaccines for Children Program pays $108 per dose of the vaccine, which is given in a series of three doses.

And there are practical reasons to expand coverage.

She said panel members who support routine vaccination cite studies showing the vaccine is safe and effective and say vaccinating both girls and boys at the same time would be easier for doctors.

A national survey of doctors showed 36 percent of pediatricians and 24 percent of family medicine physicians are administering the vaccine to males, experts told the CDC panel.