Boys may be next target for HPV vaccine; studies ongoing

Elisabeth Righter, MD, a family physician in Dayton, Ohio, has found that the male partners of her patients with cervical cancer are often distraught. Their reaction is not just because someone they love is very sick, but also because the virus that may have caused the illness, the human papillomavirus, may have come from them.

"The men feel awful that they might have given their loved one this infection. They are really upset," said Dr. Righter, the associate director of the Dayton Community Family Medicine Residency.

It is situations like this one that have many experts suggesting that the HPV vaccine, approved by the Food and Drug Administration and recommended in June by the Advisory Committee on Immunization Practices for girls ages 9 to 26, should be considered for boys, too. The hope is that a recommendation for universal vaccination would translate into fewer men transmitting the virus to their partners. Men may also be protected from genital warts and their own HPV-related cancers.

"Boys get HPV-related diseases. But, most important, they're the vector for this virus to women. People need to get this vaccine," said Bradley J. Monk, MD, associate professor in the division of gynecologic oncology at the University of California, Irvine. He wrote a commentary in the August Obstetrics and Gynecology advocating this approach.

Recommending the vaccine universally, some suspect, could also lead more girls to receive it. Many experts point to the history of rubella vaccination, which also benefits girls more and was initially only recommended for this group, as an example. Efforts against that disease only made inroads when the shot was recommended to everyone. Both sexes were more likely to get the vaccine. The herd immunity achieved also reduced the overall prevalence of the virus in the target population.

"[Universal vaccination] is a more enlightened approach," Michael Bookman, MD, director of medical gynecologic oncology at the Fox Chase Cancer Center in Philadelphia.

Opposition never gelled

Proponents of the vaccine's expanded use also feel that parents would be just as receptive to allowing their sons to receive it as their daughters. The long-discussed possible opposition, which stems from the fact that it protects against a virus primarily transmitted by sexual contact, never materialized.

The American Medical Association policy states that students and parents should be educated about HPV and the availability of a vaccine. Meanwhile, conservative organizations such as Focus on the Family support its widespread use while opposing making it mandatory for school entry. Physicians who have been administering the vaccine's first doses say they have met little, if any, resistance.

"[Parents] are requesting it. They want it," said Robert Revelette, MD, a pediatrician in Lexington, Ky.

But while there is a lot of support for using this vaccine in boys, many physicians say it is too soon to start doing so now. Though some say it makes scientific sense that the immunization would work well for everyone, the studies reviewed by the FDA and used for granting approval only included girls. And, although the data available on boys suggest that the shot creates a robust immune response, whether it is safe and prevents disease and viral transmission among males is still an open question.

"We all think it's a good idea, but we should see the data first," said Philip LaRussa, MD, professor of clinical pediatrics at Columbia University in New York and a member of the FDA's Vaccines and Related Biological Products Advisory Committee, which endorsed the vaccine's approval for use in girls. The committee did not vote on whether it should be approved for boys because data were lacking.

Merck & Co., the vaccine's manufacturer, is conducting research to answer the related questions and expects results in 2008. "The studies are ongoing, and we will continue working with the FDA," said Mary Elizabeth Blake, a Merck spokeswoman.

Significant concerns also persist about the cost of expanding the number of people who would receive this vaccine. The series of shots is expensive. For women, the cost is expected to be outweighed by the reduced need for Pap smears and follow-ups of abnormal ones as well as the reduction in cervical cancer deaths. It is unknown how cost-effective it would be to vaccinate boys who are not regularly screened for HPV-related cancers. These diseases are also less common in boys than in girls, and it is not clear how much disease this practice would actually prevent -- either in males themselves or by reducing transmission to others.

"There will be some benefit to boys, but I don't think it will be huge. Giving it to boys would basically double the cost of the vaccine, and the cost per case of cervical cancer prevented is going to be higher," said John Modlin, MD, chair of the Dept. of Pediatrics at Dartmouth Medical School in Hanover, N.H. "We need to understand what the cost effectiveness would be."