A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market

"By vaccinating men as well as women, you reduce the amount of virus that is out there that can be transmitted back and forth," said Richard M. Haupt, who leads the HPV vaccine program at Merck & Co., which makes Gardasil. "Hopefully there will be a benefit not only to men themselves, but to their partners and future partners."

After the Food and Drug Administration approved the vaccine in 2006 for girls as young as 9, medical authorities recommended that they receive it at age 11 or 12 to protect them before they start having sex. Critics worried that vaccinating children would send a subtle signal that their parents assumed they would become sexually active and that it would give youngsters a false sense of security.

Merck also began an ambitious marketing campaign and lobbying push to persuade states to add the vaccine to the list of those required for children to attend school. But the company eventually abandoned the strategy in the face of an intense backlash from critics who argued that the decision should be left to parents. Although many states considered such mandates, so far only Virginia and the District have imposed one, and Haupt said the company has no plans to pursue that strategy again.

But in December, Merck asked the FDA to approve the vaccine for males ages 9 to 26, and in February it presented the results of a large study that tested the vaccine in men to the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, in the hopes of winning the panel's endorsement. The committee's recommendations influence which vaccines schools require and whether private insurance companies and state programs will pay.

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