The Harvard School of Public Health may have thrown a wrench in Merck's plans to extend use of its HPV vaccine to boys and young men. Researchers from the school ran a cost-benefit analysis of Gardasil use in males--and the results weren't encouraging. In a British Medical Journal article, they conclude giving the humanpapillomavirus shot to boys just isn't cost-effective.
FDA is now considering whether to approve the shot for use in boys and young men, aged 9 to 26. The stated idea is to protect them directly from genital warts. The officially unstated, at least at the agency level: Conferring a "herd immunity" effect, to indirectly protect women from HPV, which can cause cervical cancer. Broadening use of the shot is key to Merck's sales-boosting strategy; growth has slowed in markets where large groups of eligible girls and young women have already been vaccinated.
An FDA advisory panel recommended approval for Gardasil use in boys, saying it appears effective and safe for prevention of genital warts. And the Harvard researchers say they think it should be approved. But widespread vaccination of both girls and boys just wouldn't be cost-effective, they said. "[F]or the resources expended, there may be better uses and other health interventions that would increase health gains in the population," said Harvard's Jane Kim.
Merck is sure to have a bone or two to pick with the study, however. Namely, the fact that it assumes 75 percent of eligible girls have been vaccinated--which so far is not the case. The figure is more like one-third. "If coverage in girls ends up being low, then vaccinating boys became much more attractive," Kim told Reuters. So don't count Gardasil-for-boys out yet.