Gardasil, Cervarix face FDA next month

Gardasil will have another chance at broader use next month. The FDA's vaccines advisory committee will meet to consider data on use of the human papillomavirus vaccine in boys and young men. In males, HPV can cause genital warts, penile cancer and other rare cancers. And then there's the herd immunity argument: By vaccinating boys and young men, we'd help prevent their passing the virus to girls and women, thereby bringing down overall incidence.

Whether the FDA's expert advisors will think that these benefits outweigh the potential risks of expanding Gardasil use is up for grabs. They weren't thrilled about the idea of expanding Gardasil use to older women--ages 27 to 45--when it came up in January. The committee asked for more data, which is expected in the fourth quarter.

Meanwhile, Gardasil faces a threat at the same committee meeting next month. GlaxoSmithKline's HPV vaccine Cervarix is up for approval then, too. If the committee chooses to recommend this Gardasil rival, Merck will face head-to-head competition for Gardasil in the U.S. for the first time.

- read the FDA meeting agenda