FDA weighs in on Gardasil, Cervarix

Merck is one step closer to broader use of its Gardasil HPV vaccine. In preparation for this week's review by an FDA advisory panel, agency staff released its own analysis of data on Gardasil use in boys and young men. The verdict? Gardasil is effective in preventing genital warts caused by particular human papillomavirus strains.

And there are no safety issues, an agency staffer said in a memo posted on the agency's website. Side effects in males were similar to those seen in females, including headache, fever and nausea. The FDA recently updated a warning of fainting as a potential side effect of Gardasil administration.

Though HPV has also been implicated in penile and anal cancers, Merck is only asking FDA for a genital-warts indication in male patients. It's part of the company's push to boost flagging sales of the vaccine; Merck has also sought approval for Gardasil use in women up to 45 years old but so far hasn't won it in the U.S.

Meanwhile, as the FDA advisory panel prepares to review this new Gardasil use, it's also looking at GlaxoSmithKline's Cervarix, a potential Gardasil competitor. Agency staff said the Glaxo vaccine protects women and teenage girls from the cervical cancer-causing HPV, but more miscarriages were reported among females given Cervarix. The data doesn't establish a causal relationship, but the risk couldn't be ruled out, either, FDA reviewers said.

- see the Gardasil briefing from FDA (pdf)
- check out the Cervarix documents (pdf)
- read the Reuters story
- get more from the Wall Street Journal

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