FDA, CDC come out swinging for Gardasil

In the wake of new safety data on Merck's human papillomavirus vaccine, both FDA and the Centers for Disease Control and Prevention have issued a statement supporting the product. "Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks," the agencies said, calling the vaccine an "important cervical cancer prevention tool."

Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there's no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.

In response to the government support, Merck sought to reassure parents, encouraging them to "look to the CDC and FDA, and to the advice of their own physicians" to help them decide whether to have their children vaccinated. "We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too," Dr. Richard Haupt, who heads up the Gardasil program, said in a statement. "Our own children are vaccinated with Gardasil."

- see the FDA/CDC statement
- read the release from Merck
- get the story in the Wall Street Journal

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