CDC: Side effects not linked to Gardasil

Merck appears to be having a few difficulties marketing Gardasil--but now it may have one less. In their first post-marketing review of the human papillomavirus vaccine, U.S. health regulators conclude that reported side effects likely weren't caused by Gardasil. Data from that post-marketing safety study, along with stats from the vaccine adverse events reporting system, together showed that there was no increased risk of certain potential side effects, including Guillain-Barre Syndrome, stroke, blood clots, anaphylaxis, and more. "Based on all of the information we have today, CDC and FDA have determined that the HPV vaccine is safe to use and effective," the CDC said.

Meanwhile, BNet and the Pharma Marketing Blog have pointed out that Gardasil could end up as a victim of its own success. "As more girls get the shot, its remaining market declines--and thus Merck must target increasingly marginally profitable populations" BNet notes, commenting on the company's aim at 19-to-26-year-olds who have been less likely to get the shot thus far.

Why not simply target the three-quarters of teenagers who haven't been vaccinated against HPV yet? For one thing, Merck is hamstrung by marketing rules; it needs parental permissions to direct promotional mail and email to kids who aren't of age. And it has to do something to reverse the shot's 33 percent decline in sales.

- check out the side effects report in the WSJ
- read BNet's take
- see the post at the Marketing Blog

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