Here's some news that Merck can really use: FDA and CDC gave its Gardasil a (re)seal of approval, saying the vaccine is safe and effective for the prevention of some of the strains of genital warts that can lead to cervical cancer. The vaccine had already received FDA approval for use in females, ages 9 through 26 years.
Agency officials reviewed nearly 10,000 reports of health problems (including 20 deaths) that followed injections with the vaccine, but both the FDA and CDC said in a statement, "There was not a common pattern to the deaths that would suggest they were caused by the vaccine." The agencies also did not find an association between the uncommon neurological disorder, Guillain-Barre Syndrome, and the vaccine, despite patient reports and found that 94 percent of the reported side effects were not serious.
Merck decreased its projections of Gardasil sales on Monday, which was the first of two major hits to its stock prices this week.
- see the official FDA statement
- read the story at the Scientific American
- check out this Pharmalot blog post
- find out more at The Guardian