A FDA panel backed GlaxoSmithKline’s Rotarix vaccine, designed to help protect infants from a gastrointestinal illness. But one member dissented when it came to the question of the drug’s safety.
There was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. Vicky Debold, a nurse and the panel's consumer representative, said she was concerned about both the pneumonia-related deaths and the overall death rate.
Rotavirus infections cause about 50,000 to 70,000 hospitalizations each year in the U.S. The agency isn't required to follow the advice of the panel.
* Morningstar February 20, 2008