FDA panel votes for rotavirus vaccine

February 25, 2008

The Food and Drug Administration has made the approval of GlaxoSmithKline's rotavirus vaccine all but official, having its advisory panel vote in favor of the vaccine...

The Food and Drug Administration has made the approval of GlaxoSmithKline's rotavirus vaccine all but official, having its advisory panel vote in favor of the vaccine.

GlaxoSmithKline submitted 11 studies on the oral vaccine Rotarix, which if approved would help prevent the dehydrating diarrhea in infants associated with the rotavirus disease. The panel voted 11-1 in favor of the oral vaccine.

Almost every time the FDA's advisory panel has approved a drug or vaccine, it has gone on to approve the drug. There was a statistically significant increase in pneumonia deaths associated with the vaccine, but GlaxoSmithKline argued the deaths came from a single trial, and weren't indicative of real-world results.

Rotarix is already approved in some countries.