Rotarix regulatory update

FDA recommended the temporary suspension of Rotarix from GlaxoSmithKline as a precautionary measure after components of extraneous virus were detected in the oral attenuated rotavirus vaccine. According to FDA, an independent U.S. academic research team found DNA from porcine circovirus 1 (PCV1) in Rotarix using a new technology to detect viral genetic matter. GSK and the agency conducted follow-up testing that showed the virus has been present since the early stages of development, including during clinical trials. FDA said there is no known safety risk associated with the virus. Preliminary testing of another rotavirus vaccine, RotaTeq from Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.), did not detect components of PCV1. The agency plans to convene an advisory committee to discuss the use of rotavirus vaccines in 4-6 weeks. ...