Rotarix regulatory update

FDA revised its recommendations for rotavirus vaccines and determined that it is appropriate to resume use of Rotarix from GlaxoSmithKline and continue use of RotaTeq from Merck. The decision reverses the agency's temporary suspension of Rotarix on March 22 after DNA from porcine circovirus 1 (PCV1) was found in the vaccine. PCV1 and PCV2 DNA was subsequently also discovered in RotaTeq. FDA said both vaccines have strong safety records, adding that there is no evidence that PCV1 or PCV2 pose a safety risk in humans. On May 7, all but one member of an FDA panel said the benefits of the rotavirus vaccines outweigh the risks of potential harm from viral contaminants (see BioCentury, May 5). ...