Rotarix regulatory update

CHMP said there is no need to restrict use of rotavirus vaccines Rotarix from GlaxoSmithKline and RotaTeq from Merck. The committee said there is no evidence that the presence of DNA from porcine circovirus (PCV) in the vaccines represents a risk to public health. In March, the European Medicines Agency (EMA) said the DNA in batches of Rotarix was not a health risk. Last week, FDA determined that it is appropriate to resume use of Rotarix and continue use of RotaTeq (see BioCentury, May 17). CHMP is part of EMA. ...