FDA, GSK to Investigate Cause of Other Virus DNA in Rotarix

March 23, 2010
The FDA and GlaxoSmithKline (GSK) are investigating the manufacturing process for the pediatric rotavirus vaccine Rotarix after DNA fragments from porcine circovirus 1 (PCV1) were detected. The presence of PCV1 DNA is not considered a health risk but raises concern about the vaccine’s overall purity, FDA Commissioner Margaret Hamburg said. The FDA wants to understand how the DNA might have been introduced into the manufacturing process and whether intact virus, not just fragments, is present, she added.
Drug Industry Daily