ROTARIX™ and Identification of Porcine Circovirus Type 1 (PCV-1)

March 26, 2010

MECS # 10-107267-655

On March 19, 2010, Health Canada was notified by GlaxoSmithKline (GSK) of the presence of DNA from a virus identified as porcine circovirus-1 (PCV-1) in batches of its oral rotavirus vaccine, Rotarix. The presence of this DNA in the vaccine was initially identified by an independent U.S. research team using a novel technique but has since been confirmed by GSK.

PCV-1 is not known to cause illness in humans or other animals and there is no evidence to date that this finding poses a safety risk. Rotarix has been extensively studied and is known to be a safe and effective vaccine.

Vaccines manufactured for the Canadian market must meet rigorous testing standards for quality, safety and efficacy. In Canada, two vaccines are authorized to protect against human rotaviruses that cause gastroenteritis (vomiting and diarrhoea) in infants, Rotarix, manufactured by GlaxoSmithKline and RotaTeq, manufactured by Merck Frosst Canada. Health Canada authorized RotaTeq in 2006 and Rotarix in 2007.

There are currently no doses of Rotarix on the market in Canada. Only RotaTeq is presently being used in Canadian clinics. Preliminary testing by the U.S. research team and the Food and Drug Administration (FDA) of the United States has not detected PCV-1 DNA in RotaTeq.

Health Canada stresses that the findings do not present a Canadian public health threat and no regulatory action is being taken at this time. 

Health Canada is working closely with GlaxoSmithKline, the World Health Organization, the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the Therapeutics Good Administration (TGA), Australia, on this issue and will inform Canadians as new information becomes available.