Important Information Regarding Rotavirus Vaccines: Rotarix and RotaTeq

Information Update
2010-69
May 7, 2010
For immediate release

OTTAWA - Health Canada is advising Canadians and Canadian healthcare practitioners that we are currently reviewing new information regarding the presence of porcine circovirus (PCV-1 and PCV-2) DNA in rotavirus vaccines. Porcine circovirus is a single stranded DNA virus, and is considered a contaminant in these vaccines.

Porcine circovirus is not known to cause illness in humans. There is no evidence to date that these findings pertaining to Rotarix and RotaTeq pose a safety risk to patients. Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients and clinical experience with millions of patients.

Health Canada has authorized the use of RotaTeq and Rotarix in the prevention of rotavirus gastroenteritis, a highly infectious form of diarrhea in infants and young children. Rotaviruses can cause severe vomiting and dehydration resulting in hospitalization, and can be life-threatening.

Health Canada is working closely with the manufacturers, GlaxoSmithKline and Merck Frosst, international health regulators, including the US Food and Drug Administration, and the World Health Organization to facilitate an international response to this issue. Health Canada will be communicating new information to Canadians and Canadian health care practitioners as soon as it is available and will take appropriate regulatory action, as needed.

Health Canada would like to remind Canadians that the RotaTeq and Rotarix product monographs can be found on the Health Canada website and will be updated to reflect new information.

For more information on the porcine circovirus DNA in rotavirus vaccines, Canadians may also visit the  Merck website and  GlaxoSmithKline website.

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