Rotavirus Vaccine Still Safe, Continued Vaccination Strongly Recommended


24 March 2010

A recent announcement has been made by the Food and Drug Administration of the USA (FDA) that an independent academic team has found traces of the DNA of a virus of pigs called porcine circovirus type 1 (PCV1) in Rotarix vaccine, the vaccine used to vaccinate children against gastroenteritis caused by the rotavirus, a diarrhoea causing virus.

This finding was subsequently confirmed by scientists employed by the company manufacturing the vaccine, GlaxoSmithKline. Consequently the FDA has recommended that doctors in the USA should temporarily suspend using this vaccine until more is learnt about this contaminant.

The FDA, however, has stressed that there is no safety risk. This recommendation has only been made by the FDA and has not been made by the European Medicines Agency.

It is the view of the National Institute for Communicable Diseases that, at this stage, there is no reason to suspend administration of Rotarix vaccine which is used for routine immunization in South Africa.

The PCV1 virus, which was discovered in pigs some 35 years ago, is not known to cause any ill effects either in pigs or in any animal or in humans and may, at any rate, be found in consumed meat – the vaccine is also administered orally. On the other hand, rotavirus is an important cause of severe disease and mortality in South Africa which is effectively prevented by this vaccine

For more information please contact Nombuso Shabalala on 011 555 0545 or 082 886 4238

Issued by the National Institute for Communicable Diseases, a division of the National Laboratory Service