Publications

Published: June 2010

Update on rotavirus vaccines

Prescriber Update 31(2): 14
June 2010

In May this year the manufacturer of RotaTeq informed Medsafe that DNA fragments of both PCV-1 and PCV-2 had been identified in the vaccine. This follows an alert in March this year that PCV-1 virus had been found in Rotarix vaccine, manufactured by GlaxoSmithKline.

There is no evidence to suggest that the presence of DNA fragments of PCV-1 and PCV-2 in rotavirus vaccines poses a safety concern for patients. PCV-1 and PCV-2 are types of porcine circovirus and are composed of a single strand of DNA. These viruses are commonly found in pigs; although PCV-2 may cause illness in pigs neither virus is known to cause illness in humans.

Having considered relevant scientific information Medsafe has concluded that the continued use of both rotavirus vaccines is supported by the weight of current evidence of safe use of these vaccines. This advice is consistent with the views of the US Food and Drug Administration and the Australian Therapeutic Goods Administration (TGA).

Medsafe advises prescribers to have a balanced discussion with people who are seeking rotavirus vaccination for their children. Discussing the potential benefits of the vaccine and any theoretical risks associated with PCV will help them to make an informed decision.1,2

Medsafe will continue to monitor this issue and provide further information as it becomes available. This issue is specific to rotavirus vaccines Rotarix and RotaTeq and there is no evidence that other vaccines produced using similar techniques are affected.

References

  1. Allan G, Ellis JA. Porcine circoviruses: a review. Journal of Vetinary Diagnostic Investigation. 12:3-14.
  2. Tham KM, Hansen M. 2003. Detection of porcine circovirus types 1 and 2 in abattoir-slaughtered pigs in New Zealand. Surveillance. 30(1): 3-5.