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Revised: 24 March 2010

Viral DNA Fragments found in Rotarix Vaccine

Medsafe is aware that the GSK product, Rotarix, an oral live attenuated vaccine for use in the prevention of rotavirus gastroenteritis, has been found to contain fragments of viral DNA from porcine circovirus 1 (PCV1). These fragments are not live virus particles and do not pose a safety concern.

The vaccine is recommended for infants aged from six weeks to six months and is given as a liquid by mouth in two doses a month apart. The vaccine is not widely used in New Zealand and is not on the immunisation schedule (vaccinations provided at no or low cost to children).

Rotarix has been tested by GlaxoSmithKline, the US Food and Drug Administration (FDA) and independent researchers all of whom confirm the presence of the DNA fragments. The fragments have been present since the early stages of the development of the vaccine.

PCV-1 is a virus first identified in 1974. The name porcine refers to the fact that this virus can infect pigs, but PCV-1 is not of animal origin. There is no evidence that PCV-1 can infect or cause disease in humans. Both dietary and respiratory exposure to the virus is said to be common through pork consumption.

Review of safety data from large scale clinical trials and from extensive use of the vaccine around the world has not found any evidence of harm associated with the presence of these viral fragments. Children who have been vaccinated with Rotarix are not at increased risk of harm and do not need medical follow-up.

In light of these findings the FDA has issued advice that clinicians should temporarily cease the use of the vaccine. In Europe the vaccine has been reviewed by the Committee for Human Medicinal Products who concluded that no action is necessary and emphasise that the findings do not present a threat to public health.

Given this unexpected new finding Medsafe advises that doctors should discuss the issue with people who are seeking rotavirus vaccination for their children. Clinicians may then choose to continue to use Rotarix, defer vaccination, or seek supplies of an alternative product. RotaTeq is another oral rotavirus vaccine that is approved for distribution in New Zealand. Clinicians should note that there are differences in the dosing schedule and the upper age limits for the vaccines, further information is available in the respective datasheets available on the Medsafe website.

Medsafe will continue to monitor the situation and issue more information as it becomes available.

Background

  1. Based on sales data it is estimated that about 500 children have received Rotarix in the last year.
  2. European Medicines Agency statement:
    www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/18935010en.pdf
  3. US FDA statement:
    www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm
  4. Information on PCV-1:
  5. Datasheet for Rotarix:
    www.medsafe.govt.nz/profs/Datasheet/r/Rotarixvac.htm
  6. Datasheet for RotaTeq:
    www.medsafe.govt.nz/profs/Datasheet/r/RotaTeqinj.pdf

 

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