The Victorian Department of Health, Immunisation Program has provided the following advice:
Detection of DNA fragments of porcine circovirus type 1 (PCV1) in the Rotarix® rotavirus vaccine
In response to the report of detection of DNA fragments of a virus identified as porcine circovirus type 1 (PCV1) in batches of the oral Rotarix® vaccine in the USA, the Australian Therapeutic Goods Administration (TGA), in a statement released on the 24th of March 2010, has not recommended any changes to the current use of the vaccine. Based on current evidence and pending further expert review, the TGA does not consider this constitutes a threat to public health.
According to the TGA, DNA fragments of PCV1 were first detected in Rotarix® by an independent academic research team that used a novel technique to look for viruses. Follow-up studies by the manufacturer of Rotarix®, GlaxoSmithKline (GSK), confirmed the presence of DNA fragments not only in finished vaccine lots, but also in the working cell bank and viral "seed" used to produce Rotarix, confirming that the material has been present since the early stages of product development, including during clinical studies. It is not yet known whether intact PCV1 is present in the vaccine.
PCV1 is common in pigs but is not associated with any known disease in pigs, other animals or humans. PCV1 is not known to replicate in humans and any risk of illness due to ingesting fragments of this virus is extremely remote. PCV1 fragments have not been detected in preliminary studies carried out by the US FDA on the RotaTeq® vaccine (the other orally administered vaccine against rotavirus infection used in the National Immunisation Program, manufactured by Merck). The TGA will provide additional advice regarding its careful scientific risk assessment as soon as it is completed.
For more information:
(Also see the documents: DoHA - Rotarix Statement for Immunisation Providers and GSK - Statement and Q&A)
Kind regards
