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Published on 7 April 2010

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Rotarix safe to use EMA claim


The presence of pig virus in GlaxoSmithKline’s Rotarix vaccine poses no threat to human health, the European Medicines Agency (EMA) has announced.

The claim comes after US scientists testing a new way to detect viruses found fragments of the biological agent in the treatment.

An EMA official said the traces in question were commonly found in pork products, and were not known to cause diseases in animals or humans. It nevertheless urged Glaxo to remove all fragments from the oral form of the drug.

The US Food and Drug Administration urged doctors not to prescribe Rotarix. It said it had decided to err on the side of caution because vaccines are supposed to be sterile.

Rotarix is prescribed to protect infants and children from the rotavirus, a potentially deadly infection that causes severe vomiting and diarrhoea.

Copyright Press Association 2010
European Medicines Agency

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