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Published on 17 May 2010

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FDA declares Rotarix “safe to use”


US regulators have cleared a controversial diarrhoea vaccine three months after it was found to contain traces of an apparently benign pig virus.

The Food and Drug Administration (FDA) urged doctors against using GlaxoSmithKline’s Rotarix after DNA traces of porcine circovirus were found in the product in March, suggesting Merck’s RotaTeq be used as an alternative while the case was investigated.

Officials reversed the decision on Friday after a probe found the product posed no danger to humans.

The oral vaccine has been used in millions of children worldwide, including 1 million in the US, with no signs of safety problems, the FDA said.

The decision follows similar findings by the European Medicines Agency.

Rotavirus causes severe diarrhoea and is a leading child killer in developing countries.

Copyright Press Association 2010

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