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GSK's Rotarix vaccine resumes use in US

The US Food and Drug Administration has recommended that inoculations with GSK's Rotarix resume, following concerns over contamination

The US Food and Drug Administration (FDA) has recommended that inoculations with GlaxoSmithKline(GSK)'s Rotarix resume, having given it the all-clear following concerns over contamination. The vaccine is designed to protect babies against rotavirus, a leading cause of severe diarrhoea – a major cause of death in developing countries.

The announcement follows an almost two-month pause in the rotavirus vaccine's use owing to the presence of porcine circovirus-1 (PCV-1) contamination.

In March, the FDA urged paediatricians to temporarily stop using the rotavirus vaccine after discovering that doses of it were contaminated with bits of an apparently benign pig virus. They suggested doctors use Merck's RotaTeq vaccine instead. 

On Friday (May 14, 2010), the agency reversed its decision, saying there is no evidence that porcine circovirus can infect or sicken humans.

In March, the European Medicines Agency (EMA) had also suggested that paediatricians should not use Rotarix, but it reversed this recommendation a few days later.

Merck's vaccine was introduced in 2006 and GSK's in 2008. GSK's oral vaccine has been used in millions of children worldwide, including one million in the US, with no signs of safety problems, health officials said.

17th May 2010


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