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FDA clears return of Rotarix vaccine

/ Source: The Associated Press

The Food and Drug Administration has cleared the use of GlaxoSmithKline PLC's Rotarix vaccine, which is designed to protect babies against a leading cause of diarrhea.

In March, the FDA had urged pediatricians to temporarily stop using the rotavirus vaccine after discovering that doses of Rotarix were contaminated with bits of an apparently benign pig virus. They suggested doctors use Merck & Co.'s RotaTeq vaccine instead. The agency reversed its decision Friday, saying there is no evidence that porcine circovirus can infect or sicken humans.

The European Medicines Agency in March also had suggested pediatricians not use Rotarix, but reversed its recommendation after a few days.

Rotavirus causes severe diarrhea and is a leading child killer in developing countries. Merck's vaccine was introduced in 2006 and Glaxo's in 2008. Glaxo's oral vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems, health officials have said.