The Food and Drug Administration advised U.S. doctors Monday to stop giving infants Rotarix, one of two available rotavirus vaccines, until the agency gathers more information about how DNA from a virus common in pigs got into it.
One million U.S. babies have received Rotarix, a two-dose oral vaccine, since its approval in 2008, FDA Commissioner Margaret Hamburg said. "We do not feel that anyone who had their kids vaccinated with Rotarix has cause for worry," she said. "We're not taking this action on the basis of a safety concern." The extraneous virus, called PCV1, isn't known to cause disease in humans or animals. Rotarix has had "an excellent safety record," she said. "However, finding this material was unexpected."
Rotavirus causes severe diarrhea and dehydration and each year kills more than 500,000 infants worldwide, mainly in developing countries. The FDA recommended temporarily stopping its use because rotavirus isn't as severe in the USA, where it kills several dozen children a year, and another vaccine, Merck's more widely used three-dose RotaTeq, is available, Hamburg said. "We suspect other countries will decide to continue using Rotarix."
U.S. scientists using a novel technique to look for viruses happened upon the PCV1 in Rotarix, Hamburg said. After learning of the discovery, maker GlaxoSmithKline conducted its own tests. "Retrospective testing of Rotarix, using new molecular detection techniques, has confirmed that material from PCV1 has been present since the initial stages of the vaccine's development," the company said in a statement, a finding confirmed by the FDA.
Before the FDA makes any more recommendations about the rotavirus vaccines, Hamburg said, it will convene an advisory panel of outside experts in four to six weeks to review the research.
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