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FDA Recommends Temporary Suspension of Rotarix Vaccine

Agency says porcine circovirus contamination in rotavirus vaccine likely poses no safety risk

MONDAY, March 22 (HealthDay News) -- The U.S. Food and Drug Administration has recommended that health care providers in the United States temporarily suspend use of the rotavirus vaccine Rotarix, manufactured by GlaxoSmithKline, because of possible contamination by an extraneous virus.

The FDA recommendation follows the discovery of DNA from porcine circovirus 1 (PCV1) in Rotarix by academic researchers. The FDA said that currently there is no evidence that the virus poses a safety risk, as PCV1 is not known to harm humans. The agency said it is collecting further information about the contamination, is evaluating vaccine testing methods, and plans to convene an expert advisory committee in coming weeks to offer recommendations on rotavirus vaccines. The FDA said preliminary testing of RotaTeq, another licensed rotavirus vaccine, did not find PCV1 contamination.

Rotarix and RotaTeq are oral vaccines administered to infants to prevent rotavirus disease, which can cause diarrhea and dehydration and results in an estimated 500,000 infant deaths worldwide annually. The FDA said that for many countries the risk of the rotavirus disease outweighs the theoretical risk of the PCV1, and those countries may elect to continue Rotarix vaccinations.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs at the U.S. Department of Health & Human Services. "There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings."

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