FDA asks healthcare professionals to hold off administering rotavirus vaccine

SILVER SPRING, Md. The Food and Drug Administration has asked healthcare professionals to temporarily stop using a vaccine used to prevent severe diarrhea in infants following the finding of DNA from a virus that affects pigs.

The FDA said Monday that an academic research team had found material from the porcine circovirus in some supplies of GlaxoSmithKline’s Rotarix, used to prevent infection by rotavirus. Rotavirus can cause severe diarrhea and dehydration and is responsible for the deaths of round half a million infants around the world each year, particularly in poorer countries and resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year before rotavirus vaccines were introduced earlier this decade.

The FDA said there was no evidence yet that the porcine circovirus posed a safety risk, and PCV is not known to cause illness in humans or other animals. Follow-up tests by GSK confirmed the findings of the academic research team. Material from the virus has not been found in a competing vaccine, Merck & Co.’s RotaTeq.

“We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” FDA commissioner Margaret Hamburg said in a statement. “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.”

GSK said it confirmed its notification of regulatory authorities, but that porcine circovirus doesn’t multiply in humans and occurs regularly in meat products without causing any health problems.

“No safety issue has been identified by external agencies or GSK,” GSK Biologicals chief medical officer and global research and development head Thomas Breuer said in a statement. “GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world.”

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