FDA OK's Resumed Rotavirus Vaccinations

WASHINGTON, May 17 (UPI) — The U.S. Food and Drug Administration says it has revised its recommendations for rotavirus vaccines, calling for the medication’s resumed use.

The FDA in March suspended the use of the vaccines after new technology detected DNA from porcine circoviurs type 1 in GlaxoSmithKline’s Rotarix vaccine and subsequently porcine circovirus type 2 in Merck’s RotaTeq vaccine.

But since neither pig virus causes disease in humans, the FDA said it determined it is appropriate to resume the use of Rotarix and RotaTeq vaccines, which are used to protect infants from enteritis, an inflammation of the intestine that is usually accompanied by diarrhea.

“The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans,” officials said. “The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.”

More information is available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm.

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