FDA Recommending Temporary Suspension of Infant Vaccine

Health Commissioner Julia Sheen announced Tuesday that the Food and Drug Administration is recommending that health care providers temporarily suspend the use of the Rotarix vaccine for rotavirus immunization in the United States.

Rotarix is given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and is estimated to be responsible for the deaths of more than 500,000 infants worldwide each year, primarily in low and middle-income countries. The Health Department’s Vaccine For Children Program does not utilize the Rotarix vaccine, Sheen said.

The FDA said it is recommending the temporary suspension of the vaccine because it wants to lean more about components of an extraneous virus detected Rotarix, but that there is no evidence at this time that this finding poses a safety risk.

“We want to make health care providers aware of information recently received by the FDA about the Rotarix vaccine,” Sheen said Tuesday. “As the FDA noted, there is no evidence at this time of safety concerns but clinicians should temporarily discontinue the use of the Rotarix vaccine use until the FDA can learn more about the situation. The Department of Health will keep physicians and the community updated on the FDA’s findings.”

The FDA recently became aware that an independent academic team in the U.S. found DNA from porcine circovirus 1 or PCV1 in Rotarix, which is manufactured by GlaxoSmithKline. The FDA said that PCV1 is not known to cause illness in humans or other animals and that Rotarix has been studied extensively, prior to and after approval, and found to have an excellent safety record.

The FDA licensed Rotarix in 2008. 

To learn more visit the www.healthvi.org or www.fda.gov or call 1-800 463-6332 or 800 INFO- FDA.

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