The Food and Drug Administration is recommending that health care providers temporarily suspend the use of a vaccine commonly used on young infants.
The Rotarix vaccine is used 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. The FDA licensed Rotarix in 2008.
Health Commissioner Julia Sheen said in a statement Tuesday that the administration wants to learn more about the components of an extraneous virus detected in 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 the information recently received by the FDA about the Rotarix vaccine,” she said. “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 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 United States 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 Health Department’s Vaccine for Children Program does not utilize the Rotarix vaccine. To learn more, visit www.healthvi.org or www.fda.gov or call 1-800 463-6332 or 1-800-INFO-FDA
