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FDA warns using one brand of Rotavirus vaccine

March 23, 2010

Yesterday, the FDA recommended that doctors temporarily stop using the Rotarix vaccine, a brand produced by Glaxo, that is used to prevent rotavirus. Rotavirus is a common cause of severe diarrhea among children and is responsible for more than 600,000 children’s deaths worldwide each year.  The Rotarix vaccine may be contaminated with a benign pig virus.  According to Yahoo’s news report, independent researchers found “porcine circovirus 1 (PCV1) in Rotarix. This virus is not known to cause illness in humans, FDA Commissioner Dr. Margaret Hamburg said during an afternoon teleconference. “There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk,” Hamburg said. “PCV1 is not known to cause any disease in humans or animals.” Still, vaccines are supposed to be sterile and although Rotarix has a good safety record, finding PCV1 in the vaccine was unexpected, Hamburg said. Rotarix, made by drug giant GlaxoSmithKline, was licensed in 2008.

“While the agency is learning more about the situation, FDA is recommending that clinicians temporarily suspend the use of Rotarix vaccine,” Hamburg said.

Tribeca Pediatrics sent out a mass email today to let their patients know that they use the Merck vaccine, Rotateq, which is not included in this recall. The rotavirus vaccine is usually given to babies at age 2,4 and 6 months, according to the AAP schedule.