Audience: all health care professionals, patients
March 22, 2010 — The FDA is updating health care professionals on information that recently has become available about Rotarix, a vaccine used to prevent rotavirus disease. The FDA has learned that components of an extraneous virus, PCV1, are present in Rotarix. There is no evidence at this time that this finding poses a safety risk.
While the agency is learning more about the situation, FDA is recommending that health professionals in the United States temporarily suspend the use of Rotarix. The FDA will keep the public and the clinical community updated as more information becomes available.
March 22, 2010 — FDA update on Rotarix Vaccine