Thursday, March 25, 2010

FDA Tells Physicians to Temporarily Stop Using Rotarix Vaccine

The FDA is advising clinicians to temporarily stop using the rotavirus vaccine Rotarix because components of a separate virus, porcine circovirus 1 (PCV1), have been detected in the vaccine.
PCV1 is not known to cause illness in humans, and according to FDA Commissioner Dr. Margaret Hamburg, "there is no evidence at this time that there is a safety concern."
The agency says that children who've already received one dose of Rotarix can receive RotaTeq instead for the next two doses to complete the series.
The FDA will continue to investigate the finding and expects to make additional recommendations on the use of rotavirus vaccines after an expert advisory committee meets in about 4 to 6 weeks.

Reference: Physician's First Watch

Background information:
Retrovirus causes stomach flu, it is a common infection that affects infants and young children worldwide. Once a child has had the infection, immunity develops. Rotavirus infection leads to vomiting, diarrhea, malabsorption and a low grade fever. Covnetional treatment focuses on symptom management ensuring adequate re-hydration and electrolyte replacement. In severe cases, death can result, however, with proper management, prognosis is excellent.

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