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European Medicines Agency statement on new information on Rotarix oral vaccine
The European Medicines Agency is aware of new information reported by the manufacturer of Rotarix, GlaxoSmithKline Biologicals, relating to the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine. Through its own tests, the company has confirmed the finding of DNA originating from porcine circovirus type 1.
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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More
FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
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