Home > In the News > FDA Takes Cautionary Measure and Suspends GSK’s Rotavirus Vaccine

FDA Takes Cautionary Measure and Suspends GSK’s Rotavirus Vaccine

By Amy Pisani

The Food & Drug Administration just announced a temporary suspension of Rotarix vaccine (manufactured by GlaxoSmithKline to prevent infantile diarrhea) due to the detection of contamination with what appears to be a non harmful virus strain. According to the CDC, the majority of children here in the U.S. receive an alternate vaccine made by a separate manufacturer.  This vaccine is called RotaTeq.  There has been no contamination detected in this vaccine.  Those children who received the complete series of Rotarix do not need to be revaccinated. Those who still need more doses of Rotarix will receive the RotaTeq vaccine instead during further investigation.

Below is an excerpt from the FDA website regarding the matter:

“FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix.  This finding was reported to FDA by GlaxoSmithKline, based on work originally performed by an independent U.S. academic research team using a novel technique to look for viruses. GlaxoSmithKline conducted additional studies and confirmed that DNA from PCV1 is present in the finished Rotarix vaccine, as well as in the cell bank and seed from which the vaccine is derived.  This confirms that the DNA from PCV1 has been present since the early stages of the vaccine’s development, including during clinical studies.

There is no evidence at this time that DNA from PCV1 in Rotarix poses a safety risk.  PCV1 is not known to cause any disease in animals or humans.  Rotarix has been extensively studied, before and after approval, and found to have an excellent safety record….The FDA is continuing to investigate the finding of DNA from PCV1 in Rotarix.  While FDA is gathering additional information to present to its expert advisory committee in four to six weeks, the agency recommends that clinicians and public health professionals in the United States temporarily suspend the use of Rotarix.”

Please visit the FDA Web site for more information: 


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