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FDA Finds GSK's Rotarix Vaccine Safe for Use


The US Food and Drug Administration has completed its review of the Rotarix vaccine, made by GlaxoSmithKline and suspended from use in March due to contamination with a pig virus, and has found that it is safe. The agency recommends that doctors resume giving the vaccine to their patients.

* Read: FDA Suspends Rotarix Due to Viral Contamination

Further research later uncovered the virus Merck and Co’s competitive vaccine RotaTeq. It was never suspended because the findings were not made public until last week, one day before the advisory panel meeting regarding Rotarix. RotaTeq is also considered to be safe and approved by the FDA to continue use.

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Both Rotarix and RotaTeq are designed to protect infants from gastrointestinal illness caused by rotavirus, which kills more than 500,000 infants each year, mostly in low- and middle-income countries. Deaths are rare in the United States, but illness can require a hospital stay due to severe diarrhea. The oral vaccines are typically given to infants between two and six months of age in a two- or three-dose series.

* Read: Ensure Children Receive Vaccinations Before School Starts

An advisory panel for the FDA found that the risk to humans from the porcine (pig) circovirus type 1, or PCV1, was theoretical. Millions of doses of the vaccines have been given to infants with no sign of significant safety problems and PCV1 is not even known to cause health problems in pigs.

Another strain of the virus, PCV2, is believed to cause a wasting syndrome in young piglets, marked by diarrhea and an inability to gain weight, but it is not known to injure humans. Only PCV1 was detected in the Rotarix vaccine, not PCV2.

The FDA will continue to work with GlaxoSmithKline and Merck to plan follow-up studies. GSK has announced plans to redesign its vaccine to eliminate the pig virus.