Barbara Loe Fisher - 4/7/2010

On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix 1 vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is “no evidence at this time” that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk. 2
Independent Lab Using New Technology Found Contamination

The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing. 3

More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral “seed” stock, from which Rotarix vaccine was first produced. 4

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