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Rotavirus vaccine suspension lifted

NEWS IN BRIEF — Posted May 31, 2010

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Physicians can resume administering Rotarix, the oral rotavirus vaccine manufactured by GlaxoSmithKline, as a temporary suspension due to a virus found in the immunization has been lifted, according to the Food and Drug Administration.

The FDA recommended temporarily suspending use of Rotarix on March 22 after porcine circovirus type 1 was found in the vaccine. The virus is not known to cause illness in humans, but the FDA said it wanted to assess the situation. In May, researchers also found PCV1 fragments in Merck's RotaTeq rotavirus vaccine, but did not make a recommendation on that vaccine's use.

The FDA on May 14 announced that both vaccines are safe to use, citing strong safety records and a lack of evidence that PCV1 or porcine circovirus type 2 cause infection or illness in humans (link).

The FDA and vaccine manufacturers are continuing to investigate the PCV components found in the vaccines and will evaluate data from ongoing testing.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2010/05/31/prbf0531.htm.

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