EU regulators start review of China's Sinovac vaccine

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The European Union's drug regulator announced Tuesday that it has started a rolling review of China's Sinovac coronavirus vaccine to assess its effectiveness and safety, a first step toward possible approval for use in the 27-nation bloc.

The European Medicines Agency said Tuesday that its decision to start the review is based on preliminary results from laboratory studies and clinical studies.

The agency said its experts will "evaluate data as they become available to decide if the benefits outweigh the risks" of the vaccine. The rolling review will continue until "enough evidence is available for a formal marketing authorization application," the EMA said, adding that it could not predict timelines.

Such approval would mark the first time that a Chinese vaccine had been granted a so-called emergency use listing from the U.N. health agency, and would trigger a broader rollout of Chinese vaccines that are already being used in some countries beyond China.

 

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