EU regulators start review of China’s Sinovac vaccine

In this file photo dated Tuesday, April 20, 2021, exterior view of the European Medicines Agency, EMA, in Amsterdam, Netherlands. The European Union’s drug regulator medicines agency said Tuesday May 4, 2021, it has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, which is a first step toward possible approval for use in the 27-nation bloc.

In this file photo dated Tuesday, April 20, 2021, exterior view of the European Medicines Agency, EMA, in Amsterdam, Netherlands. The European Union’s drug regulator medicines agency said Tuesday May 4, 2021, it has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, which is a first step toward possible approval for use in the 27-nation bloc. | AP

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 HAGUE, Netherlands — 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.

“These studies suggest that the vaccine triggers the production of antibodies” that fight the coronavirus “and may help protect against the disease,” the agency said in a statement.

The EMA, which so far has approved four coronavirus vaccines, added that no application seeking marketing authorization for the Sinovac vaccine has been submitted yet. The agency also is conducting rolling reviews of three other vaccines: the one developed by German biotech company CureVac, the American-developed Novavax and Russia’s Sputnik V.

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.

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The announcement from the Amsterdam-based agency came a day after a top World Health Organization …read more

Source:: Chicago Sun Times

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