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EMA begins review of China's Sinovac Covid-19 vaccine

A formal application for marketing authorisation has not yet been submitted.

Image: Shutterstock/PhotobyTawat

THE EU MEDICINES regulator has started a rolling review of China’s Sinovac Covid-19 vaccine to assess its effectiveness and safety.

This review is the first step towards the vaccine’s possible approval for use in the European Union.

The European Medicines Agency (EMA) said its decision to start the review is based on preliminary results from laboratory 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 added that no application has yet been submitted for marketing authorisation for the vaccine.

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It said the rolling review will continue until enough evidence is available for a formal authorisation application down the line. 

The EMA said it can’t predict an overall timeline for a completed assessment of the vaccine’s safety and effectiveness, but the ongoing review will speed up the process. 

There are currently four vaccines approved for use in the EU – Pfizer/BioNTech, Moderna, AstraZeneca and Janssen (Johnson & Johnson).

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