The European Medicines Agency (EMA) has initiated a rolling review of Sinovac’s COVID-19 vaccine, CoronaVac, based on preliminary results and data from clinical studies.
The EMA said it would evaluate data, “as they become available to decide if the benefits outweigh the risks,” and that the review would continue until enough evidence is available for a formal marketing authorisation application.
The agency said it would provide further information once the marketing authorization application for the vaccine has been submitted.
Chinese authorities approved the vaccine for emergency use in late August 2020, with high-risk groups such as medical staff receiving the jab since October. Brazil has also approved the vaccine.
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