THE HAGUE, Netherlands — The European Union’s drug regulator says 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 added that no application has yet been submitted for marketing authorization for the vaccine.
During a rolling review, drugmakers submit their study data in increments instead of waiting for research to be completed in order to speed up the process. The European Union has faced pressure to speed up the pace of its vaccine acquisition program.