After full results from a late-stage study that showed it was 94.1 per cent effective with no serious safety concerns, Moderna Inc. on November 30, said that it has applied for U.S. emergency authorization for its COVID-19 vaccine and would also seek conditional approval from the European Medicines Agency.
“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it. We expect to be playing a major part in turning around this pandemic,” said Moderna Chief Medical Officer Tal Zaks.
The U.S. Food and Drug Administration has said that an advisory committee would meet on December 17, in order to discuss the request.
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