EC authorizes Moderna's COVID-19 vaccine

By The Science Advisory Board staff writers

January 7, 2021 -- The European Commission (EC) has granted a conditional marketing authorization for Moderna's messenger RNA (mRNA) COVID-19 vaccine, mRNA-1273. The authorization allows vaccination programs using the Moderna vaccine to be rolled out across the European Union (EU).

The authorization is based on the recommendation of the European Medicines Agency (EMA) for the use of mRNA-1273 for active immunization to prevent COVID-19 in individuals 18 years of age and older. The EMA Committee for Medicinal Products for Human Use gave a positive recommendation for mRNA-1273 based on scientific evidence, including data analysis from the phase III clinical study that was announced on November 30.

The EU is the fourth jurisdiction to authorize mRNA-1273, following the U.S., Canada, and Israel. Additional authorizations are under review in Singapore, Switzerland, and the U.K.

On December 18, the EMA exercised its option to increase its confirmed order of mRNA-1273 by 80 million doses, bringing the total to 160 million doses. The first deliveries of the vaccine in Europe are expected to begin next week.

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