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.

FDA moves quickly toward formal Moderna EUA decision
The U.S. Food and Drug Administration (FDA) has informed Moderna that it will work rapidly toward the issuance of an emergency use authorization (EUA)...
Europe buys 80M more doses of Moderna COVID-19 vaccine
The European Commission has exercised an option to purchase an additional 80 million doses of Moderna's messenger RNA (mRNA) COVID-19 vaccine candidate,...
FDA issues EUA for Moderna COVID-19 vaccine
Just one day after a favorable committee recommendation, the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for...
FDA committee votes favorably for Moderna COVID-19 vaccine EUA
Moderna's messenger RNA (mRNA) COVID-19 vaccine candidate, mRNA-1273, received a favorable recommendation on December 17 from an advisory committee to...
Moderna's vaccine data support high efficacy, safety prior to FDA meeting
Moderna has published information supporting a 94.1% efficacy rate for its messenger RNA (mRNA) COVID-19 vaccine, mRNA-1273. The company made the data...

Copyright © 2021 scienceboard.net


Register below for our weekly Letter from the Editor to receive the latest Science news and insights.
Email
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter