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Moderna Seeks Conditional Marketing Approval From EMA For COVID-19 Vaccine Booster Shots

Moderna Inc. (MRNA) said it submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level.

The Phase 2 study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6 months following their second dose.

Moderna noted that an additional analysis showed that a booster dose of mRNA-1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers for all variants of concern including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.

On Wednesday, Moderna announced it submitted documents asking approval from the U.S. Food and Drug Administration to allow the use of a third booster dose of its COVID-19 vaccine.

On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing from the World Health Organization (WHO).

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