BRIEF—Moderna files for EMA approval of its COVID-19 vaccine booster dose

US messenger RNA specialist Moderna has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50µg dose level.

“We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50µg dose level. The amended Phase II study and additional analyses shows that a 50µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant,” said Stéphane Bancel, chief executive of Moderna.

“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2,” he added0.

Moderna COVID-19 vaccine, now trade-named Spikevax, gained its first European approval in January 2021 on a conditional basis, and generated first-half 2021 sales of $5.9 billion.