Moderna gets nod from EMA to submit marketing authorization

By The Science Advisory Board staff writers

October 14, 2020 -- Moderna has received written confirmation from the European Medicines Agency (EMA) that messenger RNA (mRNA)-1273, the company's COVID-19 vaccine candidate, is eligible for submission of an application for marketing authorization in the European Union.

Confirmation was given after the company submitted a letter of intent to evaluate the opportunity to submit a marketing authorization application for mRNA-1273 with the agency. The letter of intent followed as a result of positive data from a preclinical viral challenge study and positive interim analysis of a phase I study of the candidate in healthy adults and older adults.

The company is currently scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021. Moderna's European manufacturing partners include Lonza and ROVI who are providing fill-finish services.

The vaccine candidate is currently being studied in the phase III Coronavirus Efficacy (COVE) randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100-µg dose level in the U.S. Nearly 29,000 participants have been enrolled in the study, many of whom have already received their second vaccination.

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