Moderna received confirmation of eligibility for submission of MAA to the European Medicines Agency for COVID-19 vaccine
On Oct. 14, 2020, Moderna announced that it had received written confirmation from the European Medicines Agency (EMA) that mRNA-1273, the Companyメs vaccine candidate against COVID-19, was eligible for submission of an application for a European Union Marketing Authorization.
This submission follows positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.
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Source: Moderna
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