EMA confirms mRNA-1273 COVID-19 vaccine is eligible for rolling review

14 October 2020

The European Medicines Agency has confirmed that mRNA-1273, a vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure, said the vaccine’s developer, Modera (Nasdaq: MRNA), whose shares edged up 2.1% to $79.95 pre-market this morning.

Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting an MAA for mRNA-1273 with the EMA.

This submission follows positive results from a pre-clinical viral challenge study and the positive interim analysis of the Phase I 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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