UK – EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine

The European Medicines Agency (EMA) has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the agency’s centralised procedure.

The confirmation from the EMA was received in response to the submission of a letter of intent, enabling Moderna to evaluate the opportunity for submitting a marketing authorisation application for mRNA-1273.

The submission comes following positive results from a preclinical viral challenge study of mRNA-1273, as well as from an interim analysis of the phase I study of the shot in health adults ages 18-55 years and older adults ages 56-70 years and 71+ published earlier this year…