Posted by Michael Wonder on 15 Oct 2020
EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
15 October 2020 - The 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.
