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.
“We are pleased with the productive interactions with the European regulatory authorities at the national level and at the EMA level to date and we appreciate their valuable guidance and confidence in Moderna to pursue an MAA submission for approval in Europe for our COVID-19 vaccine candidate, mRNA-1273,” said Stéphane Bancel, chief executive officer of Moderna.
Moderna is working with strategic manufacturing partners in the EU – Lonza of Switzerland and ROVI of Spain – for manufacturing and fill-finish outside of the US for mRNA-1273.
The vaccine candidate is currently being studied in a phase III randomised trial of 30,000 participants in US.
As of 9 October, the phase III study has enrolled approximately 28,618 participants with over 22,194 of those having received their second vaccination.