Moderna Inc announces EMA's rolling review process of mRNA-1273 vaccine against COVID-19
18 November 2020 -

Biotechnology company Moderna Inc (Nasdaq:MRNA) said on Tuesday that the European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of its vaccine candidate mRNA-1273 against COVID-19, based on its preclinical, clinical and CMC data and the confirmation of its eligibility of submission.

The independent, US NIH-appointed Data Safety Monitoring Board (DSMB) for the company's Phase 3 study of mRNA-1273 has informed Moderna that the COVE trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.

Under the COVE study, the company enrolled more than 30,000 participants in the US.

In conjunction, the COVE is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.