On October 27, the Medicines and Healthcare products Regulatory Agency started the rolling review process of mRNA-1273 in the UK
Moderna today announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to the United Kingdom beginning in March 2021. The UK government has now secured 7 million doses of mRNA-1273.
“We appreciate the collaboration with the UK government as with many other governments and other key partners around the world,” said Stéphane Bancel, CEO of Moderna.
On November 16, the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
Moderna aims to deliver approximately 500 million doses per year beginning in 2021. The company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States. This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna.