25 November 2020 - - The European Commission has approved an agreement to secure 80m doses of mRNA-1273, US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) vaccine candidate against COVID-19, as part of the European Commission's goal to secure access to a safe and effective COVID-19 vaccine for Europe, the company said.

Under the terms of the proposed agreement, the European Commission has the option to increase their purchase of mRNA-1273, from 80m doses to a total of up to 160 m doses. The agreement will be finalized following a brief review period by the European Union Member States.

This announcement follows the conclusion of advanced exploratory talks with the European Commission that began on August 24, 2020.

Delivery of the vaccine could begin as early as 1Q21 if it is approved for use by the European Medicines Agency human medicines committee, which started a rolling review of mRNA-1273 on November 17.

In Europe, Moderna 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. The company remains on track to manufacture 500 m to 1 bn doses globally in 2021.

If the relevant regulatory approvals are granted, Moderna expects to begin shipping mRNA-1273 to the European Union beginning in December 2020.

On November 16, Moderna announced that the independent, US NIH-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273 has 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 US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, 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.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.