Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a supply agreement with the government of the United Kingdom to supply mRNA-1273, its COVID-19 vaccine candidate, beginning in March 2021 if it is approved for use by UK regulatory authorities. This agreement comes as the UK continues its efforts to secure access to safe and effective COVID-19 vaccines.
“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. “For almost a decade, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. We are proud of our progress including the positive first interim analysis from our Phase 3 COVE study recently released. As we advance the clinical development of mRNA-1273, this continues to be a pivotal moment for us all.”
Yesterday, Moderna announced that the independent, U.S. NIH-appointed Data Safety Monitoring Board (DSMB) 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 U.S. and 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 U.S. Department of Health and Human Services.
On October 27, 2020, Moderna received confirmation that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom started the rolling review process of mRNA-1273.
The investments in this proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically develop mRNA-1273 in support of the global response to the current COVID-19 pandemic. Moderna continues to scale up its global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion 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.
