Moderna, Inc. has announced a supply agreement with the United Kingdom government for an additional 2 million doses of mRNA-1273,
Moderna is a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients.
And, mRNA-1273 is Moderna’s vaccine candidate against Covid-19. As per the supply agreement, the vaccine will be supplied to the UK starting March 2021.
With this, the UK government has now secured 7 million doses of mRNA-1273. This confirmation comes as the UK continues its efforts to secure access to safe and effective COVID-19 vaccines by establishing a broad portfolio of the most promising vaccines.
Stéphane Bancel, Chief Executive Officer of Moderna, said, “We appreciate the collaboration with the UK government as with many other governments and other key partners around the world.”
He added: “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 the progress on mRNA-1273 we have made to date including the positive interim analysis from our Phase 3 COVE study.”
Moderna announced on November 16 that the independent, 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 per cent.
Known as the COVE study, it enrolled over 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.
Moderna received confirmation on October 27, 2020 that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom started the rolling review process of mRNA-1273.
mRNA-1273 is an mRNA vaccine against Covid-19 encoding for a prefusion stabilized form of the Spike (S) protein.
It was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. Funded by the Coalition for Epidemic Preparedness Innovations, the first clinical batch was completed on February 7, 2020 and underwent analytical testing.
It was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
The FDA on May 12 granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.
(With inputs from The OnLook News Research Bureau)