November 16, 2020 -- A COVID-19 vaccine under development by Moderna had 94.5% efficacy in a phase III clinical trial, according to an independent data safety monitoring board that notified the company of the results. The news builds on positive sentiment that a solution to the COVID-19 pandemic could be around the corner.
Moderna's Coronavirus Efficacy (COVE) study has enrolled over 30,000 participants in the U.S. and is being conducted in collaboration with the U.S. National Institutes of Health Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research Development Authority (BARDA).
In the study, 15,000 people received the mRNA-1273 candidate while 15,000 received a placebo. The primary endpoint of the study was the number of individuals with a confirmed case of COVID-19 two weeks after receiving a second dose of the vaccine.
There were a total of 95 cases of COVID-19 in the interim analysis, with 90 cases occurring in the placebo group versus five cases observed in the mRNA-1273 group, producing an efficacy rate of 94.5%.
The secondary endpoint analyzed in the study was severe cases of COVID-19. There were 11 severe cases, and all occurred in the placebo group. The data monitoring board did not report any significant safety concerns in its review of the phase III COVE study. The board also concluded that the vaccine was generally well-tolerated.
Based on the interim report, Moderna plans on submitting an emergency use authorization with the U.S. Food and Drug Administration in the coming weeks. Moderna also plans on submitting applications for authorizations to other global regulatory agencies.
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. and is on track to manufacture 500 million to up to 1 billion doses globally in 2021.