Phase III trial of MRNA 1273 in COVID-19 published in NEJM.- Moderna

Moderna announced that interim safety and primary efficacy results from the Phase III trial of mRNA-1273 vaccine for COVID-19 were published in the New England Journal of Medicine. The 100 microg two-dose regime of the Moderna COVID-19 Vaccine given 28 days apart was well-tolerated and demonstrated vaccine efficacy of 94.1% against COVID-19. The Phase III 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. The primary endpoint of the Phase III COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94.1% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001). a secondary endpoint analyzed severe cases of covid-19 and included 30 severe cases (as defined in the study protocol) in this analysis. all 30 cases occurred in the placebo group and none in the mrna-1273 vaccinated group. there was one covid-19-related death in the study to date, which occurred in the placebo group. the moderna covid-19 vaccine exhibited a favorable tolerability and safety profile.see: "efficacy and safety of the mrna-1273 sars-cov-2 vaccine." lindsey r. baden et al. nejm december 30, 2020 doi: 10.1056 nejmoa2035389>