Moderna has announced that the primary efficacy analysis of the phase III COVE study of mRNA-1273 conducted on 196 cases has confirmed the high efficacy observed at the first interim analysis (ClinicalTrials.gov Identifier NCT04470427). The primary endpoint of the study is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the prespecified success criterion on efficacy. The new primary 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 mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. 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 1 COVID-19-related death in the study to date, which occurred in the placebo group. Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (age 65 years and older) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants). No new serious safety concerns have been identified. Based on prior analysis, the most common solicited adverse reactions included injection-site pain, fatigue, myalgia, arthralgia, headache and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose. Moderna will now file for an emergency use authorization (EUA) in the U.S. and submit an application for conditional marketing authorization (CMA) in the E.U. The company has already initiated the rolling review process in the E.U., Canada, Switzerland, U.K., Israel and Singapore, and intends to seek prequalification (PQ) and/or emergency use listing (EUL) with the World Health Organization (WHO). The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Dec. 17 (Moderna News Release).