Moderna announced that it plans to request an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the company’s SARS-CoV-2 vaccine candidate, according to a press release from Moderna.
That decision was based on the results of the Phase 3 study of mRNA-1273 conducted on 196 cases, confirming the high efficacy observed at the first interim analysis, which the company released on November 16. The data analysis indicates a vaccine efficacy of 94.1 percent. The study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB), Moderna said. The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the United Sates 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 Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two 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 pre-specified success criterion on efficacy. Today’s 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 one 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 (ages 65+) 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).
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified, Moderna said. 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 said it will submit data from the Phase 3 COVE study to a peer-reviewed publication.
