By Audrey Lotechukwu
MON, 30 NOV, 2020-theGBJournal-Moderna, Inc. (Nasdaq: MRNA), said that the primary efficacy analysis of the Phase 3 study of their mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.
‘’Vaccine efficacy against COVID-19 was 94.1%, vaccine efficacy against severe COVID-19 was 100%,’’ Moderna announced in a statement today.
The Company also announced that it plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
‘’We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna.
The Phase 3 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 biotechnology company said 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.
‘’ 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.
Importantly, Moderna confirmed that 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).’’
Moderna is working with the U.S. CDC, Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals.
Moderna said it expects to have approximately 20 million doses of mRNA-1273 available in the U.S., and remains on track to manufacture 500 million to 1 billion doses globally in 2021.
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