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In addition, Moderna announced that a meeting of the FDA Advisory Committee on Vaccines and Related Biologics (VRBPAC) to review mRNA-1273 safety and ability data will likely be scheduled for December 17, 2020.
mRNA-1273 is an mRNA vaccine that encodes a new coronavirus protrusion protein that is stable before fusion.
3 COVE study, which recruited more than 30,000 subjects in the United States, was based on an analysis of cases of COVID-19 that began to be confirmed two weeks after the second dose of vaccination.
based on pre-defined effectiveness criteria, vaccine effectiveness was confirmed at the time of the first interim analysis, with a total of 95 cases accumulated.
today's main analysis is based on 196 cases, of which 185 COVID-19 infections were observed in the placebo group, 11 were observed in the mRNA-1273 group, and the vaccine effectiveness estimate was 94.1%.
severe cases of COVID-19 were analyzed at the secondary endpoint and 30 severe cases were included in this analysis.
all 30 cases occurred in the placebo group and none in the mRNA-1273 vaccination group.
, one COVID-19-related death in the study occurred in the placebo group.
the statistical efficacy of different age, race and ethnicity, as well as gender groups.
196 COVID-19 cases included 33 elderly persons (over 65 years of age) and 42 subjects from different ethnic minority groups.
safety data from the MRNA-1273 Clinical Phase 3 study is under constant review and no new serious safety issues have been found.
analysis, the most common adverse reactions include pain at the injection site, fatigue, muscle pain, joint pain, headache, and erythema/redness at the injection site.
the frequency and severity of adverse reactions in the mRNA-1273 group increased after the second drug was given.
: s1. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization. Retrieved 2020-11-30, from Source: Medical Mission Hills
