1. Primary efficacy analysis of the Phase 3 COVE study
Moderna's mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe
Vaccine efficacy against COVID-19 was 94.1%; against severe COVID-19 was 100%.
(source: Moderna Nov 30 press release)
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.
Side effects:
Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.
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