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Background: At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA vaccine showed After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported.
The primary end point was prevention of Covid illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 SARS-CoV The data cutoff date was March 26, Results: The trial enrolled 30, participants; 15, were assigned to receive the mRNA vaccine, and 15, to receive placebo.
Vaccine efficacy in preventing Covid illness was The efficacy in preventing severe disease was Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions.
No safety concerns were identified. Conclusions: The mRNA vaccine continued to be efficacious in preventing Covid illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed.