![]() In the Covid-19 rows, censoring rules for efficacy analyses (Covid-19 cases based on eligible symptoms and positive reverse-transcriptase–polymerase-chain-reaction assay within 14 days before the second injection) were applied, except for deaths from Covid-19. The dashed vertical line represents a vaccine efficacy of 30%, based on the null hypothesis that the primary efficacy of the mRNA-1273 vaccine is 30% or less. The P value for the vaccine efficacy against Covid-19 (upper right corner) is P<0.001. placebo), and 95% confidence intervals were estimated using a stratified Cox proportional-hazards model with Efron’s method of tie handling and with the treatment group as a covariate, adjusted for stratification factor. Vaccine efficacy was defined as 1 minus the hazard ratio (mRNA-1273 vs. Three participants assigned to the mRNA-1273 group received two doses of placebo and were included in the placebo safety population, and seven participants assigned to the placebo group received one or two doses of mRNA-1273 and were included in the mRNA-1273 safety population. For safety analyses, participants were evaluated according to the injection received. The safety population included all participants who had undergone randomization and received at least one injection this population was used for all safety analyses except the analysis for solicited adverse events. The full analysis population comprised all participants who had undergone randomization and received at least one injection the modified intention-to-treat population included participants in the full analysis population who had no immunologic or virologic evidence of previous Covid-19 (i.e., had both a negative nasopharyngeal swab specimen and a negative anti-nucleocapsid antibody test result) at day 1 before the first injection and the per-protocol population consisted of all participants in the modified intent-to-treat population who received planned injections according to the schedule and had no major protocol deviations that affected key trial data. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases COVE number, NCT04470427.).Ĭopyright © 2021 Massachusetts Medical Society.Įight participants, including six with major protocol deviations and two who erroneously underwent randomization twice, were excluded from the original randomization population (30,423 participants) and from all analysis sets. The mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. person-years 95% CI, 7.2 to 12.5) and 744 in the placebo group (136. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval, 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. ![]() The trial enrolled 30,415 participants 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. The primary end point was prevention of Covid-19 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-2). We enrolled volunteers who were at high risk for Covid-19 or its complications participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. Final analyses of efficacy and safety data from the blinded phase of the trial are reported. After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. ![]() At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19).
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