Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase

Richard J. Whitley, Abdel Babiker, Lisa Angeline Cooper, Susan Smith Ellenberg, Alan Fix, Marie Griffin, Steven Joffe, Jorge Kalil, Myron M. Levine, Malegapuru William Makgoba, Anastasios A. Tsiatis, Renee H. Moore, Richard J. Hamill, Lewis Lipsitz, Eric S. Rosenberg, Anthony Faugno, Robert Bruno, Richard Gorman, Holli Hamilton, Gary HorwithChuong Huynh, Nutan Mytle, Corrina Pavetto, Xiaomi Tong, John Treanor, Hana M. El Sahly, Lindsey R. Baden, Brandon Essink, Susanne Doblecki-Lewis, Judith M. Martin, Evan J. Anderson, Thomas B. Campbell, Jesse Clark, Lisa A. Jackson, Carl J. Fichtenbaum, Marcus Zervos, Bruce Rankin, Frank Eder, Gregory Feldman, Christina Kennelly, Laurie Han-Conrad, Michael Levin, Kathleen M. Neuzil, Lawrence Corey, Peter Gilbert, Holly Janes, Dean Follmann, Mary Marovich, Laura Polakowski, John R. Mascola, Julie E. Ledgerwood, Barney S. Graham, Allison August, Heather Clouting, Weiping Deng, Shu Han, Brett Leav, Deb Manzo, Rolando Pajon, Florian Schödel, Joanne E. Tomassini, Honghong Zhou, Jacqueline Miller

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

BACKGROUND 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). 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. METHODS 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. 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). The data cutoff date was March 26, 2021. RESULTS The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. 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. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). 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. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified. CONCLUSIONS 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.

Original languageEnglish (US)
Pages (from-to)1774-1785
Number of pages12
JournalNew England Journal of Medicine
Volume385
Issue number19
DOIs
StatePublished - Nov 4 2021

ASJC Scopus subject areas

  • Medicine(all)

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