tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Sep 22.
doi: 10.1056/NEJMoa2113017. Online ahead of print.
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase
Hana M El Sahly[SUP] 1 [/SUP], Lindsey R Baden[SUP] 1 [/SUP], Brandon Essink[SUP] 1 [/SUP], Susanne Doblecki-Lewis[SUP] 1 [/SUP], Judith M Martin[SUP] 1 [/SUP], Evan J Anderson[SUP] 1 [/SUP], Thomas B Campbell[SUP] 1 [/SUP], Jesse Clark[SUP] 1 [/SUP], Lisa A Jackson[SUP] 1 [/SUP], Carl J Fichtenbaum[SUP] 1 [/SUP], Marcus Zervos[SUP] 1 [/SUP], Bruce Rankin[SUP] 1 [/SUP], Frank Eder[SUP] 1 [/SUP], Gregory Feldman[SUP] 1 [/SUP], Christina Kennelly[SUP] 1 [/SUP], Laurie Han-Conrad[SUP] 1 [/SUP], Michael Levin[SUP] 1 [/SUP], Kathleen M Neuzil[SUP] 1 [/SUP], Lawrence Corey[SUP] 1 [/SUP], Peter Gilbert[SUP] 1 [/SUP], Holly Janes[SUP] 1 [/SUP], Dean Follmann[SUP] 1 [/SUP], Mary Marovich[SUP] 1 [/SUP], Laura Polakowski[SUP] 1 [/SUP], John R Mascola[SUP] 1 [/SUP], Julie E Ledgerwood[SUP] 1 [/SUP], Barney S Graham[SUP] 1 [/SUP], Allison August[SUP] 1 [/SUP], Heather Clouting[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Shu Han[SUP] 1 [/SUP], Brett Leav[SUP] 1 [/SUP], Deb Manzo[SUP] 1 [/SUP], Rolando Pajon[SUP] 1 [/SUP], Florian Schödel[SUP] 1 [/SUP], Joanne E Tomassini[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Jacqueline Miller[SUP] 1 [/SUP], COVE Study Group
Affiliations
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. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).
. 2021 Sep 22.
doi: 10.1056/NEJMoa2113017. Online ahead of print.
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase
Hana M El Sahly[SUP] 1 [/SUP], Lindsey R Baden[SUP] 1 [/SUP], Brandon Essink[SUP] 1 [/SUP], Susanne Doblecki-Lewis[SUP] 1 [/SUP], Judith M Martin[SUP] 1 [/SUP], Evan J Anderson[SUP] 1 [/SUP], Thomas B Campbell[SUP] 1 [/SUP], Jesse Clark[SUP] 1 [/SUP], Lisa A Jackson[SUP] 1 [/SUP], Carl J Fichtenbaum[SUP] 1 [/SUP], Marcus Zervos[SUP] 1 [/SUP], Bruce Rankin[SUP] 1 [/SUP], Frank Eder[SUP] 1 [/SUP], Gregory Feldman[SUP] 1 [/SUP], Christina Kennelly[SUP] 1 [/SUP], Laurie Han-Conrad[SUP] 1 [/SUP], Michael Levin[SUP] 1 [/SUP], Kathleen M Neuzil[SUP] 1 [/SUP], Lawrence Corey[SUP] 1 [/SUP], Peter Gilbert[SUP] 1 [/SUP], Holly Janes[SUP] 1 [/SUP], Dean Follmann[SUP] 1 [/SUP], Mary Marovich[SUP] 1 [/SUP], Laura Polakowski[SUP] 1 [/SUP], John R Mascola[SUP] 1 [/SUP], Julie E Ledgerwood[SUP] 1 [/SUP], Barney S Graham[SUP] 1 [/SUP], Allison August[SUP] 1 [/SUP], Heather Clouting[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Shu Han[SUP] 1 [/SUP], Brett Leav[SUP] 1 [/SUP], Deb Manzo[SUP] 1 [/SUP], Rolando Pajon[SUP] 1 [/SUP], Florian Schödel[SUP] 1 [/SUP], Joanne E Tomassini[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Jacqueline Miller[SUP] 1 [/SUP], COVE Study Group
Affiliations
- PMID: 34551225
- DOI: 10.1056/NEJMoa2113017
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. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).