Author
Baden, Lindsey REl Sahly, Hana M
Essink, Brandon
Kotloff, Karen
Frey, Sharon
Novak, Rick
Diemert, David
Spector, Stephen A
Rouphael, Nadine
Creech, C Buddy
McGettigan, John
Khetan, Shishir
Segall, Nathan
Solis, Joel
Brosz, Adam
Fierro, Carlos
Schwartz, Howard
Neuzil, Kathleen
Corey, Larry
Gilbert, Peter
Janes, Holly
Follmann, Dean
Marovich, Mary
Mascola, John
Polakowski, Laura
Ledgerwood, Julie
Graham, Barney S
Bennett, Hamilton
Pajon, Rolando
Knightly, Conor
Leav, Brett
Deng, Weiping
Zhou, Honghong
Han, Shu
Ivarsson, Melanie
Miller, Jacqueline
Zaks, Tal
Date
2020-12-30Journal
New England Journal of MedicinePublisher
Massachusetts Medical SocietyType
Article
Metadata
Show full item recordAbstract
BACKGROUND Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. METHODS This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. 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 SARS-CoV-2. RESULTS The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. CONCLUSIONS The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.Rights/Terms
Copyright © 2020 Massachusetts Medical Society.Identifier to cite or link to this item
http://hdl.handle.net/10713/14768ae974a485f413a2113503eed53cd6c53
10.1056/NEJMoa2035389
Scopus Count
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