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dc.contributor.authorBaden, Lindsey R
dc.contributor.authorEl Sahly, Hana M
dc.contributor.authorEssink, Brandon
dc.contributor.authorKotloff, Karen
dc.contributor.authorFrey, Sharon
dc.contributor.authorNovak, Rick
dc.contributor.authorDiemert, David
dc.contributor.authorSpector, Stephen A
dc.contributor.authorRouphael, Nadine
dc.contributor.authorCreech, C Buddy
dc.contributor.authorMcGettigan, John
dc.contributor.authorKhetan, Shishir
dc.contributor.authorSegall, Nathan
dc.contributor.authorSolis, Joel
dc.contributor.authorBrosz, Adam
dc.contributor.authorFierro, Carlos
dc.contributor.authorSchwartz, Howard
dc.contributor.authorNeuzil, Kathleen
dc.contributor.authorCorey, Larry
dc.contributor.authorGilbert, Peter
dc.contributor.authorJanes, Holly
dc.contributor.authorFollmann, Dean
dc.contributor.authorMarovich, Mary
dc.contributor.authorMascola, John
dc.contributor.authorPolakowski, Laura
dc.contributor.authorLedgerwood, Julie
dc.contributor.authorGraham, Barney S
dc.contributor.authorBennett, Hamilton
dc.contributor.authorPajon, Rolando
dc.contributor.authorKnightly, Conor
dc.contributor.authorLeav, Brett
dc.contributor.authorDeng, Weiping
dc.contributor.authorZhou, Honghong
dc.contributor.authorHan, Shu
dc.contributor.authorIvarsson, Melanie
dc.contributor.authorMiller, Jacqueline
dc.contributor.authorZaks, Tal
dc.date.accessioned2021-02-26T15:19:03Z
dc.date.available2021-02-26T15:19:03Z
dc.date.issued2020-12-30
dc.identifier.urihttp://hdl.handle.net/10713/14768
dc.description.abstractBACKGROUND 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.en_US
dc.description.urihttps://doi.org/10.1056/NEJMoa2035389en_US
dc.language.isoenen_US
dc.publisherMassachusetts Medical Societyen_US
dc.relation.ispartofNew England Journal of Medicineen_US
dc.rightsCopyright © 2020 Massachusetts Medical Society.en_US
dc.subjectmRNA-1273 vaccineen_US
dc.subject.meshCOVID-19 Vaccinesen_US
dc.subject.meshSARS-CoV-2en_US
dc.subject.meshRNA, Messengeren_US
dc.titleEfficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccineen_US
dc.typeArticleen_US
dc.identifier.doi10.1056/NEJMoa2035389
dc.identifier.pmid33378609
dc.source.volume384
dc.source.issue5
dc.source.beginpage403
dc.source.endpage416
dc.source.countryUnited States


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