Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

摘要: Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and protect persons who at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based that encodes the prefusion stabilized full-length spike protein of severe acute respiratory syndrome 2 (SARS-CoV-2), virus causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted 99 centers across United States. Persons SARS-CoV-2 infection or its complications were randomly assigned in 1:1 ratio receive two intramuscular injections (100 μg) placebo 28 days apart. primary end point prevention Covid-19 illness with onset least 14 after second injection participants had not previously been infected SARS-CoV-2. Results enrolled 30,420 volunteers either (15,210 each group). More than 96% received both injections, 2.2% evidence (serologic, virologic, both) baseline. Symptomatic confirmed 185 group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 65.3) 11 (3.3 CI, 1.7 6.0); efficacy 94.1% (95% 89.3 96.8%; P Conclusions showed preventing illness, including disease. Aside from transient local systemic reactions, no safety concerns identified. (Funded by Biomedical Advanced Research Development Authority National Institute Allergy Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).