BACKGROUNDEarly clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recom-binant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) that contains the full-length spike glycoprotein of the prototypestrain plus Matrix-M adjuvant, showed that the vaccine was safe and associatedwith a robust immune response in healthy adult participants. Additional data wereneeded regarding the efficacy, immunogenicity, and safety of this vaccine in alarger population.METHODSIn this phase 3, randomized, observer-blinded, placebo-controlled trial conductedat 33 sites in the United Kingdom, we assigned adults between the ages of 18 and84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373or placebo administered 21 days apart. The primary efficacy end point was viro-logically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onsetat least 7 days after the second injection in participants who were serologicallynegative at baseline.RESULTSA total of 15,187 participants underwent randomization, and 14,039 were includedin the per-protocol efficacy population. Of the participants, 27.9% were 65 yearsof age or older, and 44.6% had coexisting illnesses. Infections were reported in 10participants in the vaccine group and in 96 in the placebo group, with a symptomonset of at least 7 days after the second injection, for a vaccine efficacy of 89.7%(95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths werereported among the 10 cases in the vaccine group. Five cases of severe infectionwere reported, all of which were in the placebo group. A post hoc analysis showedan efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variantand 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity wasgenerally mild and transient. The incidence of serious adverse events was low andsimilar in the two groups.CONCLUSIONSA two-dose regimen of the NVX-CoV2373 vaccine administered to adult participantsconferred 89.7% protection against SARS-CoV-2 infection and showed high efficacyagainst the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020 - 004123 - 16.)

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine PDF

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