Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

作者：PT Heath, EP Galiza, DN Baxter, M Boffito, D Browne, F Burns, DR Chadwick, R Clark, C Cosgrove, J Galloway, AL Goodman, A Heer, A Higham, S Iyengar, A Jamal, C Jeanes, PA Kalra, C Kyriakidou, DF; id_orcid 0000-0002-3283-1947 McAuley, A Meyrick, AM Minassian, J Minton, P Moore, I Munsoor, H Nicholls, O Osanlou, J Packham, CH Pretswell, A San Francisco Ramos, D Saralaya, RP Sheridan, R Smith, Rl Soiza, PA Swift, EC Thomson, J Turner, ME Viljoen, G Albert, I Cho, F Dubovsky, G Glenn, J Rivers, A Robertson, K Smith, S Toback · 发表于：UCL Discovery (University College London) · 年份：2021 · 被引用次数：664 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Retinal and Optic Conditions

BACKGROUND: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. \n \nMETHODS: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. \n \nRESULTS: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94....