Heath, Paul T; Galiza, Eva P; Baxter, David N; Boffito, Marta; Browne, Duncan; Burns, Fiona; Chadwick, David R; Clark, Rebecca; Cosgrove, Catherine; Galloway, James; +36 more... Goodman, Anna L; Heer, Amardeep; Higham, Andrew; Iyengar, Shalini; Jamal, Arham; Jeanes, Christopher; Kalra, Philip A; Kyriakidou, Christina; McAuley, Daniel F; Meyrick, Agnieszka; Minassian, Angela M; Minton, Jane; Moore, Patrick; Munsoor, Imrozia; Nicholls, Helen; Osanlou, Orod; Packham, Jonathan; Pretswell, Carol H; San Francisco Ramos, Alberto; Saralaya, Dinesh; Sheridan, Ray P; Smith, Richard; Soiza, Roy L; Swift, Pauline A; Thomson, Emma C; Turner, Jeremy; Viljoen, Marianne E; Albert, Gary; Cho, Iksung; Dubovsky, Filip; Glenn, Greg; Rivers, Joy; Robertson, Andreana; Smith, Kathy; Toback, Seth; 2019nCoV-302 Study Group; (2021) Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. The New England journal of medicine, 385 (13). pp. 1172-1183. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa2107659
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Abstract
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. METHODS: 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. RESULTS: 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 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. CONCLUSIONS: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).
Item Type | Article |
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Faculty and Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
Research Centre | Covid-19 Research |
PubMed ID | 34192426 |
Elements ID | 166296 |