Heath, PT;
Galiza, EP;
Baxter, DN;
Boffito, M;
Browne, D;
Burns, F;
Chadwick, DR;
Clark, R;
Cosgrove, C;
Galloway, J;
et al.
Heath, PT; Galiza, EP; Baxter, DN; Boffito, M; Browne, D; Burns, F; Chadwick, DR; Clark, R; Cosgrove, C; Galloway, J; Goodman, AL; Heer, A; Higham, A; Iyengar, S; Jamal, A; Jeanes, C; Kalra, PA; Kyriakidou, C; McAuley, DF; Meyrick, A; Minassian, AM; Minton, J; Moore, P; Munsoor, I; Nicholls, H; Osanlou, O; Packham, J; Pretswell, CH; San Francisco Ramos, A; Saralaya, D; Sheridan, RP; Smith, R; Soiza, RL; Swift, PA; Thomson, EC; Turner, J; Viljoen, ME; Albert, G; Cho, I; Dubovsky, F; Glenn, G; Rivers, J; Robertson, A; Smith, K; Toback, S; 2019nCoV-302 Study Group
(2021)
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
N Engl J Med, 385 (13).
pp. 1172-1183.
ISSN 1533-4406
https://doi.org/10.1056/NEJMoa2107659
SGUL Authors: Cosgrove, Catherine San Francisco Ramos, Alberto
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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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Additional Information: |
From New England Journal of Medicine, Heath, PT; Galiza, EP; Baxter, DN; Boffito, M; Browne, D; Burns, F; Chadwick, DR; Clark, R; Cosgrove, C; Galloway, J; et al. , Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine, 385, 1172-1183. Copyright © 2021 Massachusetts Medical Society. Reprinted with permission. |
Keywords: |
2019nCoV-302 Study Group, 11 Medical and Health Sciences, General & Internal Medicine |
SGUL Research Institute / Research Centre: |
Academic Structure > Infection and Immunity Research Institute (INII) |
Journal or Publication Title: |
N Engl J Med |
ISSN: |
1533-4406 |
Language: |
eng |
Dates: |
Date | Event |
---|
23 September 2021 | Published | 30 June 2021 | Published Online |
|
Publisher License: |
Publisher's own licence |
PubMed ID: |
34192426 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/113401 |
Publisher's version: |
https://doi.org/10.1056/NEJMoa2107659 |
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