{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T12:32:11Z","timestamp":1793709131838,"version":"4.6.1"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2022,10,10]],"date-time":"2022-10-10T00:00:00Z","timestamp":1665360000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014101","name":"Novavax","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014101","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,2,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adults aged 18\u201384 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%\u201388.8%). Vaccine efficacy was 100% (95% CI, 17.9%\u2013100.0%) against severe disease and 76.3% (95% CI, 57.4%\u201386.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein\u2013specific induction of interferon-\u03b3 secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through &amp;gt;6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>EudraCT, 2020-004123-16.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciac803","type":"journal-article","created":{"date-parts":[[2022,10,10]],"date-time":"2022-10-10T11:53:34Z","timestamp":1665402814000},"page":"398-407","source":"Crossref","is-referenced-by-count":68,"title":["Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial"],"prefix":"10.1093","volume":"76","author":[{"given":"Paul T","family":"Heath","sequence":"first","affiliation":[{"name":"Vaccine Institute and Paediatric Infectious Disease Research Group, St. George's, University of London and St. George's University Hospitals National Health Service Foundation Trust , London , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva P","family":"Galiza","sequence":"additional","affiliation":[{"name":"Vaccine Institute, St. George's, University of London and St. George's University Hospitals National Health Service Foundation Trust , London , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Neil","family":"Baxter","sequence":"additional","affiliation":[{"name":"Medical Education, Stockport National Health Service Foundation Trust, Stepping Hill Hospital , Poplar Grove, Stockport , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Boffito","sequence":"additional","affiliation":[{"name":"Chelsea and Westminster Hospital National Health Service Foundation Trust and Faculty of Medicine, Imperial College London , London , United 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