Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial.

Paul T Heath ; Eva P Galiza ; David Neil Baxter ; Marta Boffito ; Duncan Browne ; Fiona Burns ; David R Chadwick ; Rebecca Clark ; Catherine A Cosgrove ; James Galloway ; +35 more... Anna L Goodman ; Amardeep Heer ; Andrew Higham ; Shalini Iyengar ; Christopher Jeanes ; Philip A Kalra ; Christina Kyriakidou ; Judy M Bradley ; Chigomezgo Munthali ; Angela M Minassian ; Fiona McGill ; Patrick Moore ; Imrozia Munsoor ; Helen Nicholls ; Orod Osanlou ; Jonathan Packham ; Carol H Pretswell ; Alberto San Francisco Ramos ; Dinesh Saralaya ; Ray P Sheridan ; Richard Smith ; Roy L Soiza ; Pauline A Swift ; Emma C Thomson ORCID logo ; Jeremy Turner ; Marianne Elizabeth Viljoen ; Louis Fries ; Iksung Cho ; Irene McKnight ; Greg Glenn ; E Joy Rivers ; Andreana Robertson ; Katia Alves ; Kathy Smith ; Seth Toback ; (2023) Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial. Clinical infectious diseases, 76 (3). pp. 398-407. ISSN 1058-4838 DOI: 10.1093/cid/ciac803
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BACKGROUND: 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. METHODS: Adults aged 18-84 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. RESULTS: 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%-88.8%). Vaccine efficacy was 100% (95% CI, 17.9%-100.0%) against severe disease and 76.3% (95% CI, 57.4%-86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein-specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. CONCLUSIONS: A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through >6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated. CLINICAL TRIALS REGISTRATION: EudraCT, 2020-004123-16.


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