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, Anna L Goodman, Amardeep Heer, Andrew Higham, Shalini Iyengar, Christopher Jeanes, Philip A Kalra, Christina Kyriakidou, Judy M Bradley, Chigomezgo Munthali, Angela M MinassianFiona 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, Jeremy Turner, Marianne Elizabeth Viljoen, Louis Fries, Iksung Cho, Irene McKnight, Greg Glenn, E Joy Rivers, Andreana Robertson, Katia Alves, Kathy Smith, Seth Toback

Research output: Contribution to journalArticlepeer-review

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Abstract

BACKGROUND: The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against 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 two 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 seroconverted to immunoglobulin G (IgG) against the nucleocapsid protein and did not meet criteria for symptomatic COVID-19 were classified as having asymptomatic disease. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses.

RESULTS: Of 15185 participants, 13989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5 months) 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% CI: 73.3-88.8). Vaccine efficacy was 100% (17.9-100.0) against severe disease and 76.3% (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 two-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 dose may be indicated.

Original languageEnglish
Pages (from-to)398-407
Number of pages10
JournalClinical Infectious Diseases
Volume76
Issue number3
Early online date10 Oct 2022
DOIs
Publication statusPublished - 1 Feb 2023

Bibliographical note

Acknowledgements
The study and article were funded by Novavax. We would like to thank all the study participants for their commitment to this study. We also acknowledge the investigators and their study teams for their hard work and dedication. In addition, we would like to thank the National Institute for Health Research, representatives from the Department of Health and Social Care laboratories and
NHS Digital and the members of the UK Vaccine Task Force. Editorial support was provided by Kelly Cameron of Ashfield MedComms, an Inizio company

Funding
This work was funded by Novavax, and the sponsor had primary responsibility for study design, study vaccines, protocol development, study monitoring, data management, and statistical analyses. All authors reviewed and approved the manuscript before submission. LF reports a position as a prior full-time employee, now contractor to Novavax re-imbursed hourly for work performed on this study and in analyses and drafting this report. IC reports providing medical writing support for this work as an employee of Novavax

Keywords

  • CoVID-19
  • Immunogenicity
  • Asymptomatic Infections
  • SARS-CoV-2
  • Vaccine efficacy

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