Evidence map›Paper›PMID 36210481›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

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 and 35 more

Open access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 4 pooled it
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Analysis of Antibody Markers as Immune Correlates of Risk of Severe COVID-19 in the PREVENT-19 Efficacy Trial of the NVX-CoV2373 Recombinant Protein Vaccine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  11. Article
  12. Article
  13. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  14. Article
  15. Promising Vaccine Formulations for Emerging Infectious Diseases.International journal of molecular sciences · 2025
    Review
  16. Review
  17. SARS-CoV-2 Vaccines and Multiple Sclerosis: An Update.Neurology(R) neuroimmunology & neuroinflammation · 2025
    Review
  18. Review
  19. Article
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

45 authors at 20 institutions in 2 countries.

Paul T HeathVaccine 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.
Eva P GalizaVaccine Institute, St. George's, University of London and St. George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.
David Neil BaxterMedical Education, Stockport National Health Service Foundation Trust, Stepping Hill Hospital, Poplar Grove, Stockport, United Kingdom.
Marta BoffitoChelsea and Westminster Hospital National Health Service Foundation Trust and Faculty of Medicine, Imperial College London, London, United Kingdom.
Duncan BrowneEndocrinology/Diabetes/General Medicine, Royal Cornwall Hospitals National Health Service Trust, Truro, United Kingdom.
Fiona BurnsFaculty of Population Health Sciences, Institute for Global Health, University College London, and Royal Free London National Health Service Foundation Trust, London, United Kingdom.
David R ChadwickCentre for Clinical Infection, South Tees Hospitals National Health Service Foundation Trust, James Cook University Hospital, Middlesbrough, United Kingdom.
Rebecca ClarkLayton Medical Centre, Blackpool, United Kingdom.
Catherine A CosgroveVaccine Institute, St. George's, University of London and St. George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.
James GallowayCentre for Rheumatic Disease, Kings College London, London, United Kingdom.
Anna L GoodmanDepartment of Infectious Diseases, Guy's and St Thomas' National Health Service Foundation Trust, and Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom.
Amardeep HeerLakeside Healthcare Research, Lakeside Surgeries Corby, Northants, United Kingdom.
Andrew HighamGastrointestinal and Liver Services, University Hospitals of Morecambe Bay National Health Service Foundation Trust, Kendal, United Kingdom.
Shalini IyengarAccelerated Enrollment Solutions, Synexus Hexham Dedicated Research Site, Hexham General Hospital, Hexham, United Kingdom.
Christopher JeanesDepartment of Microbiology, Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, Norfolk, United Kingdom.
Philip A KalraNephrology, Salford Royal Hospital, Northern Care Alliance National Health Service Foundation Trust, Salford, United Kingdom.
Christina KyriakidouAccelerated Enrollment Solutions, Synexus Midlands Dedicated Research Site, Birmingham Research Park, Birmingham, United Kingdom.
Judy M BradleyDentistry and Biomedical Sciences, School of Medicine, Wellcome-Wolfson Institute for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland, United Kingdom.
Chigomezgo MunthaliAccelerated Enrollment Solutions, Synexus Merseyside Dedicated Research Site, Burlington House, Waterloo, Liverpool, United Kingdom.
Angela M MinassianCentre for Clinical Vaccinology and Tropical Medicine, University of Oxford, and Oxford Health National Health Service Foundation Trust, Warneford Hospital, Oxford, United Kingdom.
Fiona McGillMicrobiology, Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.
Patrick MooreThe Adam Practice, Poole, Dorset, United Kingdom.
Imrozia MunsoorAccelerated Enrollment Solutions, Synexus Glasgow Dedicated Research Site, Venture Building, Kelvin Campus, Glasgow, Scotland, United Kingdom.
Helen NichollsAccelerated Enrollment Solutions, Synexus Wales Dedicated Research Site, Riverside Court Gwaelod-y-Garth, Cardiff, Wales, United Kingdom.
Orod OsanlouSchool of Medical Sciences (Pharmacology/Pharmacy), Bangor University, and Clinical Pharmacology and Therapeutics/General Internal Medicine, Betsi Cadwaladr University Health Board, Wales, United Kingdom.
Jonathan PackhamAcademic Unit of Population and Lifespan Sciences, University of Nottingham, Nottingham, United Kingdom.
Carol H PretswellAccelerated Enrollment Solutions, Synexus Lancashire Dedicated Research Site, Matrix Park Buckshaw Village, Chorley, Lancashire, United Kingdom.
Alberto San Francisco RamosVaccine Institute, St. George's, University of London and St. George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.
Dinesh SaralayaNational Institute for Health Research Patient Recruitment Centre and Bradford Teaching Hospitals National Health Service Foundation Trust, Bradford, United Kingdom.
Ray P SheridanGeriatric Medicine, Royal Devon & Exeter Hospital, Exeter, Devon, United Kingdom.
Richard SmithNephrology, East Suffolk and North Essex National Health Service Foundation Trust and University of Essex, Wivenhoe Park, Colchester, Essex, United Kingdom.
Roy L SoizaAberdeen Royal Infirmary and Ageing Clinical and Experimental Research Group, University of Aberdeen, Aberdeen, Scotland, United Kingdom.
Pauline A SwiftRenal Services, Epsom and St Helier University Hospitals National Health Service Trust, London, United Kingdom.
Emma C ThomsonSchool of Infection & Immunity, Medical Research Council-University of Glasgow Centre for Virus Research, and Queen Elizabeth University Hospital, National Health Service Greater Glasgow & Clyde, Glasgow, Scotland, United Kingdom.
Jeremy TurnerDiabetes and Endocrinology, Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, Norfolk, United Kingdom.
Marianne Elizabeth ViljoenAccelerated Enrollment Solutions, Synexus Manchester Dedicated Research Site, Kilburn House, Manchester, United Kingdom.
Louis FriesClinical Immunology, Novavax, Inc, Gaithersburg, Maryland, USA.
Iksung ChoBiostatistics, Novavax, Inc, Gaithersburg, Maryland, USA.
Irene McKnightMedical Writing, Novavax, Inc, Gaithersburg, Maryland, USA.
Greg GlennDiscovery, Novavax, Inc, Gaithersburg, Maryland, USA.
E Joy RiversClinical Development, Novavax, Inc, Gaithersburg, Maryland, USA.
Andreana RobertsonBiostatistics, Novavax, Inc, Gaithersburg, Maryland, USA.
Katia AlvesClinical Development, Novavax, Inc, Gaithersburg, Maryland, USA.
Kathy SmithGlobal Vaccine Safety, Novavax, Inc, Gaithersburg, Maryland, USA.
Seth TobackMedical Affairs, Novavax, Inc, Gaithersburg, Maryland, USA.
Novavax (United States) · USNational Health Service · GBSynexus (United Kingdom) · GBSt George's, University of London · GBUniversity College London · GBBangor University · GBBradford Teaching Hospitals NHS Foundation Trust · GBEast Suffolk and North Essex NHS Foundation Trust · GBHexham General Hospital · GBImperial College London · GBJames Cook University Hospital · GBKing's College London · GBNorfolk and Norwich University Hospitals NHS Foundation Trust · GBQueen's University Belfast · GBRoyal Devon and Exeter Hospital · GBSalford Royal Hospital · GBStepping Hill Hospital · GBUniversity Hospitals of Morecambe Bay NHS Foundation Trust · GBUniversity of Aberdeen · GBUniversity of Glasgow · GB

Funding

Medical Research Council MC_PC_19026Medical Research Council MC_UU_00004/04Medical Research Council MC_UU_00034/6
6 · The paper itself

Abstract

backgroundThe 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.

methodsAdults 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.

resultsOf 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.

conclusionsA 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.

Indexed as

COVID-19COVID-19 VaccinesAdultAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineImmunoglobulin GSARS-CoV-2Vaccines, SyntheticAntibodies, ViralCOVID-19 VaccinesImmunoglobulin GNVX-CoV2373 adjuvated lipid nanoparticleVaccines, Syntheticasymptomatic infectionCOVID-19immunogenicitySARS-CoV-2vaccine efficacy

Identifiers

PMID36210481
PMCPMC9619635
OpenAlexW4303982806

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.