Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

  1. Paul T. Heath
  2. Eva P. Galiza
  3. David N. Baxter
  4. Marta Boffito
  5. Duncan Browne
  6. Fiona Burns
  7. David R. Chadwick
  8. Rebecca Clark
  9. Catherine Cosgrove
  10. James Galloway
  11. Anna L. Goodman
  12. Amardeep Heer
  13. Andrew Higham
  14. Shalini Iyengar
  15. Arham Jamal
  16. Christopher Jeanes
  17. Philip A. Kalra
  18. Christina Kyriakidou
  19. Daniel F. McAuley
  20. Agnieszka Meyrick
  21. Angela M. Minassian
  22. Jane Minton
  23. Patrick Moore
  24. Imrozia Munsoor
  25. Helen Nicholls
  26. Orod Osanlou
  27. Jonathan Packham
  28. Carol H. Pretswell
  29. Alberto San Francisco Ramos
  30. Dinesh Saralaya
  31. Ray P. Sheridan
  32. Richard Smith
  33. Roy L. Soiza
  34. Pauline A. Swift
  35. Emma C. Thomson
  36. Jeremy Turner
  37. Marianne E. Viljoen
  38. Gary Albert
  39. Iksung Cho
  40. Filip Dubovsky
  41. Greg Glenn
  42. Joy Rivers
  43. Andreana Robertson
  44. Kathy Smith
  45. Seth Toback

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Abstract

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  1. Version published to 10.1056/nejmoa2107659
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    SciScore for 10.1101/2021.05.13.21256639: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: All participants provided written informed consent before enrollment in the trial.
    IRB: The trial protocol was approved by the North West—Greater Manchester Central Research Ethics Committee (Ref 20/NW/03/99) and was performed in accordance with the International Council for Harmonisation Good Clinical Practice guidelines (see protocol in the Supplementary Appendix).
    Sex as a biological variableEligible participants were men and non-pregnant women 18 to 84 years old (inclusive) who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (and receiving highly active antiretroviral therapy) and cardiac and respiratory diseases.
    RandomizationTrial Procedures: Participants were randomly assigned in a 1:1 ratio via block randomization to receive two doses of NVX-CoV2373 or placebo (normal saline), 21 days apart, using a centralized Interactive Response Technology system according to pre-generated randomization schedules.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This trial has several limitations. Although approximately 7500 participants received NVX-CoV2373, it is not possible to exclude the occurrence of rare adverse events. Such events may, however, be captured through the ongoing follow-up of participants, which is planned to continue until 12 months after the second dose of vaccine and will also be assessed in the larger PREVENT-19 phase 3 trial.15 Similarly, the efficacy estimates reported here are derived from a relatively short duration of observation (median 3 months after dose 2). The ongoing follow-up will therefore allow determination of the durability of vaccine efficacy, continued assessment of severe cases, and the assessment of efficacy against asymptomatic disease. A further limitation is the lack of sequencing data on study isolates, although the use of S gene target failure, as detected by the Thermo Fisher TaqPath™ assay used in DHS Public Health England has proved to be a good proxy for the B.1.1.7 variants.16 Additionally, a convenience sample of isolates from this study were sequenced by the Covid-19 genomics UK consortium and demonstrated a similar proportion of B.1.1.7 variants as detected by PCR.17 The results of this trial provide further evidence that both prototype and B.1.1.7 Covid-19 can be prevented by immunization, providing the first evidence for a protein-based, adjuvanted vaccine. NVX-CoV2373 can be stored at standard refrigerator temperatures and has the potential to induce a broad epitope respons...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04583995RecruitingA Study Looking at the Effectiveness, Immune Response, and S…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  4. Version published to 10.1101/2021.05.13.21256639 on medRxiv