Messenger RNA Vaccine Effectiveness Against Coronavirus Disease 2019 Among Symptomatic Outpatients Aged ≥16 Years in the United States, February–May 2021

  1. Sara S Kim
  2. Jessie R Chung
  3. Edward A Belongia
  4. Huong Q McLean
  5. Jennifer P King
  6. Mary Patricia Nowalk
  7. Richard K Zimmerman
  8. Goundappa K Balasubramani
  9. Emily T Martin
  10. Arnold S Monto
  11. Lois E Lamerato
  12. Manjusha Gaglani
  13. Michael E Smith
  14. Kayan M Dunnigan
  15. Michael L Jackson
  16. Lisa A Jackson
  17. Mark W Tenforde
  18. Jennifer R Verani
  19. Miwako Kobayashi
  20. Stephanie J Schrag
  21. Manish M Patel
  22. Brendan Flannery

Reviewed by

Read the full article See related articles

Discuss this preprint

Start a discussion What are Sciety discussions?

Listed in

Log in to save this article

Abstract

Evaluations of vaccine effectiveness (VE) are important to monitor as coronavirus disease 2019 (COVID-19) vaccines are introduced in the general population. Research staff enrolled symptomatic participants seeking outpatient medical care for COVID-19–like illness or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing from a multisite network. VE was evaluated using the test-negative design. Among 236 SARS-CoV-2 nucleic acid amplification test-positive and 576 test-negative participants aged ≥16 years, the VE of messenger RNA vaccines against COVID-19 was 91% (95% confidence interval, 83%–95%) for full vaccination and 75% (55%–87%) for partial vaccination. Vaccination was associated with prevention of most COVID-19 cases among people seeking outpatient medical care.

Article activity feed

  1. Version published to 10.1093/infdis/jiab451
  2. ScreenIT

    SciScore for 10.1101/2021.07.20.21260647: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This activity was reviewed by the institutional review boards of the Centers for Disease Control and Prevention (CDC) and other participating institutions and was conducted consistent with applicable federal law and CDC policy.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    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:
    These results were subject to several limitations. First, because Johnson & Johnson’s Janssen vaccine uptake in the general population was limited during the study period, participants vaccinated with the Janssen vaccine were not included in this analysis. Including the 22 vaccinated participants who received Janssen vaccine (4 in cases, 18 in controls) resulted in similar estimates of VE (Supplemental Table 2). Second, surveillance populations at the study sites are not representative of the U.S. population, and this analysis did not evaluate VE by race and Hispanic ethnicity. Additional evaluation of VE among racial/ethnic groups disproportionately affected by the pandemic and among other specific populations, such persons with underlying health conditions, are needed. Third, because we relied on vaccine documentation to determine vaccination status, we may have missed unrecorded vaccine doses. However, estimates including self-reported doses, without documentation, showed similar VE (Supplemental Table 2). Finally, unmeasured selection bias based on healthcare seeking behaviors and potential for differential participation response is a possible risk in the test-negative design. As of July 1, 2021, 55% of the U.S. population had received at least one dose of a COVID-19 vaccine [14]. A growing number of vaccine effectiveness studies have provided evidence that mRNA vaccines confer similar protection against COVID-19 in real-world conditions as in clinical trials, reducing ri...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    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.

  3. Version published to 10.1101/2021.07.20.21260647 on medRxiv