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Perspective

Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

School of Public Health and Health Systems, University of Waterloo, Waterloo, ON N2L3G1, Canada
Academic Editor: Edgaras Stankevičius
Medicina 2021, 57(3), 199; https://doi.org/10.3390/medicina57030199
Received: 13 January 2021 / Revised: 15 February 2021 / Accepted: 22 February 2021 / Published: 26 February 2021
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy. View Full-Text
Keywords: mRNA vaccine; COVID-19 vaccine; vaccine efficacy; relative risk reduction; absolute risk reduction; number needed to vaccinate; outcome reporting bias; clinical epidemiology; critical appraisal; evidence-based medicine mRNA vaccine; COVID-19 vaccine; vaccine efficacy; relative risk reduction; absolute risk reduction; number needed to vaccinate; outcome reporting bias; clinical epidemiology; critical appraisal; evidence-based medicine
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MDPI and ACS Style

Brown, R.B. Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials. Medicina 2021, 57, 199. https://doi.org/10.3390/medicina57030199

AMA Style

Brown RB. Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials. Medicina. 2021; 57(3):199. https://doi.org/10.3390/medicina57030199

Chicago/Turabian Style

Brown, Ronald B. 2021. "Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials" Medicina 57, no. 3: 199. https://doi.org/10.3390/medicina57030199

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