Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

Medicina (Kaunas). 2021 Feb 26;57(3):199. doi: 10.3390/medicina57030199.

Abstract

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.

Keywords: COVID-19 vaccine; absolute risk reduction; clinical epidemiology; critical appraisal; evidence-based medicine; mRNA vaccine; number needed to vaccinate; outcome reporting bias; relative risk reduction; vaccine efficacy.

MeSH terms

  • 2019-nCoV Vaccine mRNA-1273
  • BNT162 Vaccine
  • Bias*
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / therapeutic use*
  • Clinical Trials as Topic / statistics & numerical data*
  • Humans
  • Numbers Needed To Treat / statistics & numerical data*
  • RNA, Viral / drug effects
  • Risk
  • SARS-CoV-2 / drug effects
  • Treatment Outcome

Substances

  • COVID-19 Vaccines
  • RNA, Viral
  • 2019-nCoV Vaccine mRNA-1273
  • BNT162 Vaccine