ResearchVaccine

Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

CONCLUSION: A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.

Ronald B. Brown
Edgaras Stankevičius, Academic Editor
Medicina (Kaunas). 2021 Mar; 57(3): 199.
Published online 2021 Feb 26. doi: 10.3390/medicina57030199
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