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Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

Journal: Int J Clin Pract.
Lead Author: Cardozo and Veazey
Original date of publication: 03/01/2021
Link: https://pubmed.ncbi.nlm.nih.gov/33113270/

Summary Context

This study outlines how patients could not have received adequate informed consent given the danger of worsening disease due to antibody-dependent enhancement (ADE)

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This article is copyrighted by Health Freedom Defense Fund, Inc.
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This study raised the alarm that informed consent is not adequate given the potential for antibody-dependent enhancement from covid-19 vaccination

Abstract or Results, Key Passages

“vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.”

Keywords: ADEadverse eventsantibody-dependent enhancementcovid vaccinationinformed consentmRNAPfizerside effects
Full Author List: Timothy Cardozo, Ronald Veazey