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Disclosure to vaccine trial subjects of specific risk of COVID-19 vaccines worsening clinical disease in informed consents
  • Timothy Cardozo,
  • Ronald Veazey
Timothy Cardozo
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Ronald Veazey
Tulane University School of Medicine
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Abstract

Aims of the study Patient comprehension is a critical part of meeting standards of informed consent in study designs. The aim of the study was to determine if extant literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Methods used to conduct the study Published literature was reviewed to identify extant preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Results of the study Based on the history of coronavirus vaccine development, COVID-19 vaccines designed to elicit neutralizing antibodies may sensitize vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralizing 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) of either infection or disease. Conclusions drawn from the study and clinical implications The specific and significant COVID-19 risk of ADE should have been and should be clearly and emphatically disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension.

Peer review status:Published

03 Sep 2020Submitted to International Journal of Clinical Practice
05 Sep 2020Submission Checks Completed
05 Sep 2020Assigned to Editor
11 Sep 2020Reviewer(s) Assigned
19 Sep 2020Review(s) Completed, Editorial Evaluation Pending
02 Oct 20201st Revision Received
08 Oct 2020Submission Checks Completed
08 Oct 2020Assigned to Editor
08 Oct 2020Reviewer(s) Assigned
19 Oct 2020Review(s) Completed, Editorial Evaluation Pending
21 Oct 2020Editorial Decision: Accept
28 Oct 2020Published in International Journal of Clinical Practice. 10.1111/ijcp.13795