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Science Library Abstract
Published: 2020
SYNOPSIS

The risk antibody‐dependent enhancement (ADE) during COVID-19 vaccine trials was sufficiently obscured in clinical trial protocols and consent forms that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

TITLE

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

CITATION

Timothy Cardozo; Ronald Veazy; Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease.  International Journal of Clinical Practice. October 28, 2020; https://doi.org/10.1111/ijcp.13795

SUMMARY

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). 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.

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