Informed Consent Disclosure to Vaccine Trial Subjects of Risk of COVID-19 Vaccines Worsening Clinical Disease

Timothy Cardozo, Ronald Veazey

COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe dis- ease 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 corona- virus 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.

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