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THE RISK OF ADE IN COVID-19 VACCINES IS NON-THEORETICAL AND COMPELLING

Vaccine-elicited enhancement of disease was previously observed in human subjects with vaccines for respiratory syncytial virus (RSV), dengue virus and measles.1 Vaccine-elicited enhancement of disease was also observed with the SARS and MERS viruses and with feline coronavirus, which are closely related to SARS-CoV-2, the causative pathogen of COVID-19 disease. ...

Given the strong evidence that ADE is a non-theoretical and compelling risk for COVID-19 vaccines and the “laundry list” nature of informed consents, disclosure of the specific risk of worsened COVID-19 disease from vaccination calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards. The informed consent process for ongoing COVID-19 vaccine trials does not appear to meet this standard.