patrick.net

Vaccine-elicited enhancement of disease was also observed with the SARS and MERS viruses and with fe- line coronavirus, which are closely related to SARS-CoV-2, the caus- ative pathogen of COVID-19 disease. ...

The prior evidence that vaccine-elicited, antibody-de- pendent enhancement (ADE) of disease is likely to occur to some degree with COVID-19 vaccines is vertically consistent from con- trolled SARS studies in primates to clinical observations in SARS and COVID-19. Thus, a finite, non-theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS-CoV-2 viral spike and eliciting anti-SARS-CoV-2 antibod- ies, be they neutralising or not, place vaccinees at higher risk for more severe COVID-19 disease when they encounter circulating viruses. Indeed, studies in mice of prior SARS vaccines revealed this exact phenotype, with four human vaccine candidates elic- iting neutralising antibodies and protecting against SARS chal- lenge, but viral re-challenge of thus vaccinated animals resulting in immunopathologic lung disease.5 ...

Given the strong evidence that ADE is a non-theoretical and com-
pelling 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 on- going COVID-19 vaccine trials does not appear to meet this standard. While the COVID-19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an accelera- tion is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID-19 vaccine risks.