https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795

“3 CONCLUSION

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. While the COVID-19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an acceleration is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID-19 vaccine risks.”