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[1] Vaccine-associated enhanced disease (VAED) is an immune response to a vaccine that is ‘causally linked’ to a higher risk of adverse outcomes upon infection compared to infection without prior vaccination. (A vaccinated person carries higher risk of suffering from adverse events upon infection)
[2] The only way to assess the safety & efficacy of a vaccine and address the theoretical risk of VAED is in
a. phase 3 efficacy trials with sufficient numbers of endpoints
b. rigorous post-licensure surveillance.
[3] If VAED is frequent or clinically distinctive, the clinical trial participants would experience natural infection with SARS-CoV-2.
