Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease

… COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated

… Vaccines for SARS, MERS and RSV have never been approved

… be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease

… This risk is sufficiently obscured in clinical trial protocols and consent forms

… the worst damage occurring in delayed fashion in synchrony with ramping up of the immune response

… neutralising antibodies controlled the virus in the animal, but then would precipitate a severe, tissue‐damaging, inflammatory response in the lung

… anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses

… An unknown variable is how long this tissue damage lasts, possibly resulting in permanent morbidity (eg, diabetes from pancreatic damage)

… Phase 1 and 2 clinical trials of vaccine candidates have only been designed around immunogenicity as an efficacy end point

… mention the risk of disease enhancement by the vaccine, but all three list this risk last or next to last in the list of risks

… Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk

… Given the strong evidence that ADE is a non‐theoretical … calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards