Uninformed Consent: Do Subjects Need Warning that a COVID-19 Vaccine Can Worsen Disease?

On October 28, the International Journal of Clinical Practice published, “Informed consent disclosure to vaccine trial subjects of risk of COVID?19 vaccines worsening clinical disease.” The authors of this perspective piece are NYU Grossman School of Medicine molecular pharmacologist Timothy Cardozo and Tulane University primate disease expert Ronald Veazey. Noting that “patient comprehension” is a key element of meeting ethical standard for informed consent, the authors sought to see if the extent literature leads to a requirement that clinicians, “disclose the specific risk that COVID?19 vaccines could worsen disease upon exposure to challenge or circulating virus.” To conduct the review, published literature was examined for preclinical or clinical evidence that a COVID-19 vaccine might worsen the disease when subjects get exposed to the virus in the community or in a clinical challenge. The clinical trial protocols for vaccines were analyzed to see if such, “risks were properly disclosed.”


