Disclosure to vaccine trial subjects of specific risk of COVID-19
vaccines worsening clinical disease in informed consents
Abstract
Aims of the study Patient comprehension is a critical part of meeting
standards of informed consent in study designs. The aim of the study was
to determine if extant literature exists to require clinicians to
disclose the specific risk that COVID-19 vaccines could worsen disease
upon exposure to challenge or circulating virus. Methods used to conduct
the study Published literature was reviewed to identify extant
preclinical and clinical evidence that COVID-19 vaccines could worsen
disease upon exposure to challenge or circulating virus. Results of the
study Based on the history of coronavirus vaccine development, COVID-19
vaccines designed to elicit neutralizing antibodies may sensitize
vaccine recipients to more severe disease than if they were not
vaccinated. Vaccines for SARS, MERS and RSV have never been approved,
and the data generated in the development and testing of these vaccines
suggest a serious mechanistic concern: that vaccines designed
empirically using the traditional approach (consisting of the unmodified
or minimally modified coronavirus viral spike to elicit neutralizing
antibodies), be they composed of protein, viral vector, DNA or RNA and
irrespective of delivery method, may worsen COVID-19 disease via
antibody-dependent enhancement (ADE) of either infection or disease.
Conclusions drawn from the study and clinical implications The specific
and significant COVID-19 risk of ADE should have been and should be
clearly and emphatically disclosed to research subjects currently in
vaccine trials, as well as those being recruited for the trials and
future patients after vaccine approval, in order to meet the medical
ethics standard of patient comprehension.