@bubu12
Results of the study
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, 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 neutralising
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).
This risk is sufficiently obscured
in clinical trial protocols and consent forms for ongoing COVID-19
vaccine trials that adequate patient comprehension of this risk is
unlikely to occur, obviating truly informed consent by subjects in these
trials.
Conclusions drawn from the study and clinical implications :
The specific and significant COVID-19 risk of ADE should have been
and should be prominently and independently 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 for informed
consent.