Informed Consent Disclosure to Vaccine Trial Subjects of Risk of Covid-19 Vaccines Worsening Clinical Disease

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.

Go to the study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/

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