Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical diseaseRead Now
Upfront - The article below is well researched, well written and points out legal issues, related to Covid-19 vaccination. Many people don`t know, what INFORMED CONSENT means. A simple consent can be, you sign something, and don`t really know, what you just signed. As we are dealing here with a new and untested kind of "vaccination", which isn't a vaccination at all, there need to be INFORMED consent! INFORMED CONSENT is the missing part here!
Article written by Timothy Cardozo and Ronald Veazey
First published: 28 October 2020
DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE)
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.
Please Read HERE the full article! (New Window at https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795/)
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