Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
onlinelibrary.wiley.com ^ | October 20, 2020 | Ronald Veazy, Timothy Cardozo
Posted on 3/29/2021, 12:01:38 PM by ransomnote
Published literature was reviewed to identify preclinical and clinical evidence that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID‐19 vaccines were reviewed to determine if risks were properly disclosed.
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.
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.
Posted on 3/29/2021, 12:10:23 PM by Red Badger
A Covid Note personal experience.
Recently had appt. with my Dr., who works for major hospital chain here in Fla.
After visit received survey wanting to know how the visit was. Most of the pages were the usual stuff we all see when filling out these surveys, except the last page was 5 questions of getting the Covid “vaccine” with a comment section at the end. Naturally I check all the never boxes relating to the Covid shot. Then in the comment section blasted them about calling an EUA shot a vaccine that was not FDA approved and that no there is no way in He^^ I will get the current available shots. Said it in nice matter of fact manner. Point is even hospitals are pushing these Covid shots. They must be getting payouts for patients receiving Covid “shots” as well as in hospital Covid patients. I had heard that hospitals get up to $50k for Covid patients, wonder what they get paid for administering Covid shots.
A Covid Note personal experience.
Recently had appt. with my Dr., who works for major hospital chain here in Fla.
After visit received survey wanting to know how the visit was. Most of the pages were the usual stuff we all see when filling out these surveys, except the last page was 5 questions of getting the Covid “vaccine” with a comment section at the end. Naturally I check all the never boxes relating to the Covid shot. Then in the comment section blasted them about calling an EUA shot a vaccine that was not FDA approved and that no there is no way in He^^ I will get the current available shots. Said it in nice matter of fact manner. Point is even hospitals are pushing these Covid shots. They must be getting payouts for patients receiving Covid “shots” as well as in hospital Covid patients. I had heard that hospitals get up to $50k for Covid patients, wonder what they get paid for administering Covid shots.
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