US Govt Funded Study Shows COVID Vaxx Risks Not Adequately Disclosed
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U.S. Government-Funded Study Concludes Risks Of COVID-19 Vaccines Not Being Adequately Disclosed
Published by Paul Anthony Taylor at March 12, 2021
A recent study published in the International Journal of Clinical Practice examines whether sufficient literature exists to require clinicians to disclose the risk that receiving COVID-19 vaccines could sensitize people to more severe viral disease than if they were not vaccinated. Finding that adequate communication of this risk is unlikely to occur, the authors say it should be prominently disclosed to people taking part in COVID-19 vaccine trials as well as those vaccinated following regulatory approval. The study concludes that a specific, separate, informed consent form and demonstration of patient understanding of this risk is necessary in order to meet medical ethics standards.
Funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID), an organization that is part of the U.S. government’s National Institutes of Health, the study reviewed published literature to identify evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. The authors examined clinical trial protocols for COVID-19 vaccines to determine if the risks were properly disclosed to participants.
The study found that vaccines designed to elicit neutralizing antibodies against COVID-19 may sensitize their recipients to more severe disease than if they were not vaccinated. Pointing out that vaccines previously developed for other coronavirus diseases such as Severe Acute Respiratory Syndrome ( SARS) had failed to be approved, the authors describe how data suggest current vaccines may worsen COVID-19 via a phenomenon known as ‘antibody-dependent enhancement’ (ADE). This occurs when antibodies generated during an immune response unexpectedly and paradoxically enhance the entry of a virus into cells, and in some cases also its replication. The study authors describe this as a “serious mechanistic concern.”
The study states there is strong evidence that ADE is a “non-theoretical and compelling risk for COVID-19 vaccines” and that this risk is “obscured” in clinical trial protocols and participant consent forms. The result, the authors explain, is that patients are unlikely to understand the risk of accepting such vaccines, thus meaning that truly informed consent cannot be said to have been obtained.