Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

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Int J Clin Pract -  2021 Mar

Abstract

Methods used to conduct the study: 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.

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.

© 2020 John Wiley & Sons Ltd.

Conflict of interest statement

The authors have declared no conflicts of interest for this article.

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References

  1. Huisman W, Martina BE, Rimmelzwaan GF, Gruters RA, Osterhaus AD. Vaccine‐induced enhancement of viral infections. Vaccine. 2009;27:505‐512. - PMC - PubMed
  2. Boyoglu‐Barnum S, Chirkova T, Anderson LJ. Biology of infection and disease pathogenesis to guide RSV vaccine development. Front Immunol. 2019;10:1675. - PMC - PubMed
  3. Chen WH, Hotez PJ, Bottazzi ME. Potential for developing a SARS‐CoV receptor‐binding domain (RBD) recombinant protein as a heterologous human vaccine against coronavirus infectious disease (COVID)‐19. Human Vacc Immunother. 2020;16:1239‐1242. - PMC - PubMed
  4. Jiang S, He Y, Liu S. SARS vaccine development. Emerg Infect Dis. 2005;11:1016‐1020. - PMC - PubMed
  5. Tseng CT, Sbrana E, Iwata‐Yoshikawa N, et al. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012;7:e35421. - PMC - PubMedShow all 20 references

MeSH terms

  • COVID-19 Vaccines*
  • COVID-19*
  • Disclosure
  • Humans
  • Informed Consent
  • SARS-CoV-2

Substances

  • COVID-19 Vaccines

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Covid virus mutated 40 times in woman who acted as a 'gym' for deadly disease.  3 AUGUST 2021

GERMS DEBUNK CORONA
The truth about ALL germs and the history of germ theory. Viruses aren't the only mythical unicorns out there. - First published at 10:54 UTC on June 19th, 2021.  (video)

The Vaccine Causes The Virus To Be More Dangerous

Bannons War Room Published July 28, 2021

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Copy & Paste the link above for Yandex translation to Norwegian.

WHO and WHAT is behind it all ? : >

The bottom line is for the people to regain their original, moral principles, which have intentionally been watered out over the past generations by our press, TV, and other media owned by the Illuminati/Bilderberger Group, corrupting our morals by making misbehavior acceptable to our society. Only in this way shall we conquer this oncoming wave of evil.

Commentary:

There is a great danger in enhancing/modifying a virus. Giving it free reins is like playing Russian roulette to modify itself without limits.  The live test specified on the dying Russian woman above where the virus had changed 40 times where it also seemed to behave in an intelligent way to avoid detection by our defense system.  There is a great danger in playing around with virus creations which might get totally out of hand and subject the world to deadly pandemoniums.

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