Everyone who received a COVID vaccine should have been informed that they are at risk of more severe disease should they become infected compared to those who were not vaccinated.
This study found that comprehension of that risk is “unlikely to occur” because “the risk is sufficiently obscured.”
Informed Consent Disclosure To Vaccine Trial Subjects Of Risk Of COVID‐19 Vaccines Worsening Clinical Disease, International Journal of Clinical practice, 4 December 2020
The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.
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.
Wow. This statement. Strong language: “nontheoretical”:
Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses.
But:
Both Moderna and Johnson and Johnson term the risk of vaccine‐elicited disease enhancement as “theoretical.”
More strong language:
Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk to vaccine research subjects that they may experience severe disease once vaccinated, while they might only have experienced a mild, self‐limited disease if not vaccinated.
Do you think people know this? And is this what has been going on in Israel?
In Israel:
“95% of the severe patients are vaccinated”.
“85-90% of the hospitalizations are in Fully vaccinated people.”
“We are opening more and more COVID wards.”
“The effectiveness of the vaccine is waning/fading out”
(Dr. Kobi Haviv, earlier today on Chanel 13 @newsisrael13 )