Given that governments around the world are launching their COVID_19 vaccination programs, an article that appeared in the Intonations Journal of Clinical Practice is particularly pertinent. The Perspective written by Timothy Cardozo and Ronald Veazey entitled "Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease" provides us with some very interesting background given that the current crop of highly experimental and unprecedented vaccines for the SARS-CoV-2 virus are being rolled out at "warp speed"
Here is the aim of the study:
"…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."
The authors reviewed published literature to determine if there was preclinical and clinical evidence for COVID-19 vaccines worsening disease and also looked at clinical trial protocols for COVID-19 vaccines to see if risks were properly disclosed to test subjects.
The authors open by noting that vaccine-elicited enhancement of disease was previously observed in humans with vaccines for respiratory syncytial virus (RSV), measles and Dengue virus. As well, vaccine-elicited enhancement/antibody dependent enhancement (ADE) was also observed with the experimental vaccines for SARS and MERS viruses, both of which are closely related to the current SARS-CoV-2 virus. Here is an article from the National Institutes of Health website that provides a clear example of vaccine-elicited (vaccine-induced) enhancement of lentiviruses, HIV/AIDS in particular:
In the examples given in this article, vaccines actually increased susceptibility to viral infections rather than protecting the test subject from them. Here is a quote from the conclusion of the study:
"Vaccine-induced enhancement of infection or disease pathogenesis has been a major stumble block in the development of certain flavi-, corona- and paramyxovirus vaccines and also the recent failures in the development of a safe and effective vaccine against HIV can at least in part be attributed to the induction of enhancement rather than the induction of protection towards virus replication by the current vaccine candidates. There may well be a delicate balance between these two outcomes and the final result of vaccination is most likely determined by the sum of these parameters. Other confounding factors that may be involved include type of candidate vaccine used, viral and/or host factors, co-infections and time after vaccination. Research specifically aimed at the identification of the mechanisms that lead to either protection or enhancement would greatly stimulate our ability to design safe and effective vaccines against lentivirus infections, and more specifically an HIV vaccine."
Let's go back to the Perspective by Cardozo and Veazey. Here is a quote with my bolds:
"A recent study revealed IgG‐mediated (Immunoglobulin G – the most common antibody in the human body, responsible for protecting against bacterial and viral infections) acute lung injury in vivo in macaques infected with SARS that correlated with a vaccine‐elicited, neutralising antibody response. Inflammation and tissue damage in the lung in this animal model recapitulated the inflammation and tissue damage in the lungs of SARS‐infected patients who succumbed to the disease. The time course was also similar, with the worst damage occurring in delayed fashion in synchrony with ramping up of the immune response. Remarkably, neutralising antibodies controlled the virus in the animal, but then would precipitate a severe, tissue‐damaging, inflammatory response in the lung. This is a similar profile to immune complex‐mediated disease seen with RSV vaccines in the past, wherein vaccinees succumbed to fatal enhanced RSV disease because of the formation of antibody‐virus immune complexes that precipitated harmful, inflammatory immune responses. It is also similar to the clinical course of COVID‐19 patients, in whom severe COVID‐19 disease is associated with the development of anti‐SARS‐CoV‐2 serum antibodies, with titres correlating directly with the severity of disease. Conversely, subjects who recover quickly may have low or no anti‐SARS‐CoV‐2 serum antibodies."
Most of the research into COVID-19 vaccines has the goal of eliciting neutralizing antibodies. Prior evidence (as noted above) shows that vaccine-elicited antibody-dependent enhancement or ADE is likely to occur in some degree with COVID-19 vaccines. Here's what the authors say:
"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."
While the current data for COVID-19 vaccines is limited to the past few months at best, at this point, it does not appear to reveal evidence of antibody-dependent enhancement. That said, it is quite possible that the test subjects had not encountered the "wild" circulating SARS-CoV-2 virus and it is also important to note that the studies were not designed to capture exposure of individuals to the circulating virus after vaccination, the point where antibody-dependent enhancement is likely to occur. In addition, while most preclinical studies have been performed using the Wuhan or closely related strains of the novel coronavirus, the most prevalent circulating form has mutated into a different form termed the D614G virus.
The authors go on to note that consent forms for the three leading vaccine contenders list the risk of vaccine-induced enhancement either last or second to last in the list of risks to vaccine test subjects with Moderna and Johnson & Johnson terming the risk of vaccine-elicited disease enhancement as "theoretical". In their consent forms, Pfizer and Moderna do note that there is evidence for vaccine-elicited disease enhancement in both RSV and Dengue virus diseases but d not mention the issues with vaccines for SARS and MERS, two viruses that are closely related to the SARS-CoV-2 virus.
Now, let's look at what Pfizer has to say about the risk of vaccine-induced enhancement in its Briefing Document supplied to the United States Food and Drug Administration as part of its request for an Emergency Use Authorization:
Note that this risk warning falls right at the very end of the Benefit/Risk Assessment.
Let's look at the authors' conclusions remembering that they are focussing on informed consent for vaccine trial participants:
"Given the strong evidence that ADE is a non‐theoretical and compelling risk for COVID‐19 vaccines and the “laundry list” nature of informed consents, disclosure of the specific risk of worsened COVID‐19 disease from vaccination calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards. The informed consent process for ongoing COVID‐19 vaccine trials does not appear to meet this standard. While the COVID‐19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an acceleration is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID‐19 vaccine risks."
As though the possibility of vaccine-induced enhancement is not serious enough, recent research at the University of Pennsylvania by Paul Axelson et al shows that the mutated form of the SARS-CoV-2 virus may retain the ability to evade recognition by antibodies that arise in response to both the wild virus and the antibodies created by a vaccine. Here is a quote:
"Therefore, it also seems likely that reinfection with a variant strain of SARS-CoV-2 may occur among people who recover from Covid-19, and that vaccines with the ability to generate antibodies against multiple variant forms of the spike protein will be necessary to protect against variant forms of SARS-CoV-2 that are already circulating in the human population."
If this is the case, it pretty much renders the current form of vaccines less than effective.
Given that most vaccines take up to ten years to receive government approval, the unprecedented rush to get an unprecedented vaccine into the arms of humanity is immoral, particularly given that one of the most serious side effects, vaccine-induced enhancement, is a complete unknown. Apparently, according to our political masters, our "informed consent" for the COVID-19 vaccines is completely unnecessary. We should just roll up our sleeves and take the vaccine "like a man", vaccine-induced enhancement be damned.
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