7.5.6 Natural Immunity and Early Treatments Rebuffed to Favour Generalized Vaccination

Introduction

One of the most disturbing aspects of the vaccination strategy debacle was the orchestrated propaganda launched early in the pandemic to undermine the well-established foundation of natural immunity and to denigrate early treatments. Generalized vaccination was sponsored as the unique and ultimate solution for the pandemic. This propaganda was propelled by layers of lies.

We were asked to believe that we were facing a new and exceptionally dangerous virus for which natural immunity would fail to protect us, that no viable treatments existed, and that only new wonder vaccines, developed at “warp speed,“ could save us.

The first issue with this deceptive narrative is that the analysis of all-cause mortality across the world led to the conclusion that a not particularly virulent pathogen was in circulation. The pandemic was declared as a red flag signal for danger with fairly tenuous infection morbidity and fatality case numbers. When one considered the real prevalence of SARS-CoV-2 infection, it had been grossly underestimated, as was typically the case in early days of any pandemic declaration. This was mainly attributable to a vast underestimation of the true infection rate, understandable when infections were often asymptomatic or pauci-symptomatic (presenting few symptoms).

There was no need to contain this new virus by any extraordinary health measures. Normal personal hygiene and well-established public heath protocols targeting the protection of the most vulnerable in an adequately protected environment were sufficient.

Whether the population had much higher preexisting immunity to this new coronavirus than reported or the virus was not as lethal as initially broadcast, conclusions from many studies, even early on, indicated a fatality rate in the same range as severe flu seasons, for which no overall excess deaths are discernible except for the elderly population. But clearly, public health authorities couldn‘t claim, on the one hand, that there was a serious pandemic of global concern and, on the other hand, say, “Don‘t worry. It‘s going to be business as usual. Be prudent, self-isolate when you are sick, and do not panic. Stress is bad for your immune system, which is the best line of defence against any potential infection, or cancer.“

Rather, public health authorities had to be perceived as saviours, in full control of what needed to be done in circumstances they declared as dire, and they did it in unison with the same pre-formatted messages in their fear campaign.

Even if, hypothetically, there was a strong case for vaccination to control a putative deadly virus, we should have acknowledged that for this type of virus in the family of coronaviruses, we have never been able to develop an effective vaccine, either for humans or animals. Typically, the genetic variability of coronaviruses based on RNA genomes confers only partial immunization. We have experienced this firsthand, suffering with recurring colds from the four endemic coronaviruses in the human population. Many expert virologists and vaccinologists knew that, but their voices were either silenced or dismissed.

We were also asked to believe that our scientific and technology progress enabled us to quickly develop a new generation of vaccines based on gene therapy technology that would be safe, effective, and readily produced on a commercial scale.

In reality, the support for these false hopes was on very shaky scientific and technological foundations. Nothing in the proposed gene-based vaccines was going to meaningfully address the shortcomings of natural immunity—for example, the recurrent infections, although of less severity, with variants in the coronavirus family. To make matters worse, the selection of the spike protein as the preferred viral antigen disregarded the known biological toxicity of this protein. Its uncontrolled production throughout the human body led to countless vaccine adverse reactions that became the object of intensive investigations.

Another problem is the known facilitating epitopes in the spike protein. These epitopes were known to likely trigger the production of antibodies that would make the infection worse. Also, the epitopes that were shared with human proteins ended up generating countless autoimmune diseases.

As for the rapid production of the gene therapy vaccines, the process for the adenovirus-based vaccines was fairly well-established by decades of research and clinical trials in gene therapy. However, early on, the adenovirus-based vaccines displayed significant toxicities, leading to their withdrawal in many countries.

By contrast, the mRNA lipid nanoparticle (LNP) vaccines had never been scaled-up, posing a significant challenge for their mass production, which continued to be plagued by many manufacturing issues.

We were also misled to believe that there were no possible treatments, a sine qua non condition to pave the way to the emergency-use authorization (EUA) of vaccines and unproven, patented, poorly tested antivirals, such as remdesivir, that ended up doing more harm than good. We already knew the SARS-CoV-2 virus shared extensive homology with other coronaviruses. Therefore, partial cross-immunity stemming from previous infections with other coronaviruses was likely.

Also, early studies based on generic molecules to treat the closely related SARS-CoV-1 had already established their potential treatment—HCQ, for example—to be effective against SARS-CoV-1 infection. Notably, all countries that made wide use of these generic drugs displayed a much better performance in controlling the COVID-19 pandemic.

This COVID-19 Virus is Novel, Very Dangerous, and Not Treatable

The message hammered home in the media was that there was no preexisting immunity in the population, that everybody was equally susceptible to serious illness and death following infection, and that we should, at all costs, prevent infection and transmission until a vaccine was available to confer protection. All of the NPIs were therefore deployed to control the spread of the virus until we could all get adequately protected by the COVID-19 vaccine.

Consequently, a surreal “COVID-zero“ policy was aggressively promoted in many “democratic“ countries—in the footsteps of the authoritarian CCP policies in China. The policy was promoted by the baseless allegation that this new public health policy would be successful if only we implemented it hard enough.

This fantasy was based on glaring ignorance or, at best, serious confusion of the functioning of the immune system, as well as the poorly understood theory of respiratory virus transmission. The immune system has evolved to respond to an almost infinite number of pathogens and is exquisitely adapted to respond effectively, in the vast majority of the cases, with every first encounter with any pathogen from the moment we are born. The first line of defence for a respiratory virus is the mucosal innate immunity. That eventually builds up a stronger adaptive response once mucosal IgAs (immunoglobulin A) targeting the pathogen help neutralize it.

As for suppressing the transmission of respiratory viruses, nothing short of the strict confinement in a BSL-4 (bio safety lab) laboratory works. That level of confinement, however, is impossible to implement in real-world settings. Most of the NPIs are, at best, delusional.

Furthermore, serological data proved the presence of the SARS-CoV-2 virus as early as the end of summer of 2019 without any clear indication of massive infection, morbidity, and mortality. The virus was running in the population at least nine months before the declaration of the pandemic, and as a result, a significant proportion of the population had already been naturally immunized without significant signs of the COVID-19 disease.

Throughout the pandemic saga, we were deceived countless times by a “scientific consensus“ that was created by silencing dissenting voices questioning the hegemonic narrative. In the absence of healthy debates, a so-called consensus was only an indisputable dogma, and therefore unscientific.

There is, however, a scientific consensus to the effect that for the hundreds of putative pathogens we are exposed to, the immune system, innate and acquired, protect the vast majority of individuals rather well and for a long time. One notable and exceedingly rare exception was HIV infection, which could destroy our immune defences. But this was clearly not the case with SARS-CoV-2 or the other natural coronaviruses. Doubting this scientific consensus was like doubting the law of gravitational force.

Good health is dependent on a strong and resilient natural immune system, referred to as the terrain. It included a healthy microbiota, which plays a crucial role in educating the immune system. The optimal functioning of the natural immune system is empowered by a host of good habits like real food consumption with fibres essential for a healthy microbiota, vitamins and other supplements, sufficient sleep, nourishing social bonds, regular exercise, and stress-reduction practices. It is nothing new for populations that have shown remarkable longevity over the centuries.

Strangely, many of these healthy lifestyle habits were either suppressed or compromised by fiat. Instead, public health focused obsessively on avoiding COVID-19 by controlling transmission of the virus, ignoring the crucial importance of the terrain. This obsessive focus restricted the goal of public health to the avoidance of only one putative pathogen.

The epidemiological data spoke volumes. Heathy individuals were only mildly affected by the SARS-CoV-2 infection, and most infections were asymptomatic.

Given the futility and harmfulness of most NPIs, letting the virus run in the general population of low-risk individuals while protecting the most fragile should have been the preferred approach to build the so-called herd immunity, which was one of the best ramparts for the most vulnerable. That approach was taken in Sweden and many other countries that did not mandate NPIs.

Besides, a host of treatments and vitamins were available for those whose bodies were not strong enough to combat the infection. Sadly, these treatments were disqualified as “useless“ by health authorities in many Western countries, like Canada. Fortunately, they were available for the most vulnerable during the course of the pandemic and were successfully deployed in many poor countries and in a limited number of hubs in Western countries.

New Gene Therapy Vaccines: Better Than Traditional Vaccines?

Knowing that traditional vaccines had failed at providing protection against coronaviruses, hype was generated around a new platform of mRNA genetic vaccines never shown to be successful for any infectious diseases. The promise of these genetic vaccines was, among other things, that they could be manufactured much faster and could therefore be more readily adapted to the ever-evolving variants of SARS-CoV-2 that could escape vaccine-induced immunity.

There are several misconceptions with that premise. Importantly, the promise of the wonder vaccines to end the pandemic was based on three interrelated lies. The first lie was that those so-called vaccines were sterilizing, preventing infection and transmission. This was impossible to begin with, but a well-funded propaganda campaign got the population to believe it. The mantras were incessant: “Nobody is safe until everybody is safe.“ “To be safe, you must be vaccinated to protect yourself and others.“ “This is a pandemic of the unvaccinated.“

Nothing was further from the truth. The selective pressure imposed by these non-sterilizing subunit vaccines was, fostering a selective milieu favourable for the selection of new variants escaping the suboptimal vaccine immunity—constantly promoting the emergence of new variants of concern. From the perspective of the pandemic dynamic, it is more accurate to describe it as a pandemic of the vaccinated.

The second lie was, we were promised that with the prowess of gene therapy technology and fuelled by very large financial resources, we could make available successful vaccine candidates in record time, at “warp speed,“ without compromising the quality and safety of the products. We were told that we should focus primarily on vaccination. Natural immunity was fraudulently portrayed as much less protective.

A third essential lie was the misnaming of gene therapy-based products as vaccines. From a marketing point of view, the most important reasons to mislabel the mRNA gene therapy products as vaccines were (1) to facilitate public acceptance of the products (as traditional vaccines generally benefited from a positive reputation), and (2) to expedite regulatory approval by skipping the tedious and long-term studies of genotoxicity, tumorigenicity and autoimmunogenicity, which are mandatory for gene therapy products.

Thirdly, the mRNA vaccine platform offered the prospect of rapid vaccine production to catch up with the ever-mutating coronavirus variants that escaped immune protection, which had made it so challenging in the past to produce an effective vaccine.

In theory, it looked like a good idea, but in practice, it had several flaws. One was the assumption that mRNA manufacturing was so much faster than the manufacturing of traditional vaccines: new mRNA vaccines for the variant du jour could be made available more readily. However, this would have been a reasonable assumption only if robust current good manufacturing practices (cGMP) were in place for mRNA vaccines, better than for the other vaccine platforms. This was not the case, as was evident by the numerous quality issues with truncated spike mRNA sequences, plasmid DNA contamination, and sourcing of low-toxicity cGMP-grade (good manufacturing practice) lipids for the formulation of the LNPs (lipid nanoparticles).

Many unresolved quality issues were tolerated by regulatory agencies under the pretext of the alleged emergency. The result was batch variations that were far above the acceptable threshold of injectable products. The magnitude of the issues was difficult to formally assess as it had not been opened to systematic, transparent, and independent analysis.

This rapid scheme of vaccine production also required that the relevant “optimal sequence“ for the next vaccine could be identified in a timely fashion. This was, at best, a big gamble with our current knowledge of coronavirus biology and epidemiology. By the time the sequence was selected for mass production and deployed, it was entirely possible that a new dominant variant would be so different that matching the vaccine to the variant in circulation would be suboptimal. It was a futile exercise of chasing a moving target.

Furthermore, this idealized scheme assumed, without documentation, that the new sequence would not affect the overall manufacturing process and safety profile of the new product. This was a leap of faith that was not compliant with a rigorous approval process, at least in the modus operandi of the legacy regulatory agency.

Another crucial issue with the mRNA platform was that neither the dose nor the bio-distribution of the viral antigen ultimately produced in people could be controlled. This was in contrast to traditional vaccines based on inactivated pathogens, as well as current recombinant protein-based vaccines like the COVID-19 NovoVax for sub-unit vaccines. That mattered a lot because we knew that overdose and/or inappropriate site of expression of the viral antigen could lead to many adverse events not observed with traditional vaccines.

It was well acknowledged that ectopic expression of the spike protein in the heart was responsible for a large number of cases of myocarditis and pericarditis with high morbidity and mortality outcomes, much higher than traditional vaccines. Furthermore, long-term side effects, most likely of autoimmune etiology, were manifested in countless neuropathies like Bell’s palsy, and menstrual dysregulation, as well as countless other side effects are constantly growing.

Also, preliminary epidemiological data point to an alarming increase of cancers reappearing after remission, new types of cancers, and fulgurant cancers (or “turbo-cancers“). Even if the causal link with the mRNA vaccines needs to be more formally established, many possible mechanisms have been postulated to support the hypothesis of cancer induction. These genetic injections also perturb the usual immune response and could therefore hamper the ability of the immune system to combat other infections—especially with latent viruses—or keep cancers under control.

The perturbation of the immune system is observable both in the increased COVID-19 infection rate in the weeks following the injections and the propensity for increased infections with an increasing number of doses.

Several features of the mRNA platform potentially contribute to the innate immune system suppression brought about by the reduction of interferon production, which plays a central role in the control of viral infections and further stimulation of the adaptive immune response. For example, the codon optimization done for improved protein production resulted in the generation of secondary structures of mRNA called G-quadruplexes.

Also, a massive concentration of pseudouridine was incorporated to extend the half-life of the mRNA and to prolong its expression over weeks or months. This pseudouridine contributed to higher spike production, several orders of magnitude higher than natural infection. Together, these features of the synthetic mRNA contribute to reduced interferon production and suppress the innate immune response, at least temporarily, with a host of unknown consequences.

Even if it‘s been observed that repeated doses of injection increased the titer of antibodies (IgGs) binding the spike protein, the direct demonstration that more IgGs resulted in better protection was lacking. Clearly, it was not only a matter of the amount of IgG but also of binding quality or type of IgG, not to mention the essential contribution of cellular immunity, which was often overlooked.

Alarming concentrations of IgG4 have been measured in people after the third and fourth dose of injection. IgG4 has been associated with making the immune system tolerant to a given antigen, in this case the spike, as we see in protocols designed designed to reduce allergic reaction by repeated injection of an allergen. This could partly explain why people became more susceptible to COVID-19 infection following repeated injections of mRNA LNPs. Also troubling is the observation that the class switch from IgG1 and IgG3 to IgG4 is associated with higher incidence of aggressive cancers. Given the well-known role of IgG4 in cancer progression by immune tolerance, these observations warrant serious further investigation.

Finally, the entire concept of subunit vaccines depended on selecting the proper target antigen with the right balance of optimal immune induction that causes minimal toxicity. No significant study had been done to support the contention that the spike protein was the ideal target. Given the known toxicity of the spike protein, the rationale of this choice is questionable.

Avoiding most of the short- and long-term side effects would have been possible with the use of traditional vaccines. When evidence was lacking for selecting an optimal target antigen for a subunit vaccine and the safety and efficacy and cGMP production of an unproven vaccine platform were uncertain, it was much wiser to rely on an established technology like inactivated viruses produced in a well-established, large-scale cell culture platform. This was done by the Chinese company SinoVac. Their vaccine was ready at about the same time and was deployed in China as well as many other countries. Whether it was ultimately better than the mRNA vaccines remains to be studied more thoroughly. In any case, it demonstrated that the speed of development and production rivalled the mRNA platform, with much less uncertainty about the safety profile because it was based on a technology with a long track record.

Mass Vaccination to Reach Herd Immunity?

Some scientists and doctors claimed that mass vaccination, whether with traditional or subunit genetic vaccines, would restrict the chance of variants emerging by reducing the viral load sufficiently that the population of viruses would be so small that the probability of variants emerging would be practically nil. This hypothesis suffered from several serious conceptual shortcomings.

It‘s rather the opposite that was likely happening. We saw vaccine-immune escape variants flourishing in highly vaccinated countries, extending the infection waves long past the time the infection was mostly over in low-vaccinated countries, such as in Africa. Several experienced vaccinologists argued that it was unwise to mass vaccinate during a pandemic, especially with a non-sterilizing subunit vaccine, but their advice fell on deaf ears.

Hypothetically, even if the vaccines prevented transmission and even if we vaccinated 100 per cent of the human population, many animal reservoirs could serve as hosts to incubate the evolution of new variants. For example, new variants emerged from mink farms in Denmark and France and led to waves of localized outbreaks. Pursuing the fantasy of global vaccination to control the pandemic was scientifically baseless and absurd.

Any vaccine strategy is based on the concept that our immune system, after a primary infection, develops an effective response against re-exposure to a pathogen, thus preventing us from becoming ill again. For serious infectious diseases, a good vaccine would protect against infection and transmission (sterilizing) and against serious illness, thus preventing severe symptoms and deaths. It would therefore be prophylactic, as it could prevent us from getting sick following the first exposure to the pathogen.

Several but not all vaccines in our arsenal exhibit this profile. Those for influenza have fairly low relative efficacy that varies with seasonal strains. Either way, the best we could hope for from a vaccine is to rival the protection of natural immunity without the drawbacks associated with natural infection. This is really the level to reach, and there was no evidence that we had managed to do better.

For respiratory viruses, natural infection effectively protects against reinfection by stimulating local mucosal immunity. Without this robust mucosal immunity, featuring IgAs as one important component, neither infection nor transmission can be prevented. Those who doubted that the most widely deployed COVID-19 subunit genetic vaccines did not protect against infection or transmission needed only to look at the data on infections around the world.

The most vaccinated places were also the places where the highest incidence rates of COVID-19 were observed. Conversely, it was particularly striking to observe what was happening in Africa, which had much lower incidence rates despite the lowest vaccination rate (7%), ten times less than the continents more vaccinated. Undoubtedly, many factors contributed to Africa‘s good performance in managing COVID-19, but vaccination was not one of them.

One couldn‘t block the replication of a respiratory virus, such as SARS-CoV-2, unless one induced local mucosal immunity in the respiratory tract, which couldn‘t be done by injecting a vaccine into the muscle of the patient‘s shoulder. It was for this reason that among the approximately 143 COVID-19 genetic vaccines in clinical trials, several were being evaluated for nasal administration. One of these vaccines, developed by the Chinese company CanSino Biologics, had been approved for nasal administration and was planned to be deployed in China. In any case, if the name of the game, for whatever reasons, was to prevent SARS-CoV-2 infection to avoid the most deleterious effects from the infection, all of the COVID-19 genetic vaccines in use were unable to do that.

Therefore, in addition to the unavoidable risk of vaccine-induced adverse effects, they mostly failed to protect from the pathologies associated with the course of an untreated infection, assuming that the individual had generated an adequate immune response to begin with. Indeed, there had been reports of obese individuals who became fairly sick from COVID-19 in spite of having a fairly high level of neutralizing antibodies against the vaccine spike protein. Presumably, factors such as the optimal diversity of gut microbiota and robust cellular immunity were not at play in those individuals.

As we have seen from the data in clinical trials, no attempt was made to test the reduction of transmission, so this contention was not based on the highest criteria of scientific evidence, RCTs. The only conclusion presented from the Pfizer RCT was that these genetic vaccines reduced the occurrence of symptomatic infections, not transmission or severe forms of COVID-19. Symptomatic infections were at an absolute risk reduction of about 1 per cent. This anemic absolute risk reduction was due to the fairly low number of infection cases registered during the course of the clinical trial.

The absolute risk reduction, which should have been reported, but was glossed over in the marketing materials, was much less impressive than the widely reported relative reduction of 95 per cent and, at the very least, should have raised questions about the seriousness of SARS-CoV-2 infection cases in the midst of an alleged grave pandemic.

The evidence collected following the deployment of genetic vaccines in the general population also did not support the prevention of transmission, unless the data were manipulated in their collection, attribution, or representation. As for the more severe forms of COVID-19, the evidence for their reduction by genetic vaccines was rather weak to non-existent, particularly since the start of the Omicron wave.

We must also emphasize that the vaccine response decreased significantly over time. The same phenomenon was observed in many states, including Vermont, the most vaccinated American state, which reported higher infection rates than in the past, and Gibraltar, which had one of the most vaccinated populations. Even with the third dose, Gibraltar experienced a strong surge of positive cases but with a relatively lower morbidity and mortality.

As for the real-world data that provided the initial impression that infection and transmission were reduced following vaccination, many confounding factors could have distorted the picture. One important factor was statistical biases. We know that the false impression of reduction in transmission was mostly statistical illusions.

It was created by the arbitrary attribution of COVID-19 infections of the injected individuals labelled as unvaccinated for the first 14–21 days post injection, depending on the states. A simple delay in tabulation of COVID-19 cases of 14–21 days could create the statistical illusion. Interestingly, the Pfizer files obtained by court order revealed that a third of the adverse reactions after vaccination were COVID-19 infection. The high occurrence of COVID-19 infection in the first 14 days post injection was corroborated by data from health agencies in Alberta and Ontario.

That the COVID-19 genetic vaccines didn‘t prevent infection and transmission was no longer disputed in the Omicron phase because the high rate of infection made it impossible to claim any reduction of transmission. But it was also already apparent with the countless so-called “breakthrough infections“ during the Delta wave in the summer of 2021. We learned, through a FOIA (Freedom of Information Act), that the CDC (Centers for Disease Control and Prevention), the NIH (National Institutes of Health), and probably the FDA (Food and Drug Administration) were aware of these breakthrough infections as early as January 2021, most likely from the Pfizer real-world data.

Examining the data from the Canadian government‘s website, the confusion about the effectiveness of genetic vaccines was understandable. Indeed, several official government data sites reported the figures in a way that left the impression that vaccination had prevented COVID cases (and therefore the transmission) or, at the very least, the more serious symptoms leading to hospitalization or death.

Even if we accepted the dubious attribution of exaggerated cases by overcycled RT-PCR tests or that hospitalizations or deaths with COVID-19 were really caused by COVID-19, a more appropriate representation of official data cast doubt on the merits of the intensive promotion of vaccination. Several tables from the government‘s site conveyed the illusion of vaccine efficacy but reported and interpreted data in a misleading way.

The tables failed to consider that (1) the vaccination deployment began at different times, starting from December 2020, and that (2) a valid comparison could not be made by aggregating the unvaccinated and vaccinated populations at the beginning when everyone was unvaccinated. A valid comparison of vaccinated and unvaccinated populations required matching time periods (during which the same variants circulate) and accounting for vaccination status (as multiple doses of genetic vaccines were administered).

When we re-plotted the cases by counting from the start of the declaration of cases with additional doses—for example, from June 5, 2022, instead of the start of the vaccination campaign (December 14, 2020)—we observed that people with three and four doses had more COVID-19 cases (and deaths) than unvaccinated people and people with only two doses. Again, the biased PHAC (Public Health Agency of Canada) report suggested the opposite: that more doses conferred greater protection.

It got worse over time as the rate of people recovering from a previous infection constantly increased. The fact that natural immunity was superior to vaccine-induced immunity was a major confounding factor that made the assessment of potential vaccine efficacy futile unless people were tested systematically for previous infections. Given the evidence, the authorities‘ relentless promotion of comprehensive vaccination for everyone was difficult to understand.

Rationale for Vaccination and Challenges to Prove a Positive Vaccine Risk–Benefit

From the get-go, any risk–benefit analysis of lockdowns or COVID-19 vaccines was fatally flawed because it was based on the false premise of an uncontrolled spread of a deadly virus. When the risk of dying from COVID was so low to begin with, how could any measure, whether lockdowns or vaccines, actually protect the general population? The potential benefits barely existed, so the harms were likely excessive.

The first principle of ethical medicine, “First, do no harm,“ was flouted. Focused protection, as advocated in the Great Barrington Declaration and as was done in the past, should have been the way to protect the most vulnerable. Strangely, the most appropriate and well-established personal and public health measures were brushed aside, and this cost countless lives. Focused protection would have advocated for targeted vaccination for the population most at risk from COVID-19 complications, assuming that a safe and effective vaccine had been available.

Any medical intervention has an intrinsic harm–benefit profile. For vaccines, the safety profile must be paramount because they are administered to healthy individuals. Vaccine-induced adverse effects had been documented for decades prior to COVID and were deemed to be rare.

The potential risks of an unknown vaccine platform and its long-term adverse effects could not be evaluated properly without years of pharmacosurveillance data. That means gambling on a potential positive risk–benefit ratio could only have been advocated to prevent severe diseases and deaths, a concern primarily for the most vulnerable and not for the general population. But vaccination had been pushed with the promise of preventing transmission and reaching the elusive herd immunity that would have put an end to the pandemic more quickly. Measuring potential benefits and risks of vaccination at the individual level is equally challenging on both accounts—of safety and efficacy.

Without a proper harm–benefit analysis, Informed Consent cannot be given. Health authorities lacked the knowledge to conduct a meaningful risk–benefit analysis for vaccination that would consider the profile of each individual. At the very least, people should have been tested for previous infection before vaccinating them. Logistically, this test should not have been more challenging than the pre-vaccine campaign of massive COVID-19 tests and the routine mandatory tests for people refusing the vaccines.

However, such a health measure would have been at odds with the propaganda claiming the inferiority of natural immunity compared to vaccines. Vaccine efficacy had not even been established by formal epidemiological studies. Efficacy had been assessed using an unsubstantiated biomarker proxy of efficacy—monitoring antibody titers.

From a public health perspective, the buildup of natural immunity would have likely outpaced the vaccine deployment to confer protection against severe diseases because most people infected by SARS-CoV-2 were not seriously sick and were even often asymptomatic. That perspective, of course, assumed the vaccines would have conferred protection, a contention which had not been demonstrated.

Importantly, for vaccination to be effective, an individual‘s immune system ought to be functioning properly. The conundrum of higher vulnerability to COVID-19, which was going to be remedied by vaccination, is that what makes people more susceptible to the disease is precisely their anemic immune response. That could be based on genetics, with immunodeficiency syndrome, for example, or epigenetic, as a result of poor diet and lack of sleep and exercise, which perturbs the equilibrium of gut microbiota, essential for proper immune homeostasis. In other words, what makes the terrain weak and renders an individual more susceptible to severe disease is not going to be fixed by a vaccine whose mechanism of action requires a good immune terrain to be responsive.

The phenomenon of vaccine non-responders has been widely documented for protein-based vaccines such as the hepatitis B vaccine. Up to 15 per cent are non-responders. It‘s noteworthy that healthcare worker mandates for hepatitis B vaccines acknowledge natural immunity, and those who have recovered from hepatitis B are exempted from vaccination if they provide proof of immunity. In an obvious contradiction of immunology science, such exemptions were systematically denied for COVID-19.

It is also well established that immune senescence of the elderly is a major issue for the effectiveness of flu vaccines. Large-scale epidemiological studies would be required to properly ascertain the likely extent to which this problem affected the efficacy of the COVID-19 vaccines. In the absence of such studies, the recommendations of health agencies for general vaccination are, at best, faith-based, not science-based.

The Challenge of Assessing Vaccine Efficacy and Safety

The ultimate test for assessing vaccine efficacy and safety is whether the vaccine protects against deliberate controlled exposure to the disease agent. The test is routinely performed on animals but is considered unethical to perform on humans. Vaccine effectiveness is easier to assess in animals because we can control the infection process by using an inoculum that has been ascertained to make the animals sick 50 per cent of the time. Also, it‘s possible to minimize variability of outcomes due to genetic and epigenetic factors by selecting animals with a similar genetic background and putting them in a similar environmental conditions. That avoids the problem of confounding factors.

Even under these ideal conditions, no safe and effective animal coronavirus vaccine has been granted approval for wide distribution, which suggests that the development of safe and effective vaccines for coronaviruses is even more challenging than for other pathogens. Nevertheless, we were asked to believe that the unproven mRNA platform would somehow overcome that biological hurdle.

To minimize the undue influence of confounding factors, randomized controlled trials (RCTs) are the gold standard to assess vaccine efficacy and safety and to establish the risk–benefit profile. Many issues have been raised about the efficacy and safety of all genetic vaccines, but we focused on the analysis of the mRNA platform as it was the most widely deployed.

What the Randomized Controlled Trials Proved and Didn‘t Prove

Many issues were highlighted with respect to the quality attributes of the vaccine product, the design of the clinical trials with their selected endpoints, the low level of absolute risk reduction, the irregularities in the execution of the clinical trials, and the underestimation of the vaccine-induced adverse effects. After the systematic suppression of any potential treatments paved the way for the EUA of the genetic vaccines, vaccination was promoted as the only way out the pandemic. It was sold as the way to prevent people from getting infected and seriously sick from COVID-19. It had to be expedited at an unprecedented pace, at warp speed, and against all odds.

Vaccination was going to allegedly protect both individuals and the healthcare system from being overwhelmed. To fulfil these hopes, the RCTs should have been designed with endpoints showing prevention of transmission and severe diseases and death. They were not. Instead, the only endpoint was reduction of RT-PCR confirmed cases with mild symptoms. Surprisingly, 162 RT-PCR positive cases were reported in the placebo group versus eight in the injected group. Although this represented an impressive relative risk reduction (RRR) of 95 per cent, it corresponded to an overall absolute risk reduction (ARR) of less than one per cent. These figures meant that we needed to vaccinate 123 people in order to avoid one infection (defined as RT-PCR positive cases with mild symptoms).

As the occurrence of severe symptoms leading to death was up to 100 to 1000 times lower, depending on the target population, we would have needed to vaccinate up to 123,000 people to avoid one case of severe disease. The RCT, with only about 40,000 participants, was not powered to make that assessment.

It‘s noteworthy that 170 total cases represented a COVID-19 positivity rate of only 0.004 per cent in six months of follow-up. With this anemic incidence rate, one would have to conclude that the COVID-19 pandemic wave was rather feeble during the RCT or that the testing was not thorough enough. At least, the testing was not as systematic as that which had been deployed to document the worrisome successive COVID-19 waves. Notwithstanding, it‘s striking that this low incidence rate yielded a very weak overall ARR.

Telling people who are afraid of getting sick with COVID-19 that (1) the mRNA vaccine would reduce their chance to be infected by less than one per cent, (2) it would not stop them from transmitting the virus, and (3) it was not tested for reducing severe disease or death conveyed a very different message than telling them that the mRNA vaccine was 95 per cent effective. By FDA rules, reporting both RRR and ARR was mandatory, but it was conveniently obfuscated. Informed consent was irremediably compromised with their misleading statements. In addition, the validity of vaccine mandates was shown to be baseless.

To make matters worse, mild symptoms like fever, sore throat, and sniffles overlapped with a host of respiratory infections from multiple different viruses or bacteria, which introduced sampling and attribution biases. Those could have been avoided by regularly testing everyone enrolled in the RCT. Instead, the method used to assess the endpoint was fairly limited in detecting COVID-19 cases, and that cast doubt on the soundness of RRR reported in the RCT.

This contention was bolstered by the surprising number of cases that were rejected from the report because of the lack of participant follow-up and the more than 10-fold number of suspected but unconfirmed cases. Indeed, 1594 in the inoculated arm were rejected versus 1816 in the placebo arm, a difference of 222. Also, there was a strikingly disproportionate number of participants excluded from efficacy evaluation for protocol deviations, with 311 in the vaccine arm versus 60 in the placebo arms, a 5-fold difference, or a 251 difference, in the number of participants.

This must be put in perspective when you consider the difference in the calculation of RRR versus the calculation of ARR. In a thought experiment, if one adds all of the confirmed and suspected cases, the RRR was only 19 per cent, much lower than the threshold of 50 per cent set by the FDA for the approval of the vaccine under EUA. Failure to systematically test all participants without subjective attribution of who needed to be tested or not, raised suspicion about the validity of the reported efficacy.

The massive RT-PCR testing on the population generated the waves of positive cases, most of which were asymptomatic, and created the illusion of asymptomatic transmission. This was the real-world proof that this kind of testing could have been deployed during the RCT to avoid attribution biases. Using a different methodologies to monitor vaccine efficacy and epidemic waves was a clear demonstration of a double standard, insofar as testing of asymptomatic people was mandatory in many settings—for travellers; unvaccinated healthcare workers, even those working remotely; and children in schools, where a few positive cases had been detected.

Furthermore, although not reported in the publication describing the result of the RCT, a different way of monitoring SARS-CoV-2 infection was also measured during the RCT, but it was only revealed by documents obtained by a court order. This other method was to test for antibodies binding to at least one of the viral proteins, such as the nucleocapsid protein N, as irrefutable proof of infection. If the RRR is calculated based on seropositivity to the N protein, the RRR in vaccine efficacy was 55 per cent instead of 95 per cent.

But even that assessment was overestimated. A large-scale clinical trial on more than 4000 people established that the seropositivity focusing on only the N protein underestimated the true infection rate (as measured by antibodies against all of the other viral proteins) by a factor of about two. That meant that during the Pfizer RCT, the real RRR was probably in the range of about 25 per cent—again, much lower than the threshold of 50 per cent set by the FDA for the approval of the vaccine under EUA. Pfizer was aware of that , or should have been, before the deployment of their vaccine in the population, but they concealed the information.

Lastly, another systematic bias in the assessment of vaccine efficacy was the time frame selected to monitor its efficacy. Given that COVID-19 infection rates had been demonstrated to be higher for the first few days after the injection, if “protection“ was only monitored seven days after the second dose and the window of negative efficacy was not considered, the true picture of vaccine efficacy would be distorted.

As shown in the Pfizer documents obtained by a court order, while Pfizer and the FDA had hoped to keep the information confidential for 75 years, the third most frequent adverse effect observed in the first weeks following the injection was COVID-19 infection. Therefore, Pfizer was aware of this increased sensitivity to infection, a window of negative vaccine efficacy, in the first months of vaccine deployment.

Also, if after the peak in neutralizing antibodies, a constant decline occurred until the protection vanished and this was not properly monitored, a distorted report of vaccine efficacy would result. The waning protection would have called for repeated boosters, and this had been obfuscated.

Assuming, without evidence, that neutralizing antibodies to the vaccine spike would be a valid proxy of protection, monitoring the antibody response on a relatively short time frame could have led to a misrepresentation of the perceived vaccine benefit.

Incidentally, there has been a strange paucity of testing of neutralizing antibodies in the course of the RCT. They were monitored two months after the second dose and again at six months. The absence of systematic measures of antibody titers during the two-to-six-month interval precluded a proper assessment of the rate of antibody reduction as a proxy for waning vaccine protection—important information that could have contextualized the real efficacy of the vaccines over time. For most people, vaccines are expected to last for several years, not a few months.

Even more worrisome is that according to independent experts in clinical trial standard operating protocols (which are strictly regulated by ICH (The International Council for Harmonization) guidelines, followed by industry, and overseen by regulatory agencies), several irregularities had been communicated to authorities by whistleblowers and were ignored.

The first notable one about irregularities, denounced by Brook Jackson, from the contract research organization Ventavia, was commented on in the British Medical Journal. Not only were the issues raised by Jackson completely ignored by Ventavia, Pfizer, and the FDA, but she was also fired for raising troubling questions. At the time of this report, her allegations were being disputed in court.

There is also the widely publicized case of the vaccine-injured Maddie de Garay in the RCT, whose gravity of injury was not properly acknowledged—a clear breach of clinical practice protocol. A similar situation happened in Argentina at the unique, large clinical trial site managed by the military. Out of the 5700 enrolled participants, one participant, Augusto Roux, developed severe myocarditis and almost died during the RCT, yet this event was not reported. He was suing for fraud.

Collectively, all of these five clinical trial sites (three for Ventavia) enrolled over 7000 participants whose data integrity should be evaluated by proper audits that have not yet taken place.

Some commentators dismissed those problems by suggesting that even if we removed these sites from the trial report, which had not yet been done by Pfizer, the data would still support a highly positive RRR number. This is questionable. Removing more than 7000 participants from an RCT of about 42,000 in which 3410 participants had already been discounted would bring the number down to about 32,000 participants. That may or may not challenge the statistical significance of the results or the overall result of the RRR assessment.

Nevertheless, in spite of the speculative nature of these suspicions, there was enough of a smoking gun to justify a formal audit to ascertain whether or not these allegations of clinical trial malpractice were founded. A confirmation by an independent audit would compromise the validity of the whole RCT.

How plausible was it that Pfizer had not been honest? Since 1995, Pfizer had been fined in 40 court cases for 6.5 billion dollars of compensation—for scientific fraud, wild RCTs, corruption of decision- makers, and diffusion of false information. The pattern was well-established.

Current Good Manufacturing Process (cGMP), Chief Manufacturing Issues

Another troubling issue was the quality of the vaccine product. It had been questioned by the European Medicines Agency (EMA) when a number of quality attributes did not conform to expected norms. Notably, there was a significant discrepancy in the integrity of the mRNA as well as the degree of DNA contamination between the batches used in the RCT and the commercial batches for worldwide distribution. Even after Pfizer had been notified to fix these issues, they were unable to comply. Because of the alleged emergency, the EMA turned a blind eye.

Obviously, the significant discrepancy between the RCT batches and the commercial batches was proof that the manufacturing processes were different, which was acknowledged by Pfizer. This was a clear deviation of both normal clinical trials standard operating procedures and cGMP processes, and it raised major concerns about the batch quality and consistency.

Indeed, in a normal RCT protocol, although tolerated, it‘s highly recommended to avoid changing the manufacturing process in the path of moving from preclinical to the various phases of the clinical trials. At the very least, the process must remain the same from phase 3 to commercial manufacturing. Otherwise, a bridging study is needed to validate that the product will behave as it did in the phase 3 trial.

This consistency is even more important for a complex drug product such as these genetic vaccines. Unlike small molecule drugs, which are amenable to full physicochemical characterization, complex biologics such the mRNA genetic vaccines cannot be fully characterized. For such products, the “product is the process.“ Changing the process in the course of product development almost guarantees that the product quality will vary unless the new manufacturing process is well mastered, which was far from being the case for the mRNA-LNP products.

Pfizer acknowledged that their process 1, which was hastily developed for the product used in the clinical trials, could not be scaled up to the level required for commercial manufacturing (process 2). They therefore did a small bridging study during the RCT on 250 participants who received the products manufactured using process 2. That meant that almost 90 per cent of the RCT was done with a different product than the one that was used on the general population. Does anyone besides the regulatory agencies think that testing this product in a RCT with only 250 participants would yield reliable, statistically significant data?

The regulatory agencies advertise on their website that they audited the manufacturing batches; however, the reports of such audits are not made public. It‘s therefore unclear to what extent the batch quality issues are limited or widespread.

Independent analyses by several experts have revealed that the issues of RNA integrity and DNA contamination have persisted in many batches. Most notably, functional plasmid DNA harbouring antibiotic-resistant genes as well as the SV40 strong promoter sequence have been detected at more than10-fold the level of the acceptable norm. Both the short- and long-term consequences of the poor batch quality have not yet been fully examined.

One big concern is that, unlike mRNA, DNA can integrate in the cell genome without the step of reverse transcription, so this event could occur at a higher frequency. Also, the SV40 strong promoter sequence, once integrated, could activate distant genes and perturb normal gene expression in unknown ways. Only rigorous genotoxicity and tumorigenicity analyses could determine the long-term consequences of such events. Such studies have been waived, so we are left to just hope for the best.

The complacency of the health authorities does not augur well for redressing the pitfalls of the cGMP issues that they have been so far reluctant to require to get resolved. This was further exacerbated by the silent approval of new bivalent mRNA vaccines that use the same suboptimal manufacturing process. There was no acknowledgement that changing the RNA sequence was not a minor modification with untold and unexamined consequences. How can we conclude that changing the RNA sequence is a minor modification without assessing it with RCTs (which have been deemed unnecessary)?

Despite what has been claimed by governments and echoed in the mainstream media, corners have been cut, and the trend has been worsening. How can any health regulatory agency endorse the alleged safety and efficacy label of a product with questionable quality and consistency and in blatant contraventions of quality standards established in the industry for decades? Perhaps that is part of the new normal—regulatory bodies no longer enforcing the high-quality standards essential for public safety and endorsing an accelerated process development and approval cycle. If it is justified by an emergency, what is the emergency?

Underestimation of Vaccine-Induced Harms

Underestimating the occurrence and hazards of vaccine adverse reactions has been the modus operandi of the Pharma industry in concert with public health authorities for decades. This was done under the guise of the greater good to suppress vaccine hesitancy at all costs and to promote vaccination as widely as possible as an indisputably beneficial health measure. And, to that noble end, anything in the play book is acceptable. This includes attacking dissenting voices with derogatory terms among which the label “anti-vax” sits at the pinnacle.

Nothing can be more unscientific than resorting to ad hominem attacks to silence legitimate debate. Sadly, character assassination is not the only tactic. People who dared to question the orthodoxy that controls the granting system, along with the other institutions, have found their scientific careers ruined.

The quasi-religious faith in the virtues of vaccination undermines any decent assessment of its risk–benefit ratio. As vaccines are presumed to be safe and effective without rigorous testing, vaccine safety research is impeded by the lack of granting support, unlike the well-funded field of vaccine development, hence the paucity of vaccine safety studies.

An honest risk–benefit assessment of the mRNA genetic vaccine was plagued by bias measures that tended to amplify merits while downplaying adverse effects. Any positive risk–benefit analysis was so questionable that thousands of doctors and scientists across the world joined their voices to call for an immediate suspension of COVID-19 genetic vaccines until a proper risk–benefit assessment was conducted.

In the absence of solid evidence from RCTs, the opinion of health authorities relied on real-world data whose completeness and accuracies were questionable. It was more a matter of expert opinion than hard scientific evidence.

High-profile medical and scientific experts without conflicts of interest examined the data and concluded that these mRNA-LNP genetic vaccines are neither safe nor effective. The same data was examined by medical authorities and government officials in Canada and across the world who trusted the “safety and efficacy“ narrative without reliable data from the Pharma companies. Who were more credible?

At the time of writing this report, some COVID-19 genetic vaccines had been restricted in a limited number of states for unfavourable risk–benefit profiles in some segments of the population, mostly younger people. Citizens were calling for a more complete ban on COVID-19 mRNA vaccines, whereas the adenovirus-based vaccines were no longer on offer in many countries, including Canada.

It was an uphill battle. Meanwhile, the FDA was examining which sequence of Omicron variant to offer for the fall booster as the original Wuhan and bivalent vaccines were no longer promoted. In Canada, the National Advisory Committee for Immunization (NACI), whose members were as plagued by conflicts of interest as the FDA panel members, were following along the same lines as the FDA. Their implicit message was that the only problem with the mRNA-LNP products was matching the sequence of RNA with the variant du jour.

In spite of all the attempts to minimize the extent of the mRNA genetic vaccine adverse reactions, the acknowledgment of severe symptoms and the unprecedented death rate was growing. Were the high number and diversity of vaccine adverse events (VAEs) a big surprise? Not really, insofar as most of the potential adverse events to be monitored were listed on the FDA website in October 2020, and they were what we observed after the vaccine deployment: myocarditis, pericarditis, thrombosis, autoimmune diseases, and a host of invalidating neurological conditions.

These were also spelled out in the record of the Pfizer documents, obtained by court order. Pfizer‘s post-marketing pharmacovigilance study showed an impressive number of serious adverse reactions in the first months of vaccination, including more than 1200 deaths. Contrast that with the flu vaccination campaign of 1976, which was suspended after fewer than 100 deaths. The precautionary principle was still in effect at that time.

In retrospect, there were some glimpses of severe adverse effects from the Pfizer RCT, even though the formal assessment of long-term adverse reactions was abruptly interrupted during the course of the RCT. An astonishing decision to offer the vaccine to the placebo arms interfered with one of the trial‘s important objective of assessing long-term safety. Vaccinating the placebo arms after six months in the course of the RCT effectively eliminated most of the placebo arm control that would have allowed us to compare the occurrence of adverse effects for the two-year duration initially planned.

However, all of the data at the six-month interval pointed to significantly higher illness, which the vaccine was supposed to reduce. What good was a vaccine that reduced the infection cases without any indication of reducing the illness?

Although not statistically significant, it‘s noteworthy that there were more deaths in the vaccine arms than the placebo arm, 20 versus 14. Interestingly, cardiovascular events were the cause of nine of those deaths in the vaccine arm and five in the placebo arm. Given the context that myocarditis and pericarditis were among the first vaccine severe adverse effects (VAEs) acknowledged by health authorities, this confirmed the importance of such cardiovascular events. In any case, even if the analysis was deemed not statistically significant, with such data, any claim of vaccination reducing illness and death was unsubstantiated by the RCT.

More telling was what was not reported or even examined. Given that clear symptoms were the endpoints of the pathological process, it was routine medical practice to assess the early signs of pathologies using validated biomarkers. It was mind-boggling that standard biomarkers had not been deployed to monitor the myriad of expected potential side effects listed by the FDA. For example, D-dimer provides evidence of enhanced coagulation/clotting, C-reactive protein for evidence of enhanced inflammation, and troponins for evidence of cardiac damage. If biomarkers of early signs of disease are not tracked, then biosafety monitoring is of poor quality. Consequently, the assessment of vaccine safety is far from exhaustive.

From Anecdotal to Large Statistics of All-Cause Disability and Mortality

Besides the astonishing lack of acknowledgment of vaccine-injured people, the cruelest aspect was the gaslighting. How can one listen to the horror stories of people whose lives have been destroyed by vaccine injuries without being moved and shocked by the wall of indifference, or even hostility, that they had to face while desperately attempting to be heard by medical authorities?

Even more frightening was the apparent incapacity to properly diagnose the myriad of symptoms, many of which were rare or never seen before. This attitude provided little hope that treatments would be proposed for injuries that were not properly acknowledged.

Many came to share their stories with candour and despair. Although the total number and extent of vaccine-induced disabilities were challenged by the authorities, given that many had taken the injections for the cause or were coerced by social pressure or government mandates, the least that a compassionate society must do is acknowledge them, treat them, and properly compensate them—not leave them to their misery. People were mourning the death of close relatives following the injections with unresolved sentiments of guilt, helplessness, rage, and sorrow of not being recognized by the authorities.

Vaccine-injury denial was part of the propaganda of denigrating people with the anti-vax label in the effort to combat vaccine hesitancy—purportedly dangerous for public health. Vaccine-injury denial has been around for a long time, at least since 1984, but it was on steroids during the COVID-19 health crisis.

Vaccine-injured people are more than just a number in a table of vaccine-correlated symptoms. Beyond the cold statistics, there are humans who suffered twice—first, from their vaccine injuries, and then, from the denial of the authorities and the population to recognize their miserable state.

This denial is being challenged in courts all over the world, and with time, silence will be broken and justice will prevail. Otherwise, we will face another health crisis debacle when the next pandemic is declared.

While the state was diligent in procuring excess stocks of vaccines, which were subsequently destroyed when they expired, or generously given to Africa before they expired, what resources were devoted to dealing with the deleterious consequences of vaccine injuries, in terms of care and compensation disability?

The population had already payed for these free vaccines with their taxes, and they were set up to continue paying on a personal and collective level because the manufacturers had signed contracts exonerating them from prosecution.

If, despite the urgency of the authorization, these vaccines were well designed and manufactured to be safe and effective, why did the manufacturers have to protect themselves from legal prosecutions by passing the bill on to the public, who still has to pay and be further impoverished by the indebtedness of the state?

In the context of strained resources for healthcare, which monopolizes a substantial part of state budgets, one cannot ignore the significant direct and indirect costs of the unjustified massive vaccination campaign. Hasn‘t this vaccination campaign resulted in a vast wealth transfer to the pharmaceutical industry? Not only is there no benefit to public health, but we will be paying for the increasingly heavy toll of damages for decades to come.

Due to a toxic combination of willful blindness and collective guilt of the medical establishment that took part in the vaccination campaign and fiercely fought vaccine hesitancy, calling it irresponsible and harmful for public heath, the lack of acknowledgment and the gaslighting of the vaccine injured has been a major obstacle to their therapeutic care. From the analysis of the VAEs in the RCTs to the endless lists of injuries reported in the various pharmacosurveillance systems, the alarming number and diversity of disabilities induced by the COVID-19 genetic vaccines are unquestionable.

An independent reanalysis of Pfizer and Moderna RCTs done by Fraiman and collaborators revealed that SAEs (severe adverse events) occurring at a rate of one in 556 is categorized as “uncommon,“ according the accepted classification, not “rare,“ as was displayed on the various government websites. Since this rate is 18-fold higher than was used in the past for withdrawing other vaccines, why were the COVID-19 genetic vaccines not withdrawn?

Experts monitoring all of the governmental pharmacosurveillance systems worldwide—for example, VAERS in the USA, Yellow Card in UK, EudraVigilance and the WHO VigiBase system—have recorded numbers of injuries, disabilities, and deaths that are more than 20 times higher than for traditional vaccines. There were enough safety signals in VAERS in January 2021—almost 700 deaths—to stop the rollout of the Pfizer vaccines. Based on that, the Moderna vaccines should not have been rolled out. However, all of the historical safety signals for suspending vaccines were ignored.

As a result, countless VAEs piled up for more than two years before the CDC was forced to release the data from their V-safe system. It revealed more than 700 safety signals from over 10 million self-reported VAEs, of which 7.7 per cent were deemed severe adverse events.

It‘s noteworthy that both the number and the diversity of VAEs were much higher. The types of VAEs linked to COVID-19 mRNA-LNP were up to 15,042, which is greater than 10 times more diverse than for all other traditional vaccines. This diversity in adverse events was probably liver related. As it turned out, the mRNA-LNP vaccine was very stable and had an ill-defined pharmacodistribution profile. Accumulation of spike proteins in the ovaries was a concern, but the liver was the second site of greatest accumulation after the injection site. Accumulation in the ovaries was likely the reason for the menstrual dysregulation and partly explained the significant reduction in fertility rates in many highly vaccinated countries. It also correlated with increased stillbirth rates.

This increase in stillbirths was documented in a study co-authored by Dr. McCullough in which it was reported that COVID-19 genetic vaccines had a greater than two-fold, or 100 percent increase, in VAEs as compared to traditional flu vaccines. This represented a clear safety signal requiring further investigation, according to the CDC. Furthermore, a major increase in stillbirth rates were observed in many states, correlating with higher vaccination rates of pregnant women.

While the result of the RCT conducted by Pfizer on pregnant women was not disclosed even many months after the trial has been terminated, it‘s unfathomable that the vaccines were promoted to pregnant women without any safety or efficacy data. That was in blatant disregard of the precautionary principle. Also unfathomable was the willful blindness of the medical establishment who endorsed it without scientific evidence. Their faith in the Pharma industry and the regulatory agencies was misguided.

It was shown that spike mRNA was persistent in the liver, and liver accumulation is likely the main reason for the diverse pathophysiological symptoms. Among the main physiological systems in the liver, we found a number of proteins involved in the regulation of the ACE2 renin-angiotensin system (RAS), a key system that was most likely disrupted by the spike protein by virtue of its binding to the ACE2 receptor.

Also, the liver was the production centre of many proteins involved in the coagulation cascade; its dysregulation could lead to all kinds of clotting issues. Numerous VAEs had common etiology involving aberrant coagulation and wound healing. Further research is required to decipher the specific mechanisms involved.

Interestingly, the perturbation triggered by spike-induced liver inflammation which affected normal liver coagulation homeostasis, combined with the propensity of the spike protein for aberrant folding, could provide some fertile research hypotheses to explore the underlying mechanisms of the unusual clot formations that has been observed by embalmers.

Ectopic over-expression of the spike protein in other tissues, such as the endothelium of veins and arteries, is likely involved in many coagulation pathologies. Similarly, ectopic over-expression of the spike protein in the brain could be at the root of a host of neurological diseases. Again, this will only be unravelled by much-needed additional research.

Even in the absence of the precise pathophysiological mechanisms of injuries that need to be further investigated for the myriad of VAEs, a significant number of autopsies documented the plausible causal link of the COVID-19 genetic vaccines in many cases of suspicious sudden deaths. The COVID-19 genetic vaccines were also a plausible explanation for the abnormal surge of non-COVID excess deaths in 2022 in most of the highly vaccinated countries, especially noticeable in the younger population.

From the more than 4,300 peer-reviewed papers examining vaccine injuries, a study co-authored by Dr. McCullough found that in the 44 papers describing autopsy reports, 74 per cent of the 325 autopsies were adjudicated to be mostly caused by COVID-19 vaccination. The deaths occurred within a mean average of 14 days of the last injection, with the majority occurring within a week. The close temporal association made the adjudication more plausible. For all of these cases, 53 per cent of the time, cardiac issues were the main cause of death, followed by hematological issues (17 per cent).

The magnitude of death and injuries can be realized from the May 5, 2023, VAERS. It counted more than 1.5 million VAEs, including 35,324 deaths in the U.S. With a conservative under—reporting factor of 20, this represented 706,480 deaths in the U.S. alone, a staggeringly high death toll if proven correct.

In the absence of data transparency—governments refusing to report the vaccination status of people dying of all-causes—it was very difficult to appreciate if vaccinated people were dying proportionally more than unvaccinated people. It was therefore difficult to assess the magnitude of health damages generated by the broad vaccination campaigns.

However, this information was obtained from the analysis of insurance companies and the U.S. Bureau of Labor Statistic (BLS), as testified to by Edward Dowd. Indeed, the careful investigation of the tables led to the disturbing conclusion that in 2021, 2022, and continuing in 2023, it was detrimental to your health to be employed in the United States. Financial analysts referred to it as a black swan event.

Given that the working population in the U.S. was likely to be the healthiest, finding that they were dying at a higher rate than the unemployed was astonishing. For example, in the third quarter of 2021 (Q3), there was 40 per cent excess mortality in the population aged 25 to 64. To put this in context, a 10 per cent increase in excess mortality was a 1-in-200-year event, hence very rare; a 40 per cent increase was off the charts. And these off-the-chart excess mortality rates happened immediately after the vaccine mandates, which were systematically implemented for every federal government employee and for private companies of more than 100 employees.

The best explanation for such a coincidence is that the vaccine-hesitant millennials were coerced to take the jab or lose their job, and the rapid vaccine uptake resulted in the increase of all-cause mortality in the subsequent quarters. No other event could meaningfully account for that.

Furthermore, the staggering amount of lost work-time data from the BLS showed a huge increase in lost workdays in 2021 and 2022 (due to approximately 26 million vaccine-injured people, when we considered a 30–40 underreporting factor in VAERS): it was another black swan event. This significant disability of almost 10 per cent of the workforce was going to result in major loss of productivity for the U.S. economy in years to come. No one meaningfully challenged the quality of this financial analysis, yet no authority was willing to acknowledge the consequences of this dire situation and propose a remedy.

Finally, because of unavoidable attribution biases, a clear correlation of COVID-19 genetic vaccines and deaths could ultimately be best established by a statistical analysis of all-cause mortality worldwide, as testified by Dr. Denis Rancourt. From his careful and detailed analysis of the statistics on all-cause mortality over a century, by age and discrete temporal categories, he concluded, beyond a shadow of a doubt, that the worldwide vaccination campaigns were responsible for a massive amount of deaths (and still counting).

The first insight about vaccination as the main culprit of an increase in all-cause deaths came from a study in India in which a huge peak of excess deaths (3.7 million) was linked to the vaccine rollout that targeted mainly elderly and frail people in the first wave of vaccination, called the “Vaccine Festival.“ As it turned out, the vaccine-dose fatality rate (vDFR), as calculated using a large body of data, was much higher in older people.

The vDFR increases exponentially with age, ranging up to 3 per cent for the most vulnerable elderly, with a doubling time of five years. In the Indian vaccination campaign, the vDFR was, on average, one per cent because of the target population.

The statistics for Australia went from zero excess deaths to a huge excess in deaths immediately following the vaccine rollout. The trend continued and was very visible after the third dose. In Mississippi, the “Vaccine Equity Campaign“—again, for the most vulnerable in the population aged 24 to 65—also yielded a huge excess in deaths immediately following the vaccine rollout. Similar profiles were also easily discernible in Alabama and Michigan.

In Canada, the excess mortality seen in 2020, did not decrease in 2021–22 following vaccination. In fact, in 2022, there was significantly higher mortality than in 2020 or 2021. As soon as the vaccination was rolled out, we saw an extra peak of mortality. The rollout of the third dose gave the highest peak of mortality, suggesting that the toxicity was dose dependent.

The data from many Western countries allowed Dr. Rancourt to calculate a vDRR between 0.05–0.1 per cent and 1 per cent (and up to 3 per cent for the most vulnerable). Excess deaths were 13 million worldwide—3.7 million in India, 330,000 in the USA, and around 28,000 to 31,0000 in Canada—for a vDFR of 0.03 per cent or 1 death per 3000 doses. Again, the astonishing numbers of COVID-19 genetic vaccine deaths were not meaningfully challenged.

In most countries, excess mortality was dropping and returning to normal, but there were a few countries like Canada where excess mortality was higher in 2022, and the reason behind this phenomenon was being explored.

Poor Modelling Says Millions Saved by Mass Vaccination

As the data on vaccine serious adverse effects piled up, the heath authorities reluctantly started to acknowledge their existence. With the growing evidence on causality, they tried to evade responsibility. Their justification went something like this: “Of course, no vaccine is perfectly safe, but causality has not yet been demonstrated in the majority of the cases, and overall, they save many more lives, even if the vaccines, potentially, are causing some deaths.“

The incentive to make such baseless claims was also motivated by the systematic suppression of life-saving treatments, which potentially cost millions of lives. The suppression was a necessary condition to get COVID-19 genetic vaccine approval under EUA.

It would have been possible to conduct rigorous statistical analysis to prove that a reduction in COVID-19 or all-cause mortality following vaccine rollout in 2021 was strongly correlated with the vaccine rollout. The fact that no such study was published by any government in the world was a clear indication that prevention of COVID-19 mortality by vaccination was not observed in the real world.

Ignoring the data, health authorities resorted to “garbage in, garbage out“ modelling, like the one published by Neil Ferguson at the beginning of the pandemic that predicted COVID-19 mortality. Due to incorrect assumptions, his model exaggerated deaths by a factor of 10 to 20.

The same playbook was used in the infamous Lancet paper that claimed that the COVID-19 genetic vaccines would save up to 14.4 million lives in 2021. This modelling was based on false assumptions about the infection fatality rate (IFR) and vaccine efficacy that resulted in at least a 200-fold overestimation of vaccine‘s putative benefit on death reduction. These absurd modelling results were widely publicized in the mainstream media.

Similarly, a paper co-authored by Theresa Tam, falsely claimed that Canada’s drastic health measures, in terms of NPIs and vaccination, had a combined benefit of preventing 1.1 million COVID-19 deaths. The figure was produced by massively overestimating IFR and putative effectiveness of both NPIs and vaccines. The claim that those drastic measures brought down the excess-death statistics to exactly the expected historical level was simply absurd, as testified to by Dr. Denis Rancourt. The fact that such a poor-quality paper was published in the peer-reviewed literature was mind-boggling.

Conclusions

There was malpractice by public health and individual healthcare practitioners. Relentless vaccination and denial of early outpatient treatment for COVID-19 were rivalled only by bureaucratic stubbornness.

Given the limited evidence-based justification for widespread vaccination and concerns regarding the experimental mRNA-LNP gene therapy injections, we concluded that:

• These injections did not undergo the standard approval process for gene therapy products.

• Manufacturing issues led to quality concerns that deviated from historical regulatory standards for protecting human health.

• The unprecedented level of reported morbidity and mortality, particularly among vulnerable populations, surpassed what was observed with traditional vaccines or COVID-19 infections.

• Rigorous randomized controlled trials (RCTs) failed to demonstrate their efficacy in stopping transmission or reducing severe illness, hospitalization, or death. Instead, the vaccines were associated with more harm than benefit.

• The injections were administered without obtaining free and Informed Consent, contravening the principles of the Nuremberg code.

• During the early days of the pandemic, politicians said that one death from COVID-19 was one too many, implying an all-out war on COVID, regardless of collateral damages. Although they claimed that drastic measures were necessary to prevent COVID-19 deaths, the vaccine-caused deaths were ignored—a double standard at play. Those deaths were tolerated for the “greater good.“ Certainly, no effort was made to avoid vaccine deaths at all costs.

In theory, reporting of VAEs was compulsory, but many doctors didn‘t report adverse events because the process was cumbersome and because they couldn‘t or wouldn‘t believe that VAEs were linked to vaccines. However, it was not up to doctors to make the call to skip the reporting process.

The net result of the authorities‘ use of inappropriate criteria was a substantial underreporting of side effects. Because the time frame of occurrence was established on the false premise that these genetic vaccines were like traditional vaccines, any side effect reported after a few weeks was arbitrarily deemed unrelated. The estimate was between a 10- to 100-fold underreporting of VAEs.

The decision to suspend a vaccine depended on the danger signals analyzed from VAE statistics. Every VAE had to be analyzed to formally incriminate the vaccine as a causal agent, but the process was long and tedious. Normally, the likelihood of suspending vaccines increased with greater numbers of injuries. During the COVID crisis, however, even though the threshold of danger signals was well above traditional vaccines, the formal process of their removal was not activated, except for some limited restrictions in some states.

Outrageously, the precautionary principle was flouted for pregnant and breastfeeding women. Without any clinical trial safety data, these vaccines were promoted after unsubstantiated data alleged pregnant and breastfeeding women were more at risk from COVID-19 than the general population. The reckless decision to recommend the vaccine to pregnant and breastfeeding women resulted in a notable increase in miscarriages, stillbirths, and serious health problems for babies.

The contention that the COVID-19 genetic vaccines had shown any positive risk–benefit in any segment of the population was refuted by the bulk of the evidence provided by independent expert witnesses. Their overall conclusion was that these genetic vaccines did more harm than good. They remarked on the limited efficacy and imminent danger of these vaccines, and they called for an immediate withdrawal from the market until rigorous studies proved the vaccines were safe and effective.

The onus of proof was seen to be on the vaccine manufacturers. The regulatory agencies were admonished by expert witnesses to get back to the best practices of protecting the public from the harms of a product hastily developed, tested, and manufactured.

Working at “the speed of science“ was denounced by expert witnesses. People would be justifiably reluctant to fly in a plane under construction that had not been fully tested for safety. People were similarly justified in their vaccine hesitancy. At best, these mRNA vaccines were poorly tested experimental prototypes that should have been sent back to the drawing board. This was unlikely to happen unless the perverse incentives for these products were eliminated.

Unfortunately, suspending the vaccines would have required government officials to admit their initial reckless mistake. The further they persisted without acknowledging their error, the more they doubled down and pushed the approval of new mRNA formulations without proper RCTs. We saw this with the approval of vaccines for children and the approval of the bivalent Omicron vaccines.

They wanted us to believe that because the initial concoction had been declared safe and effective, the new mRNA sequences in the same LNP platform would also be safe. They were saying, without proof, that new mRNA coding sequences didn‘t make any difference. This approach violated the spirit of the historical drug approval process that had been practised for decades (although with some gaps) to protect public safety. A new drug was presumed unsafe and ineffective until proven otherwise, and changing anything in the content of the product made it new.

Recommendations

We recommend the suspension of any further vaccination for COVID-19 until (1) the issues of cGMP production are resolved; (2) the genotoxicity, auto-immunogenicity, and tumorigenicity assays are conducted to the appropriate level for gene therapy products; and (3) rigorous RCTs demonstrate the reduction of morbidity and mortality in a representative population, including the most vulnerable.

Given that there was no efficacy study in the RCT with the mRNA-LNP produced in the commercial manufacturing process and that there were irregularities in the clinical trial process, we recommend that Health Canada require an independent audit of the RCT.

Victims have to be compensated more readily. We also recommend that the government set up a special centre to take care of the vaccine-injured.

Regulatory agencies must revisit the warp-speed-development mindset of the COVID-19 genetic vaccines and rebut the allegation that the mRNA-LNP products have been proven safe and effective and that they can therefore be further used as a vaccine platform for other diseases without proper safety testing.

A Pandora‘s box has been opened, and promoting any future products based on that mRNA-LNP platform technology for expedited marketing, within one year, without the proper efficacy and safety assessment will only perpetuate bad health outcomes of similar magnitude.

In alignment with the views of numerous medical doctors and scientists worldwide, the following recommendations are made:

A. Immediately halt the use of experimental mRNA-LNP gene therapy injections for COVID-19 prevention.

B. Approve any future applications of these injections through the standard gene therapy product approval process.

C. Ensure that the regulatory approval process and recommendations by vaccine immunization committees are reviewed by independent medical and scientific advisory committees without conflicts of interest.

D. Establish clear safety signal thresholds that would necessitate the automatic removal of any vaccine or therapeutic product from the market, with legal accountability for officials failing to adhere to these pre-established norms.

E. Acknowledge, treat, and adequately compensate individuals who have experienced vaccine-related injuries.