The Covid-19 vaccines are not actually vaccines but rather largely untested genetic therapies that employ previously patented technologies such as mRNA and Lipid Nanoparticles (LNPs) to trick your cells into producing toxic spike proteins and ostensibly trigger your immune response.
There were a number of these developed simultaneously by the following companies in response to emergency measures introduced by governmental agencies all over the world:
- Pfizer (USA)
- Moderna (USA)
- Johnson & Johnson (USA)
- Astra-Zeneca (UK)
Moderna and Pfizer are mRNA vaccines (messenger ribonucleic acid) containing material from the virus that causes COVID-19 that gives our cells instructions for how to make a protein that is unique to the virus. Our bodies recognize that the protein should not be there and build T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19.
AstraZeneca, Covishield, and Janssen which are (DNA) Vector vaccines- these COVID-19 vaccines use an inactivated (“replication incompetent”) cold virus called adenovirus serotype 26 (Ad26). The Ad26 virus has been modified to carry the genetic code so your muscle cells can make the SARS-CoV-2 virus “spike protein”. The spike protein serves to cause your immune system to make antibodies against the SARS-CoV-2 virus to protect you against future infection.
The Approval Process
- On paper, COVID-19 vaccines have been treated in the same fashion as all previous vaccines approved in Canada, just in a drastically accelerated manner. Specifically, Health Canada regulates and authorizes all vaccines for use in Canada through the Food and Drugs Act. Usually, vaccines must be put through Phases I, II and III of clinical trials, with each phases including larger groups of people and testing more intensively for safety and clinical efficacy of the vaccine. Phase III trials typically include many thousands of people and must be completed have their data reviewed before a vaccine is officially approved. Phase IV is “after-market”, i.e., there is continued data collection on the safety and effectiveness of a vaccine after it has been authorized for use by the general public.
- The Minister of Health, Patricia “Patty” Hajdu, believedi that COVID-19 presented a sufficient emergency to warrant deviation from the normal vaccine approval process. A series of Interim Orders (IO) from Health Canada effectively createdii an alternative pathway for the approval of COVID-19-related medical devices and drugs. The Pfizer-BioNTech vaccine was the first to be approvediii under IO on December 9, 2020. Importantly, all of the vaccines that were granted effective temporary authorization under these IOs were expected to “transition to a new drug submission”iv, i.e., to apply for full authorization. Health Canada granted full authorization to the Pfizer-BioNTech and Moderna vaccines on September 16, 2021, and to the Astra Zeneca and Johnson & Johnson vaccines on November 19 and November 23, 2021, respectively. This means that by these dates Health Canada had reviewed all of the available Phase III trial data and come to the definite conclusion that these vaccines were safe and effective for use by Canadians.
- At the time of the IO authorizations, the data that Health Canada was relying on to approve the vaccines for public use were not available to the public. The data is now available. There are at least three major issues that arise, from the data and from reports relating to the data.
- The misrepresentation of data. Perhaps the most egregious example of this is Pfizer’s deliberate confusion between Absolute Risk Reduction (ARR) and Relative Risk Reduction (RRR). The former, ARR, is actually the most relevant, and is routinely used in assessing the effectiveness of treatments. At the 2-month point, very small numbers of participants had contracted COVID-19 during the trial period: 8 out of 18,198 experimental [or treatment] group (=vaccinated) participants (i.e., 0.04%) and 162 out of 18,325 placebo [or control] group (=unvaccinated) participants (i.e., 0.88%). The Absolute Risk Reduction, ARR, is the difference between 0.88% and 0.04%, i.e. the vaccine’s ARR is 0.84%. This is a disappointingly low number (from Pfizer’s perspective), but that is primarily because COVID19’s infection rate in both the placebo and the experimental groups is so low. Of course, this is a good thing for the public, strongly implying (1) that COVID-19’s infectivity rate is relatively low and consequently (2) that the benefit that the drug provides is for a very small proportion of the population. But for the drug manufacturer, this is not a good thing: their solution to this disappointing news was to use the Relative Risk Reduction, RRR, and not the industry-standard ARR. This way they calculated that the reduction was 95% (i.e., 0.84% / 0.88%). To the uninformed, 95% Relative Risk Reduction is a much more impressive efficacy number than 0.84% Absolute Risk Reduction. Unfortunately, all of the media, including so-called health journalists, behaved as if they were uninformed, bought this sleight-of-hand and unquestioningly reported 95% efficacy.
- What the data actually tell us – The adverse events including deaths during the early trials were minimized and/or ignored. Simply put, the results in Pfizer’s own documentation should have brought an immediate end to the trials and any public inoculation drive. While the trial showed that there was still a RRR of 91% at the 6-month point, at that time point there were 300% more related adverse events (1,311 in placebo group vs. 5,241 in experimental group), 75% more serious adverse events (150 placebo vs. 262 experimental) and even 10% more serious adverse events requiring an ER visit or hospitalization (116 placebo vs. 127 experimental). Crucially, deaths were about even in the two groups, with one more death in the experimental group (15) than in the placebo group (14). As stated earlier, the purpose of these trials is to establish safety and efficacy. By this point in time (trial ended March 2021, data published September 2021), Pfizer and anyone who read the documents that Pfizer produced, including Health Canada officials, knew that their experimental treatment was neither safe nor effective. Additionally, even in an underpowered trial for adolescent children (i.e., there were only 1,005 participants, and a Phase III trial typically contains many thousands of participants), there was at least one case indicating significant safety issues .
- In its documentation Pfizer itself admits that they had to hire more people to capture adverse event data. In order to “alleviate the large increase of adverse event reports, Pfizer conceded that at the time of the report (end April 2021) it had already hired an additional 600 full-time staff and expected that number to increase to 1,800 by the end of June 2021. In addition, reports from a whistleblower employed briefly in 2020 by clinical trial contractor Ventavia Research Group suggest that procedures and protocols relating to Pfizer’s trials were poorly managed or entirely omitted in some instances. Based on internal documents obtained via the whistleblower, problems related to a range of issues, such as incomplete adverse event reporting, breaches of patient confidentiality (and risk of trial unblinding) and informed consent errors. Any one of the points raised above, on its own, should be sufficient to cause a responsible, diligent, conscientious and independent public health regulator to refuse – or withdraw – a drug approval. Together, they should result in an immediate and absolute refusal to expose the public to such a product. For comparison: in the 1970s, the first mass inoculation of Americans with a rushed coronavirus vaccine (against swine flu) resulted in a measured increased risk of contracting Guillain-Barré Syndrome of approx. 1 in 100,000. This risk, i.e. about 400 people with GBS among the 40 million inoculated, with an associated number of deaths apparently so small that it has not been recorded, was deemed too high to continue the national influenza immunization program. Today we have far higher risk levels for multiple conditions, including thousands of deaths, associated with these COVID-19 inoculations, and our regulatory authorities have not so much as shrugged their shoulders as they approve these products.
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