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Interestingly,
Moderna describes its technology as the “software of life,” not a vaccine.
Media outlets, politicians, and public health officials have blared the 95% efficacy for both formulations. To the casual observer, this would denote 95% reduction in hospitalizations or deaths.
When in fact the 95% is calculated, based upon the “Primary Efficacy Endpoints.”
In the trial literature these endpoints are described by both companies as non-severe cold/flu SYMPTOMS coupled with a positive PCR.
Pfizer has reported:
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: Fever; New or increased cough; New or increased shortness of breath; Chills; New or increased muscle pain; New loss of taste or smell; Sore throat; Diarrhea; Vomiting.”
Moderna reported in likeness:
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was defined as: At least TWO of the following systemic symptoms: Fever (≥38ºC), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR At least ONE of the following respiratory signs/ symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; and NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.”
To reiterate, in both trials, once one/two symptoms appeared in a participant, it was designated a “case” or “event” when coupled with a positive PCR “test”. Once 170 “cases” occurred in Pfizer/BioNtech trial, and 196 “cases” occurred in Moderna trial, this data was used to calculate efficacy. Shockingly, only under 200 cases for a novel therapy which is being deployed/subjected on millions of people around the world.
Furthermore, people are not being informed that “95%” or so efficacy, is calculated based on a useless metric of relative efficacy and is therefore very misleading.
Eg.Pfizer/BioNtech:
8 “cases” in vaccine group
162 “cases” in placebo group
8/162 = 5%
100%-5%= 95%
Therefore, they are claiming that the synthetic gene therapy injections are 95% efficacious. What they are not factoring in is the size of the denominator. If it is large, then with 8 vs 162, the difference becomes less significant. It matters how many people were in each group, for example, whether this be 200, 2,000, or 20,000.
This is the absolute risk reduction for Pfizer/BioNtech, each group had over 18,000 people!
Injection Group: 8/18,198 = 0.04%
Placebo Group: 162/18,325= 0.88%
Therefore, the absolute risk reduction for Primary Efficacy Endpoint is 0.84%. (ie. 0.88-0.04)
This means, that
someone who takes the Pfizer/BioNtech injection, has less than 1% chance of reducing at least one symptom of non-severe “Covid” for a period of 2 months. This means that someone who takes this injection has over 99% chance that it won’t work, regarding the efficacy. Over 100 people have to be injected for it to “work” in one person.
The actual efficacy of Pfizer/BioNtech Synthetic Gene Therapy
The actual efficacy of Moderna Synthetic Gene Therapy
There are many issues with the trial data, and design.
It must be noted that PCR tests are not fit for purpose and without Sanger sequencing we have no idea how many of these people actually had “Covid” vs another respiratory virus or something else. This is a preeminent reason why Dr Yeadon and Dr Wodarg filed a Stay of Action on the vaccine trials.
As Dr Peter Doshi, Associate Editor of BMJ highlighted, access to the raw data is required to further elucidate the areas of concern:
With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.”
Approximately 5-6 symptoms listed as “side effects” are the same as Covid symptoms. Pfizer/BioNtech only started counting “cases” one week after the second dose, and Moderna, 2 weeks after the second dose. Therefore, if these side effects were labelled as “Covid” symptoms instead, even the paltry efficacy of about 1% would be relegated into the negative integers.
In others words, the injected group may have been sicker with “Covid” more than the placebo group.
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To convey informed consent, the side effect profile must also be considered.
Up to 80% of injected trial recipients experienced side effects, in a setting for a nebulous syndrome where 80% of people are asymptomatic.
The incidences of immediate side effects in both trials were significant and dwarfed the absolute risk reduction in both the primary efficacy endpoints, as well as for “severe” Covid.
For example, for Moderna 81.9% experienced any systemic reaction.
Grade 3 reactions (considered severe) were experienced by 17.4%. This is 79X more likely than the incidence of severe Covid in the Moderna group. (17.4/.22=79X) Based on preliminary reports of adverse events [emphasis added]:
This is an injury rate of 1 in every 40 jabs. This means that the 150 shots necessary to avert one mild case of COVID will cause serious injury to at least three people.“
The safety data for both companies is approximately only two months before receiving emergency use authorization status. Therefore,
there is no data for mid-long term side effects, as the trials are ongoing.
The estimated completion date for Pfizer/BioNtech trials is Jan 31, 2023. The estimate completion date for Moderna trials is October 27, 2022.
According to the data, and elaborated by Tal Zaks (CMO of Moderna)
the trials are not designed to demonstrate a reduction in transmission, due to “operational realities”. It is therefore baffling how medical doctors and public health officials are proclaiming these SGTs will promote herd immunity.
The manufacturers have also made it clear that efficacy beyond 2 months or so is unknown. Therefore, the 1% absolute risk reduction in mild/moderate, cold/flu symptoms may not last more than a few months.
Tragically, there is no pervasive data-centred discourse, only excessive fear-mongering. Without addressing the data people cannot make an informed choice about experimental SGTs.
Many are not aware any SGT recipient who participates in this therapy is now a part of an unprecedented experiment. When Health Canada shockingly agreed to interim authorization of the Pfizer/BioNtech injection, it came alongside a caveat:
The company must submit 6 months of trial data when it is available.
To underscore: Health Canada approved this experimental SGT on the populace without even 6 months of trial data.
It is difficult to embark on a comprehensive risk-benefit analysis, as there is no safety data beyond a couple of months. New vaccines typically take about 7 to 20 years of research and trials before going to market. Pfizer/Moderna ran all of their trials simultaneously, including their animal trials, instead of sequentially. As retired Health Canada research scientist Dr Qureshi elaborated,
it is during proper animal trials that meaningful toxicology data is obtained.
The anaphylactic reactions observed in some people is also worrisome, worthy of analysis.
Children’s Health Defense submitted a request to the FDA to address PEG allergies, as up to 70% of the populace has antibodies to these compounds. PEG has never been a component in a vaccine before.
It must also be noted that according to an internal Health Human Services and Harvard study, less than 1% of vaccine side effects are reported. At this juncture, based on: paltry efficacy, issues with data transparency and trial design, high level of immediate side effects,
and low IFR for Covid, there is already enough reason for concern.
Yet,
the more disconcerting side effects are the potential mid-long term effects.
Many doctors and researchers around the world have promulgated concerns about the well-documented phenomena referred to as Antibody Dependent Enhancement (ADE) seen in some viruses such as coronaviruses.
In previous SARS, MERS, Dengue fever and RSV virus vaccine trials the exposure of wild viruses to vaccine recipients resulted in severe disease, cytokine storms, and deaths in some animal and human trials. The phenomenon of ADE did not present initially in vaccine recipients, rather it presented after vaccine recipients were exposed to wild viruses.
This is the reason we do not have a vaccine for the common cold, MERS and SARS which is 78% homologous with SarsCov2 (based on analysis of the digital genome). Immunology Professor Dolores Cahill warned that this disease enhancement may cause many vaccine recipients to die months or years down the road. Esteemed German infectious disease specialist, Dr Sucharit Bhakdi opined:
This vaccine will lead you to your doom.”
Researchers in The International Journal of Clinical Practice stated:
The absence of ADE evidence in COVID-19 vaccine data so far does not absolve investigators from disclosing the risk of enhanced disease to vaccine trial participants, and it remains a realistic, non-theoretical risk to the subjects. Unfortunately, no vaccines for any of the known human CoVs have been licensed, although several potential SARS-CoV and MERS-CoV vaccines have advanced into human clinical trials for years, suggesting the development of effective vaccines against human CoVs has always been challenging.”
Traditional vaccines involve injection of the pathogen/toxin in whole/part to elicit an immune reaction. For the first time in history, the recipients’ cells will manufacture the pathogen, the S1 spike protein of SarsCov2 virus.
In a presentation for Emergency Use Authorization to the FDA, Moderna reps explained that the mRNA stays in the cytoplasm of the cells, manufactures the S1 Spike Protein and then is destroyed.
As Dr Sucharit Bhakdi and others have queried:
Where else do these packages go?”
Also, based on a couple of months of safety data, we do not know that these mRNAs last long enough to manufacture the protein but not long enough to exert deleterious effects. This nascent technology is risky.
Firstly, the RNA sequences are synthetic. Therefore, we do not know how long they will last in the cells. Dr Judy Mikovits has expressed concerns in that they may not be degraded immediately, and perhaps linger for days, months, years.