The rushed “warp speed” development and approval of completely novel Covid-19 mRNA and DNA vaccines pushed on millions of people has resulted today in millions of reported injuries and deaths according to public health databases such as VAERS (US), Eduravigilance (EU), Yellow Card (UK) and others. In March 2022 a package of 466 pages of Pfizer non-clinical submission (animal studies) to the FDA was obtained by Judicial Watch via FOIA. The cursory nature of the entire preclinical program for mRNA injections conducted by Pfizer can be briefly summarized as “we did not find any safety signals because we did not look for them”. The omissions of standard safety studies and glaring scientific dishonesty in the studies that were performed are so obvious that they cannot be attributed to the incompetence of the manufacturers and regulators.
Finding 1: Pfizer’s program did not include a comprehensive end-to-end test of all components as well as the final chemical entity of the mRNA product. The studies included in the FDA approval package were for a variety of versions of the product with no comparability assessments, thus no comprehensive assessment of the product safety can be made.
Finding 2: The toxicity/safety pharmacology of the Covid 19 vaccine’s active ingredient (mRNA BNT162b2) was never evaluated!
Finding 3: Pfizer claimed absence of potential for “vaccine-elicited disease enhancement” based on studies of an animals that did not get sick from Sars-Cov-2.
Finding 4: CDC, FDA and Pfizer lied about “vaccine staying in the injection site” - the injected substance is carried by the LNPs all over the body and into all organs.
Finding 5: Pfizer waived major categories of safety testing for their product altogether using self-serving interpretation of WHO recommendations from 2005.
Finding 6: Both FDA and Pfizer knew about major toxicities associated with gene therapy class of medicines, and therefore cannot claim lack of anticipatory knowledge of these risks.
Pfizer states that the primary pharmacology, distribution, metabolism, safety, and immunogenicity of BNT162b2 were studied in-vitro and in-vivo in mice, rats and rhesus monkeys as well as several cell-culture assay experiments. There was a total of 18 studies included in the Non-Clinical package: 7 were for the V9 candidate (including 1 non-GLP or non-Good Laboratory Practice compliant study which should not be acceptable for regulatory approval and labelling), and 6 studies were for only two of the four lipid excipients (ALC-0315 and ALC-0159). The other lipids included in the Lipid Nanoparticle Platform (LNP) – DSPC and cholesterol were not studied. Pfizer and regulators claimed elsewhere that DSPC and cholesterol are “naturally occurring”, which in general is true. However, neither occur in nature in the exact lipid nanoparticle formulation used in Pfizer’s product. In fact, some publications by Moderna refer to cholesterol analogues, i.e., modified cholesterol molecules to achieve intra cellular penetration. Pfizer’s documents do not explain what form of cholesterol is used and how it is formulated. No biocompatibility, biosimilarity or toxicity tests are provided. In addition, in the European Medicines Agency documents for Pfizer, the DSPC was labelled as “non-pharmaceutical grade”
FDA guidance on early-phase clinical trials program from 2015 is extensive and warns of severe known risks from prior experience with gene therapies:
Multi-organ failure and death
Potential for tumors/cancer development
Late onset T-cell leukemia
Potential for prolonged uncontrollable activity after single administration
Immunogenicity as a risk (autoimmunity)
Uncontrolled expression of genes
Migration of product to undesired organ systems
Possibility of shedding: excretion/secretion of viral particles that could be transmitted to other individuals
Studies in healthy volunteers are not generally advised due to potential severe toxicities
lol
Age-stratified infection fatality rate of COVID-19 in the non-elderly population
https://www.sciencedirect.com/scienc...1393512201982X
Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA
Sezione di Igiene, Dipartimento di Scienze della Vita e Sanità Pubblica, Università Cattolica del Sacro Cuore, Rome, Italy
Division of Infectious Diseases, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA
Faculty of Medicine, Université de Montréal, Montreal, Canada
Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, Stanford University, Stanford, CA, USA
Received 11 October 2022, Revised 21 October 2022, Accepted 22 October 2022, Available online 28 October 2022, Version of Record 3 November 2022.
Highlights
Across 31 systematically identified national seroprevalence studies in the pre-vaccination era, the median infection fatality rate of COVID-19 was estimated to be 0.034% for people aged 0–59 years people and 0.095% for those aged 0–69 years.
The median IFR was 0.0003% at 0–19 years, 0.002% at 20–29 years, 0.011% at 30–39 years, 0.035% at 40–49 years, 0.123% at 50–59 years, and 0.506% at 60–69 years.
At a global level, pre-vaccination IFR may have been as low as 0.03% and 0.07% for 0–59 and 0–69 year old people, respectively.
These IFR estimates in non-elderly populations are lower than previous calculations had suggested.
he US Food and Drug Administration (FDA), which mocked Americans for taking Ivermectin to treat Covid-19, now says their campaign telling people to "stop" taking it was informal and just a recommendation, according to an argument made by government lawyers during a recent hearing.
"The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,"
"They use informal language, that is true," Belfer continued, adding "it’s conversational but not mandatory."
Yet, in 2021 the FDA created a web page titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19," before then tweeting: "You are not a horse. You are not a cow. Seriously, y’all. Stop it."
https://twitter.com/US_FDA/status/1429050070243192839
https://twitter.com/justin_hart/status/1594328373467443200
Separately, there have been several studies funded by the Indian government, primarily conducted through their largest govt. public medical university (AIIMS).
Role of ivermectin in the prevention of SARS-CoV-2 infection among healthcare workers in India: A matched case-control study
Conclusion: Two-dose ivermectin prophylaxis at a dose of 300 μg/kg with a gap of 72 hours was associated with a 73% reduction of SARS-CoV-2 infection among healthcare workers for the following month.
Sharp Reductions in COVID-19 Case Fatalities and Excess Deaths in Peru in Close Time Conjunction, State-By-State, with Ivermectin Treatments (source, peer-reviewed, University of Toronto, Universidad EAFIT)
For the 24 states with early IVM treatment (and Lima), excess deaths dropped 59% (25%) at +30 days and 75% (25%) at +45 days after day of peak deaths. Case fatalities likewise dropped sharply in all states but Lima
Meanwhile, There are ongoing or completed clinical trials on Ivermectin around the world.
Ivermectin: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19
https://pubmed.ncbi.nlm.nih.gov/34466270/
Affiliations
Department of Obstetrics & Gynecology, Yale University School of Medicine, New Haven, CT, USA.
US Public Health Service, Inactive Reserve, Blacksburg, VA, USA.
Texas A & M College of Medicine, Dallas, TX, USA.
Ōmura Satoshi Memorial Institute, Infection Control Research Center, Kitasato University, Tokyo, Japan.
Centre for Digestive Diseases, New South Wales, Australia.
In 2015, the Nobel Committee for Physiology or Medicine, in its only award for treatments of infectious diseases since six decades prior, honoured the discovery of ivermectin (IVM), a multifaceted drug deployed against some of the world's most devastating tropical diseases. Since March 2020, when IVM was first used against a new global scourge, COVID-19, more than 20 randomized clinical trials (RCTs) have tracked such inpatient and outpatient treatments. Six of seven meta-analyses of IVM treatment RCTs reporting in 2021 found notable reductions in COVID-19 fatalities, with a mean 31% relative risk of mortality vs. controls
Review of Pfizer’s Chemistry Manufacturing and Controls module from EMA materials obtained via a data leak at the end of 2020 revealed the following information about the ingredients, dosage, and the total volume of the finished product in the vials:
Clearly, this means a 0.45 mL of drug product, when diluted with 1.8 mL of saline is supposed to deliver 5 doses of 30 mcg of mRNA each. The same dosage information, was provided in Pfizer’s briefing document for the FDA VRBPAC meeting on December 10, 2020, requesting the initial Emergency Use Authorization.
The label dosage information for Pfizer COMIRNATY currently available on the FDA website. Section 11 lists the ingredients in text form. The quantities per dose listed are the same as were provided in the FDA and EMA documents at the end of 2020. The total supplied volume of product in the vial is also the same – 0.45ml and calls for the same amount of the dilutant to arrive at the individual doses.
"COMIRNATY […] supplied as a frozen suspension in multiple dose vials with purple caps […]; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP […]. Each 0.3 mL dose of COMIRNATY supplied in multiple dose vials with purple caps […]contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each 0.3 mL dose of the COMIRNATY […] also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate 20 dihydrate, and 6 mg sucrose. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose."
The math clearly doesn’t add up: 225 mcg of the active mRNA substance in a vial equals to 50 mcg in a 5-dose vial and 38 mcg in a 6-dose one.
The explanation of this apparent mystery is that the mRNA injection ingredients are specified by weight while the dose administration is by liquid volume. Translation from one to the other is complicated. At the injection administration site, the untrained and unsupervised vaccinators who, no doubt, will be thrown under the proverbial bus first when this scam fully unravels, are involved in the last phase of mRNA product manufacturing – the making of the individual doses, outside of any possibility of quality control by the pharmaceutical company. If you are wondering if this violates the FD&C Act – yes, it does. This is like the illicit drug dealers cutting cocaine by hand in a basement lab, however, much less precise.
The vials, after dilution, contain 7.5 doses by liquid volume, and they always did. Pfizer relabeled vials from 5 to 6 doses without making any changes to the product but rewarding themselves with 20% more revenue while selling the same vials with the same effective number of doses. Genius. The dose therefore is sort of probabilistic. Assuming the ingredients, and especially mRNA distribute absolutely evenly in the vial after someone manually injects saline into it, turns it over 10 times, and then leaves it in the fridge for 6 hours, then each dose may be 30 mcg of mRNA. However, that’s a silly assumption. Of course, they do not. A technician draws a dose, lets the vial sit for 6 hours, draws some more doses, forgets it’s 6 hours, or forgets to put the vial into the fridge, and then decides that they too should make an extra buck by drawing the 7th dose from what is supposed to be only 5 or 6 doses – there are numerous scenarios that can be imagined (and are documented in VAERS database and other sources).
mRNA and LNPs are known to be highly unstable and to degrade rapidly. They also will not distribute evenly in a vial as this is a manually made water-fat mixture with fat tending to float to the top, especially after several hours. The doses are extremely uneven in composition of ingredients, some will contain 50%+ more mRNA and would this introduce 5-6 trillion extra mRNA molecules in the injection which will distribute all over the body in minutes, rapidly make toxic spikes, and may kill a person quickly. Pfizer’s internal pharmacovigilance report obtained by FOIA had thousands of severe adverse events and deaths documented in 2 months after roll-out with median onset below 48 hrs. Some doses will end up containing mostly water. We are all familiar with the fact that lots of people have no adverse events after the injections, while many thousands have died, got severely injured and permanently disabled by these injections. My own educated guess on this topic is that the doses from freshly opened and stirred vials would be the deadliest ones. The doses that were drawn from the vials that set on a shelf for a while, especially if the syringe is taking the liquid from the bottom of the container first will tend to be mostly harmless.
This was never tested by any regulator as no acceptance criteria for vials/doses exist.
Batches of the product are released based on self-declared testing of the bulk products by the manufacturer. Nobody can know the composition of the shots as they are administered to people with catastrophic consequences. It is NOT POSSIBLE to manufacture this product to Good Manufacturing Practice (cGMP) standards, i.e. with full assurance and verification of the ingredients and their precise quantities per dose. This was known by the manufacturers long ago when they attempted and repeatedly failed to bring any mRNA/DNA “therapy” to market in the past 20+ years.
I’ve never seen this show before but trust me fellas, this is completely normal…
https://twitter.com/eightredux/status/1611232451749380103
https://twitter.com/SKMorefield/status/1609717126138314752
Imagine supporting this cunt
"Nobody was forced"
noun: coercion
the practice of persuading someone to do something by using force or threats.
"our problem cannot be solved by any form of coercion but only by agreement"
Similar:
force
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Last edited by OK2; 01-06-2023 at 02:01 PM.
“I have enough confidence in the vaccine to get it done. .. Those of you who think the vaccine kills people can use me as a test.
If I die, you were right. If I don't die, and have no ill effects, you were wrong, and should admit it”
-Doug Brignole
April 4, 2021
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https://www.msn.com/en-us/health/med...690069522ff88f
FDA grants accelerated approval to Alzheimer's drug.
I can say with almost absolute certainty this drug is insanely expensive and probably does more harm than good. It certainly doesn't help with Alzheimer's.
That how blatant of a scam HC has become. It's time for the Druff's of the world to quit propping up this corrupt system.
Last edited by Entropy; 01-06-2023 at 03:03 PM.
Several of Canada’s largest legacy media companies failed to reveal nearly $2 million worth of Pfizer Pharmaceuticals funding that a leading pediatrics professor from Alberta has received while pushing for vaccination of 5-11-year-olds.
Dr. Jim Kellner, a pediatrician and University of Calgary professor, has been cited as an authority in dozens of articles published by CTV News, CBC, Global News, the Toronto Star, and the Globe and Mail on vaccinating children and other pandemic related issues.
Since 2014, Kellner’s research has received $1,940,443 from Pfizer Pharmaceuticals for various vaccine studies, with the most recent grant of $787,004 being allocated until the year 2022.
Kellner’s research funding was not disclosed by the above outlets in numerous articles going back to 2020 despite it being publicly reported in his CV, which is published on the University of Calgary’s website.
As for the Toronto Star, Kellner shows up as an expert in at least 11 articles, many of which promote vaccination of children all without disclosing his funding.
"It is not that you take this medication and your memory gets better," said Dr. Babak Tousi, lead investigator at the Cleveland Clinic study site and an associate professor of neurology and medicine at Lerner College of Medicine at Cleveland Clinic.
"It is a newer concept for many patients. It is not treating the symptoms but it slows down the decline," Tousi said.
And it comes with potentially significant side effects for some patients.
"There are some important safety concerns here, particularly bleeding in the brain, so patients will need to discuss those risks on a case-by-case basis with their doctors," Croll said.
Yo, Doc. I think my brain is bleeding fam. Was it this shit or what?
OK2,
If I die suddenly it wasn't from the vaccine. I never took those worthless clot shots.
https://sfstandard.com/technology/th...ey-dont-exist/
Low level psy-op tactic, imo, that typically only works on the true believers anyway (oh, and the retarded).
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