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COVID 19 deaths and injuries

Sudden Adult Death Syndrome, Killer Blood Clots and the Poisoning of Humanity

Sudden Adult Death Syndrome, Killer Blood Clots and the Poisoning of Humanity

As I always encourage you, please use this article as a jumping-off point for your own independent research. You could start with following the links in the RESEARCH AND STUDIES heading below, where many important research papers are listed. This article is an adapted reposting of many other people’s tremendous work and addresses some of the following questions:
• Is there a diabolical plan behind superparamagnetic graphene/iron oxide nano-particles that are being found in the bloodstreams of people who have received the Covid vaccine or died from Sudden Adult Death Syndrome?
• Could the super-permeation of graphene family substances in food, drinks, water, vaccines, medicines, cosmetics, packaging, and medicines be a planned conspiracy against human health?
• Are graphene oxide “circuits” being created in the human body to control the many nano-particle metals being injected into people through vaccines and through the ingestion of food?
• Can graphene oxide be “pre-programmed” before being inserted into injections, food, and the environment?
• Is the transhumanistic plan for “aggressive remote-control of all things” (Internet of Things, Internet of the Body) actually possible through new scientific “mad-scientist” experiments of human subjects using the Graphene Family of Nano-materials?
What’s Causing the “Killer” Blood Clots?
Throughout the world, doctors are putting the Covid vaccine under the microscope, along with human blood from vaccinated people, and discovering the most astoundingly disgusting results that prove that pharmaceutical companies are lacing jabs with nano-metals, graphene and iron oxide nano-structures, and many other substances of “unknown” origin.
These substances are accumulating in blood vessels as they self-organise and self-replicate with the magnetic and electrically conductive materials found in the vaccines that are being used by the pre-programmed graphene oxide to build as-yet unidentifiable structures in blood vessels and tissue that block our blood flow, thus creating strokes and heart attacks. These clot-like “structures” have also been analysed and found to contain the same metallic substances.
Graphene Oxide flakes, sheets, webs, and 3D structures build blood clots that create vascular obstructions and heart problems leading to the “vaccine death” now called Sudden Adult Death Syndrome.
Graphene oxide “quantum dots” pass through the brain-blood barrier and deposit toxic Graphene Oxide in the mid-brain, causing Alzheimer’s and Parkinson’s-like symptoms. This condition is also being called human spongiform encephalitis.
Many of these new illnesses and symptoms are caused by, or exacerbated by, Graphene Oxide substances that “build” unwanted, and unnatural structures in the human body that are foreign, man-made, sub-natural substances causing toxicity, harm, and death. Graphene Oxide organises nano-metals into circuits that become sensors, activators, antennas, broadcasters, magnetic triggers, bio-electric devices, and mechanisms for diagnostic feedback in magnetic resonance imaging. A doctor can take readings from these circuits with external devices. These anomalies are being picked up in breast mammograms all over the world, interfering with the breast scans of inoculated women.
Unfortunately, these experimental, immoral, research projects got out-of-hand during the fake pandemic when all safety protocols were ignored. Humans became the “animal trials” and “lab rats” for vaccine “gain of function” bioweapon experimentation without any consideration for adverse vaccine reactions. It was not possible for people to give “Informed Consent” for these jabs as they were never given true and accurate information about what was contained in the so-called “vaccines” which in effect were experimental genetic technologies never before used on human populations.

Of course, the bigger question for ALL Australians, and indeed the entire world, is: Why did the TGA, ATAGI, State and Federal Parliaments and Health Ministers, Health “authorities” like our Australia-wide Primary Health Networks, legal system and courts, police and military sanction these crimes against humanity?
This question needs to be answered not only by Australian bodies responsible for the vaccine rollout, but also by international bodies leading the hysterical pandemic response. This includes the WHO, UN, WEF, CDC, NIH, US Congress, US courts, and all world politicians who coerced, threatened and intimidated people into being force-jabbed. This also includes perhaps the most powerful political human on the planet today – former US President Donald Trump, who to this day refuses to acknowledge the great harm done to millions of vaccine-injured people and continues the false narrative that the jab is “safe and effective”, despite overwhelming evidence that it is neither safe nor effective, and never was – even during the Pfizer vaccine trials, as Pfizer’s own data clearly proves.
Millions of people who are AWAKE to the deceit that has been carried out on the world population have discovered that the answer to this vexing question is that this is Standard Operating Procedure for Big Pharma that is actually not an industry of health, but one of promoting illness and death – a pharmaceutical killing-field of depopulation.
It is easy to understand why so many people believe that Big Pharma is a depopulation syndicate of rich elite who wish to decrease the Earth’s population by billions of people – and, as quickly as possible without being noticed and with complete impunity. Sadly enough, there seems to be no other answer than the fact that this is all a planned eugenics policy of transnational pharmaceutical (vaccine) syndicates aligned with Big Pharma, WHO, CDC, NIH and many other agencies and organisations.
First, let’s take a look at the proof that this toxic poison is in the bodies of vaccinated people via microscopic examination. It is important to remember that most Covid vaccinations have these graphene/iron oxide “adjuvants” in them, especially childhood vaccines since 2008, flu shots, shingles and pneumonia vaccinations, as well as many medical treatments and procedures.
Hundreds of doctors worldwide are now examining the Covid vaccines, and human blood samples, under microscope and finding results that seem to be from a horrifying science-fiction movie.
In an article from The Defender, on August 25, 2022, entitled, Toxic, Metallic Compounds Found in All COVID Vaccine Samples Analyzed by German Scientists, by The Epoch Times, Enrico Trigoso:
A group of independent German scientists found toxic components – mostly metallic – in all the COVID-19 vaccine samples they analysed, “without exception” using modern medical and physical measuring techniques. The Working Group for COVID Vaccine Analysis says that some of the toxic elements found inside the AstraZeneca, Pfizer, and Moderna vaccine vials were not listed in the ingredient lists from the manufacturers. The following metallic elements were found in the vaccines:
• Alkali metals: caesium (Cs), potassium (K)
• Alkaline earth metals: calcium (Ca), barium (Ba)
• Transition metals: cobalt (Co), iron (Fe), chromium (Cr), titanium (Ti)
• Rare earth metals: cerium (Ce), gadolinium (Gd)
• Mining group/metal: aluminium (Al)
• Carbon group: silicon (Si)
• Oxygen group: sulphur (S)
“We have established that the COVID-19 vaccines consistently contain, in addition to contaminants, substances the purpose of which we are unable to determine,” their study says.

Caption: Comparison of crystals in the blood and in the vaccine; on the left, crystalline formations are found in the blood of test subjects vaccinated with Comirnaty (BioNTech/Pfizer), the images on the right show that these types of crystals are also found in Comirnaty vaccines. Image credit: Helen Krenn

In an article from The Expose entitled: Covid Injection Aftermath: Study finds 94% of “Vaccine” Recipients have Pre-Blood Clot Formations and Foreign Particles, by Rhonda Wilson, on 8/24/2022 the author states: “An Italian study published two weeks ago in the International Journal of Vaccine Theory, Practice, and Research revealed almost everyone who had been injected had abnormalities after Covid vaccination. In 94% of vaccinees’ blood, there was an aggregation of red blood cells and the presence of particles of various shapes and sizes.” The study began in March 2021. Using dark-field microscopy, the researchers analysed blood samples from 1,006 referred to the Giovannini Biodiagnostic Centre for various disorders after being injected with Pfizer/BioNTech or Moderna mRNA vaccines.
In the study, authors noted that the vaccines are purported to contain at least the spike protein from SARS-CoV-2 but are known also to contain foreign particles. “Among those foreign components are metallic objects as demonstrated previously in this journal by Lee et al. (2022) which are confirmed in our results.” Of the 1,006 cases analysed, only 58 – equal to 5.77% of the total – presented a completely normal haematological picture upon microscopic analysis after the last mRNA injection with either the Moderna or Pfizer vaccine. The blood of 948 – 94% of the study’s participants – showed aggregation of red blood cells and the presence of particles of various shapes and sizes of unclear origin one month after the mRNA injection.
Blood clots found by morticians have been sent all over the world to be studied by independent teams. The only thing that is for sure is that something is taking the injected metals and building them into “killer clots” throughout the body. These clots have substances and structures inside of them that are “unidentifiable” and cannot be explained by anyone. But they are obviously designed to kill the host body that receives the injections.
Deadly Graphene Oxide
Graphene Oxide flakes self-organise, move towards each other, and build layers like an independent robot. That is why they are used in hydrogels for the slow release of medicine in a patch, a patch that can sense what the Graphene Oxide receivers are broadcasting about the chemical function of the liver, pancreas, or most any other diseased area. A doctor can also read a Graphene Oxide “infested” organ and then give electrical/magnetic commands for a hydrogel to release a specific amount of medicine. Graphene Oxide (GO) can do wonders because it is monoatomic – one atom thick, either as a “dot”, “flake”, “sheet”, “tube”, “web”, or “buckyball/fullerene.” Graphene is carbon and carbon is the source of organic processes because it is seemingly amorphous, like silica in the inorganic world. As GO sheets, GO hyper-connects in all directions (superconductivity) in length and breadth and scientists say it is 2D – which it is not. A sheet of GO is transparent, electro-conductive, 100 times stronger than steel, self-organising, and self-replicating when in the presence of specific EMFs and magnetic fields. Graphene Oxide, GO, can be the scaffolding for just about anything, organic or inorganic.
Graphene Oxide as nano-tubes has created a diabolic industry of nano-technology that is far more evil than most people are aware of and yet touches most aspects of their life through myriad industries beyond just medical uses. Graphene Oxide and iron oxide (both superparamagnetic) are everywhere, but especially in vaccines, medicines, food and cosmetics. They supposedly control and target vaccine delivery but are also known for being a common adjuvant, a substance that is seen as “foreign” (xenobiotic/inhuman) that creates an immune reaction because it is seen as an antigen or pathogen trying to harm the body. Graphene Oxide is considered toxic (cytotoxic) in the smallest amounts and accumulates in the body and yet it is used everywhere, including the lipid-coated nanotubes that deliver vaccines and other medicines.

It is also mutagenic, causing DNA damage and continuing mutation, just as mRNA vaccines have recently been proven to do.
Graphene Oxide as nanowebs can combine dots, flakes, tubes, and sheets into animated nanowebs that self-organise, self-replicate and direct the building of tissue-like material in the circulatory system, as well as nanocircuits that target certain organs (brain, heart, ovaries, testes, liver, etc.) and carry the payload inside the nanotube to the targeted organ.
All of these things are already happening, these are not science predictions, they are science fact. These types of inhuman, mechanical, anti-life systems are being used right now, approved by the FDA, CDC, NIH, WHO, AMA, etc., to target and attack cancer cells in a variety of organs. Doctors can inject and move large amounts of Graphene Oxide with a magnet to a specific organ, inject a hydrogel and control the release of more nano-tubes from the hydrogel with a phone app while conducting a telemedicine appointment.
These GO nano-technologies, merged with mRNA, are creating the most-deadly genocide in human history. We have only seen the initial results so far. Some estimates are that over twelve million people have died directly associated with the current jab. Untold others have experienced terrible adverse reactions and complete loss of their quality of life. That doesn’t take into consideration the millions who have died due to the same vaccine death shots given out continuously for flu, pneumonia, shingles, or childhood vaccines.
The vaccine-induced Sudden Infant Death Syndrome is now joined by the Sudden Adult Death Syndrome and the medical authorities actively look the other way as hundreds of athletes drop dead on the playing field before the audience. And still, the vaccine has not been pulled from the market and the guilty prosecuted.
Graphene Oxide as fullerenes (buckyballs) is, as yet, little used. It is a man-made 3D structure folded from GO sheets which can also make other 3D geometric solids.
This is totally different than C-60, a natural occurring substance which is presumed to be from meteorites. Naturally occurring C-60 (fullerenes/buckyballs), which can be found in the rare mineraloid shungite, has nothing to do with the GO buckyballs created in laboratories.
Scientists believe that bucky-balls (C-60) originate in space and are a highly developed form of carbon exposed to cosmic heat. There is also C-70, C-80, and other carbon compounds found in space that have exposed carbon to tremendous heat, which is one way to create Graphene Oxide – burn a steak on your barbeque and you have simple Graphene Oxide.
It seems quite likely that as human intelligence develops, so too does carbon develop in its many organic forms through a natural process of metamorphoses. We owe our life to carbon and if more perfect forms of carbon already exist in our solar system and cosmos, then obviously we can metamorphose carbon into higher forms and functions. Unfortunately, our voodoo witch-doctor mad-scientists haven’t considered any of these ideas as they are actively devolving into a “Graphene World” of one, two, and three-dimensional, man-made monstrosities by injecting a Frankenstein mutation (mRNA is mutagenic) into the new Graphene Oxide, Genetically Modified Human Being, a new species that has fallen out of the 3D world into the 2D Graphene World.
Humans can advance to an objective view of time and enter a world of spiritual endurance (4D) instead of the illusion of linear time (3D). Modern materialistic science has devolved into two dimensional nanowebs that mimic human neural nets with 2D nanosheets/nanowebs that build “fake” human tissue with their 1D nano graphene dust/graphene flakes that are designed to kill human beings, ultimately leading to 0D – death. This is clearly planned elimination of everyone who does not know the secret – “Don’t take any injections of any kind.”

Graphene World is a world of sub-nature, a step backwards into immoral animal, plant, and mineral realms, not a step forward into higher forms of carbon in super-nature that are part of human ascension. Graphene Oxide is a man-made sub-element that can only lead into darkness and the horrifying medical genocide we are seeing around us in all fields of medicine.
Every person involved in gain of function research on deadly viruses and vaccines is an enemy to humanity. Using GO to deliver any vaccine is diabolical, then add mRNA and you have a truly evil group of murderers. These types of experiments on “uninformed” humans are creating a new species of ill and dying humanity and an elite pharmaceutical syndicate that openly advocates depopulation by injection, toxic food, toxic chemtrail air, a medical industry creating illness, economic slavery, psychological subliminal programming, and the mass hypnosis of media propaganda that sold the world a fake pandemic – the fear of Virus X.
Virus X, the highly prophesied pandemic of huge proportions, is spliced into the synthetic virus that was created in a bioweapon P-4 lab and disseminated to all other P-4 secure biolabs throughout the world (including here in Australia). This biological weapon of mass destruction was bio-engineered with funding from Dr. Anthony Fauci and the US National Institutes of Health, the CDC, and the World Health Organisation of the United Nations. The United Nations is a clear Anti-Humanity war-actor that has taken over our freedoms via Pharmaceutical Terrorism with a fake pandemic supported with lies and bad protocols that have killed and maimed millions across the entire planet.
Iron oxide as a vaccine adjuvant has been in most childhood vaccines since 2008. Graphene Oxide is present everywhere in the environment and yet is poisonous, as proven in every study of its toxicity. And yet the medical industry pushes forward without any moral reflection on the harm being done to humans. These Big Pharma doctors and drug-pushers are individuals who have devolved into immoral animals who are now below even what an animal would do to another animal.
The demonic forces involved in this global Pharmaceutical World War III are quite real and wish to turn all humans into machine-augmented cyborgs who can be “stopped” or “controlled” by pushing a button that activates transhuman networks inside the human body. This nefarious plan has been patented by Richard C. Walker and is called “The Aggressive Remote Control of Everything”, which can only be fully accomplished by having an “OFF” button on every human being created by nano graphene technology.
What is Graphene Oxide (GO)?
Graphene Oxide (GO) is a single atom carbon layer where both surfaces of the layer are modified by oxygen containing functional groups that are bonded together in a repeating pattern of hexagons. There is tremendous interest in graphene and its derivatives [graphene oxide (GO) and reduced GO (rGO)] due to their superior mechanical, thermal, electrical, optical, and chemical-adsorption properties. In the past few years, graphene-based materials attracted much attention and were used for many practical applications in various industries. Recent developments on graphene synthesis from foodstuffs, use of graphene for food analyses, and graphene-based analytical methods in detection (e.g., composition, contaminants, toxins, and volatile organic compounds) are used to help to ascertain the quality and/or safety of foods. There are also antibacterial properties of graphene-based nanomaterials and their applications in food packaging.
Graphene Family Nano-materials trigger local and systemic toxic effects, induce genotoxicity in vitro and in vivo, alter the gut microbiome, cause genetic mutations, and are inedible. Further toxicological and risk assessment studies are needed especially when used in food or injections of any type.
Different applications have been suggested for graphene nano-materials (GFNs) in the food and feed chain.

However, it is necessary to perform a risk assessment before they become market-ready, and when consumer exposure is demonstrated. For this purpose, the European Food Safety Authority has published a guidance that has been recently updated to identify and characterise toxicological hazards related to GFNs after oral exposure. GFNs seemed to resist gastrointestinal digestion, and were not able to be absorbed, distributed, and excreted, inducing toxic effects at different levels, including genotoxicity. Also, dose has an important role as it has been reported that low doses are more toxic than high doses because GFNs tend to aggregate in the digestive system, changing the internal exposure scenario. Thus, further studies including a thorough toxicological evaluation are required to protect humanity from these, as yet unknown, effects of GFNs.
Although Graphene Oxide – like graphene – is also a 2-Dimensional material, its properties are very different from that of graphene. It does not absorb visible light, has a lower electric conductance compared to that of graphene, and demonstrates significantly higher chemical activity. Its high electron mobility is 100x faster than silicon; it conducts heat 2x better than diamond; its electrical conductivity is 13x better than copper; it absorbs only 2.3% of reflecting light; it is impervious so that even the smallest atom can’t pass through a defect-free monolayer graphene sheet with a thickness of about 0.33 nanometers. There are about 3 million layers of graphene in a 1 mm thick sheet of graphite. Harder than diamond yet more elastic than rubber; tougher than steel yet lighter than aluminium – graphene is the strongest known material.
Some of the most promising applications of graphene are publicised as being in electronics (as transistors and interconnects), detectors (as sensor elements) and thermal management. The first graphene field-effect transistors (FETs) have already been created and used for nano analog communication or nano digital applications.
An ever-increasing number of research groups are exploiting programmable self-assembly properties of nucleic acids in creating rationally designed nano-shapes, nano-machines, and nano-electronic devices that can self-assemble for many different uses. These devices include nano-routers, nano-antennas, and nano-circuit boards. Medical nano-technology researchers have created nano-bots, a popular term for molecules with a unique property that enables them to be programmed to carry out a specific task.
When Graphene Oxide is injected into the body and interacts with biological blood or tissue, the GO picks up hydrogen and becomes graphene hydroxide. The OH (hydroxy) groups can then split off a proton which leaves a negative charge affecting the whole graphene sheet and making it highly acidic and damaging to red blood cells. It also is incredibly sharp and acts like razor blades cutting blood vessels, tissue, and organs. Self-organising GO tubes and sheets can block capillaries and arteries, with devastating effects when this occurs in the heart and lungs.
Graphene Oxide inside the body causes thrombogenicity, blood clotting, post inflammatory syndrome or systemic or multi-organ inflammations, causes alteration of the immune system, collapse of the immune system, cytokine storms, neurodegeneration, and mutagenic effects changing the DNA of the host. Inhaled Graphene Oxide spreads evenly throughout the alveolar tract and causes bilateral pneumonias, inflammation of the mucous membranes, and loss of taste and smell. Graphene Oxide toxicity in the human body behaves like SARS-CoV-2, generating the same symptomatology.
Graphene, Graphene Oxide (GO), carbon nano-tubes, and the entire graphene-family nano-materials (GFN) are toxic in almost all their forms, causing mutagenesis (cancer, chromosomal alteration), cell death, apoptosis, necrosis, and the release of free radicals.

It creates immunosuppression, damage to the central nervous system, circulatory, endocrine, reproductive, and urinary systems, which can cause anaphylactic death, and multi-organ dysfunction. It increases toxicity rapidly in the lungs, creating cytokine storms leading to bilateral pneumonia, genotoxicity, and DNA damage.
Several typical mechanisms underlying Graphene Oxide nano-material’s toxicity have been revealed in numerous studies, for instance, physical destruction, oxidative stress, DNA damage, inflammatory response, apoptosis, autophagy, and necrosis. In these mechanisms, toll-like receptors, transforming growth factor-beta (TGF-β) and tumour necrosis factor-alpha (TNF-α) dependent-pathways are involved in the signalling pathway network, and oxidative stress plays a crucial role in these pathways. Many experiments have shown that Graphene Oxide nano-materials have toxic side effects in many biological applications. According to the USA FDA, graphene, Graphene Oxide, and reduced graphene oxide elicit toxic effects both in vitro and in vivo. Graphene-family nano-materials (GFN) are not approved by the USA FDA for human consumption.
Graphene Oxide has been used in a wide variety of nano-medical applications including tissue engineering, cancer treatment, medical imaging, and drug delivery. Its physiochemical properties allow for a structure to regulate the behaviour of stem cells, with the potential to assist in the intracellular delivery of DNA, growth factors, and synthetic proteins. Due to its unique behaviour in biological environments, GO is used in cancer therapies. It has also been used in vaccines and immunotherapy, including as a dual-use adjuvant and carrier of biomedical materials.
In September 2020, researchers at the Shanghai National Engineering Research Center for Nanotechnology in China filed a patent for use of Graphene Oxide in a recombinant vaccine under development against SARS-CoV-2.
The properties of graphene are exceptional from a physical, thermodynamic, electronic, mechanical, and magnetic point of view. Its characteristics allow it to be used as a superconductor, crystallized graphene nano-antenna, and graphene quantum dot nano-routers. It is an electromagnetic wave absorbing material, a signal emitter-receiver, and an antenna which makes it possible to create advanced nano and micrometric scale electronics. Graphene is a radio-modulatable nano-material. The graphene molecule also has the ability to inject electrons into other biological substances depending on the electromagnetic environment and temperature. Graphene is activated at room temperature and above.
Graphene can multiply radiation, acting as a nano-antenna, or else a signal repeater, a transistor. Exposure to electromagnetic radiation – such as from smartphones and communications towers – can cause the exfoliation of the material into smaller particles called Graphene Quantum Dots (GQD), whose properties and physical peculiarities are enhanced since they act by amplifying electromagnetic signals and, with that, the emission distance, especially in environments such as the human body. Graphene quantum dots can acquire various morphologies like hexagonal, triangular, circular, bucky-bulls, or irregular polygons and geometric solids.
The nightmare of Graphene Oxide circuits in human food is a Frankenstein monster that kills. As Mark Wilson’s headline reads: Edible Graphene Is Here, And Electronics In Your Food Are Coming. Mark’s article highlights the research conducted by Jeff Fitlow from Rice University that uses a stock laser to carve edible circuits into food. These researchers have successfully used a commercial laser to transform the surface carbon in foods – like toast, coconuts shells, potatoes, and Girl Scout cookies – into graphene. Without using any special vacuums or clean rooms, graphene can be patterned into an impossibly thin, edible circuit.

Graphene can be used to help fuel cells to store power, radio hardware to transmit data, glowing elements to light up, and all sorts of sensors, as well as deliver a pre-programmed piece of toast that can control your body. These graphene circuits resemble a dark, inky tattoo, a bit like very burnt toast. But, don’t forget, graphene is inedible, toxic, and a nerve poison.
Iron Oxide and Graphene Technology
Iron oxide nano-structures (IONs) in combination with graphene or its derivatives – e.g., Graphene Oxide and reduced graphene oxide – hold great promise toward engineering of efficient nano-composites for enhancing the performance of advanced devices in many applicative fields. Due to the peculiar electrical and electrocatalytic properties displayed by composite structures in nanoscale dimensions, increasing efforts have been directed in recent years toward tailoring the properties of IONs-graphene based nanocomposites for developing more efficient electrochemical sensors.
Unique features of IONs e.g., strong magnetic properties, low toxicity, high adsorption ability for immobilisation of desired biomolecules and good biocompatibility, together with elegant properties of this new member of the carbon family e.g., high electrical/thermal conductivity, large surface area and electrocatalytic properties, have stimulated many interests for overcoming difficulties in realising new scientific ideas or improving the performance of many current devices and methods. Catalytic activity of the graphene-IONs can be improved due to enhanced electronic communication e.g., charge transfer between catalyst and support. Additionally, synergistic effects of graphene sheets and IONs components provide nano-composite with novel physicochemical properties and consequently enhance electrochemical performance. As a result, graphene-IONs nano-composites have been considered as one of the most promising hybrid materials that can boost the development of more efficient electrochemical sensors.
Hydrogels and Graphene Oxide
Due to their tissue-like mechanical properties, hydrogels are being increasingly used for biomedical applications; a well-known example are soft contact lenses. These gel-like polymers consist of 90 percent water, are elastic and particularly biocompatible. Hydrogels that are also electrically conductive allow additional fields of application, for example in the transmission of electrical signals in the body or as sensors. Graphene and graphene derivatives (e.g., Graphene Oxide (GO) reduced graphene oxide (rGO)) have been incorporated into hydrogels to improve the properties (e.g., mechanical strength) of conventional hydrogels and/or develop new functions (e.g., electrical conductivity and drug loading/delivery). Unique molecular interactions between graphene derivatives and various small or macromolecules enable the fabrication of various functional hydrogels appropriate for different biomedical applications. Hydrogels are widely used in all anti-wrinkle cosmetic fillers. In order to produce electrically conductive hydrogels, conventional hydrogels are usually mixed with current-conducting nano-materials that are made of metals or carbon, such as gold nano-wires, graphene or carbon nano-tubes.
To demonstrate the truth and efficacy of the above statements concerning the graphene family materials, we present below a series of research projects which summarise the “state of the art” concerning research in Graphene Oxide in its many forms. Much of what has been said above may have sounded alarmist, or even like wild, sci-fi fairytales of transhumanism, but the research below demonstrates that all of the experiments on humans with graphene substances has been going on for many years on a massive scale. The “innovations” in nano-particle research are not “illegal” but should certainly be “not allowed” by any moral scientist, doctor, or sane person.

For the sake of innovation, humanity is now a collective lab rat to be experimented on by morally bankrupt drug-doctors preaching the Gospel of Transhuman manipulation of the building blocks of DNA, human organs, tissue creation, neurological control through networks, and inhuman mechanical thinking that dominates “precision medicine” and nano-biology. Essentially, nano-biology should be an oxymoron, instead of the current medical, experimental treatment, vaccine, or deadly medical procedure. Man-made toxic graphene does not belong in the human body. After reading these studies, I believe you will agree with the author that all Graphene Oxide use must end immediately and parties guilty of these heinous crimes against humanity must be brought to justice.
Graphene and Iron Oxide in Vaccines
From: ACS Publications, February 17, 2021, In Situ Transforming RNA Nanovaccines from Polyethylenimine Functionalized Graphene Oxide Hydrogel for Durable Cancer Immunotherapy,Yue Yin, Xiaoyang Li, Haixia Ma, Jie Zhang, Di Yu, Ruifang Zhao, Shengji Yu, Guangjun Nie, and Hai Wang

Abstract: Messenger RNA (mRNA) vaccine is a promising candidate in cancer immunotherapy as it can encode tumor-associated antigens with an excellent safety profile. Unfortunately, the inherent instability of RNA and translational efficiency are major limitations of RNA vaccine. Here, we report an injectable hydrogel formed with graphene oxide (GO) and polyethylenimine, which can generate mRNA and adjuvants (R848)-laden nanovaccines for at least 30 days after subcutaneous injection. The released nanovaccines can protect the mRNA from degradation and confer targeted delivering capacity to lymph nodes. The data show that this transformable hydrogel can significantly increase the number of antigen-specific CD8+ T cells and subsequently inhibit the tumor growth with only one treatment. Meanwhile, this hydrogel can generate an antigen specific antibody in the serum which in turn prevents the occurrence of metastasis. Collectively, these results demonstrate the potential of the PEI-functionalized GO transformable hydrogel for effective cancer immunotherapy.
The Food and Drug Administration (FDA) has approved many types of iron oxide nanoparticles for clinical use, such as treating iron deficiency, contrast agents for magnetic resonance imaging (MRI) and drug delivery platforms. In one study, researchers explored the combined use of iron oxide nanoparticles (superparamagnetic Fe3O4 nanoparticles) as a vaccine delivery platform and immune potentiator, and investigated how this formulation affected cytokine expression in macrophages and dendritic cells (DCs) in vitro and tumor growth in vivo. Their iron oxide nanoparticles greatly promoted the activation of immune cells and cytokine production, inducing potent humoral and cellular immune responses. These results suggest that this nanoparticle-based delivery system has strong potential to be utilized as a vaccine for viruses.
Superparamagnetic iron oxide nanoparticles (SPIONs) as a contrast agent have been widely used in magnetic resonance imaging for tumor diagnosis and theranostics. However, there has been safety concern of SPIONs with cirrhosis related to excess iron-induced oxidative stress. Analysis with PCR array of the toxicity pathways revealed the high dose of SPIONs induced significant expression changes of a distinct subset of genes in the cirrhosis liver.

All these results suggested that excess iron of the high dose of SPIONs might be a risk factor for cirrhosis because of the marked impacts of elevated lipid metabolism, disruption of iron homeostasis and possibly, aggravated loss of liver functions.
At present, nanoparticles are used for various biomedical applications where they facilitate laboratory diagnostics and therapeutics. More specifically for drug delivery purposes, the use of nanoparticles is attracting increasing attention due to their unique capabilities and their negligible side effects not only in cancer therapy but also in the treatment of other ailments. Among all types of nanoparticles, biocompatible superparamagnetic iron oxide nanoparticles (SPIONs) with proper surface architecture and conjugated targeting ligands/proteins have attracted a great deal of attention for drug delivery applications.
Superparamagnetic iron oxide nanoparticles (SPIONs) have drawn attention because of their excellent superparamagnetic properties such as controllable size, large surface area-to-volume ratio, and nontoxicity. Surface functionalization of SPIONs with therapeutic molecules, including antimicrobial agents, has been successfully used in nanomedicine. Through application of an external magnetic field, antimicrobial-loaded SPIONs can be guided to the desired infection site allowing a direct and specific therapeutic effect with minimum side effects. The great advantage of SPIONs is their magnetic properties that allow direct delivery of matter into the pathogen zone without influencing the whole organism, which incites an increasing interest in the development of antimicrobial SPIONs.
When infused intravenously, these SPIONs can be used to detect and characterize small focal lesions in the liver. They also can be administered orally in order to visualize the digestive tract, and can be used as biomarkers to evaluate the efficacy of treatments. But still further investigations are required using labeled SPIONs in the field of molecular imaging.
Superparamagnetic iron oxide nanoparticles (SPIONs) have been studied for various biomedical applications, such as contrast agents, iron replacement therapies, drug delivery, tissue repair, hyperthermia, cell and tissue targeting, and transfection. SPIONs have an iron oxide core that is coated by an organic or inorganic layer. Bare SPIONs may be toxic because there is chemical reactive, so the coating layer prevents aggregation and agglomeration of the nanoparticles and reduces iron oxide oxidation. SPIONs are largely studied for magnetic resonance imaging and targeted delivery of drug and antigen to the required sites.
SPIONs have been approved by the FDA for treatment of anemia in adult patients with chronic renal disease. SPIONs are also used for noninvasive diagnosis of chronic liver diseases, nonalcoholic steatohepatitis, cirrhosis, liver tumors, magnetic resonance angiography, lymph node imaging, bone marrow imaging, and atherosclerotic plaque imaging.
Graphene Oxide as a Vaccine Carrier and Adjuvant
From: Acta Biomaterialia, Volume 112, August 2020, Pages 14-28, Recent progress of graphene oxide as a potential vaccine carrier and adjuvant, WanjunCaoab, LinHea, Weidong Caob, Xiaobing HuangaKun, Jiac Jingying Dai

Adjuvants and carriers have been appropriately added to the vaccine formulation to improve the immunogenicity of the antigen and induce long-lasting immunity. Graphene oxide (GO), widely employed for the delivery of biomolecules, excels in loading and delivering antigen and shows the potentiality of activating the immune system. However, GO aggregates in biological liquid [blood clots] and induces cell death, and it also exhibits poor bio-solubility and bio-compatibility.

COVID 19 deaths and injuries

The UK Government Is Now Admitting the Injections Are Not Safe for Pregnant Women

The UK Government is Now Admitting the Injections Are Not Safe for Pregnant Women

The UK government is now admitting the injections are not safe for pregnant women:

Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech- Updated 16 August 2022

Toxicity conclusions

“In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated.”

Summary of the Public Assessment Report

Authorisation for Temporary Supply, COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection

Department of Health and Social Care (DHSC), Pfizer Limited & BioNTech Manufacturing, GmbH

Lay summary, COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection (BNT162b2 RNA)

This is a summary of the Public Assessment Report (PAR) for COVID-19 mRNA Vaccine BNT162b2. It explains how this product was assessed and authorised under Regulation 174 of the Human Medicine Regulations, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

The product will be referred to as BNT162b2 in this lay summary for ease of reading.

For practical information about using BNT162b2 patients should read the Information for UK recipients or contact their doctor or healthcare practitioner.

What is BNT162b2 and what is it used for?

BNT162b2 is a vaccine indicated for active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 12 years of age and older.

How does BNT162b2 work?

When a person is given BNT162b2, it triggers the body to naturally produce antibodies and stimulates immune cells to protect against COVID-19.

How is BNT162b2 used?

The pharmaceutical form of this medicine is an injection. Following dilution with saline, BNT162b2 is given to you by an authorised practitioner as an intramuscular injection into the muscle at the top of the upper arm (deltoid muscle). You should receive two doses (each 0.3mL) given 21 days apart.

For further information on how BNT162b2 is used, refer to the Information for UK Healthcare Professionals and the Information for UK recipients available on the Medicines and Healthcare products Regulatory Agency (MHRA) website.

This vaccine can only be obtained with a prescription.

If a person has any questions concerning the vaccine, they should ask the administering healthcare practitioner.

What benefits of BNT162b2 have been shown in studies?

BNT162b2 has been studied in approximately 43,000 individuals 16 years of age and older who were equally allocated to the vaccine or a placebo. Those who received vaccination with BNT162b2 had a reduction in the rate of COVID-19 illness compared to those who received placebo (8 cases of COVID-19 illness in the vaccinated group compared to 162 cases in the placebo group). These results were observed 7 days following the second dose in study participants with no evidence of prior SARS-CoV-2 infection.

A similar benefit of the vaccine was observed in subjects with one or more other medical conditions that increase the risk of severe COVID-19 disease, such as obesity, hypertension, diabetes, or asthma.

What are the possible side effects of BNT162b2?

The most common side effects with BNT162b2 (which may affect more than 1 in 10 people) were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. Adverse events were usually mild or moderate in intensity and resolved within a few days after vaccination.

Why was BNT162b2 approved?

It was concluded that BNT162b2 has been shown to be effective in the prevention of COVID-19. Furthermore, the side effects observed with use of this vaccine are considered to be similar to those seen with other vaccines. Therefore, the MHRA concluded that the benefits are greater than the risks and recommended that this medicine can be authorised for temporary supply during the COVID-19 pandemic.

What measures are being taken to ensure the safe and effective use of BNT162b2?

All new medicines approved require a Risk Management Plan (RMP) to ensure they are used as safely as possible. An RMP has been agreed for the use of BNT162b2 in the UK. Based on this plan, safety information has been included in the Information for UK Healthcare Professionals and the Information for UK recipients, including the appropriate precautions to be followed by healthcare professionals and patients.

All side effects reported by patients/healthcare professionals are continuously monitored. Any new safety signals identified will be reviewed and, if necessary, appropriate regulatory action will be taken. The MHRA has also put in place an additional proactive safety monitoring plan for all COVID-19 vaccines to enable rapid analysis of safety information which is important during a pandemic.

Other information about BNT162b2

Authorisation for the temporary supply of BNT162b2 was granted in the UK on 1 December 2020.

The full public assessment report for BNT162b2 follows this summary.

This summary was last updated in June 2021.

A marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002).

1. Introduction

This report is based on the information provided by the company in a rolling data submission procedure and it covers the authorisation for temporary supply of BNT162b2. At the time of writing, the main clinical study is still on-going and additional data is being collected. Due to differences in the collection date, the data and information in this report may differ from that contained in documents relating to BNT162b2 released by other regulatory authorities. Quality aspects of the vaccine are reviewed on a batch-specific basis.

In December 2019, a pneumonia outbreak of unknown cause occurred in Wuhan, China and in January 2020, a novel coronavirus was discovered as the underlying cause. Infections by the virus, named SARS-CoV-2, and the resulting disease, COVID-19, have spread globally. On 11 March 2020, the WHO declared the COVID-19 outbreak to be a pandemic.

At the time of this report, the number of COVID-19 cases in the UK is estimated at 1.64 million and more than 60,000 deaths have been attributed to the disease. These numbers continue to rise. The elderly and those with pre-existing medical conditions are at an increased risk of severe disease and death from COVID-19. Vaccination is the most effective medical intervention to decrease risk and reduce spread of the SARS-CoV-2 virus.

The Department of Health and Social Care (DHSC) is leading the Government’s deployment of vaccinations against COVID-19. In order to save lives, and to reduce the number of people who need hospital treatment due to COVID-19, the DHSC have sought to deploy a safe and effective vaccination as soon as possible. In a letter dated November 17th 2020, the DHSC requested authorisation, on a temporary basis, of its proposed supply of a vaccine manufactured by Pfizer/BioNTech collaboration, named “COVID-19 mRNA Vaccine BNT162b2”, under Regulation 174 of the Human Medicines Regulations 2012, (“the Regulations”).

Following an extensive review of the quality, safety and efficacy data, COVID-19 mRNA Vaccine BNT162b2 has been authorised for temporary supply in the UK for the following indication: active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.

The active substance of the COVID-19 mRNA Vaccine BNT162b2 is a multi-dose concentrate of RNA-containing lipid nanoparticles formulated in saline and sucrose to be diluted for intramuscular (IM) administration. A single vial contains 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles).

COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5’-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates.

COVID-19 mRNA Vaccine BNT162b2 encodes a mutant viral spike (S) protein of SARS-CoV-2, with two point mutations inserted to lock S in an antigenically preferred prefusion conformation (P2 S). It is formulated as an RNA-lipid nanoparticle of nucleosidemodified mRNA containing N1-methylpseudouridine instead of uridine. Encapsulation into lipid nanoparticles enables transfection of the mRNA into host cells after intramuscular injection. During mixing of the RNA and the dissolved lipids, the lipids form the nanoparticles encapsulating the RNA. After injection, the lipid nanoparticles are taken up by the cells, and the RNA is released into the cytosol. In the cytosol, the RNA is translated into the encoded viral protein. The viral spike (S) protein antigen induces an adaptive immune response through neutralising antibodies. Furthermore, as the expressed spike (S) protein is being degraded intracellularly, the resulting peptides can be presented at the cell surface, triggering a specific T cell-mediated immune response with activity against the virus and infected cells.

The authorisation is for an identified batch of the vaccine (provided certain conditions are met), together with future batches, which will each be approved by MHRA on a batch-specific basis. These conditions are published on the MHRA website.

The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product at all sites responsible for the manufacture, assembly and batch release of this product.

A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with this application and are satisfactory.

This batch, and any future batches, of COVID-19 mRNA Vaccine BNT162b2 are subject to Qualified Person (QP) certification and batch evaluation by an independent control laboratory before the vaccine is released into the UK.

The COVID-19 Vaccine Benefit Risk Expert Working Group (Vaccine BR EWG) have met several times to review and discuss the quality, safety and efficacy aspects in relation to batches of COVID-19 mRNA Vaccine BNT162b2. The manufacturer, Pfizer/BioNTech, was also invited to a separate meeting with the quality subgroup of the Vaccine BR EWG to review and discuss questions related to manufacture and control of the product.

The Vaccine BR EWG gave advice to the Commission of Human Medicines (CHM) on 11th September 2020, 8th October 2020, 27th October 2020, 28th November 2020 and 30th November 2020, regarding the requirements for authorisation for the temporary supply of COVID-19 mRNA Vaccine BNT162b2. The requirements for quality, safety and efficacy were considered, taking into account the urgent public health need and risk to life, the pandemic situation and a lack of COVID-19 vaccines. As well as data on quality, safety and efficacy, specific mitigations and conditions on the product were discussed to ensure adequate standards of quality and safety are met.

The CHM concluded that the proposed supply of COVID-19 mRNA Vaccine BNT162b2 for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older, is recommended to be suitable for approval under Regulation 174 provided the company meets the conditions set out by the MHRA.

Authorisation for the temporary supply of COVID-19 mRNA Vaccine BNT162b2 was granted in the UK on 1 December 2020. This report covers data received and reviewed for this authorisation only. This authorisation is valid until expressly withdrawn by MHRA or upon issue of a marketing authorisation.

Whilst an acceptable level of information has been received to provide assurance that appropriate standards of quality, safety and efficacy have been met for authorisation of specific batches for temporary supply under Regulation 174 of the Regulations, it should be noted that COVID-19 mRNA Vaccine BNT162b2 remains under review as MHRA continues to receive data from the company as it becomes available. This will include, for example, long-term follow-up efficacy and safety data. Further information that is received by the MHRA will be reviewed as part of the ongoing assessment for this product and updates will be made to this PAR to reflect that in due course.

On 4 June 2021 the MHRA granted an extension of indication to ‘the active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 12 years of age and older’.

2. Quality aspects

2.1 Introduction

This product is a white to off-white solution provided in a multidose vial and must be diluted before use. One vial contains 5 doses of 30 micrograms of BNT162b2 RNA embedded in lipid nanoparticles (LNPs). COVID-19 mRNA Vaccine BNT162b2 is provided in a pack size of 195 vials.

COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5’-capped messenger RNA (mRNA) in lipid nanoparticles (LNPs). The mRNA is produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

In addition to BNT162b2 RNA this product also contains the excipients ALC-0315 = (4- hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3 phosphocholine, cholesterol, potassium chloride, potassium dihydrogen phosphate, sodium chloride, disodium hydrogen phosphate dihydrate, sucrose and water for injections.

The finished product is packaged in a 2 mL clear vial (type I glass) with a stopper (coated bromobutyl) and a plastic flip-off cap with aluminium seal. Container closure components comply with the relevant regulatory requirements. Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with the current Ph. Eur. quality standards

2.2 Active substance

Drug Substance (BNT162b2 RNA)

BNT162b2 drug substance is a single-stranded, 5’-capped mRNA encoding the full-length viral S (S1S2) protein of SARS-CoV-2. The optimised codon sequence encoding the spike glycoprotein antigen of the SARS-CoV-2 virus results in a protein expressed with two proline mutations that fix the S1S2 spike protein in a pre-fusion conformation to increase potential to elicit virus neutralising antibodies. In addition, the RNA contains common structural elements optimised for mediating high RNA stability and translational efficiency (5’-cap, 5’-UTR, 3’-UTR, poly(A) – tail). Uridine is replaced by modified N1- methylpseudouridine (m1ΨTP) in the RNA synthesis which increases RNA persistence invivo through dampening of innate immune response to itself. The 5 prime end is capped with a structure which will not activate the innate immune system.

Chemical Name: messenger RNA (mRNA), 5’-capped, encoding a full-length, codonoptimised pre-fusion stabilised conformation variant (K986P and V987P) of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, GenBank: MN908947.3) spike (S) glycoprotein, flanked by 5’ and 3’ untranslated regions and a 3’ poly(A) tail; contains N1-methylpseudouridine instead of uridine (all-U>m1 Ψ). Immunological agent for active immunisation (anti-SARS-CoV-2)

Appearance: Clear to slightly opalescent, colourless to slightly brown liquid

BNT162b2 RNA is not the subject of a European Pharmacopoeia monograph (Ph. Eur.) or other pharmacopoeial monograph.

Overall, production of the active substance from the designated starting materials has been adequately described and appropriate in-process controls and adequate starting material specifications are applied.

The starting materials are adenosine triphosphate, cytidine triphosphate, guanosine triphosphate, modified uridine triphosphate, 5’ Cap and the DNA template from which the RNA is transcribed.

The DNA template from which the RNA is transcribed is critical for the fidelity of the mRNA. The manufacture of the DNA template has been described. It is manufactured through fermentation in an established and well-controlled Escherichia coli cell line, extracted and purified. The specifications controlling the quality of the DNA template are satisfactory. Batch data for the DNA template have been supplied for several batches for which an acceptable level of batch to batch consistency is observed. The genealogy of the finished product can be traced back to the batch of originating DNA template.

The in vitro enzymatic RNA transcription process has been adequately described. The 5’cap and poly(A) tail are co-transcribed with the S1S2 spike protein codon. It is noted that the operating parameters for this process span a wide range however this does not raise any immediate concerns for the batch under review.

Full scale validation data for RNA transcription demonstrates consistency and repeatability of the process operation and is accepted as qualifying the process operated at its target set points.

The manufacturer has performed a comparability assessment of drug substance batches used in the clinical trial programme and batches representative of the subsequent manufacturing changes occurring during product development, such as introduction of new manufacturing sites, manufacturing process changes and increase in batch scale, including full scale validation batches. The drug substance batch release data for essential parameters that control the quality of the active RNA and several extended characterisation test parameters were considered. These data demonstrate consistency between the drug substance described for this application and those used in the pivotal clinical study.

Analytical procedure methods have been described and are considered appropriately qualified to control this batch in the context of a batch specific approval.

The shelf-life for BNT162b2 RNA (drug substance) has been provided and is satisfactory in relation to the cadence of drug substance to drug product manufacture.

2.3 Drug product

The data submitted to describe the drug product have been evaluated.

Pharmaceutical development

The manufacturer has described the finished product development strategy. This utilised principles described in ICH Q8 Pharmaceutical Development and was based on the available scientific knowledge and the manufacturer’s prior experience with similar RNA-lipid nanoparticle vaccines, as well as risk assessments and development studies.

The characteristics of the drug product were provided, as well as formulation development and process characterisation studies. The development history, including process changes have been summarised. The manufacturer has described their approach to defining critical quality attributes and the rationale for their criticality decisions, as well as their process risk assessment strategy and methodology, which was accompanied by a description of the manufacturer’s product development and characterisation strategy. Operating ranges have been defined and the manufacturer is working on the validation of the final commercial process, which follows process optimisation.

A quality target product profile for the finished product has been established taking into consideration the World Health Organization’s WHO Target Product Profiles for COVID19 Vaccines.

Development studies have been submitted which support the compatibility of the vaccine with the container closure and the unpreserved sodium chloride 0.9% diluent as well as commonly used needles and syringes.

The manufacturer has performed a comparability assessment of batches used in the clinical trial programme and batches representative of manufacturing changes occurring during product development, such as introduction of new manufacturing sites, process changes and increase in batch scale. In addition to release testing, the manufacturer also investigated several extended characterisation test parameters. These data will be supplemented as further experience with the manufacturing process accumulates. The recommendation for the batch which is the subject of this assessment was based on a direct comparison of the batch release results with the results for the clinically qualified batches.

Manufacture of the product

A description of the manufacturing method for COVID-19 mRNA Vaccine BNT162b2 has been provided and consists of: thawing and dilution of the drug substance, lipid nanoparticle formation upon mixing organic and aqueous phases (where specialised equipment is used for LNP formation), buffer exchange, concentration, filtration, formulation, sterile filtration, aseptic filling, visual inspection, labelling and freezing, and storage packaging and shipment.

In-process monitoring and control are performed. In-process controls and process parameters for each manufacturing step are provided and criticality has been assigned. Further in-process details are expected from the manufacturer however the information provided to date are acceptable.

As part of the control of the product, once vials are manufactured, they undergo 100% visual inspection for defects.

A condition of authorisation under this regulation is that the manufacturer will provide further data on the drug product manufacturing process as it is scaled up.


The excipients sucrose, sodium chloride, potassium chloride, dibasic sodium phosphate dihydrate, monobasic potassium phosphate and water for injection are all of Ph. Eur. grades, which are acceptable.

In addition to those excipients, the vaccine contains four lipids, of which two are used in approved medicinal products (cholesterol and 1,2-distearoyl-sn-glycero-3-phosphocholine, hereafter termed DSPC) and two are considered novel in that they have not been used in an authorised medicinal product in the UK:

  • ALC-0315 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate))
  • ALC-0159 (2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide).

The lipids are intended to encapsulate the mRNA in the form of a lipid nanoparticle to aid cell entry and stability of the RNA/lipid nanoparticles.

ALC-0315 is the functional cationic lipid component of the drug product. When incorporated in lipid nanoparticles, it helps regulate the endosomal release of the RNA. During drug product manufacturing, introduction of an aqueous RNA solution to an ethanolic lipid mixture containing ALC-0315 at a specific pH leads to an electrostatic interaction between the negatively charged RNA backbone and the positively charged cationic lipid. This electrostatic interaction leads to encapsulation of RNA drug substance resulting with particle formation. Once the lipid nanoparticle is taken up by the cell, the low pH of the endosome renders the LNP fusogenic and allows the release of the RNA into the cytosol.

The primary function of the PEGylated lipid ALC-0159 is to form a protective hydrophilic layer that sterically stabilises the LNP which contributes to storage stability and reduces nonspecific binding to proteins. As higher PEG content can reduce cellular uptake and interaction with the endosomal membrane, PEG content is controlled.

Cholesterol is included in the formulation to support bilayer structures in the lipid nanoparticle and to provide mobility of the lipid components within the lipid nanoparticle structure. The specification for the conventional lipid, cholesterol, is considered acceptable for the purpose of this application.

DSPC is a phospholipid component intended to provide a stable bilayer-forming structure to balance the non-bilayer propensity of the cationic lipid. DSPC is a non-pharmacopeial excipient and an adequate specification has been provided.

The controls in place for the excipients are considered suitable for this application.

Excipients of human and animal origin

No excipients of animal or human origin are used in the finished product.

Novel excipients

ALC-0315 is a cationic lipid and is critical to the self-assembly process of the particle itself, the ability of the particle to be taken up into cells and the escape of the RNA from the endosome. ALC-0159 is a polyethylene glycol (PEG) lipid conjugate (i.e. PEGylated lipid).

Finished product control

The product specification includes relevant control parameters considering the nature of the product and its manufacturing process.

Batch release data for this batch have been evaluated comparing the results with the clinically qualified ranges from batches used in the clinical trial programme.

Independent batch testing

Independent batch testing is required for vaccines and provides additional assurance of quality before a batch is made available to the market. Independent batch testing is a function that is undertaken by an Official Medicines Control Laboratory (OMCL) and, under Regulation 174A, the UK’s National Institute for Biological Standards and Control (NIBSC) is responsible for this function. Each batch will be independently tested prior to deployment.

Independent batch testing is product-specific and highly technical: it requires specific materials and documentation from the manufacturer and comprises laboratory-based testing and review of the manufacturer’s test data. If all tests meet the product specifications a certificate of compliance is issued by the OMCL.

Characterisation of impurities

The impurity profile of the BNT162b2 drug product is based primarily on the impurity profile of the materials used for its manufacture.

The manufacturer has described four identified drug product manufacturing process-related impurities. A safety risk assessment for each of these four potential impurities has been performed and they are below the safety threshold given the intended product administration schedule.

Process-impurities from the sucrose, phosphate and chloride salts used in the final drug product formulation are controlled through testing and specifications ensuring compliance to relevant compendial monographs. This is acceptable.

The lipid impurities are controlled through the acceptance criteria used for their manufacture.

No critical issues have been identified with respect to the lipids that would preclude the emergency use of the vaccine.

Reference standards or materials

The manufacturer has defined reference materials that are used in the determination of drug product content and in the determination of lipid content for the four lipids used for nanoparticle formation. These methods are considered conventional and uncomplicated to perform.

Container closure system

Overall, the container closure system has been well described and complies with the relevant quality standards of the Ph.Eur. The vaccine requires storage at ultra-low temperature conditions and the rubber septum is punctured at least 6 times to reconstitute the product and recover 5 doses from the vial. The manufacturer has provided details of adequate testing to provide evidence that the self-sealing capacity of the elastomeric closure is retained upon freezing and repeated thawing of product, even though the storage requirements do not permit this. The testing also accounted for the recommended needles for diluent addition.


The manufacturer has provided all stability data available to date. Information on the stability of batches used in clinical trials has been used to support conclusions on product storage and storage conditions.

Based on the stability information currently available, a shelf-life of 6 months at -80°C to -60°C can be accepted for this vaccine, with the following storage conditions:

  • Store in a freezer at -80°C to -60°C
  • Store in the thermal container at -90ºC to -60ºC

Store in the original package in order to protect from light.

After removal from frozen storage, the undiluted vaccine can be stored for up to 5 days (120 hours) at 2°C to 8°C and up to 2 hours at temperatures up to 25°C, prior to use. Once thawed, the vaccine cannot be re-frozen.

During storage, it is recommended that exposure to room light is minimised, and exposure to direct sunlight and ultraviolet light avoided. Thawed vials can be handled in room light conditions.

After dilution with unpreserved normal saline, the vaccine should be stored at 2°C to 25°C and used as soon as practically possible. Since the vaccine does not contain a preservative, once the stopper has first been punctured on addition of the diluent, the vial should be used within 6 hours as is recommended by WHO guidance. After 6 hours, any unused vaccine left in the vial should be discarded.

Deployment of this vaccine is subject to the conditions of this Regulation 174 approval.

Suitable post approval stability commitments have been provided to continue stability testing on batches of COVID-19 mRNA Vaccine BNT162b2, including for the batch concerning this Regulation 174 application. The manufacturer has committed to provide these data to the MHRA on an on-going basis as it becomes available.

Handling of Pfizer Vaccine BNT162b2

Lipid nanoparticles (LNPs) are complex particles made of four lipid components that entrap the mRNA. Because of this complexity LNPs are potentially fragile to degradation and damage through inappropriate handling.

The published storage conditions are qualified by the data reviewed by the MHRA.

  • Long term storage: It must be stored frozen at ultra-low temperature (ULT).

After removal from frozen storage, it has a shelf life of up to 120 hours at 2-8 ºC before being diluted (label to be added once box removed from freezer).

In addition to the 120-hour period at 2-8 ºC, an undiluted vial can be stored for 2 hours at up to 25 ºC. This is intended to qualify removing the vial from the fridge for up to two hours immediately before it is diluted in preparation for use. It is not intended to qualify ad hoc removal from fridge within the 120-hour period with a view to then replacing back into stock were it not to be used.

Once thawed, the vaccine cannot be refrozen.

Before dilution the vial must be inverted gently 10 times without shaking (to avoid foaming). Once the specified diluent is added, the vial must be inverted gently 10 times without shaking (to avoid foaming).

Once diluted, the vials should be marked with the dilution date and time.

Transportation by motor vehicle of diluted vaccine away from the site of dilution is not currently supported by any relevant stability data.

After dilution the vaccine should be used as soon as is practically possible and within 6 hours of dilution; it can be stored at 2-25 ºC during this period. It would not normally be considered good practice to store diluted product for 6 hours at 25ºC before being administered.

Similarly, there are no data supporting multiple temperature cycling within that 6 hours that would qualify the product being repeatedly removed and replaced into a fridge, as doses are administered over the course of 6 hours.

Following dilution, vials should be used in the shortest time period possible.

2.4 Regulation 174

Authorisation for temporary supply of COVID-19 mRNA Vaccine BNT162b2 under this Regulation 174 has been given following review of batch analytical data by MHRA.

Independent batch release by the National Institute for Biological Standards and Control (NIBSC) will be performed on all batches to be supplied to the UK.

The quality data currently available for COVID-19 mRNA Vaccine BNT162b2 can be accepted as sufficient with specific conditions in place. There are no scientific objections arising from this review to the authorisation for temporary supply for this product under Regulation 174 of the Human Medicine Regulations.

3. Non-clinical aspects

3.1 Introduction

COVID-19 mRNA Vaccine BNT162b2 has been developed for use in healthy subjects to prevent COVID-19 on exposure to SARS-CoV-2. The vaccine has as its active agent messenger ribonucleic acid (mRNA), made by transcription of a DNA template, encoding for the full-length spike (S) protein of SARS CoV-2 with two point mutations, to lock S in an antigenically preferred prefusion conformation.

COVID-19 mRNA Vaccine BNT162b2 is given as two intramuscular injections (IM), 21 days apart, of the same dose of 30 μg mRNA.

COVID-19 mRNA Vaccine BNT162b2 is made up of the mRNA component with 4 lipid components forming nanoparticles, of which two are novel and not used before in pharmaceutical products in the UK. The lipids function to encapsulate, stabilise the mRNA and mediate its delivery to cells.

The following non-clinical studies were submitted with this application:


  • Study 20-0211: In vitro expression of BNT162b2 drug substance and drug product
  • Study R-20-0085: COVID-19: Immunogenicity of BNT162b2 in mice
  • Study R-20-0112: Characterizing the immunophenotype in spleen and lymph node of mice treated with SARS-CoV-2 vaccine candidates
  • Study VR-VTR-10671: BNT162b2 immunogenicity and evaluation of protection against SARS-CoV-2 challenge in rhesus macaques


  • Study PF-07302048: Single dose pharmacokinetics study of ALC-0315 and ALC-0159 following intravenous bolus injection of a nanoparticle formulation in rats
  • Study R-20-0072: Biodistribution of BNT162b2 using the luciferase protein as a surrogate marker protein after intramuscular injection in mice. Toxicology
  • Study 38166: Repeat-dose toxicity study of three LNP-formulated RNA platforms encoding for viral proteins by repeated intramuscular administration to Wistar Han rats
  • Study 20GR142: 17-day Intramuscular Toxicity Study of BNT162b2 and BNT162b3 in Wistar Han Rats

These studies were conducted in accordance with current Good Laboratory Practice (GLP).

3.2 Pharmacology

This vaccine acts by intracellular translation of mRNA to the SARS-CoV-2 S protein to induce an immune response, a humoral neutralizing antibody response and Th1-type CD4+ and CD8+ cellular response, to block virus infection and kill virus infected cells, respectively.

The vaccine was tested for its ability to result in S protein expression in a mammalian cell population in vitro, for its immunogenicity in mice in two studies, and in one study in rhesus monkeys, including its capacity to prevent disease after challenge with SARS Cov-2 virus in rhesus monkeys. The vaccine also induced an immune response in rats in the two toxicity studies.

Study 20-0211 analysed SARS-CoV-2 P2 S expression in HEK293T cells. The initial demonstration of in vitro expression in HEK293 cells confirmed that transfection and subsequent protein expression could take place, including in cells incubated with the nanoparticle presentation of the vaccine.

In Study R-20-085, four groups of eight female mice were immunised once by the IM route on day 0 with 0.2 µg, 1 µg or 5 µg RNA/animal of COVID-19 mRNA Vaccine BNT162b2, or with a control. Antibody response was assessed at days 7, 14, 21 and 28.

Study R-20-0112 aimed to characterise T- and B-cell responses in the spleen, lymph nodes and blood of BNT162b2 immunised mice. It characterised changes in the myeloid cell compartment, determined the ability of CD8+ T-cells to react to cells presenting the vaccineencoded antigen, and determined antibody responses.

In Studies R-20-085 and R-20-0112 in mice, a dose-response effect was seen in the IgG responses specific for the SARS CoV-2 S1 protein fragment and its receptor binding domain.

A high and dose-dependent pseudovirus neutralising antibody response was confirmed. CD4+ and CD8+ T cell cellular responses with a Th1 pattern of response (e.g. production of IFN-γ) were observed. Booster responses were not evaluated in these studies.

Study VR-VTR-10671 was performed in male rhesus macaques aged 2-4 years vaccinated with 30 μg COVID-19 mRNA Vaccine BNT162b2, 100 μg COVID-19 mRNA Vaccine BNT162b2 or a control.

Results showed COVID-19 mRNA vaccine BNT162b2 was immunogenic, eliciting IgG responses after a single dose, which were boosted by a second dose. It also showed a dose response. At 30 μg BNT162, the neutralising geometric mean titre in a SARS-CoV-2 neutralization assay was compared to that seen in convalescent serum (HCS) from humans recovered from SARS CoV-2 infection/COVID-19 and found to be ~8-times higher. Seven days after Dose 2 of 100 μg, the neutralising GMT reached 18-times that of the HCS panel and remained 3.3-times higher than this benchmark five weeks after the last immunisation. In monkeys, the cellular immune response was characterised as a strongly Th1-biased CD4+ T cell response with a concurrent interferon-γ (IFNγ)+ CD8+ T cell response.

For the challenge portion of the study, SARS-CoV-2 challenge was performed on the COVID-19 mRNA Vaccine BNT162b2-immunised animals (100 µg/animal dose level) and on animals dosed with a control. Upon challenge with SARS CoV-2, the resulting clinical pattern in monkeys was unremarkable and no signs of clinical illness resulted from this exposure. Total viral RNA (genomic and subgenomic RNA) was detected in bronchoalveolar lavage fluid of control monkeys but not detected in monkeys immunised with BNT162b2; in the nasal swabs viral RNA was detected in monkeys given BNT162 but clearance was faster than in controls. This is evidence of the beneficial effect of this vaccine. In lung tissues, control monkeys had evidence of some pulmonary disease indicated by their increased scores on computed tomography scans with a suggestion of recovery in those scores at day 10 that were less than those at day 3; in contrast, the monkeys given COVID-19 mRNA Vaccine BNT162b2 had lower scores than controls.

The absence of secondary pharmacology and safety pharmacology studies is acceptable for a vaccine and is in line with relevant regulatory guidance (WHO Guidelines on nonclinical evaluation of vaccines, 2005). The guidance does not mention secondary pharmacodynamics: however, it does state that if data from other studies suggest that the vaccine may affect physiological functions (central nervous system, renal, respiratory or cardiovascular system functions), safety pharmacology studies should be incorporated into the toxicity assessment. This does not apply for COVID-19 mRNA Vaccine BNT162b2.

There are no major public health concerns identified. Since this authorisation the manufacturer has provided further information on the methodology used to determine antispike protein antibodies in mice which has been reviewed as part of the ongoing assessment for this product. These data are not discussed here.

3.3 Pharmacokinetics

The active substance of COVID-19 mRNA Vaccine BNT162b2 is N1-methylpseudouridine instead of uridine containing mRNA expressing full-length SARS-CoV-2 spike protein with two proline mutations (P2 S) to lock the transmembrane protein in an antigenically optimal prefusion conformation. The vaccine is formulated in lipid nanoparticles (LNPs). The LNP is composed of 4 lipids: ALC-0315, ALC-0159, 1,2-distearoyl-sn-glycero-3-phosphocoline (DSPC), and cholesterol. Of the four lipids used as excipients in the LNP formulation, two are naturally occurring (cholesterol and DSPC) and will be metabolised and excreted like their endogenous counterparts.

Pharmacokinetic studies have not been conducted with COVID-19 mRNA Vaccine BNT162b2 and are generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005; WHO, 2014).

The ADME profile of COVID-19 mRNA Vaccine BNT162b2 included evaluation of the PK and metabolism of the two novel lipid excipients (ALC-0315 and ALC-0159) in the LNP and potential in vivo biodistribution using luciferase expression as a surrogate reporter.


No absorption studies were conducted for COVID-19 mRNA Vaccine BNT162b2 since the route of administration is intramuscular (IM).

The “Single dose pharmacokinetics study of ALC-0315 and ALC-0159 following intravenous bolus injection of a nanoparticle formulation in rats” was conducted to assess the PK and metabolism of the two novel lipid excipients (ALC-0315 and ALC-0159). This study used LNPs containing surrogate luciferase RNA, with the lipid composition being identical to BNT162b2, to investigate the in vivo disposition of ALC-0159 and ALC-0315.

Concentrations of ALC-0159 dropped approximately 8000- and >250-fold in plasma and liver, respectively, during this 2-week study. For ALC-0315, the elimination of the molecule from plasma and liver was slower, but concentrations fell approximately 7000- and 4-fold in two weeks for plasma and liver, respectively. Overall, the apparent terminal t½ in plasma and liver were similar in both tissues and were 2-3 and 6-8 days for ALC-0159 and ALC0315, respectively. The apparent terminal t½ in plasma likely represents the re-distribution of the respective lipids from the tissues into which they have distributed as the LNP, back to plasma where they are eliminated.


Study R-20-0072 evaluated the in vivo potential biodistribution of COVID-19 mRNA Vaccine BNT162b2 in mice using luciferase expression as a surrogate reporter. Protein expression was demonstrated at the site of injection and to a lesser extent, and more transiently, in the liver after mice received an IM injection of RNA encoding luciferase in an LNP formulation like BNT162b2. Luciferase expression was identified at the injection site at 6 hours after injection and diminished to near baseline levels by day 9. Expression in the liver was also present at 6 hours after injection and was not detected by 48 hours after injection. Information regarding the potential distribution of the test articles to sites other than the injection site following IM administration has been provided and is under review as part of the ongoing rolling assessment.


The in vitro metabolism of ALC-0315 and ALC-0159 was evaluated in blood, liver microsomes, S9 fractions, and hepatocytes from mice, rats, monkeys, and humans. The in vivo metabolism was examined in rat plasma, urine, faeces, and liver samples from the PK study. Metabolism of ALC-0315 and ALC-0159 appears to occur slowly in vitro and in vivo. ALC-0315 and ALC-0159 are metabolised by hydrolytic metabolism of the ester and amide functionalities, respectively, and this hydrolytic metabolism is observed across the species evaluated.


No excretion studies have been conducted with COVID-19 mRNA Vaccine BNT162b2. In the PK study, it appears that 50% of ALC-0159 was eliminated unchanged in faeces. Metabolism played a role in the elimination of ALC-0315, as little to no unchanged material was detected in either urine or faeces. Investigations of urine, faeces and plasma from the rat PK study identified a series of ester cleavage products of ALC-0315. The manufacturer has proposed that this likely represents the primary clearance mechanism acting on this molecule, although no quantitative data is available to confirm this hypothesis. In vitro, ALC-0159 was metabolised slowly by hydrolytic metabolism of the amide functionality.

Pharmacokinetic drug interactions

No PK drug interaction studies have been conducted with COVID-19 mRNA Vaccine BNT162b2. This is acceptable and in line with relevant guidelines (WHO 2005; WHO 2014).

3.4 Toxicology

Single dose toxicity

No single dose toxicity studies have been performed. This is acceptable and in line with relevant guidelines (WHO 2005; WHO 2014).

Repeat-dose toxicity

Study 38166 was a GLP-compliant repeat-dose study performed in rats to evaluate toxicity of the LNP and mRNA platform used in BNT162b2.

Study 20GR142 was a GLP-compliant repeat-dose study performed in rats to evaluate toxicity of COVID-19 mRNA Vaccine BNT162b2.

In Study 38166, male and female Wistar rats were given BNT162b2 as IM injection(s) into the hind limb on three occasions each a week apart (dosing days 1, 8 and 15). Different doses (10, 30, and 100 μg) were tested; the lower doses were given as a single injection of 20-70 μL, while the highest dose (100 μg) and controls were given as two injections (one in each hindlimb) of 100 μL each. The control was phosphate buffered saline/300 mM sucrose, corresponding to the storage buffer of the vaccine product. Each group had 18 male and 18 female rats, assigned as 10 to the main study, 5 for recovery groups and 3 as additional animals for cytokine analyses. The recovery period was 3 weeks after the last dose. Necropsy was performed on study day 17, ~48 hours after the last dose, and after the 3-week recovery period.

No unscheduled deaths were observed.

Dosing was considered well tolerated and did not present any signs of systemic toxicity; there was a slight increase in body temperature in the hours after dosing and some loss in body weight over the same period but these were not of a magnitude to be considered adverse.

Local inflammatory reactions were observed at the intramuscular injection site. Injection site changes noted were of oedema, erythema, and induration, more severe and more frequent after the second and/or third doses compared to the first; however, these resolved prior to subsequent dosing and were fully recovered at the end of the 3-week recovery period.

Macroscopic findings at the injection sites included induration or thickening, occasionally accompanied by encrustation, which was noted for nearly all rats. This correlated microscopically with inflammation and variable fibrosis, oedema, and myofibre degeneration. Inflammation at the injection site was accompanied by elevations in circulating white blood cells and acute phase proteins (fibrinogen, alpha-2 macroglobulin, and alpha-1 acid glycoprotein).

Inflammation was occasionally evident extending into tissues adjacent to the injection site. There was enlargement of the draining (iliac) lymph nodes evident at the end of dosing. This correlated with increased cellularity of germinal centres and increased plasma cells in the draining (iliac) lymph node and is an anticipated immune response to the administered vaccine.

Enlargement of spleen and increased spleen weights correlated microscopically to increased haematopoiesis and increased haematopoiesis was also evident in the bone marrow. These findings are likely secondary to the immune/inflammatory responses to the vaccine.

At the end of the recovery period, injection sites were normal, clinical pathology findings and macroscopic observations had resolved and there was evidence of recovery of the injection site inflammation on microscopy.

Microscopic vacuolation of portal hepatocytes was present. There were no elevations in alanine aminotransferase (ALAT). There were elevations in gamma-glutamyltransferase (GGT) in all vaccinated rats, but there were no macroscopic or microscopic findings consistent with cholestasis or hepatobiliary injury to explain the increased GGT activity, which was completely resolved at the end of the 3-week recovery period.

The vacuolation may be related to hepatic distribution of the pegylated lipid in the LNP. No changes were seen in serum cytokine concentrations. Additional ADME data has been received since this authorisation and has been reviewed as part of the ongoing assessment for this product. This data is not discussed here.

There were no effects noted on ophthalmological and auditory assessments, nor on external appearance or behaviour; in particular, gait was normal meaning that the changes seen did not affect the rats’ mobility. No vaccine-related changes were seen in serum cytokine concentrations.

Testing for immunogenicity showed that COVID-19 mRNA Vaccine BNT162b2 elicited a specific IgG antibody response to SARS CoV-2 spike protein directed against the S1 fragment and the receptor binding domain. A neutralizing antibody response was also observed with the vaccine in a pseudovirus neutralization assay.

In conclusion, COVID-19 mRNA Vaccine BNT162b2 was well tolerated, and produced inflammatory changes at the injection sites and the draining lymph nodes, increased haematopoiesis in the bone marrow and spleen, and clinical pathology changes consistent with an immune response or inflammation in the injection sites. The findings in this study are typical of those expected with dosing of LNP encapsulated mRNA vaccines.

Study 20GR142 had the objective to determine toxicity in rats given COVID-19 mRNA Vaccine BNT162b2. This study was in compliance with Good Laboratory Practice. Two candidate vaccines were tested; however, results are presented here only for COVID-19 mRNA Vaccine BNT162b2.

Male and female Wistar Han rats were given BNT162b2 as an IM injection into the hind limb on three occasions, each a week apart (dosing days 1, 8 and 15). Necropsy was performed on study day 17, ~48 hours after the last dose, and after the 3-week recovery period. COVID-19 mRNA Vaccine BNT162b2 was supplied at 0.5 mg/ml, and the dose volume was 60 μL, to give 30 μg per dose. Control rats received saline. Each group contained 15 males and 15 females.

All rats given COVID-19 mRNA Vaccine BNT162b2 survived to their scheduled necropsy: there were no changes noted in clinical signs or body weight changes noted. A reduction in food intake was noted on days 4 and 11 (to 0.83x controls) and there was an increase in mean body temperature post-dose on day 1 (up to 0.54°C), day 8 (up to 0.98°C) and day 15 (up to 1.03°C) compared to controls.

At injection sites, there were instances of oedema and erythema on days 1 (maximum of slight oedema and very slight erythema), 8 (maximum of moderate oedema and very slight erythema) and 15 (maximum of moderate oedema and very slight erythema) which fully resolved and were not noted prior to dosing on days 8 and 15.

Haematological tests showed higher white blood cells (up to 2.95x controls), primarily involving neutrophils (up to 6.80x controls), monocytes (up to 3.30x controls), and large unstained cells, LUC, (up to 13.2x controls) and slightly higher eosinophils and basophils on days 4 and 17. White blood cells were higher on day 17 as compared with day 4. There were transiently lower reticulocytes on day 4 (to 0.27x controls) in both sexes and higher reticulocytes on day 17 (up to 1.31x controls) in females only. Lower red blood cell mass parameters (to 0.90x controls) were present on days 4 and 17. There were lower A:G ratios (to 0.82x) on days 4 and 17. Higher fibrinogen was noted on day 17 (up to 2.49x) compared to controls, consistent with an acute phase response. The acute phase proteins alpha-1-acid glycoprotein (up to 39x on day 17) and alpha-2 macroglobulin (up to 71x on Day 17) were elevated on days 4 and 17 with higher concentrations in males. There were no changes urinalysis parameters.

At post-mortem there were higher absolute and relative spleen weights in vaccinated rats (up to 1.42x in males and to 1.62x in females). There were no other changes in organ weights. Macroscopic findings included enlarged draining lymph nodes and pale/dark firm injection sites in a minority of vaccinated rats. The dosing is reported as tolerated without inducing any systemic toxicity and with all changes consistent with an inflammatory response and immune activation: findings are consistent with those typically associated with dosing of lipid nanoparticle-encapsulated mRNA vaccines. Since this authorisation the manufacturer has provided the final study report which has been reviewed as part of the ongoing assessment for this product and is not discussed here.


No toxicokinetic studies have been performed with the vaccine. This is consistent with WHO guidelines on the nonclinical evaluation of vaccines (WHO 2005).


No genotoxicity studies are planned for BNT162b2, as the components of all vaccine constructs are lipids and RNA that are not expected to have genotoxic potential (WHO, 2005).


Carcinogenicity studies with BNT162b2 have not been conducted as the components of all vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005).

Reproductive and developmental toxicity

Fertility and early embryonic development and embryofoetal development

In the general toxicity studies, macroscopic and microscopic evaluation of male and female reproductive tissues showed no evidence of toxicity.

A combined fertility and developmental study (including teratogenicity and postnatal investigations) in rats is ongoing.

Prenatal and postnatal development, including maternal function

No such studies have been done.

Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

No such studies have been done.

Local tolerance

No such studies have been done. The assessments made as part of the general toxicity study should suffice and a separate study is not needed.

Other toxicity studies

No such studies have been done.

Toxicity conclusions

The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.

3.5 Ecotoxicity/Environmental Risk Assessment

It is agreed that, in accordance with CHMP guidance EMEA/CHMP/SWP/4447100 entitled, “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” published 01 June 2006, due to their nature, vaccines and lipids are unlikely to result in a significant risk to the environment. Therefore, an environmental risk assessment is not provided in this application. This is acceptable.

3.6 Discussion and conclusion on the non-clinical aspects

The non-clinical data currently available for COVID-19 mRNA Vaccine BNT162b2 can be accepted as sufficient with specific mitigations in place. There are no scientific objections arising from this review to the authorisation for temporary supply for this product under Regulation 174.


COVID 19 deaths and injuries

Australia Jab Injuries – Susan

Australia Jab Injuries – Susan

By Jab Injuries Australia

Susan, Australia

Original source:

COVID 19 deaths and injuries

Europe Officially Records a Shocking 691% Increase in Excess Deaths Among Children Since EMA First Approved COVID Vaccine for Children

Europe Officially Records a Shocking 691% Increase in Excess Deaths Among Children Since EMA First Approved COVID Vaccine for Children

By The Exposé

Official mortality figures for Europe show that there has been a shocking 691% increase in excess deaths among children since the European Medicines Agency extended the emergency use authorisation of the Pfizer Covid-19 vaccine for use in children aged 12 to 15 in May 2021.

Before this decision by the European Medicines Agency, deaths among children in 2021 were below the expected rate. But following the emergency use authorisation, excess deaths among children by the end of the year had risen by a deeply troubling 1,599% compared to the 2017 to 2020 average.

Unfortunately, this trend has continued into 2022, with Europe officially recording a 381% increase in excess deaths among children this year so far, compared to the 2018 to 2021 average.

EuroMOMO is a European mortality monitoring activity. The organisation states that its aim is to “detect and measure excess deaths related to seasonal influenza, pandemics and other public health threats”.

Official national mortality statistics are provided weekly from the 29 European countries or subnational regions in the EuroMOMO collaborative network, supported by the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO), and hosted by Statens Serum Institut, Denmark.

The following chart shows the weekly excess deaths throughout 2020 and 2021 among children aged 0 to 14 across Europe. The graph has been taken from the EuroMOMO website and can be accessed here.


As you can see from the above, deaths among children throughout 2020 were generally below the expected number of deaths. This trend continued throughout 2021 up to week 22, at which point excess deaths were recorded week on week until the end of the year.

What’s interesting about the fact excess deaths began to be recorded among children in week 22 of 2021 is that it coincides with the week the European Medicines Agency (EMA) granted “an extension of indication for the COVID-19 vaccine Comirnaty (Pfizer) to include use in children aged 12 to 15″.


Just a few months later, the EMA also gave emergency use approval for the Pfizer vaccine to be administered to children as young as 5.


The following chart, extracted from the EuroMOMO website, shows the cumulative total number of excess deaths throughout both 2020 and 2021 from week 22 (the week the Covid-19 vaccine was approved for children) to week 52 (the end of the year).


According to EuroMOMO, Europe recorded 1,015 excess deaths among children during this time frame in 2021, whilst recording 491 fewer deaths than expected during this time frame in 2020.

The following chart shows the weekly excess deaths throughout 2022 among children aged 0 to 14 across Europe. The graph has been taken from the EuroMOMO website and can be accessed here.


The data so far covers up to week 33 of 2022 (mid-August), and as you can see the majority of weeks have seen deaths among children well above the expected rate. Week 24 saw a record 101 excess deaths among children aged 0 to 14.

The following chart, extracted from the EuroMOMO website, shows the cumulative total number of excess deaths throughout both 2022 up to week 33.


According to EuroMOMO, Europe recorded 841 excess deaths among children during this time frame compared to the expected rate.

Since the EMA first approved the Pfizer Covid-19 injection for use in children in May 2021, Europe has recorded 1,856 excess deaths among children aged 0 to 14 against the expected rate. This statistic alone is sickening because it represents an unbelievable 185,600% increase in deaths.

However, because that number is so unbelievably high it would be fairer to actually compare excess deaths among children post-Covid-19 vaccination against the average number of deaths among children in the previous few years.

The following chart shows the total number of excess deaths among children aged 0 to 14 in 2021 before EMA approval of the Covid-19 vaccine for 12 to 15-year-olds in week 22, compared to the same time frame in other years. The numbers have been extracted from the EuroMOMO website and can be accessed here.

Source Data

The 2018 to 2020 average number of excess deaths among children across Europe between week 1 and week 21 equates to 191.3. But during the first 21 weeks of 2021, there were actually 198 fewer deaths among children than expected and 389.3 fewer deaths than the 2018 to 2020 average.

The following chart shows the total number of excess deaths among children aged 0 to 14 in 2021 following EMA approval of the Covid-19 vaccine for 12 to 15-year-olds in week 22, compared to the same time frame in other years. The numbers have been extracted from the EuroMOMO website and can be accessed here.

Source Data

The 2017 to 2020 average number of excess deaths among children across Europe between week 22 and week 52 equates to 59.75. But during the same period in 2021, following EMA approval of the Pfizer Covid-19 vaccine for children, there were 1,015 more deaths among children than expected and 955.25 more deaths than the 2017 to 2020 average.

This means excess deaths among children throughout 2021 after EMA approval of the Covid-19 injection for children aged 12 to 15, increased by 1,599% compared to the 2017 to 2020 average.

The following chart shows the total number of excess deaths among children aged 0 to 14 in 2022 so far (Week 33) compared to the same time frame in other years. The numbers have been extracted from the EuroMOMO website and can be accessed here.

Source Data

In 2022, children aged 5 and over across Europe have been offered the Covid-19 injection, and children aged 12 and over have been offered up to three doses of the Covid-19 injection.

The 2018 to 2021 average number of excess deaths among children between week 1 and week 33 equates to 175. But during the first 33 weeks of 2022, there were 841 more deaths among children than expected and 666 more deaths than the 2018 to 2021 average.

This means excess deaths among children throughout 2022 so far after EMA approval of the Covid-19 injection for children aged 5 and above, have increased by 381% compared to the 2018 to 2021 average.

Once we combine the figures for week 22 in 2021 onwards up to week 33 of 2022 (1,856 excess deaths), and compare them against the combined 2017 to 2020 & 2018 to 2021 average (234.75 excess deaths), we find that excess deaths among children across Europe have increased by 691% since the European Medicines Agency first approved a Covid-19 vaccine for children aged 12 to 15 in May 2021.

Is this just an unfortunate coincidence to add to the long list of “coincidences” that have occurred since early 2020? The authorities would most definitely like you to think so. But they still need to explain why thousands more children are dying than normally expected across Europe.

Original Source:


Does Donald Trump Promoting the Vaccine, Even If He Was Given Bad Advice by the Corrupt Fauci, Concern You Enough to No Longer Support His Bid to be Re-elected? (Even if you aren’t American and Can’t Vote for Him)

Does Donald Trump Promoting the Vaccine, Even If He Was Given Bad Advice by the Corrupt Fauci, Concern You Enough to No Longer Support His Bid to be Re-elected? (Even if you aren’t American and Can’t Vote for Him)

Telegram Post By Jamie McIntyre

Does Donald Trump promoting the vaccine, even if he was given bad advice by the corrupt Fauci, concern you enough to no longer support his bid to be re-elected? (Even if you aren’t American and can’t vote for him).

Original Source:

COVID 19 deaths and injuries

Australia Jab Injuries – Valerie

Australia Jab Injuries – Valerie

By Jab Injuries Australia

Valerie, Australia

Original source:


The London Times, One of the World’s Most Respected Newspapers, Published an Explosive Article Entitled, “Smallpox Vaccine Triggered AIDS Virus”

The London Times, One of the World’s Most Respected Newspapers, Published an Explosive Article Entitled, “Smallpox Vaccine Triggered AIDS Virus”

By Senator – Politico

On May 11, 1987, The London Times, one of the world’s most respected newspapers, published an explosive article entitled, “Smallpox vaccine triggered AIDS virus.”

The story suggested the smallpox eradication vaccine program sponsored by the WHO (World Health Organization) was responsible for unleashing AIDS in Africa. Almost 100 million Africans living in Central Africa were inoculated by the WHO (World Health Organization). The vaccine was held responsible for awakening a “dormant” AIDS virus infection on the continent.

An advisor to the WHO admitted, “Now I believe the smallpox vaccine theory is the explanation for the explosion of AIDS.”
Robert Gallo, M,D., the co-discoverer of HIV, told The Times, “The link between the WHO program and the epidemic is an interesting and important hypothesis.

Original source:


CDC Backtracks on COVID Guidance as Damning Studies Mount

CDC Backtracks on COVID Guidance as Damning Studies Mount

By Joseph Mercola

While it’s refreshing, considering how hard health officials have fought to segregate, bully, demonize and dehumanize people, it’s still like a slap in the face. And it’s not over yet – prepare for the biggest vax drive in history, and another round of gaslighting.


  • August 11, 2022, the U.S. Centers for Disease Control and Prevention reversed its COVID-19 guidelines, thereby vindicating every “misinformation spreader” out there
  • The CDC is now advocating for taking personal responsibility and for everyone to decide for themselves “which prevention behaviors to use and when (at all times or at specific times), based on their own risk for severe illness and that of members of their household, their risk tolerance, and setting-specific factors”
  • The CDC is also giving up on discrimination based on COVID jab status, stating, its “COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur.” They also admit natural immunity exists and works
  • Testing is now reserved for those who “are symptomatic, or have a known or suspected exposure to someone with COVID-19,” isolation is only for those who are symptomatic and have tested positive, and contact tracing is now restricted to health care settings and select “high-risk congregate settings”
  • The CDC’s about-face appears to be politically motivated, to give the Biden administration a “win” before the midterm elections. Post-election plans include “the biggest vaccination campaign in history,” so tyrannical overreaches may later resume, even as mounting data show the COVID shots are causing depopulation

Without fanfare, the U.S. Centers for Disease Control and Prevention, August 11, 2022, reversed all its COVID-19 guidelines. In fact, many have noted it appears the CDC wanted to bring as little attention to it as possible.1 This is understandable, considering the new guidelines more or less admit the original rules were in error, without actually stating as much.

The new guidance is listed in the CDC’s Morbidity and Mortality Weekly Report (MMWR) under the title, “Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022.”2 As noted by Jeffrey Tucker, founder and president of the Brownstone Institute:3

“It would have been fascinating to be a fly on the wall in the brainstorming sessions that led to this little treatise. The wording was chosen very carefully, not to say anything false outright, much less admit any errors of the past, but to imply that it was only possible to say these things now.”

The CDC insists that while COVID-19 infection continues to be a reality around the world, “high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools have substantially reduced the risk for medically significant COVID-19 illness … and associated hospitalization and death.”

Consequently, COVID countermeasures that create “barriers to social, educational, and economic activity” can be ditched and everything can go back to normal.

CDC Introduces Personal Responsibility

Considering how hard health officials have fought to segregate, bully, demonize and dehumanize people who didn’t agree with their tyrannical and irrational COVID measures over the past 19 months, the new guidelines are refreshing, but they’re still like a slap in the face. First and foremost, the CDC is now suddenly advocating for taking personal responsibility — for everything:4

“Persons can use information about the current level of COVID-19 impact on their community to decide which prevention behaviors to use and when (at all times or at specific times), based on their own risk for severe illness and that of members of their household, their risk tolerance, and setting-specific factors …

Education and messaging to help individual persons understand their risk for medically significant illness complements recommendations for prevention strategies based on risk.”

Individual risk assessment and risk-based countermeasures are both something we “misinformation spreaders” have called for from the beginning. The risk is not identical for all; hence, risk reduction strategies should not be uniformly applied. Finally, 19 months late, the CDC agrees.

Under the subhead, “Protecting Persons Most at Risk for Severe Illness,” the CDC now takes a page straight out of The Great Barrington Declaration and recommends focused protection, meaning protecting those “at particularly high risk … because of older age, disability, moderate or severe immunocompromise, or other underlying medical conditions.”

Need anyone be reminded that doctors and scientists have been defamed and dragged through the mud for saying this? And Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, and his former boss, Dr. Francis Collins, then-director of the National Institutes of Health, were the masterminds behind the effort to discredit and take down the authors of the Barrington declaration.5

CDC Reneges on Discrimination

The CDC is also giving up on discrimination based on COVID jab status:6 “CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur …”

They even admit that “persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection,” and therefore are not to be treated any differently than someone who has received the COVID jab. As noted by Tucker:7

“Remember when 40% of the members of the black community in New York City who refused the jab were not allowed into restaurants, bars, libraries, museums, or theaters? Now, no one wants to talk about that.

Also, universities, colleges, the military, and so on — which still have mandates in place — do you hear this? Everything you have done to hate on people, dehumanize people, segregate people, humiliate others as unclean, fire people and destroy lives, now stands in disrepute.

Meanwhile, as of this writing, the blasted US government still will not allow unvaccinated travelers across its borders! Not one word of the CDC’s turgid treatise was untrue back in the Spring of 2020. There was always ‘infection-induced immunity,’ though Fauci and Co. constantly pretended otherwise.

It was always a terrible idea to introduce ‘barriers to social, educational, and economic activity.’ The vaccines never promised in their authorization to stop infection and spread, even though all official statements of the CDC claimed otherwise, repeatedly and often.”

Testing, Isolation and Contact Tracing Rules Reversed

And what about rules relating to testing, self-isolation during illness and the whole tracking and tracing business? Out the window!

  • Testing is now reserved for those who “are symptomatic, or have a known or suspected exposure to someone with COVID-19.” Testing of asymptomatic individuals is only suggested in “congregate settings” where medical care is limited, such as homeless shelters and correctional facilities, and in such instances, testing “should include all persons, irrespective of vaccination status.”
  • Isolation is only for those who are symptomatic and have tested positive. Infected individuals can end their isolation after as little as five days, if they’ve been fever-free for at least 24 hours without the use of fever-lowering medication, but should continue wearing a mask or respirator when around others through day 10.
  • Contact tracing is now restricted to health care settings and select “high-risk congregate settings.”

Is It a Political Ploy?

While I’m glad the CDC has reversed its tyrannical COVID measures to something sensible and more aligned with reality, the problem, as I see it, is threefold.

First, there’s the lateness of the hour. Any public health agency worthy of such a designation would have reached these conclusions two years ago. Instead, they spent more than two years engaged in an active search and destroy mission against those advocating for the same sensible guidelines the CDC is now suddenly adopting.

Secondly, the timing of these reversals smacks of political bias. Mid-term elections are fast approaching, and the most disliked White House administration in American history needs a “win.”

With the CDC backtracking on COVID measures, they now have certain bragging rights. “See, we brought life back to normal” — which brings us to problem No. 3, which is that this reversal may be nothing more than a malicious ploy to get us to let our guard down, only to be hit with another, even more draconian fear campaign after the elections.

Biggest Vaccination Drive in History Is Coming This Fall

While that might sound paranoid, it’s straight out of the handbooks of tyranny. The way you drive people crazy is not through consistent high-pressure tyranny, but through waves of it. The ups and downs, with each wave being more intensely repressive than the last, create confusion and foster fear and anxiety, which breeds an infantile kind of reliance on authority to just fix it.

Mark Crispin Miller, a professor of media studies at New York University, appears to agree. In an August 13, 2022, Substack article, he writes:8

“Just as the CDC pretends to have backed off, the NHS [the British National Health Service] reveals (to just a few) what’s really coming at us in the fall: ‘The biggest vaccination drive in history.’ Those who think the worst is over better think again — because it really won’t be over til [sic] WE end it …

[The] NHS alone is obviously not equipped, and certainly does not intend, to undertake the biggest vaccination drive in history — a drive that must, and will, be global, just like the orchestration of the entire COVID crisis, of which this coming drive will be the culmination (or, to quote Bill Gates, the ‘final solution’).

Nor … is it likely that this biggest vaccination drive in history will be mounted on the now-exhausted pretext of protecting all humanity from COVID-19 (or the flu). What’s it going to be, then? Monkeypox? HIV? COVID-20? Cancer? All of the above?

Whatever new threat(s) may be used to justify this final drive could never be as lethal as the psychopaths who planned it, and those entities that will not stop promoting it (even as the CDC pretends to have backed off).”

Prepare for Another Round of Gaslighting

Thacker also wonders whether the CDC’s revised guidelines may be nothing more than a political backstop to prevent Democrats from sliding into the abyss:9

“… with a majority of Americans unhappy with the President’s pandemic policies, perhaps the CDC is relying on ‘midterm science’ to guide their new appreciation for natural immunity?”

One reason for suspecting the CDC’s sudden turn-about is political in nature is the fact that it makes an absolute mess out of the carefully scripted COVID narrative, which is supposed to be in lockstep with governments and media around the world. As a result of the CDC trying to give Biden’s White House a “win,” media and Big Tech now face a massive conundrum.

Everything the CDC is now recommending was blasphemy punishable by public shaming, deplatforming and delicensing, all the way up to the day the CDC posted the new guidelines. Every COVID article and fact check ever written is now completely off-script, as are countless public statements made by public health officials.

There’s no answer to this dilemma, so they’re going to pretend it never happened and hope no one remembers what they said all those days, weeks or months ago. If you remind them, be prepared to be gaslighted with denials. Thacker writes:10

“The media’s forgetfulness of what they reported just last year on vaccines and prior infection is part of the pandemic’s Great Misremembering, a collective amnesia where we march in step to government messaging, while failing to recall prior statements and moments of glaring contradiction.

For example, when the media reported that the NIH’s Anthony Fauci was fully vaccinated and still got COVID-19, and then they misremembered to report his prior statement, ‘When people are vaccinated, they can feel safe that they are not going to get infected’ … To help everyone join the Great Misremembering, here are some incidents you must fail to recall.

Epoch Times Photo

… Late in the pandemic’s first year, a group of researchers released a statement called the ‘John Snow Memorandum’11 that helped to shape American policy … Among the signatories was Rochelle Walensky, then a Professor of Medicine at Harvard Medical School, and now the Director of the CDC.

‘Any pandemic management strategy relying upon immunity from natural infections for COVID-19 is flawed,’ reads the statement signed by the current CDC Director.

Yes, the very same person who runs the CDC that now tells us to not differentiate between vaccine and natural infection warned us early in the pandemic that any pandemic policy that relies on natural infection is flawed. As you read the CDC’s new guidance, please remember to misremember the memorandum previously signed by the current CDC Director.”

Which Vaccines Will Be Pushed Next?

While we don’t yet know how they’re going to scare the population into getting more experimental shots — now that COVID jab uptake has tanked and more than 112 million doses have had to be discarded for lack of demand12,13 — we at least have an idea of what those shots are going to be.

August 15, 2022, the U.K. became the first country to approve Moderna’s new bivalent COVID booster, which contains both the original concoction and mRNA to target an already out-of-date Omicron variant.14 The rest of the world will undoubtedly follow suit.

The British NHS will start rolling out the new bivalent COVID jab September 5, 2022, starting with care home residents and other housebound individuals.15 The wider rollout will begin September 12, just one day shy of the end of primary elections in the U.S.16

Of course, the monkeypox vaccine is also being pushed on certain groups,17 and there’s the seasonal flu vaccine, so there are options when it comes to “picking your poison.”

So, while the good news is that the CDC is now on the hook for having vindicated all us “misinformation spreaders,” the bad news is that there’s more insanity coming, and there’s no telling exactly what form that will take as of yet.

It looks like we’ll have a short reprieve during the U.S. election period, to put a positive spin on the Biden administration’s handling of the pandemic, and whatever the new agenda is, it’ll be rolled out afterward. We do know it’ll involve “the biggest vaccine campaign in history,” though, which could get interesting, seeing how people have woken up in droves to the fact that the COVID shots are maiming and killing without providing any benefit.

The More COVID Shots, the Higher the Reinfection Rate

Evidence that COVID reinfection rates go up in tandem with the number of COVID shots administered is also mounting, which is turning former believers into skeptics. As reported by Icelander Thorsteinn Siglaugsson in a Daily Sceptic article published in mid-August 2022:18

“Does anyone still recall the excitement in late 2020 when the vaccines against COVID-19 were finally in sight? The trial results were excellent, promising an end to the pandemic in 2021 … I believed in the narrative myself … I even took part in an attempt to have one of the manufacturers arrange a population-wide trial in Iceland, similar to what Pfizer did in Israel. Today I’m very glad we didn’t succeed.

Soon it will be two years since the trial results were out … Data on infection, hospitalization and mortality already show vaccination not only failing to prevent those, but in some cases being counterproductive. In short, the vaccines have failed to deliver what we were promised.

And even worse, the skyrocketing rate of side effects may mean that for most people vaccination makes no or little sense. Still, it is for the most part forbidden to discuss this fact … As an example, it is forbidden to say COVID-19 vaccines may cause death, even if a quick search on the internet shows confirmed cases where there is no doubt about the causality.

It is forbidden also to share evidence showing higher infection rates among the vaccinated than the unvaccinated. It will therefore be interesting to see how those platforms will react to those who share the results of a new research letter published on August 3rd in Jama Network Open.19

The letter describes the result of a study which monitored for reinfection all Icelanders previously infected, during the Omicron wave, between December 1st 2021 and February 22nd 2022. The study shows a probability of reinfection of up to 15.1% among 18-29 year-olds, declining with age …

But the most interesting part is the comparison by vaccination status. It shows that for most age groups, those who have received two doses or more are more likely to become reinfected than those who have received no vaccination or one dose.”

Once the broad masses begin to accept the reality that more shots equal higher risk of COVID infection, how easy do you think it will be for government to convince them to take a bivalent COVID jab? And if resistance ends up being as high as I suspect it might be, come this fall, what measures might they take to, again, try to force people into compliance? Your guess is as good as mine.

COVID Shots Are Causing Depopulation

Another major hurdle in the plan to launch the biggest vaccination campaign in history is the evidence showing the COVID shots are already causing mass depopulation. As reported by The Exposé, August 7, 2022:20

“COVID-19 vaccination is causing mass depopulation. This is an extremely bold claim to make. But unfortunately, this bold claim is backed up by a mountain of evidence contained in the confidential Pfizer documents and official Government data from around the world.”

Indeed, excess deaths have skyrocketed since the release of the COVID jabs, and the timing is so exact, it can’t be explained away. In the U.K., they’re now massaging data to try to hide it. As explained by The Exposé,21 the five-year average that deaths are now compared to are made up of mortality data from 2016, 2017, 2018, 2019 and 2021.

Excess deaths started climbing in 2021, after the rollout of the shots, and by including 2021 (rather than calculating a five-year average from 2015 to 2019, for accurate prepandemic figures), the excess mortality in 2022 appears closer to the five-year norm than it actually is. Excess deaths are also up in most of Europe, as illustrated in the graph22 below:

Epoch Times Photo

Eliminating confusion about the cause of these excess deaths are data comparing the mortality rates among those jabbed and the unjabbed. July 6, 2022, the British Office for National Statistics issued a report23,24 showing the mortality rates per 100,000 are consistently lowest among the unvaccinated, in all age groups.

In the 18 to 39 age group, unvaccinated had a mortality rate of 14.1 per 100,000 during the month of May 2022, whereas those who got their first dose at least 21 days ago had a mortality rate of 42.6 per 100,000. The mortality rate for double-jabbed was 17.3 per 100,000 and triple-dosed had a mortality rate of 21.4 per 100,000.

As shown in the graph below, created by The Exposé,25 the identical pattern repeats for every month, January through May 2022.

Epoch Times Photo

Infant Mortality Has Skyrocketed

The Exposé26 also highlights data showing infant mortality is now far above the norm. In Scotland, official data show neonatal deaths were 119% higher in March 2022 than the annual norm. Live birth rates are also plummeting around the world.

In Germany, the birth rate for January through April 2022 was 11% lower than the seven-year prepandemic average. And the FDA, CDC and Pfizer can hardly be surprised, as Pfizer’s own documents show nearly all pregnant women who participated in its trial — for whom birth outcomes were available — lost their babies. Only one of 29 known birth outcomes were classified as “normal.” The remaining 28 miscarried.

The U.S. Vaccine Adverse Event Reporting (VAERS) database also listed 4,113 fetal deaths following COVID injection as of April 2022.27 Compare that to the fetal death reports for all other vaccines reported to VAERS in the last 30 years. That number is 2,239.28

Animal research29 published in August 2021, in which female rats were given the Pfizer jab (BNT162b2), also found it increased certain birth defects (extra ribs) by 295% compared to controls, and doubled preimplantation loss (i.e., fertilized ova that fail to implant). In other words, it doubled the risk of infertility. As noted by The Exposé:30

“With this being the case, how on earth have medicine regulators around the world managed to state in their official guidance that ‘Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy’? And how have they managed to state ‘It is unknown whether the Pfizer vaccine has an impact on fertility’?

The truth of the matter is that they actively chose to cover it up. We know this thanks to a Freedom of Information (FOI) request31 made to the Australian Government Department of Health Therapeutic Goods Administration (TGA).”

You can read more about that in The Exposé’s July 19, 2022, article, “FOIA Reveals Pfizer & Medicine Regulators Hid Dangers of COVID Vaccination During Pregnancy After Study Found It Increases Risk of Birth Defects & Infertility.”32

Final Thoughts

So, to wrap this up — yes, the CDC has vindicated truth tellers by reversing its COVID guidelines and basically adopting The Great Barrington declaration, but we’re nowhere near out of the woods yet. A major vaccination campaign is being planned for the fall, even as evidence mounts showing the shots are causing depopulation at a rate we’ve never seen before, outside of world war.

The shots are killing otherwise healthy working-age adults, they’re killing babies in the womb, and they’re causing infertility. They are, without a doubt, the most dangerous drugs ever made. So, enjoy this reprieve, but firm up your resolve to stand against another round of tyranny this fall.

Original source:

COVID 19 deaths and injuries

A Tasmanian Funeral Director is Concerned About the 50% Rise in Funerals He is Undertaking in the Last 7 Months

A Tasmanian Funeral Director is Concerned About the 50% Rise in Funerals He is Undertaking in the Last 7 Months

By Covid Vaccine and Victims

‘The previous 10 and a quarter years were very consistent. But this has been a rapid rise in the last 6 to 7 mnths’

Stats: 16.6% rise in excess deaths in Oz.

10,757 extra Australians dead in first five months of the year – up 16.6% on the historical average.

Click Here To Play Video

Original source:


Hospitals in Victoria, Australia Are Conducting Experiments on Babies Without Parental Consent

Hospitals in Victoria, Australia Are Conducting Experiments on Babies Without Parental Consent

In Victoria, Australia, hospitals are conducting experiments on newborn babies without parental consent.

Experiments involving different oxygen concentrations at the first few minutes of life.


Here’s a two-minute rundown of what I found:


Repost from GAB

Link to SMH document mentioned in video:


Ethical questions raised about trial on babies done without parents’ consent

A new clinical trial comparing different oxygen levels on preterm babies in Victorian hospitals – without telling their parents – is raising major concerns among ethics experts and hospital staff.

Premature babies often need help breathing in the first few minutes of life. The AIROPLANE Trial will test two different oxygen concentrations, 21 per cent and 30 per cent, on 1200 infants to see if it affects their health.

There is no standard level of oxygen support for babies born four to eight weeks early in Victoria, nor is there enough evidence to prove 21 per cent is better than 30. Different hospitals use concentrations between 21 and 30 per cent.

A new clinical trial testing different oxygen levels on preterm babies in Victorian hospitals - without telling their parents - has raised concerns among ethics experts and hospital staff.


A new clinical trial testing different oxygen levels on preterm babies in Victorian hospitals – without telling their parents – has raised concerns among ethics experts and hospital staff.

Therefore, the researchers say their trial does not pose any extra risk to the babies. Furthermore, seeking consent from 100,000 parents-to-be would be almost impossible, they say.

The trial was approved by the Royal Children’s Hospital in Melbourne; the researchers hope to run it at about 20 sites across the state. The researchers also received a sign-off from a consumer panel of parents and preterm survivors.

But The Age understands research ethics staff from at least one hospital hold major concerns, which are shared by some independent ethics experts.

Informed consent is a sacred scientific principle, so sacred Victoria’s Charter of Human Rights bans scientific experimentation without consent.

“The bar is very high” for experimenting without consent, said Dr David Hunter, a medical ethics researcher at the University of Adelaide, “and it should be”.

Outcomes measured in the study include whether the baby needs continuing breathing support, how long they stay in hospital, and mortality.

It is possible the study may discover higher oxygen concentrations may be better for a baby than lower concentrations. If a baby died, and their parents later discovered they had been unknowingly enrolled in the low-oxygen group, it could lead the parents to blame the researchers, Hunter said.

“‘My kid died – and that’s the fault of the research’, they might think. It’s not the fault of the research, but it’s a perfectly reasonable thing for some people to come to because getting your head around the complexities of the research is hard,” he said.

“Even if you’re not subjecting children to additional harms, the feeling of the absence of control, the not knowing about it, that is damaging to the broader project of research.”

Merle Spriggs, an honorary senior research fellow at the University of Melbourne and a pediatric bioethics expert, said the need to know if one oxygen concentration was better than the other was a good reason to run the trial.

“It is not a justification for withholding information from parents,” she said.

“The bar is very high” for experimenting without consent, says Dr David Hunter, a medical ethics researcher at the University of Adelaide, “and it should be.”

“The bar is very high” for experimenting without consent, says Dr David Hunter, a medical ethics researcher at the University of Adelaide, “and it should be.”

In a statement to The Age, the research team said it would be “ethically inappropriate” and extremely difficult to approach tens of thousands of pregnant women to get their consent for the trial when the vast majority would not birth a preterm baby.

“Without this design, we will not be able to answer this question and newborns will continue to be exposed to treatments without any proven benefit,” the researchers said.

Spriggs argued this was not a good enough reason to not seek consent.

“Taken to its logical conclusion, this suggests we should dispense altogether with consent,” she said. “Feasibility and recruitment rates do not provide an ethical justification for dispensing with consent”.

Dr David Hunter said the researchers could enrol pregnant women at prenatal screenings.

“I can’t think of why you can’t do that here. This is where I really come unstuck,” he said.

Several ethicists told The Age they could see no problem with the study at all.

“There is no ethical problem here,” said Professor Paul Komesaroff, director of the Centre for Ethics in Medicine and Society.

“There is no empirical basis for favouring one treatment rather than the other,” he said. “It would be perfectly reasonable for a hospital to toss a coin to decide whether a baby gets 30 per cent or 21 per cent oxygen – and there would be nothing unethical about that.”

But Dr David Hunter’s concerns stem in part from the response to a US clinical trial – one that ended in lawsuits from parents claiming their children had been harmed.

It was entirely possible for a parent to feel the trial had harmed their baby, even if it hadn’t, he said. “Why do I think this? Because it’s what we saw in SUPPORT.”

SUPPORT tested different levels of oxygen, both standards of care, on babies in American hospitals.

SUPPORT did seek consent from parents, but those consent forms failed to make all the risks clear, an investigation by America’s medical research watchdog claimed. That later led to an unsuccessful lawsuit by some parents involved in the trial.


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