COVID-19 Vaccines and Informed Consent
Testimony, Facts and Receipts: Updated prior essay from Hon. John Allison, J.D.
Here is the link to the entire post
Aug 2, 2023
Were you adequately informed about the COVID-19 treatment risks and options? Were you adequately informed about the COVID-19 genetic vaccine risks? Did you have full knowledge and understanding of those risks? Did you make a decision to (or not to) voluntarily accept vaccines or medical treatment(s) for COVID-19 disease? Does your physician check in with you to insure that you are providing continuous and ongoing consent if you are participating in any experimental treatments or clinical research studies?
Were you coerced, enticed, or forced to accept an experimental medical product or procedure without providing fully informed consent?
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John Allison, J.D. previously wrote and published an essay (August 2022) on the topic of COVID-19 vaccines and informed consent, and he has now updated his prior essay with additional information (updated late July 2023). Following is his updated essay, with associated references.
COVID-19 Vaccines and Informed Consent
By John Allison, J.D.
Updated July 25, 2023
Introduction.
Most Americans have long assumed that they have a fundamental right to make decisions about their own bodily health and the medical treatments they receive. Informed consent is the ethical and legal principle by which that fundamental right is enforceable. To be able to give informed consent a person needs to be informed about the risks and benefits of, and alternatives to, the proposed treatment.
The fundamental right to informed consent is particularly important with respect to the COVID-19 vaccines which are available in the United States pursuant to Emergency Use Authorizations (EUAs). Under the federal EUA statute, people are entitled to be informed about their right to accept or refuse administration of these vaccines, the consequences (if any) of refusing vaccination, and the benefits and risks of alternatives to the vaccines. A different federal statute gives the manufacturers of EUA vaccines, and the people and organizations administering them, immunity from liability suits for damages. Unless courts decide that the immunity statute cannot be applied against people who did not give their informed consent to vaccination, people who suffer severe adverse effects after receiving a COVID-19 vaccine will not be able to recover compensation, for their monetary and emotional distress damages, from the vaccine manufacturers or from the people who vaccinated them. Similarly, the family members of people who die after receiving a COVID-19 vaccine will not be able to recover compensation for their loss.
Opinions and Basis for Opinions.
Based on the results of my research to date, I have arrived at the following opinions with respect to the COVID-19 vaccines that are being widely used in the United States:
1. Government misinformation about the safety and effectiveness of the COVID-19 vaccines, censorship of credible scientific and medical information about the risks of death and serious adverse effects of the COVID-19 vaccines, and vaccination coercion, are depriving people of their ability to give informed consent to vaccination. Unless the limited effectiveness of the vaccines and the risks of death and serious adverse effects described in this memorandum are disclosed to people before they are vaccinated, informed consent has not been obtained.
2. Safe and effective drugs on the market for many years, such as ivermectin and hydroxychloroquine, have been proven by reputable doctors to be successful in the early treatment of COVID-19. If those affordable drugs had been allowed to be more widely used in the United States before people needed to be hospitalized, many tens of thousands of people who died from COVID-19 would probably be alive today.
3. The COVID-19 vaccines authorized for use in United States do not meet established criteria for establishing their short-term and long-term safety and efficacy. Serious safety signals – red flags – about these vaccines have been ignored, and continue to be ignored, by the FDA and the CDC. Also, during the past two years it has become clear that the COVID-19 vaccines do not prevent infection or transmission of COVID-19. Fully vaccinated people can become infected and can spread the SARS-CoV-2 virus to other vaccinated people and to unvaccinated people. All of these vaccines should be taken off the market immediately.
· SARS-CoV-2 is the coronavirus that causes COVID-19. Distinctive spike proteins on the surface of the virus enable the virus to penetrate cells and cause infection.
· According to a mortality analysis by the Johns Hopkins Coronavirus Resource Center, as of July 19, 2023 the United States had a COVID-19 case fatality ratio of 1.1%. The case fatality ratio is the number of deaths divided by the number of confirmed COVID-19 cases. This means that, in the United States, 98.9% of all the people with a confirmed case of COVID-19 survived the disease. Most COVID-19 deaths occurred in elderly people who were in poor health with multiple comorbidities. A study by researchers at Stanford University found that 99.9973% of COVID-19 patients 19 years of age and younger survive the disease.
· The spike proteins on the surface of the SARS-CoV-2 virus mutate, producing the Delta variant which became the dominant form of the virus by the middle of 2021. Continuing mutations of the spike proteins produced the Omicron variant which became the dominant form of the virus by the end of 2021. We are now dealing with sub-variants of Omicron.
· The first confirmed case of COVID-19 in the United States was reported in mid-January, 2020. The pandemic spread. COVID-19 vaccines were not available until the middle of December 2020 when the FDA granted emergency use authorization for the Pfizer-BioNTech and the Moderna vaccines. In February 2021 the FDA granted emergency use authorization for the Johnson & Johnson/Janssen vaccine. Early in 2021 these vaccines became widely available in the United States and mass vaccination programs began. By the middle of 2021 millions of Americans, including workers in many different occupations, were fully vaccinated.
· According to data on the CDC website accessed on July 18, 2022, in the United States there were 385,670 deaths attributed to COVID-19 in 2020 before the vaccines were widely available. In 2021, when the Pfizer-BioNTech, the Moderna and the Johnson & Johnson/Janssen vaccines were widely available and mass vaccination campaigns took place, there were 463,210 deaths attributed to COVID-19; there were 20.1% more COVID-19 deaths in 2021 than in 2020.
· The COVID-19 vaccines do not produce immunity to COVID-19 because they are not designed to trigger an immune response to the SARS-CoV-2 virus. Instead, the vaccines are designed to cause the body to produce spike proteins in order to stimulate an immune response to the spike proteins which are on the surface of the virus. The Pfizer-BioNTech and Moderna vaccines use synthetic mRNA genetic instructions to cause the body to produce enormous numbers of spike proteins. The mRNA technology used in those vaccines is a new and unproven technology that has never been used before in vaccines administered to people. The Johnson & Johnson/Janssen vaccine is a viral vector DNA vaccine that also causes the body to produce enormous numbers of spike proteins.
· An internal CDC email produced in response to a Freedom of Information Act request reveals that on January 30, 2021 the Director of the CDC had a conversation with the Director of the NIH about “vaccine breakthroughs” based on an article published in the Journal of the American Medical Association a few days earlier. “Vaccine breakthroughs” refers to fully vaccinated people who become infected with the SARS-CoV-2 virus and contract COVID-19.
· When FDA issued its EUAs for the Pfizer-BioNTech, Moderna and Johnson & Johnson/Janssen COVID-19 vaccines in late 2020 and early 2021, the CDC defined a “vaccine” as a “product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” Traditional vaccines for diseases such as smallpox and polio meet that definition, which is consistent with the definition of “vaccine” found in the 1996 edition of Webster’s New Universal Unabridged Dictionary: “any preparation used as a preventive inoculation to confer immunity against a specific disease, usually employing an innocuous form of the disease agent, as killed or weakened bacteria or viruses, to stimulate antibody production.”
· In July 2021 an outbreak of SARS-CoV-2 infections in Barnstable County, Massachusetts led the CDC to reverse its position on the wearing of masks and to recommend that all people wear masks indoors when viral transmission is likely, regardless of their vaccination status. The outbreak involved 469 people with COVID-19 infections; 79 percent of those people were symptomatic. 74 percent of the symptomatic people were fully vaccinated. Five people needed to be hospitalized; four of the five were fully vaccinated. This incident made it clear that the vaccines do not prevent infection or transmission of COVID-19. Vaccinated people can become infected and can also spread the SARS-CoV-2 virus to other people.
· Effective September 1, 2021, once it had become clear that the COVID-19 vaccines do not produce immunity to COVID-19, the CDC simply changed its definition of “vaccine” to: “A preparation that is used to stimulate the body’s immune response against diseases.” Internal CDC emails produced in response to a Freedom of Information Act request, including an August 13, 2021 email from Andrew Lowndes at CDC to Alycia Downs at CDC, indicate that the change in definition was intended to justify continuing to refer to the COVID-19 injections as “vaccines.” Redefining the word “vaccine” does not turn these experimental products into true vaccines as the term “vaccine” has been understood by people for many years. These products are, in reality, more accurately described as gene therapy injections that cause the body to produce spike proteins. As Moderna acknowledged in its quarterly report filed with the Securities and Exchange Commission for the period ending June 30, 2020, “[c]urrently, mRNA is considered a gene therapy product by the FDA.”
· In a recent letter dated April 18, 2023 Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, acknowledged the current FDA position “that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission. . . . There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.”
· Project Salus, a Department of Defense and Joint Artificial Intelligence Center study, analyzed the effectiveness of mRNA COVID-19 vaccines against the Delta variant among Medicare beneficiaries 65 years and older. The project’s September 28, 2021 report indicates, on page 7, that “In this 80% vaccinated >=65 population, an estimated 71% of COVID-19 cases occurred in fully vaccinated individuals” (emphasis in the report). The report also points out, on page 12, that “In this 80% vaccinated 65+ population, an estimated 60% of COVID-19 hospitalizations occurred in fully vaccinated individuals in the week ending August 7th” (emphasis in the report).
· When the Delta and later the Omicron variants became the dominant form of the SARS-CoV-2 virus, a number of studies in different countries show that most COVID-19 hospitalizations and deaths occur among fully vaccinated people. For example, the UK Health Security Agency’s March 3, 2022 COVID-19 Vaccine Surveillance Report contains information in Table 12, on page 43, about deaths between January 31 and February 27, 2022 among patients who died within 28 days of testing positive for COVID-19 or who had COVID-19 mentioned on their death certificate. Of the 3,957 patients who died, 3,429, or 86.6%, had received two or three doses of a COVID-19 vaccine. (725 people had received two doses, and 2,704 people had received three doses.)
· Since the Omicron variant became the dominant form of SARS-CoV-2, the effectiveness of the mRNA vaccines (Pfizer and Moderna) diminishes significantly over just a few months. According to a Danish study, which has not yet been peer reviewed, vaccinated people, more than 90 days after vaccination, are significantly more likely than unvaccinated people to be infected by Omicron. A different study published in April of this year, which has been peer reviewed, found that the “risk of COVID-19 also varies by the number of vaccine doses previously received. The higher the number of vaccines previously received, the higher the risk of contracting COVID-19.”
· On July 13, 2022 the FDA granted emergency use authorization for the Novavax adjuvanted COVID-19 vaccine for people ages 18 and older, which was later amended to authorize administration of the Novavax vaccine to people ages 12 and older.
· On August 31, 2022 the FDA granted emergency use authorizations for the Pfizer-BioNTech and the Moderna bivalent (Original and Omicron BA.4 and BA.5 strains) vaccines as boosters. No clinical (human) studies were performed on those bivalent vaccines before they were authorized for emergency use. Only non-clinical studies on a relatively small number of mice were performed. On April 18, 2023 the FDA amended and expanded the emergency use authorizations for the bivalent vaccines to make them generally available, and ended the emergency use authorizations for the original (monovalent) Pfizer-BioNTech and Moderna vaccines.
· On June 1, 2023 the FDA revoked the emergency use authorization for the Johnson & Johnson/Janssen vaccine. As a result, only the Pfizer-BioNTech and Moderna bivalent vaccines, and the Novavax adjuvanted vaccine, are now available in the United States.
· The results of a study published in a peer-reviewed article on April 19, 2023 show that the bivalent vaccines have very limited effectiveness. The authors conclude that “the current bivalent vaccines were about 29% effective when the Omicron BA.4/5 lineages were the predominant circulating strains, and effectiveness was lower when the circulating strains were no longer represented in the vaccine. A protective effect could not be demonstrated when the XBB lineages were dominant.”
· Pfizer’s Comirnaty COVID-19 vaccine received full FDA approval on August 23, 2021 and Moderna’s Spikevax COVID-19 vaccine received full FDA approval on January 31, 2022. However, those vaccines have not been available in the United States. If they were available in the United States, emergency use authorizations for the COVID-19 vaccines that are available could not lawfully be maintained. Under the EUA statute, one of the mandatory criteria for an emergency use authorization is that “there is no adequate, approved, and available alternative” to the product in question. The Pfizer-BioNTech and Moderna vaccines available in the United States are legally distinct EUA products that were not transformed into approved products by the FDA’s approval of Comirnaty and Spikevax.
· It turns out that the spike proteins produced by the body in response to the COVID-19 vaccines are, themselves, toxic to cells. For example, endothelial cells line the inside of arteries to make blood flow smoothly. Damage to the endothelial cells caused by spike proteins increases the potential for microscopic blood clots to form. Those microscopic blood clots can travel to the lungs, increasing the risk of developing pulmonary arterial hypertension which is a serious progressive condition that overtaxes and weakens the heart. There is no known cure for that condition. All of the mRNA COVID-19 vaccines, as well as the Johnson & Johnson/Janssen vaccine, have been shown to cause other serious blood clotting disorders as well.
· In the mRNA COVID-19 vaccines manufactured by Pfizer and Moderna the genetic instructions that cause the body to produce spike proteins are encapsulated in lipid nanoparticles. A preclinical study on laboratory animals conducted by Pfizer and submitted to the regulatory agency in Japan shows that the lipid nanoparticles and mRNA genetic instructions enter the bloodstream and accumulate in several organs, including the spleen, bone marrow, liver and adrenal glands, and concentrate in the ovaries. The body then starts producing spike proteins wherever the mRNA genetic instructions happen to land.
· A number of serious medical conditions have been associated with the COVID-19 vaccines, including blood clotting disorders, cardiac emergencies, myocarditis, Guillain-Barré Syndrome, autoimmune disease, spontaneous miscarriages, nervous system disorders and female infertility.
· The COVID-19 vaccines also interfere with the natural immune system, making a person more susceptible to viral infections and cancer. In a May 6, 2021 preprint article, which has not yet been peer reviewed, a group of research scientists in the Netherlands and Germany reported their conclusion that the Pfizer-BioNTech vaccine “induces functional reprogramming of innate immune responses, which should be considered in the development and use of this new class of vaccines.” They also point out that “inhibition of innate immune responses may diminish anti-viral responses.” A more recent peer reviewed article published June 2022 in Food and Chemical Toxicology explains how the mRNA COVID-19 vaccines subvert innate immunity and dysregulate the body’s system “for both preventing and detecting genetically driven malignant transformation within cells.”
· A laboratory study in Sweden shows that the Pfizer-BioNtech COVID-19 vaccine is able to enter a human liver cell line where it is reverse transcribed into DNA within a matter of hours. As a result, the possibility that the COVID-19 vaccines affect DNA cannot be ruled out.
· The mRNA COVID-19 vaccines contain problematic ingredients that should not be injected into peoples’ bodies. Both the Pfizer and the Moderna vaccines contain polyethylene glycol (PEG) as an active ingredient. Several years ago, in 1993, an Expert Panel assessing the safety of PEG recommended against using PEG in ointments applied to damaged skin because some burn patients treated with a PEG-based antimicrobial cream experienced renal tubular necrosis and died of kidney failure. The PEG used in the Moderna vaccine matches the description of a PEG product manufactured by Sinopeg, a company in China. According to the Sinopeg website, that product is for “research use only.” The Moderna vaccine also contains a lipid known by the trade name SM-102. The Pfizer vaccine also contains a lipid known by the trade name ALC-0315. According to the safety information on the website of Cayman Chemical Company, which manufactures SM-102 and ALC-0315, both of those products are “for research use – Not for human or veterinary diagnostic or therapeutic use.” Yet, in the mRNA COVID-19 vaccines, PEG, and SM-102 or ALC-0315, are being directly injected into people’s bodies.
· As Dr. Peter McCullough pointed out in his October 13, 2021 sworn expert witness Declaration filed in the U. S. District Court for the Middle District of Florida: “The COVID-19 genetic vaccines (Pfizer, Moderna, J&J) skipped testing for genotoxicity, mutagenicity, teratogenicity, and oncogenicity. In other words, it is unknown whether or not these products will change human genetic material, cause birth defects, reduce fertility, or cause cancer.”
· Pfizer reportedly cut corners in the pre-clinical animal testing of the Pfizer-BioNTech COVID-19 vaccine. According to a May 28, 2021 article on the TrialSite News website, which reports on clinical trials, Pfizer performed its pre-clinical animal tests using “surrogate” mRNA instead of the mRNA that is actually in the vaccine.
· Deficiencies in the clinical trials for the Pfizer-BioNTech COVID-19 vaccine are explained in a public document prepared by the Canadian Covid Care Alliance, a group of more than 500 independent Canadian doctors, other health care practitioners and scientists. The document also contains information from six months of follow up in the Pfizer-BioNtech clinical trial, indicating that related adverse events were 300% higher in the vaccinated group than in the placebo (control) group, and severe adverse events were 75% higher in the vaccinated group than in the control group. The document can be found at:
· No long-term clinical studies were performed to evaluate the long-term safety of the COVID-19 vaccines. As a result, there is no way of knowing whether or not vaccinated people will suffer severe adverse side effects in the future. This lack of information is of particular concern since the vaccines increase the potential for developing cardiovascular disease and autoimmune disease, which can both take months or years to fully develop. Because clinical trial participants in the placebo (control) group were subsequently given the option of getting vaccinated, and a number of them chose to be vaccinated, there is no longer a statistically viable control group for a study of the long-term adverse effects of the vaccines.
· Pfizer recognizes that the long-term adverse effects of its COVID-19 vaccines are not currently known. In its Agreement to supply Pfizer-BioNTech COVID-19 vaccines to the government of a European country, Pfizer’s subsidiary required the purchasing government, in paragraph 5.5 of the Agreement, to acknowledge “that the long-term effects and the efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known.”
· The Pfizer-BioNTech, Moderna and Johnson & Johnson/Janssen COVID-19 vaccines fail to meet reasonable expectations for product uniformity. Analyses by independent researchers show that some vaccine batches, identified by lot number, are many times more toxic than others. Roughly 80% of the vaccine batches account for 1 or 2 adverse events per batch reported in the government’s Vaccine Adverse Events Reporting System (VAERS). Other batches account for hundreds or thousands of adverse events per batch reported in VAERS, and some of those adverse events involved death, disability or serious illness. A recent study in Denmark of Pfizer-BioNTech COVID-19 vaccines confirms a correlation between adverse effects and vaccine batch. For vaccines administered in Denmark between December 27, 2020 and January 11, 2022, batches comprising 4.22% of the vaccine doses accounted for 27.49% of serious adverse events, batches comprising 63.69% of the vaccine doses accounted for 71.5% of serious adverse events, and batches comprising 32.09% of the vaccine doses accounted for 1.01% of serious adverse events.
· The government established VAERS in 1990 which is co-managed by the CDC and the FDA. It is intended to be a national early warning system to detect possible safety problems with vaccines in the United States. The number of serious adverse events and deaths that have been reported in VAERS for the COVID-19 vaccines is many times greater than the serious adverse events and deaths reported in VAERS for all other vaccines combined. As of October 7, 2022 more than 31,400 deaths, and more than 230,200 serious injuries, following administration of one of the COVID-19 vaccines have been reported in VAERS. Several thousands of those deaths occurred within a day or two after vaccination. Due to underreporting, the actual number of deaths and serious injuries following COVID-19 vaccination is likely to be higher than the number reported in VAERS. Yet the CDC and the FDA continue to ignore these serious safety signals.
Go read the rest and try not to be mad, but never trust Pharma or Government again (or China)
Delusions of Adequacy 