COVID-19 Vaccines and Informed Consent

By John Allison, J.D.

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. The manufacturers of EUA vaccines, and the people and organizations administering them, are immune from liability suits. 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.
 
Based on the results of my research to date, I have arrived at the following opinions with respect to the COVID-19 vaccines currently authorized or approved for use 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 or approved 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. The EUAs for the Pfizer-BioNTech, the Moderna and the Johnson & Johnson/Janssen COVID-19 vaccines, and the FDA’s approval of Pfizer’s Comirnaty vaccine and Moderna’s Spikevax vaccine, should be revoked. 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. The spike proteins mutate, producing the Delta variant which became the dominant form of the virus by the middle of 2021. Continuing mutations of the spike protein 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.
• 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 trigger an immune response to the spike proteins on the surface of the original virus.
• A number of studies demonstrate that the vaccines do not prevent infection or transmission of COVID-19. Fully vaccinated people can become infected and can also spread the SARS-CoV-2 virus to other vaccinated people and to unvaccinated people.
• According to data on the CDC website, in the United States there were 385,670 deaths attributed to COVID-19 in 2020, before the vaccines were widely available. In 2021, when vaccines were widely available and mass vaccination campaigns took place, there were 463,210 deaths attributed to COVID-19 – an increase of 20.1%.
• When the Delta and later the Omicron variants became the dominant form of the virus, government studies in different countries show that most COVID-19 hospitalizations and deaths occur among fully vaccinated people.
• Now that the Omicron variant is 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 more likely than unvaccinated people to be infected by Omicron.
• The COVID-19 vaccines contain genetic instructions that cause the body to produce enormous numbers of SARS-CoV-2 spike proteins in order to provoke an immune response to the spike proteins. Unfortunately, it turns out that the spike proteins, themselves, are 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 arterial hypertension which is a serious progressive condition that overtaxes and weakens the heart. There is no known cure for that condition.
• 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 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. This may explain why most COVID-19 symptomatic infections, hospitalizations and deaths are now occurring among fully vaccinated people.
• A recent laboratory study in Sweden indicates 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 also contain problematic ingredients. Both the Pfizer and the Moderna vaccines contain polyethylene glycol (PEG) as an active ingredient. 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, SM-102 and ALC-0315 are being directly injected into people’s bodies.
• Because no long-term clinical studies were performed, there is no way of knowing whether or not vaccinated people will suffer severe adverse side effects in the future. This is a significant concern, since the vaccines increase the potential for developing cardiovascular disease and autoimmune disease, which can both take months or years to develop.
• In 1990 the government established the Vaccine Adverse Events Reporting System (VAERS) 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 July 1, 2022 more than 29,200 deaths, and more than 212,600 serious injuries, following administration of one of the COVID-19 vaccines have been reported in VAERS. Yet the CDC and the FDA continue to ignore these serious safety signals.
• In contrast, in 1976 the federal government conducted a mass vaccination campaign against the swine flu. After roughly 25% of the population in the United States had been vaccinated, the government terminated the vaccination program due to reports of 25 deaths and 550 cases of Guillain-Barré Syndrome following vaccination.
• According to a mortality analysis by the Johns Hopkins Coronavirus Resource Center, 98.9% of all the people in the United States 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.
• The Society of Actuaries collected and analyzed claims data from twenty life insurance companies that provide group term coverage in the United States, representing roughly 90% of the employer-based group term life insurance industry. All-cause mortality data for the pandemic period (April 1, 2020 through September 30, 2021) was compared to all cause mortality data for the baseline period (2017 through 2019). The analysis reveals a dramatic spike in deaths from all causes during the third quarter of 2021 (July 1 through September 30). During that quarter, excess mortality for all policyholders was more than 30% above baseline. The spike in deaths was even more dramatic for working-age people. Excess mortality for people ages 25 to 34 was 81% above baseline, excess mortality for people ages 35 to 44 was 117% above baseline, excess mortality for people ages 45 to 54 was 108% above baseline, and excess mortality for people ages 55  to 64 was 70% above baseline. The dramatic increase in deaths from  all causes during the third quarter of 2021, particularly among working age people, undermines the claim that the COVID-19 vaccines are safe and effective.

Basis for Opinions.
 
1. The only COVID-19 vaccines currently available in the United States are the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson/Janssen vaccine, which are available pursuant to Emergency Use Authorizations (EUAs).
 
2. Pfizer’s Comirnaty COVID-19 vaccine has received full FDA approval and been licensed for use by FDA. However, that vaccine is not currently available in the United States. As Dr. Robert Malone pointed out in a sworn declaration filed in a case pending in the U. S. District Court for the Middle  District of Florida, the Pfizer-BioNTech vaccine and the Comirnaty vaccine are not interchangeable. They are legally distinct products. Dr. Malone is an original inventor of the core mRNA technology used in the Pfizer-BioNTech  and Comirnaty vaccines. The potential for confusion when the approved vaccine is not available, and the available vaccines do not have FDA approval but are merely authorized for emergency use, was pointed out in a letter U. S. Senator Ron Johnson sent to the Acting Commissioner of the FDA on August 26, 2021. The FDA has done nothing publicly to clear up that confusion.
 
3. Instead, the FDA perpetuated the confusion it created. On January 31, 2022 Moderna’s Spikevax COVID-19 vaccine received full FDA approval. The FDA’s press release announcing its approval claims that “Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.” However, Moderna’s Spikevax COVID-19 vaccine is not currently available in the United States.
 
4. The difference between a fully approved vaccine, and a vaccine authorized for emergency use, is highly significant for vaccine recipients. Manufacturers of fully approved vaccines are generally subject to liability claims for damages caused by the vaccines. Such liability claims can be based on design defects, manufacturing defects, and failures to adequately warn about possible complications and side effects. In contrast, manufacturers of vaccines authorized for emergency use are immune from those liability claims.
 
5. 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. The Pfizer and the Moderna COVID-19 vaccines use synthetic mRNA genetic instructions to cause the body to produce spike proteins. The Johnson & Johnson COVID-19 vaccine is a viral vector DNA vaccine that also causes the body to produce spike proteins. All of these vaccines are designed to stimulate an immune response to the spike proteins of the original SARS-CoV-2 virus. Unlike the body’s natural immune response to an infection, the vaccines do not trigger an immune response to the SARSCoV-2 virus itself, but only to the spike proteins of the original virus.
 
6. Before September 1, 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.” When it became clear by the summer of 2021 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.” 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, in reality, are more accurately described as gene therapy injections that cause the body to produce spike proteins in order to provoke an immune response to the spike proteins which are only a part of the SARS-CoV-2 virus.
 
7. It has become 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. 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.
 
8. At a symposium on December 10, 2021 Sucharit Bhakdi, M.D. and Arne Burkhardt, M.D. presented the results of their pathology analysis of the organs of 15 people who had died after receiving a COVID-19 vaccine. Both Dr. Bhakdi and Dr. Burkhardt have extensive backgrounds as academic medical researchers and professors in Germany. Based on their analysis, they concluded that the COVID-19 vaccines cannot protect against infection because the antibodies produced in response to the vaccines do not effectively protect the mucous membranes that line the respiratory tract. In their opinion, “the currently observed ‘breakthrough infections’ among vaccinated individuals merely confirm the fundamental design flaws of the vaccines.” Drs. Bhakdi and Burkhardt also described the evidence of vaccineinduced autoimmune pathology that they found.
 
9. The results of a study published October 28, 2021 in The Lancet Infectious Diseases online confirm that “fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts.”
 
10. A study of hospital workers in Vietnam compared the SARS-CoV-2 viral load in the nostrils of people who had COVID-19 in 2020 (before vaccines were available) with the viral load in the nostrils of fully vaccinated people who were infected by the Delta variant in 2021. The study showed that fully vaccinated people infected by the Delta variant in 2021 had 251 times the SARS-CoV-2 viral load of the unvaccinated people who had COVID-19 in 2020 before the virus mutated to form the Delta variant. The study also shows that fully vaccinated people can transmit the Delta variant to other vaccinated people as well as to unvaccinated people.
 
11. The results of a study reported in the European Journal of Epidemiology on September 30, 2021 indicate that COVID-19 vaccination rates do not correspond with lower infection rates. The study found that “countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people.”
 
12. A short video produced by Joel Smalley, a quantitative data analyst affiliated with the Health Advisory & Recovery Team in the UK, graphically shows dramatic spikes in COVID-19 deaths after the introduction of mass vaccination campaigns in each of 40 countries. The video can be found at:
 
https://www.youtube.com/watch?v=WR-pqrMWu3E
 
13. According to the CDC’s website accessed on July 18, 2022, deaths in the United States attributed to COVID-19 on death certificates increased from 385,676 in 2020 to 463,210 in 2021. The COVID-19 vaccines started to become available in December of 2020. Mass vaccination campaigns occurred in 2021. Yet there were 20.1% more COVID-19 deaths in 2021 than there were in 2020.
 
14. Because the COVID-19 vaccines do not trigger an immune response to the SARS-CoV-2 virus itself, mutations of the spike protein enable the virus toescape the effects of the vaccines and survive. One set of mutations produced the Delta variant, which became the dominant strain of the virus in many countries by the middle of 2021.

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