November 1, 2022
Dear Friends and Family,
Shortly after becoming CDC Director, Dr. Rochell Walensky stated, “We were not ready for this pandemic.” Natural fear existed because of the virus. The lack of readiness resulted in bad diagnoses, grossly inaccurate projections, and misinformation. The ensuing chaos perpetuated the natural fear which was further promoted by media hysteria.
A political opportunity was created, and edicts became commonplace enhancing the promoted fear. Enhanced to the point that mitigation of the virus became our sole focus. Those who thought more broadly and challenged the narrative were ridiculed and demeaned. So, we stayed in our cocoon, awaiting a vaccine to spring us. The entire pandemic was over-hyped and oversold to the point that the authors of these excerpts say the Covid pandemic should be changed to the “Pandemic of Fear.”
Happy Learning,
Harley
Dear Friends and Family,
Shortly after becoming CDC Director, Dr. Rochell Walensky stated, “We were not ready for this pandemic.” Natural fear existed because of the virus. The lack of readiness resulted in bad diagnoses, grossly inaccurate projections, and misinformation. The ensuing chaos perpetuated the natural fear which was further promoted by media hysteria.
A political opportunity was created, and edicts became commonplace enhancing the promoted fear. Enhanced to the point that mitigation of the virus became our sole focus. Those who thought more broadly and challenged the narrative were ridiculed and demeaned. So, we stayed in our cocoon, awaiting a vaccine to spring us. The entire pandemic was over-hyped and oversold to the point that the authors of these excerpts say the Covid pandemic should be changed to the “Pandemic of Fear.”
Happy Learning,
Harley
INTRODUCTION TO VACCINES: A vaccine is a substance, such as an inactivated protein from an infectious organism, that when given to a person induces an active immune response to prevent or mitigate a disease. Your immune system acts as an army. The immune system ideally detects the foreign invading germ (i.e., virus, bacterium, fungus), generally called a “pathogen,” and destroys it or contains it so that it cannot cause disease. What a vaccine does is give the immune system practice so that when it encounters the real pathogen, it is ready. Without practice from the vaccine, the pathogen can overwhelm an unprepared immune system, causing serious illness.
The immune system can protect against infection and disease in two different ways. First, it can secrete immune proteins, called antibodies, into blood or tissues that bind to the invading pathogen and prevent it from multiplying or invading cells of the human body and enhancing the uptake of the pathogens into special cells (“phagocytes”) which destroy the pathogen. Critical players in this response are B cells and specialized B cells called plasma cells. The plasma cells produce the antibodies that circulate in the blood and other body fluids and tissues, which when encountering the pathogen neutralize it or bind to it, facilitating destruction of the pathogen by other cells of the immune system. Second, the immune system consists of specialized cells, called T cells, which destroy infected human cells and prevent the pathogen from spreading and causing serious disease. This aspect of the immune systems is called the cellular immune system. So, vaccines induce individual protection by inducing protective immune responses.
Most vaccines also induce community protection or “herd or population immunity.” Since most vaccine-preventable diseases result from person-to-person spread, when an individual is infected, the pathogen reproduces in that person’s body and then spreads from the infected person to others. When the infectious person encounters a susceptible individual, the infectious person can transmit the infection. The cycle can then be repeated by infecting another contact, which is known as a chain of transmission. However, if the infectious person encounters an immune individual, there is no (or perhaps very limited) transmission. If a high percentage of the population is immune to the infection, then transmission does not occur, and the chain of human-to-human transmission is broken.
The vast majority of vaccines induce community protection because they not only protect individuals exposed to an infectious pathogen from getting ill, but they also prevent such persons from transmitting the pathogen to others who are susceptible. Thus, a goal for many vaccination programs is to induce immunity levels greater than the herd immunity threshold to terminate disease risk in that community.
Source: The COVID – 19 Vaccine Guide by Kathryn Edwards, MD; Walter Orenstein, MD, and David Stephens, MS (2021)
TYPES OF VACCINES: There are five basic categories of vaccines:
CLINICAL TRIALS: Clinical trials are usually broken into three distinct phases of escalating size and cost. Phase 1 clinical trials usually involve up to 100 healthy adult volunteers. This type of clinical trial is designed to answer two main questions: does this new vaccine confer the expected immunity and is it safe.
Phase 2 clinical trials may involve several hundred volunteers, where a small proportion of the study group are given placebos, to determine the appropriate dose of vaccine that should be administered. During this trial, the safety of the vaccine is also carefully studied by comparing the control and placebo groups for reactogenicity – fever, chills, pain or swelling/redness at the injection site – and other untoward effects.
A phase 3 clinical trial is the last stage prior to a company being able to request permission from the government regulatory agency (such as the FDA) to be allowed to bring the vaccine to the market and used by designated at-risk individuals. Phase 3 clinical trials are conducted to determine the safety and efficacy of the vaccine. Thousand of participants participate in the Phase 3 study, and this group of volunteers should always be as similar as possible to the population that will be administered the vaccine in real-world situations. Phase 3 studies are almost always randomized, double-blind, and placebo-controlled, meaning that neither the volunteers nor researchers know who is in the vaccinated or control group. This is critical, as no one working with the volunteers, or the volunteers themselves, should know which ones received the vaccine, lest the results become biased. As an example of bias could be if those knowing they received the vaccine had a stronger tendency to report medical problems.
Taking all this into account the numbers of volunteers required in an individual COVID-19 vaccine Phase 3 study must be at least 30,000 volunteers, but can range as high as 60,000, if we wish to show that the vaccine is achieving 50% efficacy with 90% confidence, the benchmark set by the FDA for a COVID-19 vaccine to be considered for approval. It is important to note that the clinical studies for COVID-19 vaccines are case driven, meaning that once a sufficient number of communities acquired COVID-19 cases have been reported in study volunteers, the clinical trial may be stopped, and results evaluated by an independent Data Safety Monitoring Board to calculate the vaccine efficacy and assess its safety profile.
To expedite the completion of COVID-19 vaccine trials, hefty development funding and innovative, combined phase protocols have been used to save valuable development time without any sacrifice in safety. As for funding, in the extraordinary effort to being COVID-19 vaccine forward in as short of a time as possible decisions have been taken by both vaccine company sponsors and government agencies to spend much larger sums of money on Phase 3 trials in order to have 100 or more vaccine research locations operating in parallel. In the case of COVID-19 pandemic, the FDA has been working closely with private vaccine manufacturers in an extraordinary collaborative manner to reduce these pauses in activity while not cutting corners on collecting and appropriately analyzing the trial data.
Source: The COVID-19 Vaccine: An Expert’s Medical Guide for All by Zeil Rosenberg MD (2021)
VACCINE APPROVAL: The U.S. Food and Drug Administration (FDA) must approve a vaccine before it can be used in the United States. FDA regulations for the development of vaccines ensure their safety, purity, potency, and effectiveness. FDA also inspects vaccine manufacturing sites to make sure they comply with current Good Manufacturing Practice regulations. Activities related to vaccines are coordinated in its Center for Biologics Evaluation and Research (CBER).
To best advise the FDA, a specialized Vaccines and Related Biological Products Advisory Committee (VBRPAC) makes recommendations to the CBER on a vaccine’s safety and efficacy prior to approval. In all cases to date, its recommendations are followed by the Commissioner of the FDA, who has the final legal authority to release a vaccine into use. The Committee consists of 15 voting members selected from among authorities knowledgeable in the fields of immunology, molecular biology, virology, vaccine development, preventive medicine, infectious disease, and pediatrics. The committee meets in open, publicly broadcast meetings where anyone can hear the experts discuss the data.
There are two different paths by which a vaccine can enter the market in order to address the COVID-19 pandemic. The first pathway is by use of a so-called “Emergency Use Authorization (EUA) from the FDA, based on data submitted to the FDA by the vaccine manufacturer. The second is by full licensure of the vaccine by the FDA in response to a complete Biologics Licensure Application (BLA) from the vaccine manufacturer. Reviewing the FDA’s own published guidance documents, a COVID-19 vaccine perfectly fits the EUA scenario envisioned for this alternative and usually temporary status. To obtain emergency use authorization for marketing a COVID-19 vaccine, four criteria must be satisfied.
Source: The COVID-19 Vaccine by Zeil Rosenberg, M.D. (2021)
MONITORING OF VACCINES AND VACCINATIONS AFTER MANUFACTURERS RECEIVE APPROVAL Many critical questions may not have been answered in studies or clinical trials of vaccines prior to licensure or granting of an EUA. For example, most clinical trials will not evaluate duration of immunity beyond a few months or years at most. It is important to determine how long immunity lasts and, if immunity wanes, when it wanes, which would be helpful in determining whether and when booster doses are needed.
Another major issue that may not be addressed in phase 3 trials is whether the vaccine provides a community or herd protection. Most phase 3 trials are individually randomized versus placebo or comparator vaccines arms. Hence, they assess individual protection from disease induced by the vaccine. With many vaccines, individual protection against disease is also associated with protection against asymptomatic infection and with reduced shedding of the pathogen and reduced transmission to susceptible individuals. But that is not always the case. Most vaccines require more than one dose to induce optimal levels of protection against the disease.
Another question deals with whether persons with prior infection need to be vaccinated. For many diseases, such as measles, natural infection leads to permanent immunity. However, for others, such as influenza, immunity wanes, and there is a need for vaccination of a person who previously had the disease. If immunity wanes after natural infection, such persons should be vaccinated.
In the U.S. there are several systems in place to monitor vaccine safety after vaccines are licensed and in use. One is the Vaccine Adverse Event Reporting System (VAERS). VAERS is a system that encourages healthcare providers, vaccinees, or parents of vaccinees to report potential safety signals called adverse events following vaccination. Adverse events include local and systemic reactions or a new illness that may be linked to the vaccines. VAERS is most helpful in developing hypotheses regarding whether vaccines caused a clinical condition that occurred after vaccination.
The major system to evaluate causation of adverse events in the U.S. is the Vaccine Safety Datalink (VSD). The VSD is a collaboration between the U.S. CDC and nine integrated healthcare organizations and has data on over 12 million persons per year.
Source: The COVID-19 Vaccine Guide by Kathryn Edwards MD, Walter Orenstein MD, David Stephens MD (2021)
INTRODUCTION TO COVID-19 mRNA VACCINES (Pfizer and Moderna): In the United States, in just over 11 months, two mRNA vaccines were developed and manufactured in parallel, tested in phase 1,2, and the phase 3 large clinical trials, found to be safe and efficacious, and distributed initially in December 2020 to healthcare workers and residents of long-term care facilities, followed by those over 65 and with underlying medical conditions in January 2021. We know that the two initial mRNA vaccines prevent illness with 94-95% efficacy in individuals. However, we do not yet know if they prevent infection or transmission.
While one dose of a vaccine would be ideal for control of the outbreak, for most of the COVID-19 vaccines becoming available, two doses are necessary to achieve high levels of protection against the disease. Unlike weak live virus vaccines that control mumps, measles, and chickenpox, the current COVID-19 vaccines are not live viruses but are directed at a single protein, the SARS-CoV-2 spike protein. While there may be some protection after the first dose, the second dose provides a boost to the immune system and magnifies the immune response to the spike protein.
The spike protein is the part of the virus that initially attaches to human cells. The spike protein is the target for the COVID-19 vaccines but must be presented to the human immune system in a way that allows a neutralizing immune response to the vaccine. A lot of attention (justifiably so) has been directed to the mutations in the spike protein that have arisen during the pandemic. One advantage of several of the vaccine platforms is that changes to the spike protein can be rapidly engineered into modification of the vaccines. These vaccines show the induction of a strong immune response to the spike protein, especially with a second dose that can generate high levels of neutralized antibodies comparable with or greater than those seen in blood samples from patients who are recovering from COVID-19. Boosting SARS-CoV-2 T cells recognizing spike and other proteins may also be crucial in limiting replication and disease severity. SARS-CoV-2 may well follow the path of previous and become endemic in the population as another common cold virus.
Source: The Covid-19 Vaccine Guide by Kathryn Edwards MD, Walter Orenstein MD, David Stephens MD (2021)
MANUFACTURER LIABILITY: The party line is that these vaccines will be safe, the truth is there is no incentive for drug manufacturers to make a safe vaccine because the vaccine manufacturers cannot be sued – even if the vaccine causes DEATH. According to U.S. Federal Law 42 U.S. Code 300aa-22 vaccine manufactures cannot be sued for harm caused by their vaccines.
The immune system can protect against infection and disease in two different ways. First, it can secrete immune proteins, called antibodies, into blood or tissues that bind to the invading pathogen and prevent it from multiplying or invading cells of the human body and enhancing the uptake of the pathogens into special cells (“phagocytes”) which destroy the pathogen. Critical players in this response are B cells and specialized B cells called plasma cells. The plasma cells produce the antibodies that circulate in the blood and other body fluids and tissues, which when encountering the pathogen neutralize it or bind to it, facilitating destruction of the pathogen by other cells of the immune system. Second, the immune system consists of specialized cells, called T cells, which destroy infected human cells and prevent the pathogen from spreading and causing serious disease. This aspect of the immune systems is called the cellular immune system. So, vaccines induce individual protection by inducing protective immune responses.
Most vaccines also induce community protection or “herd or population immunity.” Since most vaccine-preventable diseases result from person-to-person spread, when an individual is infected, the pathogen reproduces in that person’s body and then spreads from the infected person to others. When the infectious person encounters a susceptible individual, the infectious person can transmit the infection. The cycle can then be repeated by infecting another contact, which is known as a chain of transmission. However, if the infectious person encounters an immune individual, there is no (or perhaps very limited) transmission. If a high percentage of the population is immune to the infection, then transmission does not occur, and the chain of human-to-human transmission is broken.
The vast majority of vaccines induce community protection because they not only protect individuals exposed to an infectious pathogen from getting ill, but they also prevent such persons from transmitting the pathogen to others who are susceptible. Thus, a goal for many vaccination programs is to induce immunity levels greater than the herd immunity threshold to terminate disease risk in that community.
Source: The COVID – 19 Vaccine Guide by Kathryn Edwards, MD; Walter Orenstein, MD, and David Stephens, MS (2021)
TYPES OF VACCINES: There are five basic categories of vaccines:
- Inactivated Virus Vaccines: Inactivation of disease-causing virus is a staple of vaccine manufacturing and is used against diseases such as influenza, hepatitis A, and rabies. The technique of inactivation makes the virus unable to multiply or cause disease. This approach allows the immune system to be exposed to viral proteins and immunity to develop. The antibodies produced by immune cells exposed to the inactivated virus are thereby available to fight off disease when there is a later exposure to an active virus.
- Live Attenuated Vaccines: These disease-causing viruses or bacteria are attenuated or weakened, in a laboratory by repeated culturing. Then a relatively small dose of virus is administered, creating enough of the organism to stimulate an immune response, and then is rapidly cleared by the immune system. Live attenuated viral vaccines include measles, mumps, and rubella.
- Protein based vaccines: These kinds of vaccines include viral proteins and no genetic material. Whole proteins or pieces of viral proteins can be used. In COVID-19 vaccines, the key protein of interest is the so-called “spike” protein, which binds to the cells in which the virus replicates at the receptor binding domain. Protein vaccines have a long history of safety and effectiveness and are used in vaccines against hepatitis B, shingles, and whooping cough.
- Viral Vector Vaccines: These vaccines utilize harmless viruses as a vehicle to transfer genetic material into specific host cells. In the case of COVID -19, the genetic codes are inserted into the SARS-CoV-2 spike protein into specific host cells. These host cells can then produce the viral proteins that generate an immune response. Viral Vector COVID-19 vaccines are being clinically tested by vaccine companies such as AstraZeneca (together with Oxford University), Johnson & Johnson and Merck.
- Genetic Vaccines mRNA and DNA: Another approach for vaccine development is to directly deliver the SARS-CoV-2 virus spike protein’s genetic blueprint into cells as either mRNA (messenger RNA) or DNA. Immediately upon release of the genetic sequence of SARS-CoV-2 to the scientific community, many vaccine scientists turned to existing vaccine platforms to deliver the genetic material. No mRNA or DNA vaccine has ever been licensed, although there is considerable human experience using these type vaccines in clinical studies. Pfizer’s COVID-19 vaccine was the first mRNA vaccine to receive Emergency Use Authorization.
CLINICAL TRIALS: Clinical trials are usually broken into three distinct phases of escalating size and cost. Phase 1 clinical trials usually involve up to 100 healthy adult volunteers. This type of clinical trial is designed to answer two main questions: does this new vaccine confer the expected immunity and is it safe.
Phase 2 clinical trials may involve several hundred volunteers, where a small proportion of the study group are given placebos, to determine the appropriate dose of vaccine that should be administered. During this trial, the safety of the vaccine is also carefully studied by comparing the control and placebo groups for reactogenicity – fever, chills, pain or swelling/redness at the injection site – and other untoward effects.
A phase 3 clinical trial is the last stage prior to a company being able to request permission from the government regulatory agency (such as the FDA) to be allowed to bring the vaccine to the market and used by designated at-risk individuals. Phase 3 clinical trials are conducted to determine the safety and efficacy of the vaccine. Thousand of participants participate in the Phase 3 study, and this group of volunteers should always be as similar as possible to the population that will be administered the vaccine in real-world situations. Phase 3 studies are almost always randomized, double-blind, and placebo-controlled, meaning that neither the volunteers nor researchers know who is in the vaccinated or control group. This is critical, as no one working with the volunteers, or the volunteers themselves, should know which ones received the vaccine, lest the results become biased. As an example of bias could be if those knowing they received the vaccine had a stronger tendency to report medical problems.
Taking all this into account the numbers of volunteers required in an individual COVID-19 vaccine Phase 3 study must be at least 30,000 volunteers, but can range as high as 60,000, if we wish to show that the vaccine is achieving 50% efficacy with 90% confidence, the benchmark set by the FDA for a COVID-19 vaccine to be considered for approval. It is important to note that the clinical studies for COVID-19 vaccines are case driven, meaning that once a sufficient number of communities acquired COVID-19 cases have been reported in study volunteers, the clinical trial may be stopped, and results evaluated by an independent Data Safety Monitoring Board to calculate the vaccine efficacy and assess its safety profile.
To expedite the completion of COVID-19 vaccine trials, hefty development funding and innovative, combined phase protocols have been used to save valuable development time without any sacrifice in safety. As for funding, in the extraordinary effort to being COVID-19 vaccine forward in as short of a time as possible decisions have been taken by both vaccine company sponsors and government agencies to spend much larger sums of money on Phase 3 trials in order to have 100 or more vaccine research locations operating in parallel. In the case of COVID-19 pandemic, the FDA has been working closely with private vaccine manufacturers in an extraordinary collaborative manner to reduce these pauses in activity while not cutting corners on collecting and appropriately analyzing the trial data.
Source: The COVID-19 Vaccine: An Expert’s Medical Guide for All by Zeil Rosenberg MD (2021)
VACCINE APPROVAL: The U.S. Food and Drug Administration (FDA) must approve a vaccine before it can be used in the United States. FDA regulations for the development of vaccines ensure their safety, purity, potency, and effectiveness. FDA also inspects vaccine manufacturing sites to make sure they comply with current Good Manufacturing Practice regulations. Activities related to vaccines are coordinated in its Center for Biologics Evaluation and Research (CBER).
To best advise the FDA, a specialized Vaccines and Related Biological Products Advisory Committee (VBRPAC) makes recommendations to the CBER on a vaccine’s safety and efficacy prior to approval. In all cases to date, its recommendations are followed by the Commissioner of the FDA, who has the final legal authority to release a vaccine into use. The Committee consists of 15 voting members selected from among authorities knowledgeable in the fields of immunology, molecular biology, virology, vaccine development, preventive medicine, infectious disease, and pediatrics. The committee meets in open, publicly broadcast meetings where anyone can hear the experts discuss the data.
There are two different paths by which a vaccine can enter the market in order to address the COVID-19 pandemic. The first pathway is by use of a so-called “Emergency Use Authorization (EUA) from the FDA, based on data submitted to the FDA by the vaccine manufacturer. The second is by full licensure of the vaccine by the FDA in response to a complete Biologics Licensure Application (BLA) from the vaccine manufacturer. Reviewing the FDA’s own published guidance documents, a COVID-19 vaccine perfectly fits the EUA scenario envisioned for this alternative and usually temporary status. To obtain emergency use authorization for marketing a COVID-19 vaccine, four criteria must be satisfied.
- The disease agent, in this case SARS-CoV-2, must cause a serious of life-threatening disease. The COVID-19 pandemic certainly does.
- It should be reasonable to believe that the vaccine may be effective to prevent COVID-19, based on the totality of scientific evidence available, including data from adequate and well controlled trials. This is precisely the data that is being obtained through properly designed Phase 3 clinical trials.
- The known and potential benefits of the vaccine must outweigh the known and potential risks. This safety data is also coming from a series of well-designed clinical trials.
- There is no adequate, approved, and available alternative vaccine for preventing COVID-19. At this point, there are no fully licensed COVID-19 vaccines (fall - 2020).
Source: The COVID-19 Vaccine by Zeil Rosenberg, M.D. (2021)
MONITORING OF VACCINES AND VACCINATIONS AFTER MANUFACTURERS RECEIVE APPROVAL Many critical questions may not have been answered in studies or clinical trials of vaccines prior to licensure or granting of an EUA. For example, most clinical trials will not evaluate duration of immunity beyond a few months or years at most. It is important to determine how long immunity lasts and, if immunity wanes, when it wanes, which would be helpful in determining whether and when booster doses are needed.
Another major issue that may not be addressed in phase 3 trials is whether the vaccine provides a community or herd protection. Most phase 3 trials are individually randomized versus placebo or comparator vaccines arms. Hence, they assess individual protection from disease induced by the vaccine. With many vaccines, individual protection against disease is also associated with protection against asymptomatic infection and with reduced shedding of the pathogen and reduced transmission to susceptible individuals. But that is not always the case. Most vaccines require more than one dose to induce optimal levels of protection against the disease.
Another question deals with whether persons with prior infection need to be vaccinated. For many diseases, such as measles, natural infection leads to permanent immunity. However, for others, such as influenza, immunity wanes, and there is a need for vaccination of a person who previously had the disease. If immunity wanes after natural infection, such persons should be vaccinated.
In the U.S. there are several systems in place to monitor vaccine safety after vaccines are licensed and in use. One is the Vaccine Adverse Event Reporting System (VAERS). VAERS is a system that encourages healthcare providers, vaccinees, or parents of vaccinees to report potential safety signals called adverse events following vaccination. Adverse events include local and systemic reactions or a new illness that may be linked to the vaccines. VAERS is most helpful in developing hypotheses regarding whether vaccines caused a clinical condition that occurred after vaccination.
The major system to evaluate causation of adverse events in the U.S. is the Vaccine Safety Datalink (VSD). The VSD is a collaboration between the U.S. CDC and nine integrated healthcare organizations and has data on over 12 million persons per year.
Source: The COVID-19 Vaccine Guide by Kathryn Edwards MD, Walter Orenstein MD, David Stephens MD (2021)
INTRODUCTION TO COVID-19 mRNA VACCINES (Pfizer and Moderna): In the United States, in just over 11 months, two mRNA vaccines were developed and manufactured in parallel, tested in phase 1,2, and the phase 3 large clinical trials, found to be safe and efficacious, and distributed initially in December 2020 to healthcare workers and residents of long-term care facilities, followed by those over 65 and with underlying medical conditions in January 2021. We know that the two initial mRNA vaccines prevent illness with 94-95% efficacy in individuals. However, we do not yet know if they prevent infection or transmission.
While one dose of a vaccine would be ideal for control of the outbreak, for most of the COVID-19 vaccines becoming available, two doses are necessary to achieve high levels of protection against the disease. Unlike weak live virus vaccines that control mumps, measles, and chickenpox, the current COVID-19 vaccines are not live viruses but are directed at a single protein, the SARS-CoV-2 spike protein. While there may be some protection after the first dose, the second dose provides a boost to the immune system and magnifies the immune response to the spike protein.
The spike protein is the part of the virus that initially attaches to human cells. The spike protein is the target for the COVID-19 vaccines but must be presented to the human immune system in a way that allows a neutralizing immune response to the vaccine. A lot of attention (justifiably so) has been directed to the mutations in the spike protein that have arisen during the pandemic. One advantage of several of the vaccine platforms is that changes to the spike protein can be rapidly engineered into modification of the vaccines. These vaccines show the induction of a strong immune response to the spike protein, especially with a second dose that can generate high levels of neutralized antibodies comparable with or greater than those seen in blood samples from patients who are recovering from COVID-19. Boosting SARS-CoV-2 T cells recognizing spike and other proteins may also be crucial in limiting replication and disease severity. SARS-CoV-2 may well follow the path of previous and become endemic in the population as another common cold virus.
Source: The Covid-19 Vaccine Guide by Kathryn Edwards MD, Walter Orenstein MD, David Stephens MD (2021)
MANUFACTURER LIABILITY: The party line is that these vaccines will be safe, the truth is there is no incentive for drug manufacturers to make a safe vaccine because the vaccine manufacturers cannot be sued – even if the vaccine causes DEATH. According to U.S. Federal Law 42 U.S. Code 300aa-22 vaccine manufactures cannot be sued for harm caused by their vaccines.
(b) Unavoidable adverse side effects; Warnings (1). No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
The same statutory law protects vaccine manufacturers from being sued if they fail to warn you of problems or potential problems with the vaccine.
(c) Direct warnings. No vaccine manufacture shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
Source: Operation Warp Speed by Dr. Richard M. Fleming (2021)
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