James Odell, OMD, ND, L.Ac.
Reference Commentary - The material published in this commentary is intended to foster scholarly inquiry and a rich discussion of the controversial topic of bioethics and health policy. The views expressed in this article are solely the authors and do not represent the policy or position of the Bioregulatory Medicine Institute (BRMI), nor any of its Board Advisors or contributors. The views expressed are not intended to malign any religious or ethnic group, organization, company, individual, or any other. Every effort has been made to attribute the sources of this article to the rightful authors listed in references.The content of this article is presented in summary form, is general, and is provided for informational purposes only: it is not advice, nor should it be treated as such. If you have any healthcare-related concerns, please call, or see your physician or other qualified healthcare providers. Never disregard medical advice or delay seeking it because of something you have read in this article.
In my last article entitled COVID 19 mRNA Vaccines, published in the 24th BRMI E-Journal, I reviewed many of the safety concerns about the experimental messenger RNA SARS coronavirus ‘vaccines’ not being discussed in the medical media. Because no long-term safety studies have had time to be performed to ensure that any of these products do not cause cancer, seizures, paralysis, heart disease, or autoimmune diseases, it is of paramount importance for the public to become informed as to any potential risk. Unfortunately, the medical media and pharmaceutical manufacturers have not provided adequate or complete information on the potential adverse effects these experimental mRNA ‘vaccines’ may cause. Partly, because much of this research is being gathered in real-time. In short, there is a gross lack of informed consent as much is still not known about their efficacy and safety. This commentary is an attempt to disclose pertinent information that potential recipients should know to make a truly informed decision as to whether to receive the injection.
After the last article, I received many inquiries about details of vaccine immunity in relation to this new mRNA platform. Many readers requested that information be simplified on vaccine immunology, whereas others asked that for more details about the technical aspects of vaccine immunity and their potential for autoimmunity. So, this part-two reference commentary is an attempt to compromise and further evaluate both how vaccines affect immunity and their potential for causing autoimmunity.
Emergency Use Authorization
The Pfizer-BioNTech and Moderna COVID-19 ‘vaccines’ have not been approved or licensed by the U.S. Food and Drug Administration (FDA), but instead have received authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) for use in individuals 16 years of age and older. Thus, both products are experimental in that they have not been approved by the FDA for a biological license and were approved under EUA without long term safety data. The FDA has not fully evaluated the data and still has not decided if the potential risks outweigh the benefits of receiving it. Human trial data is not complete and published yet, and this is partly why it is considered ‘experimental’ and still unlicensed by the FDA as a biological drug.
According to the FDA website, medical products that may be considered for a EUA are those that "may be effective" to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a CBRN agent(s) (chemical, biological, radiological, and nuclear) identified in the HHS Secretary’s declaration of emergency or threat of emergency under section 564(b). The "maybe effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that the FDA uses for product approvals.
The World Health Organization announced on January 8th that Pfizer's COVID-19 vaccine was not recommended for pregnant women unless they are at particularly high risk for the virus or a health care worker. They followed that recommendation with another on February 2nd advising against pregnant women taking the Moderna coronavirus vaccine unless they are health care workers or have preexisting conditions. Pregnant and lactating women were excluded from Pfizer/BioNTech and Moderna's COVID-19 vaccine clinical trials, and they are not included in any ongoing trials for vaccines manufactured by other companies. That means there is no safety data available to know for sure whether these ‘vaccines’ are safe for people who are pregnant or breastfeeding. It is not known if or how these experimental drugs will affect fertility in the short or long term. What is known is that there have been several reports to Vaccine Adverse Event Reporting System (VAERS) of miscarriages following the shot.
Viral Messenger RNA as a Synthetic Pathogen of Unknown Risk
The central dogma of biology states that DNA makes RNA and RNA make proteins.However, there are many different types of RNAs, and only one of them, the messenger RNA (mRNA), gives rise to proteins. Messenger ribonucleic acids (mRNAs) transfer the information from DNA to the cell machinery that makes proteins. Specifically, mRNA delivers the information encoded in one or more genes from the DNA to the ribosome, a specialized cellular structure, or organelle, where that information is decoded into a protein. Ribosomes read the mRNA and translate the message into functional proteins in a process called ‘translation’. Depending on the newly synthesized protein’s structure and function, it will be further modified by the cell, exported to the extracellular space, or will remain inside the cell. The primary function of mRNA is to act as an intermediary between the genetic information in DNA and the amino acid sequence of proteins. Thus, messenger RNA is an intermediary between the gene, and the product, the protein.
In vaccines, it is the protein that ultimately elicits the immune response, not the RNA. Historically, vaccines are proteins, either viral, or bacterial, and it is the vaccine’s protein that, if all goes well, develops an immune response to elicit neutralizing antibodies. Vaccine-mediated immunity is often multifactorial, and the best protection is likely to be elicited by the combination of strong humoral and cell-mediated immune responses.
So, by definition, an mRNA ‘vaccine’ is not a true vaccine. First, because it is not a protein that directly elicits an immune response. It first must be decoded into protein, and it is then that protein that in turn creates the desired immune response. Secondly, by FDA definition, since it is a component used as a treatment to affect a body’s function, it is by legal definition a ‘medical device’ or a physical ‘device’ that comes in a molecular-sized package. Thus, strictly speaking, this messenger RNA device is a synthetic pathogen utilizing a genetic engineering process as a biological response modifier, not at all like a classical vaccine. In principle, biological response modifiers are biologically active agents including antibodies, small peptides, and/or other (small) molecules of mRNA, DNA, that can influence the immune response. Most importantly, this synthetic viral pathogen device is a new and different molecular platform, one that has never been injected into the public’s arm.
With these mRNA synthetic pathogens, what is injected into the body is not a weakened virus or even selected antigens, but rather protein-coding instructions that tell your body’s cells how to make the antigens on their own. Again, that process is called “translation.”
Erroneously referring to this intervention as a ‘vaccine’ exploits the public's ingrained trust in previous vaccination programs. It keeps us in the illusion of vaccine safety in place of taking the necessary measures to investigate the impact of this new experimental device on our health. In studies of vaccination decision-making, risk perception is often intricately linked with ideas of trust in health professionals, in government, or public health institutions and the interplay between these actors. When medical professionals or institutions no longer fulfill their obligation of information transparency and disclosure of potential risks, this is a harmful violation of trust. Many people do not understand what FDA Emergency Use Authorization entails. It means it is still experimental and carries risk yet unknown. The public becomes the experiment.
Another wrinkle in information disclosure is the manufacturer’s complete lack of liability. As I described in the previous article, the Public Readiness and Emergency Preparedness Act of 2005 has now allowed vaccine manufacturers unlimited freedom to create, develop, and market COVID-19 vaccines without any liability whatsoever. All liability is protected by the PREP Act, which means if anyone has an adverse event or death caused by this vaccine there really is no recourse. This was put into the Federal Register in March of 2020 and does not expire till the end of 2024. So, anything that is developed over the next four years that has to do with a biological agent, such as a vaccine or drug or biotechnology, no matter how nefarious, is protected from liability under the umbrella of COVID-19.
Messenger RNA
This mRNA experimental synthetic pathogen carries mRNA genetic material from SARS-CoV-2 coronavirus into cells where that cellular machinery with the synthetic pathogen produces a protein to which the body mounts an immune response. In the case of COVID-19, inert spike (S) antigen proteins are produced. This then enables SARS-CoV-2 coronavirus particles to enter host cells and triggers humoral (antibody-mediated) acquired immunity. So, what could possibly go wrong with bodily cells that are artificially programmed to produce foreign viral proteins to which the immune system is going mount an immune response? Well, that biochemical reaction could create an autoimmune reaction. As this mRNA platform has never been used in humans before, the potential for this to go wrong and elicit widespread autoimmune diseases and deaths is enormous.
Pfizer, Moderna, Dr. Anthony Fauci, and Dr. Soumya Swaminathan, the WHO’s chief scientist, have now made it abundantly clear that the novel mRNA strand entering the cell is not intended to stop transmission but rather as a treatment. However, America’s Frontline Doctors and numerous other doctors have been censored from public discourse on the profoundly viable and formerly ubiquitous treatments such as hydroxychloroquine, ivermectin, zinc, vitamin C, and vitamin D3. If these effective treatments had not been denied us, both in access and scientific data, but disseminated to the global community, we might not have needed an ‘emergency use’ technology at all. Bear in mind for FDA to issue an emergency use authorization, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. Could this be why these available and effective alternative products are constantly censored in the media and social media?
Antibodies and Vaccines
To understand how vaccines create immune responses it is necessary to briefly clarify and review the function of antibodies and both the adaptive and innate immune system. Antibodies, also known as immunoglobulins (Ig), are specialized proteins that bind to a uniquely shaped object – called an antigen – that is found on the surface of a pathogen. These pathogens can be things such as bacteria or viruses. Antibodies are produced by B lymphocytes, known as B cells, which are specialized white blood cells of the immune system. B cells have antibodies on their cell surface that allow them to recognize anything foreign. When they encounter a pathogen such as a virus, the B cells transform into plasma cells, which start producing antibodies that are designed to bind to an antigen that is specific to that pathogen.
B-plasma cells release large amounts of antibodies into the body’s circulation. This protects us in two main ways. First, antibodies can bind to antigens on the outside of the pathogen to stop it from entering our cells. This is particularly important for viruses, which enter human cells to replicate. Second, by binding to antigens on the pathogen, antibodies also signal other white blood cells known as phagocytic cells, which engulf and destroy the pathogen. So, in short, antibodies can both neutralize a virus and mark it for destruction.
Antibodies form part of our adaptive immune response, which is a refined, targeted response to a specific antigen. The first time we encounter a virus, some of our B cells become plasma cells, but others transform into memory B cells. The second time you are exposed to the same pathogen, these memory cells quickly transform into plasma cells that produce large amounts of antigen-specific antibodies to fight the infection.
There are many types of antibodies, each with different purposes, which are created in response to chemical signals. Different B cells in the body will produce multiple different antibodies that bind to different sites, but only binding to some of these sites will inactivate the virus. For a vaccine to work, it must produce a binding or neutralizing antibody. It is never certain that a vaccine will produce neutralizing antibodies. One important difference in antibodies produced from vaccines and antibodies from natural infections is that the immune system does not form as many different types of antibodies from a vaccination as it would in the course of a natural infection. Thus, natural infection often protects the individual for life, whereas artificial infection from a vaccine usually requires repeated boosters to maintain antibody levels.
However, in some circumstances, the binding of an antibody might worsen an infection. For example, antibodies might bind to a virus in such a way that helps the virus enter cells more easily. This might mean that a person re-infected after an initial mild infection might then have a more severe disease. Or it might mean that a person could have a worse response to a potential infection (like with COVID-19) if they have previously been vaccinated for the disease. This scenario has been called “antibody-dependent enhancement” (ADE) and will be discussed later in this article.
Three main types of antibodies are produced in response to infection: IgA, IgG, and IgM. IgM rises soonest and typically declines after infection. IgG and IgA persist and usually reflect longer-term immune responses. The detection of IgM antibodies is sometimes used as a test for recent infection. For example, an IgM antibody is commonly used to check for recent coronavirus infection. A particularly important type is IgG antibodies, which tend to be more long-lived than IgM antibodies. This subtype of antibodies is critical not just for controlling the initial disease but for preventing future disease if you are later re-exposed. It is observed that IgM levels increased during the first week after SARS-CoV-2 infection, peak 2 weeks later, and then they are reduced to near-background levels in most patients. IgG has been detectable after 1 week and may be maintained at a high level for a long period.
Some people make many high-quality antibodies that are good at recognizing the relevant antigen and binding to it. If this happens, the virus is rapidly bound by antibodies and eliminated before it can even cause an infection. Other people make antibodies, but they are not as effective at binding the pathogen. In this situation, the antibodies only provide partial protection at best. Then there are also those people who either produce little or no antibodies or poor-quality antibodies. Generally, many elderly fall into this category. In this case, vaccine immunity is not so effective, so they may experience a prolonged infection with more severe symptoms. They are also likely to be re-infected at a later point in time. This is part of the reason vaccines do not always confer immunity or confer only partial immunity for a limited period.
The adaptive immune system involves more than just B cells, plasma cells, and antibodies – it also includes T cells. T cells are another population of white blood cells that can develop into memory cells, just as B cells can. They can also differentiate into specialized cells that kill virus-infected cells. The functions of T cells and B cells are different. B cells develop into plasma cells that produce antibodies (T cells do not); T cells directly kill virus-infected cells (B cells do not). Sometimes individuals with a very vigorous T cell immune response will be protected from a pathogen even though they produce low amounts of antibody. The T cell immune response is much more difficult to measure than the antibody response and is usually only evaluated in a specialized laboratory or research setting. Our adaptive immune response is important because once developed, it is highly specific for the pathogen and provides us with immunologic memory.
We also have another type of immune system known as the innate immune system. The innate immune system is our frontline defense, the first system to respond to a new infection. This includes cells such as neutrophils, macrophages, and dendritic cells. Unlike the adaptive immune system, which includes antigen-specific antibodies that take time to develop, the innate immune system responds to antigens very quickly but in a non-specific way. It attacks anything that “looks” foreign to the body, like components of a bacterial cell wall, or viral RNA and DNA. Quite often, the innate immune response will take care of an infection before the adaptive immune system even has a chance to start manufacturing antibodies.
SARS-CoV-2 Antibody Blood Test
Many people are now taking the COVID-19 antibody blood test. This immune response test detects the immune proteins or antibodies that the body produces in response to the virus. It does not detect the virus itself; thus, an antibody test does not determine whether you are currently infected with the COVID-19 virus. Antibody testing is best undertaken at least two weeks after the onset of symptoms. Because SARS-CoV-2 belongs to a large family of coronaviruses, the test may inadvertently detect the antibody of related coronavirus strains (such as the HKU1, NL63, OC43, or 229E strains) and trigger a false-positive reading. False-negatives are even more common with SARS-CoV-2 antibody tests, due in part to the variable sensitivities of the tests. The sensitivity and specificity of antibody tests vary over time and results should be interpreted in the context of clinical history. Compared to venous blood tests, rapid finger-stick tests tend to be less reliable and more likely to return a false-negative result. In short, the evidence is currently insufficient to know whether individuals with SARS-CoV-2 antibodies have protective immunity.
Current SARS-CoV-2 ‘Vaccines’
At the time of this writing, there are 2 experimental mRNA SARS-CoV-2 ‘vaccines’ publicly available, one by Pfizer/BioNTech the other from Moderna, and one viral vector vaccine by Johnson and Johnson. As previously mentioned, mRNA-based ‘vaccines’ have never before been used on humans and these two are still not FDA licensed for human use, though they have been made publicly available through Emergency Use Authorization. These mRNA formulas contain a synthetic sequence of messenger RNA that is concealed within a patented lipid nanoparticle delivery system. After entering cellular ribosomes (that house the transcription machinery of the cells) of the muscle cells into which the synthetic pathogenic mRNA is injected, it then instructs cells to produce a copy of the spike protein of the virus. In essence, it means that the human body becomes the vaccine factory of the protein. This process is genetic engineering. Even more concerning, is that these synthetic pathogen devices place a novel molecule, spike protein, in/on the surface of host cells. This spike protein then becomes a potential receptor for another possibly novel pathogenic infectious agent.
Recently the Janssen Vaccines, a subsidiary of Johnson and Johnson has also received FDA Emergency Use Authorization for the company’s single-shot COVID-19 vaccine for adults 18 and older. Thus, it is now the third vaccine available in the U.S. This vaccine is based on an adenovirus vector Ad26 (not a mRNA vaccine like Pfizer or Moderna). Ad26.COV2.S expresses the full-length spike protein, stabilized by furin cleavage site mutations and two consecutive proline stabilizing mutations in the hinge region. It contains the wild-type signal peptide. The science behind recombinant adenoviral vector vaccines has been around for a long time, but the only commercially available adenovirus-based vaccine is a rabies vaccine for animals. Viral vector vaccines are more of a conventional vaccine platform, unlike mRNA vaccines. Viral vector vaccine work by carrying a DNA express or antigen(s) into host cells, thereby eliciting cell-mediated immunity in addition to the humoral immune responses. Adenovirus-based vaccines may also pose some problems in that the adenovirus is so common that the vaccine may not be as effective once booster doses are given, or that some people may already have immunity to the virus used in the vaccine. Additionally, incorporating a spike protein into the viral vector vaccine potentially creates this protein receptor to attract another novel pathogenic infectious agent.
Another frontrunner is the non-replicating viral vector vaccine by the AstraZeneca/Oxford University group. This also employs a genetically modified (non-replicating) chimpanzee viral vector vaccine, now designated AZD1222. The AstraZeneca/Oxford's vaccine instead of utilizing a human adenovirus in its vaccine uses a genetically modified chimpanzee-derived adenovirus that encodes the spike protein of Middle East respiratory syndrome coronavirus (MERS-CoV).
According to the recent World Health Organization’s Draft landscape of COVID-19 candidate vaccines, there are currently 64 candidate vaccines in clinical development with a further 173 in pre-clinical development, these relying on 8 different vaccine platforms in addition to the two already relied on by the 3 frontrunners. Most (31%) rely on the more conventional protein subunit platform that has been widely used for seasonal influenza vaccines.