COVID-19 mRNA Vaccines

COVID-19 mRNA Vaccines

December 28, 2020

COVID-19 mRNA Vaccines

James Odell, OMD, ND, L.Ac.

Editorial – The material published in this editorial 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.

With the recent licensing and roll out of COVID-19 vaccines in the U.K., Canada, the U.S. (Pfizer/ BioNTech and Moderna), and Russia (Sputnik) there are several serious safety concerns that have not been addressed or even mentioned in the medical media. In short, it is beyond reckless and totally unnecessary to administer these experimental vaccines to millions of people when there is only limited short term safety data. Absolutely no long-term safety studies have been done to ensure that any of these vaccines do not cause cancer, seizures, heart disease, allergies, and autoimmune diseases, as seen with other vaccines and observed in earlier coronavirus vaccine animal studies. Because animal studies were bypassed for these vaccines due to ‘fast-tracking’, millions of humans are now the primary test animal. Additionally, these vaccines were developed using a completely new mRNA technology that has never been licensed for human use. In essence, we have absolutely no knowledge of what to expect from these new mRNA vaccines. Since viruses mutate frequently, the chance of any vaccine working for more than a year is unlikely. That is why the influenza (flu) vaccine changes every year. This editorial comprehensively discloses current COVID-19 vaccine development, administration, and safety concerns in detail.


Ribonucleic acid (RNA) is a nucleic acid present in all living cells. Its principal role is to act as a messenger carrying instructions from DNA for controlling the synthesis of proteins. Although in some viruses’ RNA rather than DNA carries the genetic information. In each cell of a living organism, DNA is the molecule that contains the genetic information of the organism. It is composed of a series of four building blocks, whose sequence gives the instructions to fabricate proteins. This process requires a transient intermediary called messenger RNA that carries the genetic information to the cell machinery responsible for protein synthesis. RNA is the only molecule known to recapitulate all biochemical functions of life: definition, control, and transmission of genetic information, creation of defined three-dimensional structures, enzymatic activities, and storage of energy.


RNA became the focus of intense research in molecular medicine at the beginning of the millennium. Messenger viral RNA (mRNA) is now developed as a vaccine and this technology poses many questions and serious health concerns that have been left unanswered by the vaccine manufacturers. Unlike previous vaccines an mRNA vaccine is a new type of vaccine that inserts fragments of viral mRNA into human cells, which are reprogrammed to produce pathogen antigens, which then if all goes well, stimulate an adaptive immune response against the targeted pathogen. That seems straightforward, but what else is in the vaccines, and is this new technology truly proven safe and effective?


History of Coronavirus Vaccine Animal Studies and

Antibody Dependent Enhancement (ADE)


Researchers have been trying to develop a coronavirus vaccine since the Severe Acute Respiratory Syndrome (SARS-1) outbreak in 2002. Thus, over a span of 18 years there have been numerous coronavirus vaccine animal studies conducted, which unfortunately demonstrated significant and serious side-effects. Either the animals were not completely protected, became severely ill with accelerated autoimmune conditions, or died.1, 2, 3, 4, 5, 6, 7


Animal side effects and deaths were primarily attributed to what is called Antibody-Dependent Enhancement (ADE). In the 1960s, immunologists discovered ADE and since then have extensively researched and identified its mechanism. Virus ADE is a biochemical mechanism in which virus-specific antibodies (usually from a vaccine) promote the entry and/or the replication of another virus into white cells such as monocytes/macrophages and granulocytic cells. This then modulates an overly strong immune response (abnormally enhances it) and induces chronic inflammation, lymphopenia, and/or a ‘cytokine storm’, one or more of which have been reported to cause severe illness and even death. Essentially, ADE is a disease dissemination cycle causing individuals with secondary infection to be more immunologically upregulated than during their first infection (or prior vaccination) by a different strain. ADE of disease is always a concern for the development of vaccines and antibody therapies because the mechanisms that underlie antibody protection against any virus has a theoretical potential to amplify the infection or trigger harmful immunopathology.8, 9, 10 ADE of the viral entry has been observed and its mechanism described for many viruses including coronaviruses.11, 12, 13 Basically, it was shown that antibodies target one serotype of viruses but only sub neutralize another, leading to ADE of the latter exposed viruses. Thus, ADA of viral entry has been a major concern and stumbling block for vaccine development and antibody-based drug therapy. For example, it has been shown that when patients are infected by one serotype of dengue virus (i.e., primary infection), they produce neutralizing antibodies targeting the same serotype of the virus. However, if they are later infected by another serotype of dengue virus (i.e., secondary infection), the preexisting antibodies cannot fully neutralize the virus. Instead, the antibodies first bind to the virus and then bind to the IgG Fc receptors on immune cells and mediate viral entry into these cells.14 A similar mechanism has been observed for HIV, Ebola, and influenza viruses. Thus, sub neutralizing antibodies (or non-neutralizing antibodies in some cases) are responsible for ADE of these viruses.15, 16, 17, 18, 19, 20


Generally, the conclusion of some of those studies was that great caution needs to be exercised when moving forward to human trials primarily because of the potential of accelerated autoimmunity reaction. Because ADE has been demonstrated in animals21, coronavirus vaccine research never progressed to human trials, at least not till the recent SARS coronavirus-2 fast-track campaign.


More technical Understanding of SARS-CoV-2 ADE Mechanisms


As a forementioned, a potential barrier to the development of safe and efficacious COVID-19 vaccines is the risk that insufficient titers of neutralizing antibodies might trigger ADE of disease. Previous research in SARS-CoV infection demonstrated ADE is mediated by the engagement of Fc receptors (FcRs) expressed on different immune cells, including monocytes, macrophages and B cells.22, 23, 24 A Fc receptor is a protein found on the surface of certain cells – including, among others, B lymphocytes, follicular dendritic cells, natural killer cells, macrophages, neutrophils, eosinophils, basophils, human platelets, and mast cells – that contribute to the protective functions of the immune system.


Akiko Iwasaki and colleagues describe this coronavirus ADE mechanism in more detail in their 2020 research published in Nature Reviews Immunology.25 They confirm that pre-existing SARS-CoV-specific antibodies may thus promote viral entry into FcR-expressing cells. This process is independent of ACE2 expression and endosomal pH and proteases, suggesting distinct cellular pathways of ACE2-mediated and FcR-mediated viral entry.

In short, previous experience with veterinary coronavirus vaccines and animal models of SARS-CoV and MERS-CoV infection has raised safety concerns about the potential for ADE and/or vaccine-associated enhanced respiratory disease. These events were associated either with macrophage-tropic coronaviruses susceptible to antibody-dependent enhancement of replication or with vaccine antigens that induced antibodies with poor neutralizing activity and Th2-biased responses.


After two decades of failed animal trials, the question is posed as to why fast-tracking coronavirus vaccine will now result in a different outcome? Given that many of these fast-track trials have bypassed animal studies, are only performed on healthy volunteers and children (not the elderly or those with pre-morbidities), and that trials are conducted without an inert double-blind placebo-controlled environment, and are not given sufficient time to observe effects on the human trials, there is a serious safety concern. Many, many virologists, and epidemiologists feel this fast-track policy is a recipe for mass disaster. Microbiologist Dr. Sucharit Bhakdi and Dr. Karina Reiss in their new book Corona, False Alarm? give clarity to many of the issues surrounding the pandemic, especially the current coronavirus vaccines.26


Traditional vs. mRNA Vaccines


Historically, the manufacturing process for creating vaccines involves many trade secrets and numerous other ingredients as adjuvants and preservatives.27, 28 ‘Traditional or classical vaccines’ may contain attenuated or inactivated viruses and bacteria or proteins, as well as adjuvants, such as aluminum, to stimulate an immune response that produces artificial immunity, as well as a host of other ingredients called “excipients”. For example, older viral vaccines for smallpox and measles vaccine contain live attenuated viruses; injectable influenza vaccines contain inactivated viruses; the recombinant hepatitis B virus vaccine is a protein subunit vaccine, while the newer human papillomavirus (HPV) virus vaccine contains virus-like particles.


To date, there are several different types of potential vaccines for COVID-19 in development, including:

  • Inactivated or weakened virus vaccines, which use a form of the virus that has been inactivated or weakened, but still generates an artificial immune response.

  • Protein-based vaccines, which use fragments of proteins or protein shells that mimic the COVID-19 virus to generate an artificial immune response.

  • Viral vector vaccines, which use a virus that has been genetically engineered to generate an artificial immune response.

  • RNA and DNA vaccines, that uses genetically engineered RNA or DNA to generate a protein that itself prompts an artificial immune response.

For the past two decades, researchers have been experimenting with new technology platforms, notably ones that introduce foreign DNA and RNA into cells of the body, to develop experimental vaccines for SARS, MERS, HIV, and other diseases but, historically none have been proven effective and safe for humans.


Thus, for a traditional vaccine, the antigen is introduced in the body to produce an immune response. However, in the case of DNA- or RNA-based vaccines, no antigen is introduced, only the RNA or DNA containing the genetic information to produce the antigen. That is, for this specific class of vaccines, the introduction of DNA and RNA provides the instructions to the body to produce the antigen itself.29


mRNA vaccines differ greatly in their design and biochemical mechanisms from traditional vaccines. Traditional vaccines stimulate an antibody response by injecting a human with antigens (proteins or peptides), or an attenuated virus, or a recombinant antigen-encoding viral vector. These ingredients are prepared and grown outside of the human body, which takes time, and even when they are injected into the bloodstream, they do not enter the human cell.30


In contrast, mRNA vaccines insert a synthetically created fragment or snip of the virus RNA sequence directly into the human cells (known as transfection). This snip of viral RNA material then activates an enzyme called reverse transcriptase which replicates that RNA snip repeatedly. This then reprograms the cells to produce their own viral antigens, which, if all goes as planned, stimulates an adaptive immune response, resulting in the production of new antibodies that bind to the antigen and activate T-cells.31, 32, 33


Simply speaking, the new mRNA vaccines inject (transfects) molecules of synthetic genetic material from non-human sources (viral sequences) into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for. These created proteins are not regulated by our own DNA and are thus completely foreign to our cells. What they are fully capable of doing is completely unknown.


Till now, messenger-RNA vaccines have never been licensed for public use. In the last two decades, there has been deep-pocket funding for the development of mRNA vaccines against infectious diseases, particularly with the currently declared pandemic and vaccine fast track campaign. Historically, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA. New technological advancements in RNA biology, chemistry, stability, and delivery systems have now accelerated the development of fully synthetic mRNA vaccines. The consensus is that mRNA vaccines are faster and cheaper to produce than traditional vaccines and for vaccine manufacturers, more cost-effectiveness translates to greater profits. Certainly, there are unique and unknown risks to messenger RNA vaccines, including local and systemic (ADE) inflammatory responses that could lead to autoimmune conditions.


mRNA Vaccines Mechanisms


mRNA vaccines have strands of genetic material called mRNA inside a special coating. That coating protects the mRNA from enzymes in the body that would otherwise break it down. It also helps the mRNA enter the muscle cells near the vaccination site. mRNA vaccines use a different approach that takes advantage of the process that cells use to make proteins: cells use DNA as the template to make messenger RNA (mRNA) molecules, which are then translated to build proteins. An RNA vaccine consists of an mRNA strand that codes for a disease-specific antigen. Once the mRNA is in the cell, human biology takes over. Ribosomes read the code and build the protein, and the cells express the protein in the body. Thus, cells use the genetic information to produce the disease-specific antigen. This antigen is then displayed on the cell surface, where it is recognized by the immune system.34


mRNA vaccines have been studied before for influenza, Zika, rabies, and cytomegalovirus. The concept for the development of an mRNA vaccine is rather straightforward. Once the antigen of choice from the pathogen target is identified, the gene is sequenced, synthesized, and cloned into the DNA template plasmid. mRNA is then transcribed in vitro, and the vaccine is delivered to the subject. The mRNA vaccine utilizes the host cell machinery for in vivo translation of mRNA into the corresponding antigen, thereby mimicking a viral infection to elicit potent humoral and cellular immune responses. The final cellular location of the antigen is determined by the signal peptide and transmembrane domain. This can be intrinsic to the natural protein sequence or engineered to direct the protein to the desired cellular compartment.35, 36


Once the viral mRNA is injected into the body, it faces immune responses that are programmed to destroy it. Our cells have evolved elaborate defense mechanisms intended to destroy foreign, unprotected, or “naked” RNA. However, the susceptibility of mRNA to degradation can be reduced by modifying the RNA during synthesis. One modification is to add in ‘nucleoside analogs’ that resemble the normal nucleosides found within RNA (A, U, C and G,) but have minor structural changes that make the RNA more resistant to enzyme degradation by the body’s ribonucleases. (Nucleosides are the structural subunit of nucleic acids such as DNA and RNA.)


Additional structural modifications and the inclusion of regulatory sequences can also improve the stability of mRNA.37 For example,the vaccine viral mRNA is delivered in the form of a complex with lipid nanoparticles, to stabilize the mRNA, making it easier to penetrate the cell, and increases the amount of antigen produced per cell.38 Lipid nanoparticle formulations also elicit a stronger immune response compared to naked mRNA.39This is where it gets tricky and potentially dangerous because some of the lipid nanoparticles developed for these mRNA vaccines can be strongly immunologically reactive and elicit an unwanted autoimmune reaction.


PEGylated Lipid Nanoparticles


Thus, mRNA is threatened by rapid degradation by ubiquitous extracellular ribonucleases before being taken up by cells.40 The mRNA molecule is also vulnerable to destruction from temperature changes as well as our immune system. Thus, the efficacy of mRNA vaccines requires ‘complexing agents’ which protect RNA from degradation. Complexation may also enhance uptake by cells and/or improve delivery to the translation machinery in the cytoplasm. To this end, mRNA is often complexed with either lipids or polymers. These mRNA vaccines are coated with PEGylated lipid nanoparticles (polyethylene glycol). This coating hides the mRNA from our immune system which ordinarily would attack and destroy kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Unfortunately, PEGylated lipid nanoparticles have been shown to imbalance certain immune responses and can induce allergies and even autoimmune diseases.41, 42, 43, 44, 45, 46


A 2016 study in Analytical Chemistry reported detectable and sometimes high levels of anti-PEG antibodies (including first line-of-defense IgM antibodies and later stage IgG antibodies) in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. Of the 72% with PEG IgG antibodies, 8% had anti-PEG IgG antibodies > 500ng/ml., which is considered extremely elevated.47 Extrapolated to the U.S. population of 330 million who may receive this vaccine, 16.6 million may have anti-PEG antibody levels associated with adverse effects.The researchers confessed that the results were entirely unexpected. The authors concluded that:


“…sensitive detection and precise quantitation of anti-PEG Ab levels in a clinical setting will be essential to ensuring the safe use of PEGylated drugs in all target patient populations going forward.”


Multiple previous studies regarding the prevalence of anti-PEG antibodies in the population have stated that pre-screening should be done prior to any administration of a PEG-containing medication. Screening is likely to be even more important in the case of a vaccine intended for parenteral administration to as many people as possible that contains a substance to which a majority of the population unknowingly has anti-PEG antibodies.


Production of mRNA vaccines


To further understand PEGylated lipid nanoparticles and their role in vaccine delivery, it is helpful to understand a little more about how an mRNA vaccine is manufactured. A major manufacturing advantage of mRNA vaccines is that RNA can be produced in the laboratory from a DNA template using readily available materials, again less expensively and faster than conventional vaccine production, which utilize a variety of cell types such as chicken eggs or other mammalian cells such a fetal material.48 This all comes down to economics. It is faster and cheaper to make.


Traditional vaccines normally contain a strong adjuvant (often aluminum) supplying an enhanced signal for the initiation of the adaptive immune response. However, it is thought that mRNA vaccines sort of have their own adjuvant effect by themselves, partly by virtue of being foreign nucleic acids. It has not been disclosed if any of these candidates (from any company) have an adjuvant added to them. (More information on adjuvants later in this article.)


Moreover, according to Arcturus, the company manufacturing the Pfizer/BioNTech lipid delivery system, this involves a multi-component delivery system called LUNAR® (Lipid-enabled and Unlocked Nucleomonomer Agent modified RNA). “This system has access to over 150 proprietary lipids that have been utilized for mRNA-based COVID-19 vaccines.”49 Basically, all we know is this involves proprietary PEGylated lipid nanoparticles.


Current mRNA Vaccines and Potential Side-Effects


According to the WHO and the Milken Institute, as of August 2020, there were 202 companies and universities worldwide working on a coronavirus vaccine. The vaccine types vary from traditionally established vaccines (e.g., inactivated, and live attenuated) to vaccines that have only recently gained clinical approval (e.g., subunit) to those that have never been licensed for human use, till now (e.g., mRNA, DNA, non replicating viral vector, replicating viral vector). A striking feature of the vaccine development landscape for SARS coronavirus-2 is the range of technology platforms being evaluated, including nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches. Since November 9th, Moderna, the pharma giant Pfizer and its German collaborator BioNTech, and a Russian Institute have all offered “preliminary evidence that their mRNA spike-based vaccines can achieve greater than 90% protective efficacy.”


The vaccine pharmaceutical industry contends that an mRNA-based vaccine is “safer for the patient” than classical vaccines. But is that verified true? The manufacturer’s rationale is that mRNA is a non-infectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis. Since mRNA vaccines have never been licensed and have not undergone long-term testing, we cannot know this for certain. Additionally, there is also concern that these vaccine mRNA may have long-standing dire consequences on the body’s immunity, fertility, and DNA integrity.


According to researchers at the University of Pennsylvania and Duke University50, mRNA vaccines have these potential safety issues:

  • Local and systemic inflammation.

  • The biodistribution and persistence of expressed immunogen.

  • Stimulation of auto-reactive antibodies.

  • Induction of a potent type 1 interferon response, which has been associated with inflammation and potential autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination should be undertaken.

  • Presence of extracellular RNA, which may contribute to edema and pathogenic thrombus formation (blood clots). Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to edema.51 Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.52

  • Potential toxic effects of any non-native nucleotides and delivery system components (particularly those that have not been disclosed by manufacturers).

There is also concern about potential mRNA modifications to the genetics of the body. Once injected into the body mRNA vaccines take the RNA from the virus into the cell where it may create unwanted detrimental genetic modifications. Over the last five years, there has been an enormous increase in the amount of research into RNA modifications; this field is called epitranscriptomics. The role of DNA modification in gene regulation is well established, but much less is known about how mRNA modification influences the way genes are expressed. In fact, numerous studies have shown viral mRNAs to be implicated as a driver in some forms of cancer and autoimmune diseases.53, 54, 55, 56


Thus, long-term safety evaluation is essential and should precede the licensing of different mRNA modalities and delivery systems. Normally, vaccine development is a lengthy and complicated process, often lasting 10-15 years and involving a combination of public and private involvement. Unfortunately, the rapid worldwide competition between pharmaceutical companies to develop a COVID-19 vaccine has bypassed multiple safety controls, rendering the result both dubious and potentially dangerous for the public. Financial interests have taken precedence over the health and safety of the public. Hasty development of vaccines is always risky, and only thorough research employing all the safety precautions will lead to a safe and effective vaccine.


The current licensed COVID-19 vaccine is not being offered to pregnant women. This is because researchers do not know enough about how COVID-19 vaccination can affect children, pregnant women, or their babies. There is also no data on the safety of COVID-19 vaccines for breastfeeding women. The Pfizer/BioNTech vaccine is not available to children under age 16.


Moderna and Pfizer Vaccine Ingredients and Dosage


As unbelievable as it sounds, neither Pfizer/BioNTech nor Moderna have ‘completely’ disclosed everything in their vaccines. Apparently, to be licensed by the FDA they do not have to disclose to the public the entire composition of their vaccine. This is what we do know. Both Moderna and Pfizer/ BioNTech vaccines are mRNA vaccines and they are different in composition, delivery, and storage. They have different nucleoside analogs, and each has unique ways to essentially attenuate the capacity of messenger RNA to induce innate immunity. They each have a different complex liquid delivery system, and this is one reason why one is much more amenable to shipping and storing at minus 20º whereas the other requires shipping and storing at minus 70º.


Moderna’s vaccine uses 100 micrograms of RNA per dose, while Pfizer-BioNTech’s uses only 30 micrograms. In both the Moderna and Pfizer-BioNTech vaccines the mRNA is encapsulated in lipid nanoparticles (LPN). These microscopic droplets of oily liquid — about 0.1 micron in diameter — enclose and protect the mRNA as they are manufactured, transported, and injected into people.As previously mentioned, the composition of the lipid nanoparticles is different in the two vaccines.


Pfizer/BioNTech obtains their nanoparticles from Acuitas, a specialist Canadian company, while Moderna has developed its own lipid technology.


Listed ingredients of the Pfizer/BioNTech COVID-19 vaccine include:

  • 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2

  • lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis (hexane-6,1-diyl) bis (2-hexyldecanoic)

  • .05 mg 2[polyethylene glycol)-2000]-N,N-ditetradecylacetamide

  • .09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)

  • .01 potassium chloride

  • .01 mg monobasic potassium phosphate

  • .36 mg sodium chloride

  • .07 mg dibasic sodium phosphate dehydrate

  • 6 mg sucrose

  • the diluent (.09 percent Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose

So far as revealed in the public domain Moderna’s vaccine (mRNA-1273) specifically contains lipid nanoparticle dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA drug substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine is a phosphatidylcholine with alkyl chain comprising 18 carbons), and PEG2000 DMG (1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000). Adjuvants and other biotechnology if added have not been publicly disclosed. This vaccine requires two injections given 28 days apart.


For more information on clinical trials of all corona vaccines in development visit the Regulatory Affairs Professionals Society (RAPS).58


mRNA Vaccine Viral Shedding and Viral Vaccine Interference


Vaccine shedding is a term used for the release of virus following administration of a live-virus vaccine. This has been particularly observed in the administration of live polio vaccines. Neither of the vaccines in distribution or in development use the live virus that causes COVID-19. Thus, current consensus among vaccine developers is that vaccine viral shedding is not expected with mRNA vaccines. However, bear in mind mRNA viral vaccines is a new platform, and this issue is in unknown territory.

Viral interference describes the situation whereby infection or vaccine inoculation with one virus limits infection and replication of a second virus. For example, epidemiological studies show that following infection with influenza virus, there is a short period during which a host experiences a lower susceptibility to infection with other similar viruses. This viral interference appears to be independent of any antigenic similarities between the viruses. It certainly is possible that the mRNA vaccine may elicit vaccine viral interference and causes people to be more susceptible to other viruses, such as influenza.


SARS-CoV-2 Spike Protein Shares Sequence with a Human Protein Syncytin-1


Syncytin-1 is a protein that functions for placental development and therefore is essential for fertility. Fifteen years ago, it was proposed that a synthetic Syncytin-1 vaccine could be developed as a contraceptive that would work to produce antibodies against human Syncytin-1.59


It is proposed by some doctors that the Pfizer COVID vaccine may elicit an antibody response against Syncythin-1 and cause infertility because of a similar or shared amino acid sequence in the spike protein of SARS-CoV-2 and the Syncythin-1 placental protein. Pharmaceutically sponsored fact-checkers, and Pfizer employed virologists were quick to discount such an idea as “unlikely”. They claim that this amino acid sequence is too short for the immune system to meaningfully confuse it with this important placental protein. However unlikely, if this later proves true for some susceptible women, then that could cause infertility of an unspecified duration. Consider that scientific consensus is not 100 percent sure these similar amino acid sequences will cause Syncythin-1 antibodies to be produced. The role of retroviral proteins, especially syncytins, in the trophoblastic fusion process and placental morphogenesis were only identified and hypothesized about 20years ago.60 There is still much to learn, and much we still do not know about similar amino acid sequences and their effect on human physiology. Thus, this issue warrants further research, and until then we should proceed with caution and assume that it may possibly cause public harm.




Adjuvants are immunostimulatory molecules administered together with the vaccine to help boost immune responses mainly by activating additional molecular receptors that predominantly recognize pathogens or danger signals. These pathways function primarily within the innate immune system, and each adjuvant generally has a different range of stimulation of these pathogen or danger receptors. While the vaccine goal is to stimulate recognition and response by lymphocytes, not innate cells, the activation of the innate immune cells is required to activate the lymphocytes to obtain both B and T-cell responses. Many adjuvants have previously failed in the clinic due to toxicity issues. These chemicals can have a wide range of compositions, including lipids, proteins, nucleic acids, and even inorganic material, such as aluminum salts. What they all have in common is that they hyper-stimulate receptors in immune cells and most do this through their cellular toxicity.


Pfizer/BioNTech and Moderna do not explicitly state the use of an adjuvant within their vaccines, but RNA already contains immunostimulatory properties and signals through pathogen recognition receptors. It remains to be seen whether the immunostimulation from RNA is strong enough to confer full protection against SARS-CoV-2. There is also a possibility that the lipid nanoparticle carriers they utilize confer adjuvant properties themselves. Or for that matter, elicit an abnormal autoimmune reaction.


It is unknown if any future licensed COVID-19 mRNA vaccines will contain aluminum or something else as an adjuvant, as commonly used in other viral vaccines. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding of their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. Despite this, the false notion that aluminium in vaccines is safe appears to be widely accepted. Experimental research clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. Aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation, and associated neurological complications and may thus have profound and widespread adverse health consequences.61


Stability and Storage


These mRNA vaccines require cold storage to maintain the nanoparticles and to stop the mRNA from degrading. The Pfizer/BioNTech vaccine (BNT162b2) is to be stored at a temperature of -94 degrees Fahrenheit (-70 Celsius) and will last for only 24 hours at refrigerated temps between 35.6° and 46.4° Fahrenheit. It will be shipped on dry-ice (–80°C). The Moderna vaccine (mRNA-1273), must be stored at -4° Fahrenheit (-20 C) and shipped at this –20°C temperature using gel packs.62

Thus, preserving this constant cold temperature is a major hurdle for the implementation of its vaccine marketing campaign, particularly the Pfizer/BioNTech vaccine. Given those constraints, analysts argued that Pfizer’s vaccine could only be used at certain hospitals and clinics with the proper equipment, and would require intensive one-day vaccination events at such sites that would cover a fraction of the healthy population. Not only do most vaccination sites lack the freezing requirements needed, but also shipping companies are currently unable to ship mass quantities of ultracold vaccines. Pfizer has partnered with UPS to develop ultracold shipping containers that can hold the vaccine at the required temperature. The packages utilize cold-resistant glass vials to hold the vaccine and dry ice to maintain cold temperatures. Although this may seem like a sustainable solution, the US presently has a shortage of both dry-ice (due to a shortage in CO2) and cold-resistant glass.63 Mass shipping using these containers would cause a huge strain on the supply chain and likely would require investments of billions of dollars.64




Pfizer-BioNTech has said that they will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If licensed, Moderna has said it intends to provide the US government with 20 million doses by the end of this year, and manufacture between 500 million and one billion doses globally throughout 2021. There are currently more than 320 Covid-19 vaccine candidates in development. Several of them, including the Oxford/AstraZeneca vaccine, are emerging from phase III trials, so we can expect more announcements like this soon.


No Liability Due to the PREP Act

With the upcoming SARS coronavirus-2 vaccines the vaccine industry is completely liability-free (not legally liable). The governmental nonliability guarantee for vaccine the manufacturers of current mRNA vaccines being implemented, or any future vaccines chosen to fast-track, comes out of the Emergency Use Authorization Authority (EUA Authority) that originated out of Project Bioshield. The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was further defined by the PREP Act of 2005, the Public Readiness and Emergency Preparedness Act, which further granted the non-liability of vaccine manufacturers previously outlined in the 1986 Injury Compensation Program for childhood vaccines. On March 10, 2020, the Secretary invoked the PREP Act and determined that COVID-19 constitutes a public health emergency. Therefore, the HHS declaration authorizes PREP Act immunity for the “manufacture, testing, development, distribution, administration, and use” of covered countermeasures. An amendment to the PREP Act, which was updated in April65, stipulates that companies “cannot be sued for money damages in court” over injuries caused by medical countermeasures for Covid-19. Such countermeasures include vaccines, therapeutics, and respiratory devices. The only exception to this immunity is if death or serious physical injury is caused by “willful misconduct.” And even then, the people who are harmed will have to meet heightened standards for “willful misconduct” that are favorable to defendants.66


While people harmed by vaccines for other diseases are able to file claims with the National Vaccine Injury Compensation Program, which was established in 1986, the PREP Act now bars anyone who feels they were harmed by a vaccine for the coronavirus from using that program.


The PREP Act has allowed vaccine manufacturers unlimited freedom to create, develop, and market vaccines without any liability whatsoever. Manufacturers have been allowed to bypass animal studies and go directly to human trials. They also can add anything they deem important to the vaccine formula they choose – whether it be a known toxin or carcinogen. 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.




The world, pushed by the pharmaceutical owned media, is clamoring for a safe, effective COVID-19 vaccine. Many laboratories and companies have scrambled to rapidly develop these vaccines, resulting in more than 200 vaccine candidates. Without proceeding with animal studies, many of these companies have entered human phase I, II and III clinical trials within a short period of 6 months. Pfizer/BioNTech and Moderna ‘vaccines’ moved quickly through human testing, without giving time for proper evaluation of earlier phases. They have not been approved or licensed by the U.S. Food and Drug Administration (FDA) ,but instead have received authorization for emergency use by the FDA under an Emergency Use Authorization (EUA) for use in individuals 16 years of age and older and are being injected into millions of people. Dangers arise due to the fast-tracking process that limits the time available for large-scale studies. Owing to the accelerated development process, the interim data from ongoing clinical and preclinical vaccine studies are being published almost in real time. As a result, crucial information about the longevity and quality of vaccine-induced protective immunity is unavailable. Fast-tracking leads companies to push out the vaccine before the results of a large-scale study show the safety and efficacy of the vaccine. Scientists and epidemiologists emphatically confirm that the primary focus of vaccine research is to prove it safe for a large population or group before being unleashed. The trials should offer clear datasets before releasing the vaccine to the public (millions if not billions of people). Without clear time-tested datasets of a large population, it is not possible to ensure that the vaccine is safe for most people in the country.

Pfizer released a Peer Review study entitled Safety and Efficacy of the BNT162b2mRNA Covid-19 Vaccine, recently published in the New England Journal of Medicine.67 In the Pfizer/BioNTech COVID-19 vaccine trials conducted in the United States, there were more allergic reactions reported in the vaccine group than in the placebo control group.68 While allergic reactions occurred in less than one percent of those receiving the COVID vaccine, it is important to note that individuals with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s)” were excluded from Pfizer’s clinical trials.69, 70


Further testing and adequate time-testing may also identify specific health conditions, allergies, or related concerns of individuals that may not be qualified to take the vaccine. By fast-tracking the vaccine, the possibility of harm due to allergic reactions, autoimmune reactions, complications with an existing health condition, interactions with certain medications or other related concerns may increase when compared to a longer time frame for trials. In short, tests must prove that the vaccine is safe, which in vaccine time usually requires years rather than months.


Numbers reveal the death rate from COVID resumed to the normal flu death rate in early September 2020. Many scientists now view that the coronavirus pandemic is over. Therefore, a vaccine is no longer needed; it is totally unnecessary and comes with a potential danger. Perhaps the saddest part of this worldwide rush to the vaccine is seeing how little faith people have in their own immune systems. Somehow the powers that should not be have managed to convince the majority of the people that the immune system is just a conspiracy theory, and rather than strengthening our own innate ability to heal and regenerate our bodies, we should give our faith into the hands of pharmaceutical corporations, who profit from sickness.


When we pause for just one moment to marvel the ability of your own skin to heal a wound or a bone to mend itself, we will realize that our bodies have their own bioregulatory intelligence. This organic living intelligence is far beyond the capacities of any nanotechnology or lab-created synthetic concoctions which merely try to mimic nature and its grand design. Our immune system and a healthy biological terrain are our best defense for pathogens and there are several proven ways to keep it active. The mineral zinc is important for numerous immunological enzymes and may be taken daily. Vitamin D3 has been shown to be low or deficient in individuals that develop a serious coronavirus infection. Thus, taking vitamin D3 is preventive and may be taken daily to keep body levels therapeutic. Also, vitamin C has been extensively proven effective for infection protection. Getting fresh air and sunlight, staying active and well hydrated, and enjoying joyous social activities are all helpful in staying well.


Lastly, mRNA vaccines have never been licensed before, and now they are being administered to millions of people with no manufacturer liability. The public has become the testing ground for this new technology. If these coronavirus mRNA vaccines later prove to be harmful to fragile genetic cellular structures, then that cannot be undone. Essentially, we need a much better understanding of their potential side effects, and more evidence of their long-term efficacy. Vaccine development takes time as the vaccines must not only be proven protective but also safe. Unlike other drugs that are delivered into sick patients, vaccines are administered into healthy patients and thus require very high safety margins. There is still a lot of research that should have been done around safety before mRNA vaccines become used on the public. Unfortunately, that is not what is happening now, and consequently this has a potential to turn into a disaster on a massive scale.



Vaccine providers are supposed to report adverse events that occur after vaccinations to VAERS but vaccinated persons who experienced the reaction or a family member also can file a report if a health care provider does not do it. According to one government funded study in 2011, fewer than one percent of all vaccine reactions are reported to VAERS. Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to and include ‘Pfizer/BioNTech COVID-19 Vaccine EUA’ in the first line of box #18 of the report form.



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Recent Posts

Artemisia Annua: A Potent Antimicrobial

Artemisia Annua: A Potent Antimicrobial

August 31, 2020

Artemisia Annua: A Potent Antimicrobial

by James Odell, OMD, ND, L.Ac.

Artemisia annua has been used in China for more than 2000 years to treat fevers and more recently used in the treatment of the chloroquine-resistant and cerebral malaria (Plasmodium falciparum). Much focus has now been paid to its effectiveness in the treatment of SARS-CoV-2 (Covid-19). Its ancient Chinese name Qing Hao literally means “green herb.” Qing Hao was mentioned in the ancient text (168BC) Wu Shi Er Bing Fang or “Recipes for Fifty-Two Ailments”, as a remedy for fevers. The genus Artemisia consists of over 400 species, many of which have an aromatic, bitter taste. Herbal extracts of Artemisia annua have been used for thousands of years in other parts of the world, particularly Southeast Asia, Africa, India, and South America, to treat malaria and a variety of infectious diseases. Apart from its anti-malarial properties, Artemisia annua has been used in traditional Chinese medicine to stimulate hair growth, to promote longevity, as a food additive, as an anti-inflammatory, as well as a treatment for numerous external illnesses including hemorrhoids, lice and boils. 


Botanical Aspects


Artemisia is a large, diverse plant genus with between 200 and 400 species and consists of hardy herbs and shrubs belonging to the Magnoliopsida class of flowering plants. Artemisia annua is an annual shrub of 50–150 cm in height. The shrub grows in temperate climates and is most widespread in China and Vietnam, but is also cultivated in East Africa, the United States, Russia, India, Brazil, and several other countries.1, 2 The reproduction of the shrub occurs by insects, self-pollination, and wind distribution.3


Artemisia annua Chemical Properties


The essential oil of Artemisia annua is rich in mono- and sesquiterpenes with numerous medicinal properties. Significant variations in its percentage and composition have been identified (main constituents may be camphor (up to 48%), germacrene D (up to 18.9%), artemisia ketone (up to 68%), and 1,8 cineole (up to 51.5%)). The oil has been subjected to numerous studies supporting exciting antiparasitic, antibacterial, antiviral, and antifungal activities. One of the more medicinal components found in Artemisia annua is artemisinin, first isolated in China in 1971.4


Artemisinin is the constituent with the greatest antimalarial activity. Up to 42% of the total artemisinin content is found in the upper leaves, where it accumulates in the glandular trichomes of the leaves. Artemisinin has been found in only two other species, Artemisia apiacea and Artemisia lance 5, and since that time its efficacy against malaria has been amply demonstrated.6, 7, 8, 9, 10, 11


The total amount of artemisinin found in different varieties of Artemisia annua varies slightly depending on extraction methods, different collection periods, different sample preparation, and different environmental influences.12 The artemisinin content in the plant exhibits the highest quantities usually just before flowering. Except for Artemisia annua, artemisinin is also present in Artemisia apiacea and Artemisia lancea, but only in minor quantities.13


Nowadays, many researchers are still investigating the effect of artemisinin and its analogues on the malarial parasite (Plasmodium) by modifying the structure of peroxides, ethers and ozonides in artemisinin. This improves the killing rate of plasmodium parasites for both in vitro and in vivo models as well as a faster clinical response for humans.14


Antimalarial Mechanism of Action of Artemisia annua


Malaria is one of the most severe public health problems worldwide. It is a leading cause of death and disease in many developing countries, where young children and pregnant women are the groups most affected. Worldwide an estimated 450,000 deaths annually (around 1200 per day) are attributed to malaria. This infection is caused primarily by the Plasmodium falciparum parasite, which largely reside in red blood cells and contains iron-rich heme-groups (in the form of hemozoin). Such hematophagous organisms digest hemoglobin and release high quantities of free heme, which is the non-protein component of hemoglobin. As a result, hemozoin pigment and other toxic factors such as glycosylphosphatidylinositol (GPI) are also released into the blood. These products, particularly the GPI, activate macrophages and endothelial cells to secrete cytokines and inflammatory mediators such as tumor necrosis factor, interferon-γ, interleukin-1, IL-6, IL-8, macrophage colony-stimulating factor, and lymphotoxin, as well as superoxide and nitric oxide. These inflammatory cytokines and mediators can cause significant damage to organs and tissues.15, 16, 17


The parasite is fairly shielded from attack by the body’s immune system since it resides within the liver and blood cells for much of its human life cycle and is relatively invisible to immune surveillance. However, circulating infected blood cells are destroyed in the spleen. To avoid this fate, the Plasmodium falciparum parasite displays adhesive proteins on the surface of the infected blood cells, causing the blood cells to stick to the walls of small blood vessels, thus sequestering the parasite from passage through the general circulation and the spleen. Sequestered red blood cells can breach the blood-brain barrier and cause cerebral malaria. Artemisinin is also active against other parasite species such as Toxoplasma and Babesia that do not contain hematin.


Chemically, artemisinin is a sesquiterpene lactone that contains an unusual peroxide bridge. This 1, 2, 4-trioxane ring of endoperoxide is responsible for the drug’s mechanism of action.  Thus, the proposed antimalarial mechanism of action of artemisinin involves cleavage of endoperoxide bridges by iron, producing free radicals (hypervalent iron-oxo species, epoxides, aldehydes, and dicarbonyl compounds) which damage biological macromolecules causing oxidative stress in the cells of the parasite.18, 19


Artemisinins have also been investigated for their anti-proliferative activity against a wide range of cancer cell lines. Artemisinin results in decreased proliferation, increased levels of oxidative stress, induction of apoptosis and inhibition of angiogenesis in cancer cells. Artemisinins have also been shown to inhibit the falcipains, a papain family cysteine protease that aids hemoglobin degradation.20




Over the last ten years as the worldwide demand for artemisinin has become evident, Chinese, Vietnamese, African, and Indian plant breeding institutes have developed high-yielding Artemisia hybrids. Factories were developed in all three countries to extract artemisinin and manufacture its anti-malarial compounds. East African factories are currently exporting artemisinin to pharmaceutical factories in India and Europe, where the final products are made.


Drug resistance is a growing issue for the treatment of malaria in the 21st-century. Resistance is now common against all classes of antimalarial drugs except for artemisinins. Artemisinin treatment of resistant drug strains has therefore become increasingly popular. Unfortunately, while the cost of cultivation and production of artemisia is lower than that of other competitive pharmaceuticals, politics involving the pharmaceutical industry have restricted their use in the developing world.

From Quinine to Chloroquine to Hydroxychloroquine to Artemisinin


In 1820, the first antimalarial drug quinine was extracted from cinchona bark by French pharmacists Pelletier and Caventou.21 In the 1940s, limited by the raw materials for quinine extraction, German scientists synthesized chloroquine, which is similar to natural quinine in chemical structure.

In 1950, chemists Alexander Surrey and Henry Hammer published the synthesis of hydroxychloroquine which was even more effective with less toxicity.

By the mid-20th century, malaria was gradually controlled in China. However, parts of Africa still suffer high epidemic proportions of malaria. In the 1960’s an epidemic broke out which spread rapidly in Southeast Asia and South America. In addition, the plasmodium falciparum parasite was developing a resistance to chloroquine and hydroxychloroquine. Inspired by ancient books of traditional Chinese medicine, Youyou Tu, a Chinese scientist, successfully extracted artemisinin from Artemisia annua. With a 100% inhibition rate against plasmodium, artemisinin is now used for chloroquine and hydroxychloroquine resistant malaria. For her work, Tu was awarded the 2011 Lasker Award in clinical medicine and the 2015 Nobel Prize in Physiology or Medicine jointly with William Campbell and Satoshi Ōmura. Tu is the first Chinese Nobel laureate in physiology or medicine and the first female citizen of the People’s Republic of China to receive a Nobel Prize in any category.22

Antiviral Effects of Chloroquine and Hydroxychloroquine


To better understand the therapeutic antiviral similarities of chloroquine derivatives and Artemisia annua extracts it is beneficial to review the antiviral background of chloroquine. Chloroquine has been confirmed to be effective during epidemics of various infectious diseases, especially Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome Coronavirus (MERS). In 2003, SARS broke out in China. According to the World Health Organization, a total of 8,098 people worldwide became sick with SARS during this outbreak, of whom 774 died. In 2004, MarcVan Ranst and colleagues found that chloroquine effectively inhibited SARS coronavirus replication in vitro.23


In 2005, Stuart Nichol and colleagues found that chloroquine suppressed SARS virus replication both before and after infection, suggesting a preventative and therapeutic role of chloroquine against SARS.24


In 2014 Eric Snijder and colleagues successfully inhibited MERS coronavirus replication by chloroquine in monkeys, with similar suppressive effect against SARS and human coronavirus.25 Additionally, chloroquine has also been reported to inhibit Human Immunodeficiency Virus (HIV), Zika virus (ZIKV), and dengue virus (DENV).26 Chloroquine phosphate was also reported to alleviate lung autophagy induced by avian influenza A (H5N1) and reduce alveolar injury in mice.27


February 2020, Wuhan Virus Research Institute of the Chinese Academy of Sciences and other units jointly published the results on cell research, which showed that chloroquine phosphate effectively inhibited SARS-Cov-2 and such inhibition was superior as compared to Remdesivir.28 Other recent studies have validated those findings.29, 30


The antiviral mechanisms of chloroquine and hydroxychloroquine on SARS-Cov-2 is proposed as follows:


1) To weaken the binding of the virus to the receptor by interfering with the terminal glycosylation of the receptor protein angiotensin 2 receptor invertase of coronavirus.

2) As an alkaline drug, chloroquine increases pH value inside endosomes which was not conducive for virus-cell fusion.

3) Inhibits cell autophagy and regulates host immune reaction to suppress viral infection and replication.

4) Suppresses transcription and translation of virus protein by binding to viral protease; and

5) Alleviates cytokine storm through inhibiting the production and release of TNF-α and IL-6.


In June 2020, the U.S. Food and Drug Administration revoked the emergency use authorization that allowed for chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. More than 35 states have now restricted prescriptions for hydroxychloroquine, and at least five of those have rules specifically prohibiting prescribing the drug as a preventive measure. Fortunately, we still have artemisia extracts and other immunological nutrients (vitamin D3, zinc, vitamin C) available – for now.


Artemisia annua Extracts Effective Against Viruses


Due to its similar history to chloroquine in the treatment of malaria and viruses, scientists at several institutions have researched whether extracts of Artemisia annua – pure artemisinin and related derivatives – may be effective against the COVID-19 virus. These compounds would be attractive candidates for immediate use as they have an excellent safety profile, are readily available, and are relatively inexpensive.


Numerous in vitro studies have reported that artemisinins have antiviral properties. Artemisinins reduce replication rates of hepatitis B and C viruses 31, 32, a range of human herpes viruses 33, 34, 35, HIV-1 36, influenza virus A 37, 38, and a bovine viral diarrhea virus39, in the low micromolar range. 


Like chloroquine, Artemisia annua extracts have even shown significant activity against the SARS coronavirus. In 2003, Li and colleagues showed that artemisinin was effective in treating SARS-CoV in vitro.40 Since the beginning of the COVID-19 pandemic, formulations of Artemisia annua have been used in Africa, Madagascar, and China for both COVID-19 prevention and treatment.41


Last June 2020, chemists at the Max Planck Institute of Colloids and Interfaces (Potsdam, Germany) in close collaboration with virologists at Freie Universität Berlin demonstrated in laboratory studies that aqueous and ethanolic extracts Artemisia annua are active against the SARS-CoV-2 (COIVID-19) virus. Human clinical trials to test the efficacy of both teas and coffee containing Artemisia annua are about to begin at the University of Kentucky’s academic medical center.42 Artemisia annua leaves, from a cultivated seed line grown by ArtemiLife Kentucky, USA, when extracted with absolute ethanol or distilled water produces the strongest antiviral activity. The addition of either ethanolic or aqueous Artemisia annua extracts prior to the introduction of the virus resulted in significantly reduced plaque formation. The most active extract of both Artemisia annua and coffee was found to be ethanolic. However, artemisinin alone does not present much antiviral activity. “I was surprised to find that A. annua extracts worked significantly better than pure artemisinin derivatives and that the addition of coffee further enhanced the activity” says Klaus Osterrieder, Professor of Virology at Freie Universität Berlin who conducted all activity assays.


In SARS-CoV-2 (COVID-19), cellular adaptive immunity is primarily involved, in particular, CD8 and CD4 lymphocytes that stimulate the B lymphocytes responsible for the production of antibodies targeting the coronavirus. In addition, there is a cytokine storm in patients infected with SARS-CoV-2 which is responsible for a major inflammatory response and their very severe progressive clinical state. The increase in interleukin-10 and TNF alpha reduces CD4 counts, causes functional exhaustion of immune cells, and induces, at their site of action (liver, vascular endothelium), runaway production and action of inflammatory proteins, resulting in secondary aggravation of COVID-19 patients.


Artemisia annua has extensively recognized antiviral activity (anti HSV1, Poliovirus, RSV, hepatitis C anti-virus, type 2 dengue virus, hantavirus, human cytomegalovirus) and anti-HIV in vitro, due in partto the artemisinin, flavonoids, quercetin and dicaffeoylquinic acids it contains. These molecules have been shown to inhibit the enzymatic activity of CLPro (Chymotrypsin-like protease), an enzyme produced by SARS-CoV-2.


The antiviral action of Artemisia annua, which is achieved by stimulating adaptive immunity, regulating the production of the pro-inflammatory cytokines prostaglandin E2 (PGE2), IL-6, IL-10, TNF alpha, and increasing the genesis of CD4, CD8 and interferon gamma, involves many minerals and biomolecules: the properties of flavonoids, polyphenols, triterpenes, sterols, saponins, polysaccharides, artemisinin and its derivatives, the concentration of zinc, gallium and selenium in the plant play a role in the immune, antiviral, antioxidant and anti-inflammatory response.


The plant is rich in vitamins A and E, of which one, when supplemented, is known to reduce morbidity and mortality in viral infections, notably HIV among others, and the other is a powerful antioxidant. Therefore the combination of these biomolecules and the intake of Artemisia annua may strengthen the exhausted adaptive immunity and modulate the runaway inflammatory response during COVID-19 infection, as has already been demonstrated in other serious viral and parasitic infections.


As more research develops it is likely that Artemisia annua extracts will take their place as a first-line defense against coronaviruses. Given that this plant has been extensively used for more than 2000 years in traditional Chinese medicine for treatment of fever, viruses, and malaria, the evidence argues for the inclusion of inexpensive Artemisia annua dried leaf tablets, capsules, or teas into the arsenal of remedies to combat coronavirus.


Lastly, malaria treatment is more complicated for human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) patients. Malaria and HIV co-infection represents a major health burden in Africa, primarily because it is now well known that HIV infection results in a higher incidence and more severe manifestations of malaria. With a compromised immune system, AIDS patients are more susceptible to malaria and respond slower to malaria therapy. In several studies and in clinical observation, Artemisia annua has demonstrated anti-HIV activity.43, 44 Hence, the use of Artemisia annua not only treats malaria but should also enhance the well-being of HIV/AIDS patients.


Preparation and Dosage


Artemisia annua is typically prepared as a tea extracted with water according to the rules of traditional Chinese medicine. There have been few well-controlled studies investigating the extraction, recovery, and stabilization of artemisinin and other compounds in Artemisia annua tea infusions. A systematic study of preparations of Artemisia annua therapeutic tea infusion was performed by van der Kooy and colleagues.45 This study showed that nearly 93% of available artemisinin was extracted from dried Artemisia annua leaves, but only under certain conditions. The best preparation method was: 9 g dried leaves/L, for 5 min at 100 °C. Subsequent storage of the tea infusion at room temperature showed that the concentration of artemisinin was stable for more than 24 hours. This is important for malaria-endemic locations where there is no refrigeration. Other studies using the same extraction protocol also measured the extraction and stability of artemisinin and certain key flavonoids in the tea. Artemisinin was found to be stable at room temperature for up to 48 hours.46 However, some flavonoids were poorly extracted and not stable at room temperature, therefore it may be best to refrigerate after the infusion is complete.47


Clearly, if a tea infusion is to be a therapeutic option, it must be prepared and consumed consistently and reliably.  Artemisia annua is also available commercially in extracts such as capsules and tinctures. As with all herbal remedies, the correct dosage depends on a variety factors such as the illness treated, the age of the person, health status, and number of other conditions.


Herb-Drug Reactions


Artemisinin has no reported toxicity if taken in recommended doses for a limited period of time.51 In animal studies, artemisinin has been used in high oral doses in dogs and rabbits52 and at 200-300 mg/kg BW in mice53 without toxicity. Artemisinin has been effective against Plasmodium in humans at doses of approximately 30 mg/kg BW, but it has poor bioavailability and a short half-life that is quickly eliminated from the body.54, 55 Artemisinin derivatives (dihydroartemisinin, artesunate, artemether, arteether) present better bioavailability and antimalarial activity than artemisinin, but have different safety margins than artemisinin. The bioavailability and half-lives also vary with the delivery mechanism (intramuscular, intravenous, intraperitoneal, oral).




Evidence is mounting for the therapeutic effectiveness of the use of Artemisia annua not only in the treatment of malaria, but also for various viruses, including coronaviruses. The complex mixture of antiparasitic compounds in the plant appears to account for its therapeutic activity with the animal and human trials supporting this claim. It is also clear that the cost of using Artemisia annua is a fraction of that for any other existing or potential antimalarial or antiviral treatment. Considering that for more than 2000 years this plant was used in traditional Chinese medicine for the treatment of fever with little to no significant toxicity and no clear signs of artemisinin drug resistance. Thus, the cumulative evidence argues for the inclusion of Artemisia annua extracts,tinctures, and teas into the arsenal of remedies to not only combat malaria, but also numerous other diseases, particularly viruses.



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31. Paeshuyse, Jan, Lotte Coelmont, Inge Vliegen, Jan Vandenkerckhove, Eric Peys, Benedikt Sas, Erik De Clercq, and Johan Neyts. “Hemin potentiates the anti-hepatitis C virus activity of the antimalarial drug artemisinin.” Biochemical and biophysical research communications 348, no. 1 (2006): 139-144.


32. Romero, Marta R., Thomas Efferth, Maria A. Serrano, Beatriz Castaño, Rocio IR Macias, Oscar Briz, and Jose JG Marin. “Effect of artemisinin/artesunate as inhibitors of hepatitis B virus production in an “in vitro” replicative system.” Antiviral research 68, no. 2 (2005): 75-83.


33. Efferth, Thomas, Manfred Marschall, Xin Wang, Shu-Mei Huong, Ilona Hauber, Armin Olbrich, Martina Kronschnabl, Thomas Stamminger, and Eng-Shang Huang. “Antiviral activity of artesunate towards wild-type, recombinant, and ganciclovir-resistant human cytomegaloviruses.” Journal of molecular medicine 80, no. 4 (2002): 233-242.


34. Kaptein, Suzanne JF, Thomas Efferth, Martina Leis, Sabine Rechter, Sabrina Auerochs, Martina Kalmer, Cathrien A. Bruggeman, Cornelis Vink, Thomas Stamminger, and Manfred Marschall. “The anti-malaria drug artesunate inhibits replication of cytomegalovirus in vitro and in vivo.” Antiviral research 69, no. 2 (2006): 60-69.


35. Naesens, Lieve, Pascale Bonnafous, Henri Agut, and Erik De Clercq. “Antiviral activity of diverse classes of broad-acting agents and natural compounds in HHV-6-infected lymphoblasts.” Journal of clinical virology 37 (2006): S69-S75.


36. Naesens, Lieve, Pascale Bonnafous, Henri Agut, and Erik De Clercq. “Antiviral activity of diverse classes of broad-acting agents and natural compounds in HHV-6-infected lymphoblasts.” Journal of clinical virology 37 (2006): S69-S75.


37. Efferth, Thomas, Manfred Marschall, Xin Wang, Shu-Mei Huong, Ilona Hauber, Armin Olbrich, Martina Kronschnabl, Thomas Stamminger, and Eng-Shang Huang. “Antiviral activity of artesunate towards wild-type, recombinant, and ganciclovir-resistant human cytomegaloviruses.” Journal of molecular medicine 80, no. 4 (2002): 233-242.


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41. Suryanarayana, Lakavath, and Dhanalaxmi Banavath. “A Review On Identification of Antiviral Potential Medicinal Plant Compounds Against with COVID-19.” International Journal of Research in Engineering, Science and Management 3, no. 3 (2020): 675-679.


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COVID 19 Vaccine Safety Concerns

COVID 19 Vaccine Safety Concerns

Jun 30

COVID 19 Vaccine Safety Concerns

James Odell, OMD, ND, L.Ac.

The development of antibodies has long been the basis or rationale for vaccine efficacy against a large range of infective agents such as viruses and bacteria. However, it is well known that antibodies, which the immune system develops from natural infections, differ from those that are created from vaccines. (Bear this important difference in mind when reading this article.) Additionally, when vaccines do elicit antibodies, most are only temporary and thus require boosters, unlike lifelong immunity gained from an infectious disease, such as childhood measles. Anthony Fauci and others developing or promoting COVID-19 vaccination are talking about the likelihood that the new coronavirus vaccine will have to be administered in multiple doses, perhaps even annually like the influenza vaccine. This article explores COVID-19 vaccine development and safety concerns around “fast tracking” the manufacturing and testing process.

Antibody-Dependent Enhancement (ADE)

In the 1960s, immunologists discovered the phenomenon of what is now commonly referred to as antibody-dependent enhancement (ADE). Virus ADE is a mechanism in which virus specific antibodies (from an infection or from a vaccine) promote the entry and/or the replication of another virus into white cells such as monocytes/macrophages and granulocytic cells. ADE modulates the immune response and may induce chronic inflammation, lymphopenia, and/or a ‘cytokine storm’, one or more of which have been reported to cause severe illness and even death. Essentially, ADE is a disease dissemination cycle causing individuals with secondary infection to be more immunologically upregulated than during their first infection (or prior vaccination) by a different strain.

A more technical explanation of ADE is that when patients are infected by one stereotype of a virus (whether due to a vaccine or by nature) they produce neutralizing antibodies targeting that particular viral serotype (or distinct variation within a virus species). However, if they are later infected with another viral serotype (i.e., from a secondary infection or vaccine), the preexisting antibodies cannot completely neutralize the virus. Instead, the antibodies first bind to the virus and then bind to the immune cell IgG Fc receptors and mediate viral entry into these cells. For certain cases, however, the ADE of these viruses is responsible for non-neutralizing or binding antibodies.

Early stages of the viral infection cycle requires attachment and entry of viruses into the host cell. Virus attachment is typically mediated by the specific binding of viral surface proteins to host cell receptor molecules, concentrating the virus at the cell plasma membrane. Viruses are often studded with one or more surface proteins, each potentially containing multiple subdomains, to facilitate interaction with cellular receptors and induce the entry of the virus into the cell. However, the surface of the virus is also a highly antigenic structure that can trigger cellular and humoral immune responses that eradicate or neutralize the virus in the host. Antibodies contribute to several levels of antiviral defense to efficiently neutralize the virus and reduce its infectivity. In simple terms, antibody neutralization is good, whereas antibody binding is bad.

After the 1960s, studies on vaccine candidates for diseases such as dengue, respiratory syncytial virus and severe acute respiratory syndrome (SARS) have demonstrated a paradoxical trend. Many animals and humans who received the vaccine and were subsequently exposed to the virus developed a more serious disease than those who had not been vaccinated.1, 2, 3 ADE’s have been observed for a variety of viruses, such as dengue virus, Ross River virus, other alpha and flaviviruses, HIV and influenza viruses.4, 5, 6, 7, 8, 9

Developing the COVID 19 Vaccine

Importantly, during the production of new vaccines for a variety of infectious agents, the ADE effects must be carefully examined to ensure that the vaccines do not harm the recipients. ADE is a clear concern about coronavirus vaccines that are soon to be tested on millions – if not billions – from the healthy to the ill and young to old. As a result of ‘fast-tracking,’dozens of coronavirus manufacturers have been given the green light by the FDA to bypass critical manufacturing safety rules, such as pre-human animal trials and the use of ‘inert’ placebo controls. Most significantly the concept of ‘fast track’ means that the length of the trials will be short; not more than 6 weeks. It can take two to three years to learn if there are negative health effects resulting from a vaccine. Many autoimmune and neurological side effects will not manifest within a few short weeks. Several companies are now cutting corners by conducting phase 1, 2 and 3 human trials simultaneously. Global pharmaceutical and biotech companies are now developing over 100 experimental COVID-19 vaccines, with a few leading the race after securing billions of dollars in funding from the U.S. government, the Gates Foundation, and other organizations.10, 11

At the time of this writing, at least 10 of these vaccine-development programs have reached the clinical stage of evaluation, either phase 1 or phase 2. These include programs led by Western pharmaceutical companies such as AstraZeneca plc (in partnership with the University of Oxford); BioNTech SE partnered with Pfizer, Inc.; Inovio Pharmaceuticals, Inc.; Moderna, Inc. (in partnership with NIAID) and Novavax, Inc. 123 other programs to develop a COVID-19 vaccine remain in preclinical evaluation.

Astonishingly, the University of Oxford’s Jenner Institute and Oxford Vaccine Group in the United Kingdom have announced that their researchers are beginning to recruit children aged 5 to 12 years for phase II and phase III clinical trials of the experimental COVID-19 vaccine developed by the university in collaboration with AstraZeneca plc. Researchers at The University of Oxford and AstraZeneca researchers are proceeding with testing the experimental ChAdOx1 nCov-19 vaccine in children, although a report published on May 13, 2020 indicated that small vaccine trials in mice and monkeys were not successful in proving effectiveness against infection. While the animal studies presented evidence that the experimental vaccine induced a “robust humoral and cell-mediated response” in mice and appeared to protect against development of viral pneumonia in monkeys, it did not prevent infection with COVID-19.12, 13 In other words, the animal studies failed, but the developers intend to continue with human trials.

Some of these coronavirus vaccines being developed will use unlicensed DNA, messenger RNA and nanoparticle technology, oil-based adjuvants and even electricity, to genetically manipulate and hyper-stimulate strong inflammatory immune responses in the body.14 Messenger RNA vaccines, which have never been licensed for use in humans, inject cells with mRNA, usually within lipid nanoparticles, to stimulate cells in the body to become manufacturers of viral proteins. mRNA vaccines like all vaccines stimulate cells in the body to become manufacturers of viral proteins. mRNA vaccines have potential safety issues, including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity, as well as the development of edema (swelling) and blood clots.

Conventional vaccines usually contain inactivated disease-causing organisms or proteins made by the pathogen (antigens) that mimic the infectious agent. These activate the body’s immune response, so it is primed to respond more quickly and efficiently if exposed to the infectious agent in the future. RNA vaccines use a different approach that takes advantage of the process that cells use to make proteins: cells use DNA as the template to make messenger RNA (mRNA) molecules, which are then translated to build proteins. An RNA vaccine consists of an mRNA strand that codes for a disease-specific antigen. Once the mRNA strand in the vaccine is inside the cells of the body, the cells use the genetic information to produce the antigen. This antigen is then displayed on the cell surface, where it is recognized by the immune system.

Safety Issues Bypassed

Vaccine safety experts generally agree that animal studies should always be conducted prior to any human clinical trial with any vaccine; COVID-19 (SARS-CoV-2) vaccines are no exception. Clinical trials should always be double-blind placebo-controlled (with an inert placebo and not with another vaccine or adjuvant as a placebo).Careful assessment of possible immune complications should then be made prior to release of the vaccine to the public. In the case of vaccines, this ‘careful assessment’ is a time of waiting and should be no less than two to three years. Importantly, over the last two decades vaccines manufactures have never been able to develop an effective and safe coronavirus vaccine. Previous coronavirus vaccine animal studies with ferrets and mice have demonstrated significant and serious side-effects. After two decades of failed trials, the question is posed as to why a fast-tracking coronavirus vaccine will now result in a different outcome? Given that many of these fast-track trials have bypassed animal studies, are only performed on healthy volunteers and children (not the elderly or those with pre-morbidities), and that trials are conducted without an inert double-blind placebo-controlled environment, and are not given sufficient time to observe effects on the human trials, there is serious safety concern. Many epidemiologists feel this fast track policy is a recipe for mass disaster. According to Marc Lipsitch, an epidemiologist at the Harvard Chan School of Public Health in Boston, MA, “You really have to test a vaccine carefully and not just roll it out because people are clamoring for it with an epidemic underway.”

National Childhood Vaccine Injury Act and Immunity from Liability for Vaccine Harms

By the early 1980s, pharmaceutical companies faced crippling liability for injuries to children caused by their vaccines. Instead of allowing such market forces to push them to develop safer vaccines, Congress passed the National Childhood Vaccine Injury Act (the 1986 Act) which eliminated the liability of pharmaceutical companies for injuries caused by their vaccine products. After eliminating liability for pharmaceutical companies, the 1986 Act established the Vaccine Injury Compensation Program (Vaccine Court), part of the U.S. Court of Federal Claims, to compensate people injured by vaccines. Under the 1986 Act, the U.S. Department of Health and Human Services (HHS) is the defendant in Vaccine Court and is legally obligated to defend against any claim that a vaccine causes injury. HHS is represented by the formidable resources of the U.S. Department of Justice (DOJ). In nearly every case the injured person must prove the vaccine caused the injury. Notwithstanding these hurdles, since 1986, HHS has paid over $4 billion for vaccine injuries with taxpayers’ money, not with pharmaceutical manufacturers’ dollars. Safety is regulated, not only by comprehensive and thorough manufacturing and testing procedures, but also with liability laws. Without any liability consequences, pharmaceutical vaccine manufacturers are less likely to pay due diligence regarding the safety of the vaccine.

Upon removing the market mechanisms that assured vaccine safety, Congress made HHS exclusively responsible for vaccine safety under the ‘Mandate for Safer Childhood Vaccine’ provision of the 1986 Act. HHS recently conceded in federal court, that it did not comply with the essential provisions of this act, such as submitting reports to Congress on how HHS has improved vaccine safety. Such government neglect of vaccine safety also casts a doubt on the future development of coronavirus vaccines.  

Vaccine-Associated Enhanced Respiratory Disease (VAERD)

Similar to ADE, another immune enhancement phenomena came to the foreground in the 1960s during clinical trials in which young children were immunized with whole-inactivated respiratory syncytial virus (RSV) vaccines.15 When the children contracted RSV naturally a few months after the vaccinations, those who were immunized became significantly sicker than those who had not been vaccinated. In fact, in one trial, 80 percent of children in the youngest cohort had to be hospitalized, and two died.16 The syndrome the hospitalized children developed is sometimes called vaccine-associated enhanced respiratory disease (VAERD). VAERD is like ADE in that a high concentration of binding antibodies do not fully neutralize the virus and results in the formation of binding antibody-virus complexes that elicit a cytokine storm. As a consequence, elevated pro-inflammatory cytokines associated with the innate immune system have been associated with the VAERD phenomenon.17 In these children, the binding-antibody complexes affected the small airways of the lungs, obstructing these spaces and increasing inflammation. 

In another noteworthy study, “Abstract: a formalin-inactivated monkey kidney culture propagated 100-fold concentrated respiratory syncytial (RS) virus vaccine was administered intramuscularly to residents of Harrison and Arthur Cottages in Junior Village, a District of Columbia Welfare Institution for homeless infants and children. No significant local or systemic vaccine reactions were (initially) observed. A sharp outbreak of RS virus infection occurred approximately 9 months after the vaccine study was initiated. Recovery of RS virus was found to be significantly associated not only with the onset of febrile illness but also with the onset of febrile pneumonia illness. The vaccine not only failed to offer protection, but also induced an exaggerated altered clinical response to naturally occurring RS virus infection in the younger vaccines as 9 (69%) of 13 vaccinated and only 4 (9%) of 47 nonvaccinated Harrison Cottage residents, 6–23 months of age developed pneumonia.” The authors concluded, “The paradoxical effect of vaccination suggests that serum antibody may play an active role in the pathogenesis of RS virus disease.”18

Institutions for the homeless and ‘wards of the state’, orphanages, prisons, and developing countries (Uganda, Kenya, Latin America, Caribbean, Thailand) have historically been targeted for experimental vaccine trials. Some larger trials (rarely reported by the media) in Africa have resulted in mass sterility and even death.

The ever-changing mutation terrain of viruses results in ‘vaccine mismatch’ due to the lack of relatedness between the vaccine and the numerous circulating strains. This can potentially create vaccine reactions such as VAERD. Influenza vaccines contain inactivated virus formulated with adjuvants (aluminum, squalene, and several immunological toxins), and this formulation could certainly contribute to the pathology observed in VAERD.19

Another example of VAERD occurred with “Abstract: Field evaluation of two formalin-inactivated respiratory virus vaccines in a selected pediatric population in California during the 1966—1967 respiratory disease season. A total of 441 children ranging in age from four months to nine years were vaccinated: 219 with a respiratory syncytial (RS) virus vaccine and 222 with a trivalent parainfluenza virus (types 1, 2, and 3) vaccine. Very high attack rates of parainfluenza virus types 1 and 3 and RS virus was observed during the study period in infants and children in both vaccine groups. A protective effect was not demonstrable for either vaccine. Infants who received the RS virus vaccine and who subsequently became infected with RS virus tended to have a more severe clinical illness than infants who did not receive this vaccine.”20

There have been numerous studies on VAERD, particularly in children. Unfortunately, mainstream media report little information on this important issue.

COVID-19 Occurrence and Prior Vaccination

One of the more perplexing concerns regarding the current COVID-19 epidemic is the discrepancy between the severity of cases observed in Wuhan, Northern Italy, New York, and those occurring elsewhere in the world. Among the several reasons, such as air pollution, age, and pre-morbidities, another plausible justification is the antibody-dependent enhancement of SARS-CoV-2 due to previous exposure to coronaviruses and widespread influenza vaccine campaigns. Prior to the COVID-19 outbreak, both China and Italy implemented mass influenza vaccination campaigns.21, 22, 23 In one study, ADE was suggested to account for the severity of COVID-19 cases initially observed in China (and elsewhere) relative to other regions of the world.24 The previous infection with other coronaviruses, and/or influenza vaccines may have primed COVID 19 patients, predisposing them to the development of severe disease once infected with SARS-CoV-2.  

ADE and VAERD require prior exposure to viral antigenic epitopes, such as those contained in flu and pneumonia vaccines, making it a possible explanation for the observed geographic limitation of severe cases and deaths, as well as the age discrepancy – affecting primarily the elderly people who have received mandated flu and pneumonia vaccines, particularly in nursing homes. 

Studies have shown that vaccines developed against another coronavirus, feline infectious peritonitis virus, increased the risk for cats to develop disease caused by the virus.25 Similar effects have been seen in animal studies for other viruses, including the coronavirus, which causes SARS.26, 27

Research suggests that prior infection with other coronaviruses, from the agents of the common cold, as well as certain vaccines may have ‘primed’ COVID-19 patients, predisposing them to the development of severe disease once they have been infected with SARS-CoV-2. While severe cases of COVID-19 were reported later from all over the world, this has occurred mainly in the elderly population with pre-morbidities. Thus, the above hypothesis cannot be completey dismissed. Cross-reactivity of antibodies against to SARS-CoV-2 and SARS-CoV spike proteins is common and some preliminary data claim that they seem to be rarely cross-neutralising.28.

Safety Conclusion

Normally, vaccine development is a lengthy and complicated process, often lasting 10-15 years and involving a combination of public and private involvement. Unfortunately, the rapid worldwide competition between pharmaceutical companies to develop a COVID-19 vaccine has bypassed multiple safety controls, rendering the result both dubious and potentially dangerous for the public. Financial interests have taken precedence over the health and safety of the public. Hasty development of vaccines is always risky, and only thorough research employing all the safety precautions will lead to a safe and effective vaccine.

There are other concerns related to the safety of vaccines not discussed here due to space limitations, in particular adjuvants. Adjuvants are used to induce a stronger immune response from vaccines. These chemicals can have a wide range of compositions, including lipids, proteins, nucleic acids, and even inorganic material, such as aluminum salts. What they all have in common is that they hyper stimulate receptors in immune cells and most do this through their cellular toxicity. Animal studies reveal that aluminum adjuvant particles in vaccines deposit in the brain and bones and are neurologically (brain) toxic. Aluminum ingested in the diet has low oral absorption (about 0.3%), is rapidly excreted by the kidneys, is (mostly) excluded from the brain by the blood-brain barrier, and is in a solubilized, ionic (not particulate)Al3+ form. These defenses are adequate for protecting the brain from natural levels of aluminum exposure. These protective mechanisms are unable to protect the brain from injected aluminum adjuvant particles. Aluminum adjuvant particles are too large to be removed by the kidneys and are transmitted across the blood-brain barrier by macrophages.

Regulators (the Center for Biologics Evaluation and Testing of the U.S. Food and Drug Administration are reckless and unethical not to require that vaccine developers check for potentially adverse reactions in animal studies first, and should insist on double-blind, inert placebo controls with human trials that extend at least two to three years, if not longer. The National Institute of Allergy and Infectious Diseases (NIAID), led by Anthony Fauci argue that the risk of delaying vaccine advancement is far greater than the risk of causing illness in healthy volunteers (children remember). Testing vaccines without proper safety precautions or taking the time required to thoroughly analyze the effects of research volunteers could bring untold disastrous consequences on millions of lives well into the future.


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Gain-of-Function Studies and SARS-CoV-2 Virus (COVID-19) Emergence

Gain-of-Function Studies and SARS-CoV-2 Virus (COVID-19) Emergence

Gain-of-Function Studies and SARS-CoV-2 Virus (COVID-19) Emergence

James Odell, OMD, ND, L.Ac.

Editorial – The material published in this editorial is intended to foster scholarly inquiry and 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

Gain-of-function (GOF) research involves experimentation that aims to (and actually does) increase the transmissibility and/or virulence of pathogenic viruses. GOF research typically involves mutations that confer altered functionality of a protein, molecule, or organism such as a virus. Such research (when safely conducted by responsible scientists) allegedly intends to improve the understanding of disease-causing agents, their interaction with human hosts, and/or even their potential to cause pandemics. But concerns about the safety of GOF studies have been voiced by numerous scientists from their very beginning. No matter how anyone justifies it or spins it, GOF studies manipulate pathogenic, deadly viruses to increase their transmissibility or virulence. Within the field of virology, these studies create ‘chimeric viruses’ defined as a new hybrid microorganism.  These are created by joining nucleic acid fragments, from two or more different microorganisms, in which each of at least two of the fragments contains essential genes necessary for replication.  This type of research has proven to be historically unsafe. Serious questions arise as to whether GOF research and the development of chimeric viruses are necessary for understanding viruses considering its potential for deadly contamination (pandemics) and bioterrorism. 

The term “potential pandemic pathogen (PPP)” was coined for such manufactured viruses. The first suspected experimental effort to create a PPP occurred in 2005 with a laboratory re-creation of a strain of influenza, H1N1 from 1918, by Tumpey and colleagues. This was based on synthesizing nucleic acid sequences obtained from partially preserved viral RNA in frozen corpses from 1918, and then creating infectious viruses by reverse genetics. The pandemic influenza virus of 1918–1919 killed an estimated 20 to 50 million people worldwide. The question was raised as to whether it was wise to construct a virus that was historically associated with the worst pandemic in modern history and somewhat different from any virus currently circulating. However, the debate seems to have been internal to the US Department of Health and Human Services (HHS), particularly the National Institutes of Health (NIH), and it was judged that the work should proceed.

In the United States, more GOF study controversy occurred in 2011 when two laboratories published reports of mutational screens of H5N1 avian influenza viruses, identifying variants which proved transmissible through the air between ferrets. The Dutch virologist Ron Fouchier, based at Erasmus Medical Center in Rotterdam, and Yoshihiro Kawaoka at the University of Wisconsin-Madison announced that they had successfully mutated H5N1, a strain of bird flu, to pass through the air between ferrets, in two separate experiments. Ferrets are considered one of the best flu models because their respiratory systems react to the flu much like humans. The mutations that gave the virus its ability to be airborne transmissible were gain-of-function mutations. Of course, the concern then became that if their mutated H5N1 ever left the lab it could cause a pandemic.

Around this time more scientists raised concerns about the potential of a laboratory accident that could lead to the release of a pathogen that, by design, combined high virulence and antigenic novelty with high human-to-human transmissibility. These early critiques also questioned whether the scientific and public health value of such research justified the risks involved. One of the first major discussion meetings on this topic, to my knowledge, was held at the Royal Society of London in 2012 (, with mainly UK and North American speakers.

In 2012 and 2013, contamination and safety concerns continued to be published throughout the media and voiced by the international scientists.1 Then in 2014, as many as 75 scientists at the Center of Disease Control and Prevention were exposed to anthrax. A few weeks later, FDA officials discovered 16 forgotten vials of smallpox in storage. Meanwhile, the largest, most severe, and most complex Ebola outbreak in history was raging across West Africa, and the first patient to be diagnosed in the US had just been announced. On October 16, 2014 following these biosafety mishaps involving anthrax, smallpox, and H5N1 in government laboratories, the White House Office of Science and Technology Policy announced the launch of the U.S. Government in implementing a deliberative process to re-evaluate the potential risks and benefits associated with certain GOF experiments. The then Obama administration paused the release of federal funding for GOF studies anticipated to enhance the pathogenicity or transmissibility of respiratory influenza droplets among mammals and, in particular the COVID viruses – SARS and MERS. Thus, there was a moratorium on GOF between 2014 and 2017on the grounds of safety concerns and views of many top scientists who considered this type of viral research ‘unnecessarily dangerous’ – with potential risks of accidental release of pandemic potential viruses.

Following the funding pause, two major discussion meetings were held by the US National Academy of Sciences, and multiple meetings were held by the NSABB. A few ethicists, and others, debated the scientific and public health rationale for GOF or PPP experiments, the risks they posed, and the ethics of performing research that poses potentially major risks to unaware persons not involved in the studies. This process raised awareness of many issues that had not been previously highlighted, notably the lack of a framework for assessing research risks to persons who are not research participants, the very poor availability of data on biosafety in biological laboratories in the US and elsewhere, and the consequent uncertainty in risk-benefit calculations.

GOF Research in Europe

The debate on the risks and merits of GOF research has not been limited to the United States, as the Dutch Court of Appeals recently handed down a verdict concerning Erasmus University Medical Centers (EMC) objection to export license rules regarding the publication of highly pathogenic avian influenza virus GOF research. Export licenses are in place in the European Union to prevent the proliferation of weapons of mass destruction and apply to specific biological agents, chemical agents, and technologies. In 2012, the Dutch government ruled that EMC had to apply for an export license to publish their GOF work, which they had done in order to expedite publication. However, EMC later filed an objection, maintaining that GOF research in this context was for “basic scientific research.” The Dutch Court of Appeals ruled that EMC had no legal standing to contest the export license regulations, but did not address the legality of the export license itself, leaving the issue open for further debate. Currently, all GOF research within the European Union requires an export license for publication.

Laboratory Mishaps

GOF laboratory contamination mishaps have historically occurred on more than one occasion. In 1975 smallpox, the deadly infectious disease that killed about 30 percent of those who contracted it, finally became eradicated from the world. Around 300 million-plus people died of smallpox in the century before it was annihilated. In 1978, smallpox suddenly appeared again in Birmingham, England when Janet Parker, a photographer at Birmingham Medical School developed a horrifying rash. 2 The doctors initially mistakenly diagnosed it as chickenpox. Parker’s condition worsened and she was admitted to the hospital, where testing determined she had smallpox. Unfortunately, she died of the disease a few weeks later. People then questioned how she acquired smallpox that was supposed to have been eradicated. It turned out that the building Parker worked in also contained a research laboratory, one of a handful in the world where smallpox was still studied. Some papers reported the lab was badly mismanaged 3, with important safety precautions being ignored. Interestingly, the doctor who ran the lab died by alleged suicide shortly after Parker was diagnosed. So somehow, smallpox escaped the lab to infect this individual elsewhere in the building. Through sheer luck and a rapid response from health authorities, including quarantine of more than 300 people, the deadly error did not turn into an outright pandemic.

As previously mentioned, in 2014 the FDA did a cleanup for a planned move to a new office. They found hundreds of unclaimed vials of virus samples in a cardboard box in the corner of a cold storage room.4 Six of them, it turned out, were vials of smallpox. No one had been keeping track of them and no one apparently even knew they were there. They may have been there since the 1960s. The surprised and panicked scientists put the materials in a box, sealed it with clear packaging tape, and carried it to a supervisor’s office. This of course is not approved handling of dangerous biological materials. It was later found that the integrity of one vial was compromised, luckily, not one containing a ‘deadly’ virus. Additionally, there is also strong circumstantial evidence that the reintroduction of H1N1 into human circulation in 1977 after its disappearance in 1950 began with the accidental release of a laboratory strain.5, 6

Lab mishaps continue to occur and with GOF studies creating more virulent and pathogenic organisms, it becomes only a matter of time before dangerous organisms escape into the world or are used in bioterrorism. Highly transmissible, highly virulent GOF viruses like the modified H5N1 strains that have been created have the ability to infect millions and potentially kill a large fraction of those afflicted.

Current GOF Risks and Policy

GOF risks fall into two general categories which are separate but related: namely, biosecurity and biosafety. Biosecurity risk is the likelihood that someone would use the products or information obtained regarding a more pathogenic virus from GOF experiments that led to a more pathogenic virus that caused intentional damage in the form of bioterrorism. Biosafety risk is the likelihood of accidental escape that could trigger an outbreak and epidemic.

Here is a more in-depth review of the risk of GOF studies:

• Biosafety—i.e. health dangers associated with laboratory accidents

• Biosecurity—i.e., health dangers associated with crime and terrorism if pathogens are not physically secure and/or if malevolent actors gain access to them.

• Proliferation—i.e., dangers that might grow proportionally with an increased rate of GOF, potentially in different settings with varying biosafety standards.

• Information risk—i.e., if published studies facilitate malevolent action (e.g., by terrorists) or, possibly, breach of intellectual property.

• Agricultural—i.e., risks to agriculturally-relevant animals if enhanced pathogens arising from GOF are accidentally or intentionally released into animal populations, and possible implications for human health.

• Economic risks—i.e., financial implications of (accidental or intentional) pathogen release with resulting stock market collapse, business bankruptcies, job losses with increasing unemployment, starvation increases, suicides, and overall health-care downfall.

• Loss of public confidence—i.e., compromise of trust (in the scientific enterprise) that could result from (accidental or intentional) pathogen release.

Resuming Gain-of Function Studies

On Dec 19, 2017, the US National Institutes of Health (NIH) announced that they would resume funding GOF experiments involving influenza, Middle East respiratory syndrome coronavirus, and severe acute respiratory syndrome coronavirus. This ended the safety moratorium.

In review, during the GOF moratorium, a panel called the National Science Advisory Board for Biosecurity spent months designing a new process for determining the risks and benefits of GOF studies that could make pathogens more likely to spread and cause serious disease in humans. That led to a December 2017 HHS review framework for research on what the government now calls enhanced potential pandemic pathogens (enhanced PPPs). The policy stipulates that after a proposed enhanced PPP experiment passes NIH scientific peer review, an HHS panel of federal officials with wide-ranging expertise weighs the risks and benefits. If the committee approves, it can then receive NIH funding.

Then in February 2019, the magazine Science reported that the HHS review panel had approved two H5N1 projects in labs in Wisconsin and the Netherlands.7 These approvals and funding were for the same labs (Kawaoka and Fouchier labs) that created the controversy in 2011. Remembering that in 2011, Fouchier and Kawaoka alarmed the world by revealing they had separately modified the deadly avian H5N1 influenza virus so that it spread between ferrets.8 The news greatly disturbed opponents of such research, and they criticized federal officials for not disclosing the approvals in an op-ed in The Washington Post.9 HHS and NIH soon publicized the two approved projects, but did not release the risk reviews.

Today, much of this GOF research has little to zero transparency, particularly what is funded by the NIH and conducted in China at the Wuhan Institute of Virology. This P4 lab in Wuhan (P4 is an exceedingly high biosafety level designation) is not only the first of its kind in China, but also the first in Asia. When it opened in 2017, U.S. scientists expressed concerns that, considering China’s opaque administrative structure, if one of those killer viruses “escaped” from the lab, it could cause a doomsday disaster.

Wuhan Institute of Virology, a biosafety level 4 laboratory located in Jiangxia District, Wuhan that has engaged in gain-of-function research.

Hector Retamal/AFP/Getty Images

Dr. Marc Lipsitch is Professor of Epidemiology and Director of the Center for Communicable Disease Dynamics at the Harvard School of Public Health. He is an author of more than 100 peer-reviewed publications on antimicrobial resistance, mathematical modeling of infectious disease transmission, bacterial and human population genetics, and immunity to Streptococcus pneumoniae. Dr. Lipsitch was quoted,7 “I still do not believe a compelling argument has been made for why these studies (GOF) are necessary from a public health point-of-view; all we have heard is that there are certain narrow scientific questions that you can ask only with dangerous experiments”, he said. “I would hope that when each HHS review is performed someone will make the case that strains are all different, and we can learn a lot about dangerous strains without making them transmissible.” Lipsitch pointed out that every mutation that has been highlighted as important by a gain-of-function experiment has been previously highlighted by completely safe studies. “There is nothing for the purposes of surveillance that we did not already know”, said Dr. Lipsitch. “Enhancing potential pandemic pathogens in this manner is simply not worth the risk.”10

Gain-of-Function – Chimera Virus Research in China

Since the SARS virus of 2003 China launched extensive virology research programs. These occurred through their military labs (People’s Liberation Army) and other labs such as the P4 virology lab in Wuhan located, apparently, just 280 meters away from the Hunan Seafood Market. The P4 lab in Wuhan was initially started as a joint venture with the French government. Chinese authorities switched the management of the project to a firm with close ties to the Chinese military complex. The Lab is a subsidiary of the Wuhan Institute of Virology managed by the China Academy of Sciences. The Chinese government has been working on GOF coronavirus studies for well over a decade. One of the most renowned Chinese virologists of this field is Shi Zhen-Li (surname Shi 石) who is renowned for her extensive research of SARS-like coronaviruses of bat origin. Since the SARS virus outbreak in 2003, Shi Zhengli and her team have conducted research on coronaviruses. In 2005, Shi and colleagues found that bats are a natural reservoir of SARS-like coronaviruses.11 To further determine the mechanism by which a SARS-associated coronavirus (SARS-CoV) may infect humans, Shi led a research team that studied the binding of spike proteins (s-protein) of both natural and chimeric SARS-like coronaviruses to ACE2 receptors in human, civet, and horseshoe bat cells.12, 13 ACE2’s functions include ultimately acting as a vasodilator that influences blood flow. It is located on cells all around the body, but ACE2 receptors also occur in many organs. It is especially common on cells lining air sacs (pneumocytes) in the lungs, which is partly why infection is associated with respiratory symptoms like pneumonia.

From 2010 onwards, Shi and her team have been primarily focused on identifying the capacity for coronavirus transmission across species, specifically putting the emphasis of study on the s-protein, or spike protein, of the coronaviruses. To successfully initiate an infection, viruses need to overcome the cell membrane barrier. Enveloped viruses achieve this by membrane fusion, a process mediated by specialized viral fusion proteins.

For coronaviruses, this fusion occurs through its spike protein. Each spike protein consists of three components that combine to form a ‘trimer’ structure with two parts or ‘subunits’, S1, and S2. You can think of the spike as a multistage rocket, with S1 being the boosters and S2 as a space shuttle: once attached to the ACE2 receptor, a spike sheds its S1 subunit and the remaining S2 part changes its shape or ‘conformation’ to enable the viral envelope to fuse with the outer membrane and drop the virus’ genetic material inside the cell.

The spike proteins (shown sticking out from the round virus) have high homology with the SARS virus. These are the proteins that make up the “key” that binds with the ACE2 receptors in humans to enter the cell. This contributes to the organ failure we see with infected persons as it drives the virus into the cells of the lungs and other organs such as the heart and kidneys, which also have ACE2 receptors.

Coronavirus​ / CC BY-SA

Thus, for SARS-CoV entry into a host cell, its s-protein needs to be cleaved by cellular proteases at 2 sites, termed S protein priming, so the viral and cellular membranes can fuse.14 In other words, Shi and her research team has been dedicated to finding ways that can better allow bat coronavirus to be transmissible to other animals.

In June of 2010, Shi’s team published a paper that describes research to understand the susceptibility of angiotensin-converting enzyme 2 (ACE2) proteins of different bat species to the s-protein of the SARS virus.15 With their chimeric research, they also modified key amino acid components to mutate the bats’ ACE2 receptor in order to examine compatibility with the SARS s-protein. This paper demonstrated their awareness of the relationship between the s-protein and the ACE2 receptor.

It is now understood that 2019-nCoV can infect the human respiratory epithelial cells through interaction with the human ACE2 receptor. Indeed, the recombinant spike protein can bind with the recombinant ACE2 protein. Shi and her colleagues’ paper also signified that they had discovered the passageway for coronaviruses to infect human bodies.

Angiotensin-converting enzyme 2, a monocarboxylase that degrades angiotensin II to angiotensin 1–7, is also the functional receptor for severe acute respiratory syndrome (SARS) coronavirus (SARS‐CoV) and is highly expressed in the lungs and heart. Patients with SARS also suffered from cardiac disease including arrhythmias, sudden cardiac death, and blood pressure -systolic and diastolic dysfunction.

In 2013, Shi and her team published a paper in the journal Science China Life Sciences in which they isolated and identified numerous bat viruses (bat lyssaviruses, bat paramyxoviruses, bat filoviruses, bat reoviruses, and others).Bats are the only mammals capable of sustained flight and are notorious ‘reservoir hosts’ for some of the world’s most highly pathogenic viruses, including Nipah, Hendra, Ebola, and SARS.16 A reservoir is one or several animal species that are not or not very sensitive to the virus, which will naturally host one or several viruses. The absence of symptoms of the disease is explained by the effectiveness of their immune system, which allows them to fight against too much viral proliferation.

Bats Have Been Linked with Seven Major Epidemics Over the Past Three Decades.

In October 2013 Shi and her team published their findings in the prestigious journal Nature and claimed a breakthrough in coronavirus research.17 They provide evidence that SARS-CoV originated in bats. They concluded, “Our results provide the strongest evidence to date that Chinese horseshoe bats are natural reservoirs of SARS-CoV, and that intermediate hosts may not be necessary for direct human infection by some bat SL-CoVs.” In their research, they isolated three bat viruses, one of which had an s-protein that integrated with human ACE2 receptors. This effectively demonstrated the direct human infection of SARS-like viruses to humans without the need for an intermediate host. Then in 2014, Shi and her team collaborated on additional gain-of-function experiments led by Ralph S. Baric of the University of North Carolina, which showed that two critical mutations that the MERS coronavirus possesses allow it to bind to the human ACE2 receptor.18 In 2015, She and colleagues further showed that SARS had the potential to re-emerge from coronaviruses circulating in bat populations in the wild.19

Then in November 2015, Shi and her team from Key Laboratory of Special Pathogens and Biosafety, Wuhan Institute of Virology together with scientists from the Department of Epidemiology at the University of North Carolina at Chapel Hill, published a paper in the journal Nature Medicine describing their joint gain of function coronaviruses research and new chimeric virus creation. According to Ralph Baric, an infectious-disease researcher at the University of North Carolina at Chapel Hill and co-author of the study, this study began before the US moratorium was enacted. So, the US National Institutes of Health (NIH) allowed it to proceed while it was under review by the agency. Baric claims the NIH eventually concluded that the work was not ‘so risky’ as to fall under the moratorium.20

They revealed the formation of a new synthetic virus or self-replicating chimeric virus. This chimeric virus had SARS virus as the framework with the key s-protein replaced by one they had found in a coronavirus, she mentioned in her 2013 paper. They concluded “we synthetically re-derived an infectious full-length SHC014 recombinant virus and demonstrate robust viral replication both in vitro and in vivo (mice).” In short, they took genes from a bat coronavirus spike-protein and spliced it to a mouse coronavirus genome, then tested this for its ability to infect human airway cells through their ACE-2 receptors. This chimeric recombinant coronavirus was tested in mice with significant deadly infections occurring. According to their paper, “all mouse studies were performed at the University of North Carolina, prior to the 2014 GOF moratorium involving influenza, MERS and SARS viruses.” This new virus demonstrated a powerful ability for cross species infection. The mice infected with this chimeric virus showed severe lung damage with no cure. Shi Zhengli’s team and her US colleagues’ successful recombinant splicing of the SARS virus was strategically important to the development of cross-species transmission. Their study eerily concluded that there was “a significant risk of a SARS coronavirus re-emergence”.

The fact that scientists are deliberately manipulating the genetics of deadly viruses to manufacture chimeric viruses and then test them for their ability to cause human disease should have created an outrage in the scientific community. This event was not even reported in mainstream media. The medium (chimeric coronavirus) from transfected cells was harvested and served as seed stocks for subsequent experiments (to be performed later).

An additional piece of vaccination information emerged from their 2015 study entitled ‘A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence’. They revealed that in order “to evaluate the efficacy of existing vaccines against infection with SHC014-MA15 (chimeric coronavirus), we vaccinated aged mice with double-inactivated whole SARS-CoV (DIV). Previous work showed that DIV could neutralize and protect young mice from challenge with a homologous virus; however, the vaccine failed to protect aged animals in which augmented immune pathology was also observed, indicating the possibility of the animals being harmed because of the vaccination. Here we found that DIV did not provide protection from challenge with SHC014-MA15 with regards to weight loss or viral titer. Consistent with a previous report with other heterologous groups 2b CoVs, serum from DIV-vaccinated, aged mice also failed to neutralize SHC014-MA15. Notably, DIV vaccination resulted in robust immune pathology and eosinophilia). Together, these results confirm that the DIV vaccine would not be protective against infection with SHC014 and could possibly augment disease in the aged vaccinated group.”21 The phenomena that specific viral vaccines can exacerbate an existing viral disease is well documented, particularly with influenza vaccines.22, 23, 24, 25, 26, 27

In summary, the researchers created and examined the disease potential of a synthetic SARS-like virus, SHC014-MA15, which was chimerically created from viruses found in Chinese horseshoe bat populations. Using what they described as “SARS-CoV reverse genetics system”, the researchers said that they generated and characterized a “chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone.” The mice died a grim death and the experiment was hailed a success by the researchers.

Back in Wuhan, Shi and her team then focused their chimeric viral research on primates. At this stage, some scientists took notice and became genuinely concerned, understanding this development was a dangerous move towards simulating the infection in humans. Academic debates on GOF studies one again began worldwide.

Dr. Wain-Hobson of the Pasture Institute in France expressed his disapproval and concern. In an article, he told Nature, “If the virus escaped, nobody could predict the trajectory.” Richard Ebright, a molecular biologist and biodefence expert at Rutgers University in Piscataway, New Jersey agrees and said, “The only impact of this work is the creation, in a lab, of a new, non-natural risk.”28 Both Drs Ebright and Wain-Hobson are long-standing critics of GOF research.

In October of 2014, the Obama Administration wary of the potential threats to public health and GOF research suspended funding to these research projects. Funding cuts and scientific criticism of GOF studies however did not stop Shi Zhengli’s team research. She and her colleagues continued under the cover and funding of the Chinese Government.

The question then is why would anyone be creating a virulent designer coronavirus that can infect humans? For what purpose is this research? Is it for a bioweapon? Is it so that you can create a vaccine and be the recipient of the profits? The standard pro-gain-of-function narrative is that the ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Many scientists disagree. As Dr. Marc Lipsitch pointed out, every mutation that has been highlighted as important by a gain-of-function experiment has been previously brought to light by completely safe studies.

NIH Funding Resumes

On Dec 19, 2017, the NIH announced that they would again resume funding gain-of-function experiments involving influenza, Middle East respiratory syndrome coronavirus, and severe acute respiratory syndrome coronavirus ending the safety moratorium.29 This once again opened the door to NIH funding to GOF studies China. As a safety condition, the federal government then began requiring that any National Institutes of Health grant proposals involving gain-of-function research undergoes a review by an expert panel to evaluate the risk of such work against the potential gains. But the names of the expert-panel members are not publicly available, nor are its reviews of study proposals. “We’re not trying to say the policy is wrong, we’re trying to say the policy is ambiguous,” says Dr. Marc Lipsitch, an epidemiologist at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, and one of the researchers calling for greater transparency around such work.

In 2019, the NIH committed $3.7 million over six years for research on bat coronaviruses in China. The program followed a previous $3.7 million, a 5-year project for collecting and studying bat coronaviruses, which ended in 2019, bringing the total to $7.4 million. One primary concern by many scientists is some of this newest additional 3.7 million was directed to the Wuhan Institute of Virology for coronavirus GOF studies. When the NIH was questioned about the grants they responded, “The grant you are referencing is a multi-site, multi-country project supporting research that aims to understand what factors allow coronaviruses, including close relatives to SARS, to evolve and jump into the human population and cause disease. Specifically, the project includes studying viral diversity in animal (bats) reservoirs, surveying people that live in high-risk communities for evidence of bat-coronavirus infection, and conducting laboratory experiments to analyze and predict which newly-discovered viruses pose the greatest threat to human health.”30 The National Institute of Allergy and Infectious Diseases (NIAID), under Anthony Fauci’s leadership, has financially supported six studies of bats and their connection to coronavirus.

SARS-CoV-2 Origin Debate

Many rumors and debates have persisted as to the origins of the SARS-CoV-2 virus. Most claim it came from bats and jumped into humans, acquiring new genomic features through adaptation during undetected human-to-human transmission. The official narrative from the WHO and the CDC is that the SARS-CoV-2 virus was a natural development or mutation, from a still-unknown animal source. An excerpt from the website states, “The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV-1. All three of these viruses have their origins in bats. The sequences from U.S. patients are similar to the one that China initially posted, suggesting a likely single, recent emergence of this virus from an animal reservoir. Early on, many of the patients at the epicenter of the outbreak in Wuhan, Hubei Province, China had some link to a large seafood and live animal market, suggesting animal-to-person spread. Later, a growing number of patients reportedly did not have exposure to animal markets, indicating person-to-person spread.”

The Chinese government from the beginning has claimed the virus originated in the Hunan Seafood Market in Wuhan in December 2019. This was propagated by mainstream media and at first, was believable because 27 of the first 41 people hospitalized (66 percent) passed through a market located in the heart of Wuhan city. Yet, later it was discovered that there is also genomic evidence and reports of the virus having circulated earlier in November. A molecular dating estimate based on the SARS-CoV-2 genomic sequences indicate an origin in November 2019.31 They also concluded, “ that the human SARS‐CoV‐2 virus, which is responsible for the current outbreak of COVID‐19, did not come directly from pangolins.” Interestingly, bats were not sold in the Hunan Seafood Market. This raises questions about the link between this COVID-19 epidemic and wildlife in the Hunan Seafood Market.

Thus, the Hunan Seafood Market origin scenario is highly unlikely, particularly now that other evidence exists of numerous individuals before December with the virus who had no contact with anyone from the market. Theories about laboratory contamination surfaced immediately in China, primarily because of the proximity of the Hunan Seafood Market from the Wuhan Institute of Virology. Particularly with the ongoing history of chimeric bat coronaviruses being studied and created there.

The Chinese government has strongly pushed back conjecture that the virus was lab leaked or lab manufactured. Wuhan Institute of Virology director Wang Yanyi recently told state broadcaster CGTN that the theory Covid-19 leaked from a lab in Wuhan is “pure fabrication.” Wang adds “her lab was studying three live strains of bat coronaviruses, but none matched Covid-19.”32 An analysis by a team from the Wuhan Institute of Virology, posted to the preprint server bioRxiv, claimed that the genome of this coronavirus (the seventh known to infect humans) is 96% identical to that of a bat coronavirus, suggesting that species is the original source.33

A recent study was published in the Nature Medicine journal34 in which the authors investigated the genetic code of a key part of the coronavirus and compared this to other known coronaviruses. They concluded that “Human-SARS CoV-2 was a natural mutation from one of several possible animal sources, of which still has not been identified.” The figure below from this study demonstrates the genetic code differences between the different animal coronavirus types and the 2002 SARS coronavirus as well. The marked and different colored areas show genetic differences.

The foremost problem with the scientists’ conclusion is the insertion of a 12-nucleotide section in the “Human-SARS CoV-2” coronavirus sequence which is completely missing from every other coronavirus type known. Such a large genetic difference (insertion) does not suddenly happen at random or naturally. This sequence was not even present in the alleged bat coronavirus as the source of this pandemic. Thus, this insertion strongly suggests that this Human-SARS CoV-2 was manufactured in a lab. The researchers claim the functional consequence of this inserted sequence (polybasic cleavage site) is unknown, but that it appears to enhance infection in human cells. They still contend that this virus originating from a laboratory is “improbable” – that means possible.

They stated,

“Polybasic cleavage sites have not been observed in related ‘lineage B’ beta coronaviruses, although other human beta coronaviruses, including HKU1 (lineage A), have those sites, and predicted O-linked glycans. Given the level of genetic variation in the spike, it is likely that SARS-CoV-2-like viruses with partial or full polybasic cleavage sites will be discovered in other species. The functional consequence of the polybasic cleavage site in SARS-CoV-2 is unknown, and it will be important to determine its impact on transmissibility and pathogenesis in animal models. Experiments with SARS-CoV have shown that insertion of a furin cleavage site at the S1–S2 junction enhances cell-cell fusion without affecting viral entry.”35

a, Mutations in contact residues of the SARS-CoV-2 spike protein. The spike protein of SARS-CoV-2 (red bar at the top) was aligned against the most closely related SARS-CoV-like coronaviruses and SARS-CoV itself. Key residues in the spike protein that make contact to the ACE2 receptors are marked with blue boxes in both SARS-CoV-2 and related viruses, including SARS-CoV (Urbani strain).

b, Acquisition of polybasic cleavage site and O-linked glycans. Both the polybasic cleavage site and the three adjacent predicted O-linked glycans are unique to SARS-CoV-2 and were not previously seen in lineage B beta coronaviruses.

Studies show that the s-protein of the new SARS-CoV-2 virus, like 2002 SARS-CoV-1 counterpart binds angiotensin-converting enzyme 2 (ACE-2), but with much higher affinity and faster binding kinetics.36, 37 This finding is particularly interesting, remembering how Shi Zhengli and her team previously investigated ways their chimeric virus could better infect the ACE-2 receptors of human and animal cells.38

Recently, Dr. Luc Montagnier during a TV interview with a French TV channel stated that elements of the HIV-1 retrovirus, which he co-discovered in 1983, can be found in the genome of the new SARS-CoV-2. Along with Françoise Barré-Sinoussi and Harald Zur Hause, Luc Montagnier won the 2008 Nobel Prize for Medicine for the discovery of human immunodeficiency virus (HIV).

Dr. Montagnier said “There has been a manipulation of the virus: at least part of it, not all of it. There is one model, which is the classic virus, which comes mainly from bats, but to which HIV sequences have been added,” he said. “In any case, it’s not natural,” he continued. “It’s the work of professionals, of molecular biologists. Very meticulous work. For what purpose? I don’t know. One hypothesis is that they wanted to create an AIDS vaccine.”

To support his theory, Montagnier cited the study by a group of researchers at the Indian Institute of Technology in New Delhi titled, “Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp 120 and Gag,”

The abstract of the article read, “We are currently witnessing a major epidemic caused by the 2019 novel coronavirus (2019- nCoV). The evolution of 2019-nCoV remains elusive. We found 4 insertions in the spike glycoprotein (S) which are unique to the 2019-nCoV and are not present in other coronaviruses. Importantly, amino acid residues in all the 4 inserts have identity or similarity to those in the HIV-1 gp120 or HIV-1 Gag. Interestingly, despite the inserts being discontinuous on the primary amino acid sequence, 3D-modelling of the 2019-nCoV suggests that they converge to constitute the receptor binding site. The finding of 4 unique inserts in the 2019-nCoV, all of which have identity /similarity to amino acid residues in key structural proteins of HIV-1 is unlikely to be fortuitous in nature. This work provides yet unknown insights on 2019-nCoV and sheds light on the evolution and pathogenicity of this virus with important implications for diagnosis of this virus.”

The study was criticized by authorities and later withdrawn by its authors. Dr. Montagnier also predicted the imminent disappearance of the virus, because its supposedly artificial origin would be weakening it.“One can do anything with nature, but if you make an artificial construction, it is unlikely to survive. Nature loves harmonious things; what is alien, like a virus coming from another virus, for example, is not well tolerated,” he said. For the scientist, the parts of the virus into which HIV was inserted are rapidly mutating, causing it to self-destruct.

In a separate podcast episode with a different outlet, Montagnier further said the virus had escaped in an “industrial accident” from the Wuhan city laboratory when Chinese scientists were attempting to develop a vaccine against HIV. Dr. Montagnier claims have since been strongly attacked by the media and his TV interview censored.

Based on the history trail of bat COVID research, and reports from microbiologists, it suspiciously ‘appears’ that the SARS CoV-2 is not a natural mutation of any known coronavirus strain but in fact, a manmade – chimeric – strain that likely escaped the Wuhan lab. Time will tell the truth.

Biosafety Laboratories on the Rise – Regulations are Questionable

According to a 2011 report by the National Research Council, an arm of the U.S. National Academy of Sciences, hundreds of BSL-3 laboratories may be unknown, because “no federal agency is required to track the number of biocontainment labs.” 39, 40 Globally, BSL-3 labs have recently been built or are under construction in Bangladesh, India, Indonesia, China, Brazil, and Mexico, among others. Yet many countries have few or no regulations, the NRC concluded. The more secure but dangerous BSL-4 labs are also proliferating. A 2011 workshop in Istanbul organized by the NRC was told that there are 24 BSL-4 facilities, including in Germany, Gabon, Sweden, Russia, South Africa, and Canada. The United States has six BSL-4 laboratories.

In 2019 the BSL-4 Army laboratory at Fort Detrick that studies deadly infectious organisms like Ebola, anthrax and smallpox was shut down for a period of time after a CDC inspection, with many projects being temporarily halted. The lab itself reported that the shutdown order was due to ongoing infrastructure issues with wastewater decontamination, and the CDC declined to provide the reason for the shutdown due to national security concerns.41

While excellent biosafety conditions in the laboratories performing GOF studies are certainly important, it is not a panacea for guaranteeing safety. Of the major mishaps at US government labs in recent years, nearly all involved removing the infectious agent from the high-containment lab where it was under study to another, lower-containment lab because it was thought to be inert. High-tech containment cannot prevent the deliberate removal of supposedly safe material from a laboratory, and so human error remains a source of potential missteps, regardless of the quality of the laboratory facilities.

GOF studies have been one of the most hotly debated science policy issues during the 21st century, with the controversy surrounding a series of published experiments with potential implications for biological weapons-making. Such studies include the genetic engineering of a superstrain of the mousepox virus in 200142, the artificial synthesis (via synthetic genomics) of a “live” poliovirus from chemical components in 200243, and the reconstruction (via synthetic genomics) of the 1918 “Spanish Flu” virus in 2005.44 Though all of these studies involved claimed legitimate aims, critics argued that they should not have been conducted and/or published. Some argued that publishing studies like these in full detail provided “recipes” for especially dangerous potential biological weapons agents to would-be bioterrorists. Whether or not COVID-19 is eventually determined to have originated from gain-of-function research, this pandemic should be a stark reminder of the dangers it poses.

Considering the recent COVID-19 pandemic, GOF studies with the potential to enhance the pathogenicity or transmissibility of potential pandemic pathogens have once again raised biosafety and biosecurity fear and apprehension. Of concern in the context of life science research is that GOF advances in biotechnology may enable the development and use of a new generation of biological weapons of mass destruction. GOF studies can add to the evidence base, but it cannot qualitatively change that evidence base. Empirically, the contribution of such studies to applied public health goals has been far more modest than claimed. Vast advances in the most essential questions of influenza virology and in the public health goal of pandemic preparedness can be achieved without undertaking experiments that, if an accident occurs, could start a new pandemic. Until more evidence is shown that GOF studies can be conducted safely, or are even necessary, it would be wise and prudent to enact another moratorium on all GOF funding and studies.


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19. Menachery, Vineet D., Boyd L. Yount Jr, Kari Debbink, Sudhakar Agnihothram, Lisa E. Gralinski, Jessica A. Plante, Rachel L. Graham et al. “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence.” Nature medicine 21, no. 12 (2015): 1508.

20. Menachery, V.D., Yount, B.L Jr, Debbink, K., Agnihothram, S., Gralinski, L.E., Plante, J.A., Graham, R.L., Scobey, T., Ge, X-Y., Donaldson, E.F., Randell, S.H., Lanzavecchia, A., Marasco, W.A., Shi, Z-L., & Baric, R.S. (2015). A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence. Nature Medicine, 21, 1508– 1513. Doi: 10.1038/nm.3985 – Funding for this US/China joint chimeric research was supported by grants from the National Institute of Allergy & Infectious Disease, the National Institute of Aging of the US National Institutes of Health (NIH), the National Natural Science Foundation of China, and by USAID-EPT-PREDICT funding from EcoHealth Alliance.

Researchers and their affiliated institutions:

∙ Vineet D Menachery, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Boyd L Yount Jr, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Kari Debbink, Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, USA.

∙ Lisa E Gralinski, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Jessica A Plante, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Rachel L Graham, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Trevor Scobey, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Xing-Yi Ge, Key Laboratory of Special Pathogens and Biosafety, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, China.

∙ Eric F Donaldson, Department of Epidemiology, University of North Carolina at Chapel Hill, USA.

∙ Scott H Randell, Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, USA.

∙ Antonio Lanzavecchia, Institute for Research in Biomedicine, Bellinzona Institute of Microbiology, Zurich, Switzerland.

∙ Wayne A Marasco, Department of Cancer Immunology and AIDS, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA

∙ Zhengli-Li Shi, Key Laboratory of Special Pathogens and Biosafety, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, China.

∙ Ralph S Baric, Department of Epidemiology, University of North Carolina at Chapel Hill, USA

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Thriving Through Corona: Practical Tips For People And Pets

Thriving Through Corona: Practical Tips For People And Pets

April 28, 2020

Thriving Through Corona: Practical Tips For People And Pets

Marlene Siegel, DVM

Who would have ever imagined a worldwide crisis that would bring the WORLD to a halt!


Not minimizing the gravity of health concerns, there were other “pan epidemics” going on even before this Corona Virus threat. Most people were overworked, stressed all the time, sleep-deprived, deeply in debt with no emergency fund reserves and distracted from focusing on the meaning of “life and happiness”. Too many people were tied to the hamster wheel they were running on, working in jobs that were not fulfilling but paid the bills. Few people had a spiritual understanding of “who they were” or “what their purpose and passion in life” was. Even fewer people were living the life of their dreams.


The worldwide response to this flu epidemic has destroyed the world as we knew it, but is that a totally bad thing? If we only focus on the negative, the fear, doubt, and uncertainty, we drown in the quicksand of low vibration and become stuck there. We can not find answers, problem solve and bring our greatest gifts to light when we are contracted and stuck in a dark place.


Technically, most people have their basic human needs met, adequate food, water, and shelter. “Essential” businesses are open, and many others are finding creative ways to continue operations using a virtual platform.


Meanwhile, millions of people find themselves with a ton of free time, quarantined in their homes. This can be a positive or negative experience depending on how we choose to perceive it (note the operative word here is choose).


There are only 2 emotions that stimulate behavior: Fear and Love


Fear triggers the sympathetic part of the nervous system and releases cortisol, the stress hormone. Also known as the fight/flight response, the purpose of the sympathetic nervous system is to enable survival during life-threatening situations. Interestingly, the body doesn’t know the difference between being chased by a sabertooth tiger and the fear state created by the coronavirus threat. The end result is the same, the parasympathetic system is turned off and all resources are diverted to the sympathetic nervous system to enable the body to survive the “threat”. In this fear state, people feel depressed, stuck, energetically contracted, unable to problem solve and create solutions. People feel like victims with no control over the circumstances.


Love stimulates the parasympathetic nervous system. It creates a high vibration, an expanded energetic state, leading to feeling empowered and creative, resulting in possibilities and solutions.


It is human nature to need motivation. Contrast (experiencing what is NOT wanted) and adversity stimulate the co-creative mind to find solutions to problems the world needs. Every one of us has unique skills and passion, enabling everyone to be a part of the “new world” that will emerge as we transform and grow from where we were to where we are going.


Change is good. We are leaving a world of competition and entering a world where cooperation will be the key to survival. Embrace it, go inwards to connect to your spiritual self, because it is there that our superpowers live. It is time to birth a new vision of the world and our role in it.


Step #1 Take back your power. No one and no circumstance can make you feel any way unless you allow it. Choose to find the blessings in every moment. Even if you can’t “see” the blessing, have trust and faith that what is happening is for the highest and best purpose, you just haven’t seen what that is yet…but you will!


Step #2 Let go…let go of the “stuff” you have been chained to. Now is the time to create the “more” that is REALLY wanted and desired. Letting go is the gift, giving birth to FREEDOM from the shackles. Anything is possible if you think it is!


Step #3 Have a plan and take action. Create action plans for yourself, your family, your business/job and your pets.


You And The Family

The oxygen mask needs to go on you first or you can’t be available to help others. Take care of your health, both mental and physical.


Eat the rainbow, nutritionally healthy organic foods (no processed sugar, processed foods, and toxic drinks). Grow some of your food! Herbs, greens, and vegetables are easy and now is the time to start. There are Grow Towers, Earth boxes and tubes, hydroponics, aquaponics, raised beds, microgreens, regenerative farming, permaculture, planting food-bearing trees in your yard and community gardening.


Water is the second most critical nutrient (air is the first). Today’s tap water has over 65,000 (yes, not a typo) toxic chemicals. Criteria for water should be: highly filtered, structured (small particle size) and contain molecular hydrogen. There are 2 systems I recommend, one does not use electricity ( ) great during power outages, hydrogen water is still produced), it uses a chemical reaction with magnesium (this is great because many people are magnesium deficient). The other system uses electrolysis and does require power. This system also produces hypochlorous acid water, which is 4X stronger than bleach with no side effects. Call me to see which system is best for you.


Air quality is extra important now that people are in their homes more. Check for mold (home kits are available to test) and be aware of toxins (products impregnated with formaldehyde or fire retardants, petroleum-based candles, chemical air fresheners, and non-green household cleaners. I recommend 2 companies that both do a great job cleaning the air. has free consumer information and product ratings. Rule of thumb, if you can’t pronounce the ingredients, don’t use it. Call me to discuss companies and their products. Air Doctor offers a $300 discount when you use this link. has air and water systems.


Gut support is critical to maintaining a healthy immune system. At least 70% of the immune system lives in the gut. Foods like bone broth (easily make at home), kefir or other fermented foods should be consumed daily.

Preserve food. Consider investing in a dehydrator, freeze dryer, vacuum sealing or canning. This allows you to buy food on sale and in bulk and minimize waste. Make sauerkraut, it is inexpensive, easy and a superfood, helping to restore good gut bacteria. A healthy immune system begins in the gut with the right bacteria! Make a goal of having 2 months’ worth of food preserved which is a good idea due to natural disasters too.


Pet and Livestock Needs.

I believe they are fur angels. They model unconditional love and help lighten the heavy burden of this physical dimension. Now is a great time to learn how to keep your fur child healthy and happy. Broke care is when we wait for a health challenge and chase the symptom with a pill for an ill or a diet for disease. Health care is understanding the body’s biology, how the body works and maintaining the body for optimum health. This starts with a species-appropriate diet. Visit my websites for information blogs, articles, and videos. for education on species-appropriate diets and essential nutrients. Have a month’s supply of feed, hay, and medications. Find online resources that can deliver. My site offers grass-fed/grass-fed out raw pet food and essential supplements along with an online grass-fed meat source for humans, all delivered to your door. ( Share your bone broth and kefir or other fermented foods with the fur fam, they need to support their microbiome too!


Telemedicine. On line health care may be an option for some pet and human emergencies. Call ahead and see who is offering that service. offers basic over the phone health coaching sessions. Understand that nothing is better than a hands-on physical exam and accurate diagnosing utilizing proper testing.


Sleep. 6-8 hours a night. There are many online resources to educate and aid in how to get healthy sleep. One of my favorite products is music which has special frequencies to calm and relax the body. Contact me for details.


Exercise. At a minimum, be active for an hour a day. Mix in strength training with aerobic and high intensity plus yoga, qi gong and pilates. Youtube has loads of follow-along video training for free and Planet Fitness is offering free online classes too!


Detoxification. We (and our pets) have 6 organs of elimination. The kidney, colon, lungs, liver, skin, and lymphatics. All are important but the liver and lymphatics do a LOT of work! Herbs, homeopathic, breathing exercises, salt therapy, infrared sauna, dry brushing, rebounding exercises, coffee enemas and more (much of which can be done at home). For specific questions or resources, contact me at


Stimulate the parasympathetic nervous system at minimum twice daily, when waking up and before sleeping. The parasympathetic nervous system controls rest, digest, repair and detoxification. Deep breathing exercises and meditation are easy and readily available. There are many foods and teas to stimulate the parasympathetic nervous system. Magnesium and the amino acid Glycine are wonderful for helping the body relax. Google resources and try a variety of methods.


EMF and other household toxins. I have blogs on how to reduce toxic exposures at Make your own supplies (house cleaners and sanitizers). Great family projects that are fun, empowering and inexpensive.


Clean and organize. Remove the clutter to make room for the new. Go through closets, pantries, the “junk drawer”. Box up the things you have not used in a year and donate them to shelters, ministries or online community platforms. Things of value can be used for trade and barter.


Learning. All the things on the “bucket list” that there was no time to do, now you have the time to do! Books, video programs, youtube, the resources are endless!


Spiritual awakening. This is the deeper inner work that many did not dare to explore. Now is the time to seek the answers to “who am I”, “why am I here in this particular time and place”, “what is my purpose(s)”. Serve. What does the world need that you can provide through your unique gifts and talents? Now is the time to “just do it”


Barter. “Money” is simply a value trade for things you have that others want or what you want to have. Be creative on things you can use as barter, including your skillset. This could be physical services, emotional intelligence or intellectual property.


Conserve. Undoubtedly we as a society have been wasteful of our resources. Time to conserve and repurpose. Limit showers to conserve water. Raise (or lower) the thermostat a few degrees to conserve electricity.

Practice intermittent fasting (it is super healthy for the body) by limiting eating to a 4-6 hour window and missing a meal. Create a compost pile outside (google or YouTube if needed) to feed your garden (the one you started in step one).


Emergency kit. Thermometers, bandages, natural remedies (for colds, cough and headaches). Consider ozone for home use (ozone is the strongest sterilizer in the world) and laser therapies. Contact me for specific recommendations at


Financial emergency kit. Cut out unnecessary spending and get some liquid assets (things easily converted to cash with direct access to it). Have 2 months of emergency money set aside for paying utilities, gas and other unexpected items. Consider re financing home or business and taking out cash equity.


Homeschooling children

It is the children who will take the baton and run with it. There is a Devine blessing here. They will not be doomed to the “rat race” and ties to “things” that are not really important. Connect to your kids and explore all the above steps together. The best learning is the skills that enable optimum survival.


Children take on the beliefs and behaviors their caregivers express. Be mindful of your mindset and behavior.


Limit TV and computer time and dedicate time to hands-on exploring and creating. Arts, crafts, scrapbooking, cooking, gardening, exercising and talking about meaningful things.


Create space and alone time, this is just as important as creating quality together time.


Here is my favorite GEM (genuine encounter moment) that I do whenever possible with family and friends. This can be done before a meal, before a discussion or meeting, or as a bedtime ritual.

Each person starts with one of the phrases below: “What I love (like, appreciate, am grateful for) about you (or the situation or experience) is…’They say 1 or 2 things about each person (using the above starter sentence) AND end with themselves.



“What I love about you is… (naming character traits about that person) how creative, generous, kind…. “What I love about myself is…(naming your character traits)”


Business / Professional Life

For many people, this is going to be brand new. What was may no longer be. Allow yourself the time to feel the emotions, detach from the identity of what was and then create a plan to deal with it and future possibilities. Again, this may not be a bad thing if it makes room for something better.


1. Find your purpose. This is the perfect opportunity to get off the hamster wheel and follow your passion. What do you want? Create from a place where anything is possible. Identify your end goal, then be creative and flexible on how you get there.


2. Identify limiting beliefs and resistance that has been holding you back, then release it!


3. What does the world need that you can provide? Make a plan. Utilize the internet for resources and training. These are interesting times, ones that test the foundations of our morals, beliefs and integrity.



Without a doubt, we as a collective world, have strayed far from our sustainable roots. We have allowed fast, cheap and convenient to lure us into a false state of pleasure and security. We have been massively distracted by social media and mindless entertainment. We have become dangerously disconnected from the present by electronics and social media and we have become dependent on “the market place” for our basic survival needs. In truth, most people have been disconnected and isolated for years, not really knowing their “purpose”.


It is human nature to need motivation. Contrast (experiencing what is NOT wanted) and adversity stimulate the co-creative mind to find solutions to problems the world needs. Every one of us has unique skills and passion, enabling everyone to be a part of the “new world” that will emerge as we transform and grow from where we were to where we are going.


This worldwide crisis is an opportunity for positive change. Choose to be a part of the solution, embracing the fact that it will be far different than the “life” we have come to know. Connect deeply within, to the spiritual truths and core values, to create a world of kindness and compassion while awakening the core values of life itself, honoring mankind and mother earth.


We have 2 feet to move our bodies, but animals have 4 feet to move our soul…


For specific questions and resources, contact me at

Marlene Siegal, DVM. BRMI Veterinary Advisor

Recent Posts

Lianhua Qingwen Capsule (granule) Approved for Treatment of COVID-19

Lianhua Qingwen Capsule (granule) Approved for Treatment of COVID-19

April 22, 2020

Lianhua Qingwen Capsule (granule) Approved for Treatment of COVID-19

Dr. James Odell, ND, OMD, L.Ac.

On April 14, 2020, Yiling Pharmaceutical announced that the traditional Chinese medicine herbal formulation Lianhua Qingwen capsules (granules) were approved by The State Administration for Market Regulation People’s Republic of China to add functional indications to the originally approved indications: “In the conventional treatment of novel coronavirus pneumonia, Lianhua Qingwen can be used for common type of fever, cough, and fatigue, in treatment lasting for 7-10 days.”


During the epidemic in China, Lianhua Qingwen capsules (granules) became the most frequently recommended Chinese herbal patent medicine for treatment of COVID 19. The efficacy of the Lianhua Qingwen capsule (granule) in the treatment of COVID and influenza viruses has been previously confirmed by numerous in vitro, animal and clinical studies (see references). In studies it exerted broad-spectrum antiviral effects on a series of influenza viruses and immune regulatory effects Recently, Runfeng, Li, and his team published a paper entitled “Lianhuaqingwen exerts anti-viral and anti-inflammatory activity against novel coronavirus (SARS-CoV-2).” in the international journal Pharmacology Research. This is the first basic research article demonstrating the effectiveness of this Chinese patent herbal medicine against SARS-Cov-2. In this study, it was found that “Lianhua Qingwen exerted its anti-coronavirus activity by inhibiting virus replication and reducing the cytokine release from host cells, which supported the clinical application of LH in combination with existing therapies to treat COVID-2019.” The authors further concluded, “ These findings indicate that LH protects against the virus attack, making its use a novel strategy for controlling the COVID-19 disease.”


Composition of Formula:


Lianhua-Qingwen capsule (LQC), developed from the two classical traditional Chinese medicine (TCM) formulae Maxing-Shigan-Tang and Yinqiao-San, both which have a long history of clinical application in the treatment of influenza. It has become a popular and commonly used traditional Chinese herbal preparation to treat viral influenza. It especially played an important role in the fight against severe acute respiratory syndrome (SARS) in 2002-2003 in China. LQC is composed of 11 herbs including Fructus Forsythiae (Lianqiao), Flos Lonicerae Japonicae (Jinyinhua), Herba Ephedrae (Mahuang), Semen Armeniacae Amarum (Kuxingren), Radix Isatidis (Banlangen), Rhizoma Dryopteridis Crassirhizomatis (Mianmaguanzhong), Herba Houttuyniae (Yuxingcao), Herba Pogostemonis (Guanghuoxiang), Radix et Rhizoma Rhei (Dahuang), Radix et Rhizoma Rhodiolae Crenulatae (Hongjingtian), and Radix et Rhizoma Glycyrrhizae (Gancao), along with menthol and a traditional Chinese mineral medicine, Gypsum Fibrosum (Shigao).




Unfortunately, this formula must be ordered online. Thus, it may be a month or more wait when ordering this formula online.




Ding, Yuewen, Lijuan Zeng, Runfeng Li, Qiaoyan Chen, Beixian Zhou, Qiaolian Chen, Pui leng Cheng et al. “The Chinese prescription lianhuaqingwen capsule exerts anti-influenza activity through the inhibition of viral propagation and impacts immune function.” BMC complementary and alternative medicine 17, no. 1 (2017): 130.


Duan, Zhong-ping, Zhen-hua Jia, Jian Zhang, Liu Shuang, Chen Yu, Lian-chun Liang, Chang-qing Zhang et al. “Natural herbal medicine Lianhuaqingwen capsule anti-influenza A (H1N1) trial: a randomized, double blind, positive controlled clinical trial.” Chinese medical journal 124, no. 18 (2011): 2925-2933.


Hai, Guo, Yang Jin, Gong Jiening, and Zhang Qinghong. “Effect of Lianhua Qingwen Capsule on Pulmonary Index of Mice with Viral Infection [J].” Henan Traditional Chinese Medicine 3 (2007).


Jia, Weina, Chunhua Wang, Yuefei Wang, Guixiang Pan, Miaomiao Jiang, Zheng Li, and Yan Zhu. “Qualitative and quantitative analysis of the major constituents in Chinese medical preparation Lianhua-Qingwen capsule by UPLC-DAD-QTOF-MS.” The Scientific World Journal 2015 (2015).


Mo, Hongying, Changwen KE, Jingping ZHENG, and Nanshan ZHONG. “Anti-viral Effects of Lianhua Qingwen Capsule Against Influenza A Virus in Vitro [J].” Traditional Chinese Drug Research & Clinical Pharmacology 1 (2007).


Ouyang, Huixiang, Qingyan TANG, Yongzhong CHEN, Yu WEI, and Guoshu LI. “Clinical observation of Lianhua Qingwen Department of Emergency, Capsules in treatment of the influenza A/H1N1 [J].” China Medical Herald 30 (2010).


Runfeng, Li, Hou Yunlong, Huang Jicheng, Pan Weiqi, Ma Qinhai, Shi Yongxia, Li Chufang et al. “Lianhuaqingwen exerts anti-viral and anti-inflammatory activity against novel coronavirus (SARS-CoV-2).” Pharmacological research (2020): 104761.


Wang, Chun-Hua, Yi Zhong, Yan Zhang, Jin-Ping Liu, Yue-Fei Wang, Wei-Na Jia, Guo-Cai Wang, Zheng Li, Yan Zhu, and Xiu-Mei Gao. “A network analysis of the Chinese medicine Lianhua-Qingwen formula to identify its main effective components.” Molecular BioSystems 12, no. 2 (2016): 606-613.


Yang, Libo, J. I. Zhenhui, Xuedong Gao, and G. U. Chunhua. “Phase Ⅱ Clinical Study of Lianhua Qingwen Capsule for Influenza.” Traditional Chinese Drug Research & Clinical Pharmacology 04 (1993).


Yan-xia, LIU Geng-xin ZHANG, and Y. A. N. G. Ji-qing. “The randomized controlled study of Lianhuaqingwen capsule in treating A/H1N1 influenza.” Chinese Journal of Difficult and Complicated Cases 1 (2010): 9.

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