By ROMEO F. QUIJANO, M.D.
Department of Pharmacology and Toxicology
College of Medicine, University of the Philippines Manila
The COVID-19 (SARS-Cov-2) vaccine is fraught with hazards. This should be the obvious, rational conclusion of anyone who cares to objectively study the available scientific and other relevant information about it. There are many factual danger signals that are easily discernible.
During the 2002-2003 SARS-1 outbreak, it took about 20 months before a vaccine was made ready for human testing in clinical trials despite the fact that concerns about safety were still unresolved. This was already way too fast compared to the usual time necessary for pre-clinical trials or animal studies to be satisfactorily completed before any ethical experimentation on human beings or clinical trials can be started. Yet for Covid-19 candidate vaccines, clinical trials were started barely five months after SARS-Cov-2 emerged, bypassing the necessary pre-clinical studies normally required and ignoring the serious safety concerns in the previous attempt to rush a SARS-1 vaccine (which was eventually scrapped).
One major safety concern in developing a vaccine is how to get around the danger that the vaccine might actually “enhance” the pathogenicity of the virus, or make it more aggressive possibly due to antibody-dependent enhancement (ADE), as what happened with previous studies on test vaccines in animals. If that should happen in a major human trial the outcome could be disastrous. (1,2,3,4) This serious adverse effect may not even be detected by a clinical trial especially in highly biased clinical trials laden with conflicts of interest involving vaccine companies. Even when a serious adverse event is detected, this is usually swept under the rug.
For example, initial clinical trial results for the COVID-19 vaccine of Moderna reportedly showed that three of the 15 human experimental subjects in the high dose group suffered serious and medically significant symptoms. Moderna, however, concluded that the vaccine was “generally safe and well tolerated,” which the corporate-dominated media dutifully reported, covering-up the real danger from the vaccine.(5,6,7,8) In a brazen act of unethical behaviour, Moderna even used a volunteer vaccine recipient, Ian Haydon, to appear in many appearances on media promoting Moderna’s experimental COVID-19 vaccine. Moderna encouraged Haydon to appear on TV to deceive the public and its shareholders. Less than 12 hours after vaccination, Haydon suffered muscle aches, vomiting, spiked a 103.2 degree fever and had lost consciousness.(9) The vaccine, pushed by Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, and financed by Bill Gates, used an experimental mRNA technology that supposedly would allow rapid deployment, waiving the usual pre-clinical and animal studies.
The fact that an entirely new RNA vaccine technology which has never been used before in humans is a danger signal that should not be ignored. Several of the US candidates (Moderna, Pfizer/BioNTech, and Arcturus Therapeutics) are using this never-before-approved technology. Exogenous mRNA is inherently immunostimulatory, and this feature of mRNA could be beneficial or detrimental. It may provide adjuvant activity and it may inhibit antigen expression and negatively affect the immune response. The paradoxical effects of innate immune sensing on different formats of mRNA vaccines are incompletely understood. Potential safety concerns include local and systemic inflammation, biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies, and potential toxic effects of non-native nucleotides and delivery system components. A mRNA-based vaccine could also induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Another potential safety issue could derive from the extracellular RNA which has been shown to increase the permeability of tightly packed endothelial cells and may promote blood coagulation and pathological thrombus formation. (10)
Another danger of mRNA vaccines is the use of biotech “carrier systems” involving lipid nanoparticles (LNPs). LNPs “encapsulate the mRNA constructs to protect them from degradation and promote cellular uptake,” and additionally, rev up the immune system. The LNP formulations in the three mRNA Covid-19 vaccines are also “PEGylated,” meaning that the vaccine nanoparticles are
coated with a synthetic, non-biodegradable and increasingly controversial polymer called polyethylene glycol (PEG). LNPs could contribute to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation reactions, antibody reactions or reactions to the PEG from some lipids or PEG otherwise associated with the LNP, as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events. Furthermore, PEG can also provoke severe neuropsychiatric symptoms in offsprings, including mood swings, rage, phobias and paranoia. Investigators who once assumed that the polymer was largely “inert” are now questioning its biocompatibility and warning about PEGylated particles’ promotion of tumor growth and adverse immune responses that include “probably underdiagnosed” life-threatening anaphylaxis. This is a significant concern since a 2016 US study 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. The manufacturers of genetically engineered adenoviral vector COVID-19 vaccines undergoing clinical trials (Johnson & Johnson, Oxford, and CanSino) also use PEG as an inexpensive additive for vaccine storage. If one of the PEGylated mRNA vaccines for Covid-19 gains approval, the increased exposure to PEG will be unprecedented and potentially disastrous. (11,12)
Like the mRNA vaccines, the adenoviral vector COVID-19 vaccines are still experimental and have not been used before in mass vaccination for infectious diseases. Given the history of poor safety record of many vaccines, the risk of unpredictable and potentially disastrous adverse effects is of utmost concern.
For example, among other dangers, the virus-vectored vaccines could undergo recombination with naturally occurring viruses and produce hybrid viruses that could have undesirable properties affecting transmission or virulence. The numerous variables affecting the probability that recombination will take place and the possible outcomes of recombination are practically impossible to quantify accurately given existing tools and knowledge. The risks, however, are real, as exemplified by the emergence of mutant types of viruses, enhanced pathogenicity and unexpected serious adverse events (including death) following haphazard mass vaccination campaigns and previous failed attempts to develop chimeric vaccines using genetic engineering technology.
Genetically engineered vaccines carry significant unpredictability and a number of inherent harmful potential hazards, including unintended and unwanted side effects with regard to the targeted or non-targeted individuals. Potential undesirable immunological effects include unexpected immunopathological reaction, autoimmune reaction, long-term tolerance, persistent infection and latent infections. There is also the potential to transfer or recombine genetic material from genetically engineered viruses or GE virus-vector vaccines to the targeted individual germ line cells. It can also undergo chromosomal integration or insertional mutagenesis, leading to random insertions of vaccine constructs into host cellular genomes, resulting in alterations of gene expression or activation of cellular oncogenes, thus raising the possibility of inducing tumors. Even minor genetic changes in, or differences between, viruses can result in dramatic changes in transmission abilities, host preferences, and virulence. The new, hybrid virus progenies resulting from such events may have completely unpredictable characteristics. Virulence reversion, for example, was documented when a live recombinant vaccinia–rabies glycoprotein virus vaccine prepared for wild raccoons and foxes infected a 28-yr-old pregnant woman. (13) Virulence reversion was also documented when recombination between commercial infectious laryngotracheitis virus (ILTV) vaccines in poultry has resulted in virulent recombinant viruses that caused severe disease and that have emerged as the dominant field strains in important poultry producing regions in Australia. (14)
The risks of recombination was actually raised earlier in a meeting convened by the World Health Organization in 2003, wherein regulators representing the European Union, the US, China, and Canada raised the specific issue on recombination: “Recombination of a live virus-vectored vaccine with a circulating or reactivated latent virus could theoretically generate a more pathogenic strain…The risk of recombination should be studied if possible in a non-clinical model system, but should also be considered in clinical study designs.” This was listed among the “recommendations to WHO and priorities for future work” as one of several “issues of critical importance to be investigated further.” (15) Apparently, however, the WHO, governments and the vaccine industry never took this recommendation seriously. This comes as no surprise, given the history of WHO’s rapid approval and endorsement of several such live virus-vectored vaccines without the necessary and thorough safety studies, made especially concerning during the current mad scramble for a COVID-19 vaccine.
There’s also a concern that some people may already be immune to the adenovirus carrying the coronavirus gene into the body since adenoviruses circulate through the human population making the vaccine ineffective. (16) Data on the initial clinical trial of the adenoviral vector COVID-19 vaccine made by CanSino Biologics of China that was published in the Lancet showed that in the highest of the three doses used in the study, the number of side effects was high — 75% of the people in the highest dose group reported at least one side effect. Side effects included fever — pain at the injection site, headache, fatigue, among others. Ten volunteers (9% of the overall study group) had Grade 3 side effects, defined as “serious and medically significant symptoms,” six (17%) in the highest dose group and two (6%) each in the low and middle dose groups. The study also found that one dose of the vaccine, tested at three different levels, appeared to induce a good immune response in some subjects. But about half of the volunteers — people who already had immunity to the backbone of the vaccine — had a dampened immune response. (17)
The Dengvaxia vaccine fiasco in the Philippines also illustrates the danger of rushing a vaccine and allowing corporate interests driven by market forces to address people’s health needs. As a result, many of the vaccinated suffered or died after a botched mass vaccination program.(18) According to the Chief Pathologist of the Public Attorney’s Office, 153 of those vaccinated with Dengvaxia had died as of February 18, 2020. (19)
Another example of the danger of corporate fast-tracking of vaccine clinical safety trials is the case of the HPV (Human Papilloma Virus) vaccine. Two of the biggest vaccine manufacturers spiked their placebos with a neurotoxic aluminum adjuvant and cut observation periods. Numerous adverse events, including life-threatening injuries, permanent disabilities, hospitalizations and deaths, were later reported after vaccination with bivalent, quadrivalent or nine-valent HPV vaccines. The company scientists routinely dismissed, minimized or concealed those injuries using statistical gimmicks and invalid comparisons designed to diminish their relative significance. Some regulatory agencies were complicit in covering up increased incidence of adverse effects in post-marketing surveillance studies.(20, 21)
Another concern is that vaccines produced with cell cultures are often contaminated with naked nucleic acids, genomic fragments, retroviruses and other foreign materials that carry uncertain but potentially serious hazards. This contamination may be present in the source material, e.g. human blood, human or animal tissues, cell banks, or introduced in the manufacturing process through the use of animal sera. Many candidate COVID-19 vaccines are produced on what is called “immortal” cell lines or cancerous types of cells (e.g. Vero cells derived from the African green monkey) that could spread cancer-promoting material into the human recipient. Manufacturers and authorities assure us that these do not cause tumors per se. However, scientific studies tell us that after these cells have been repeatedly cultured a certain number of times, they can convert to a cancerous state. Immortal cell lines show 100-times greater number of DNA recombination events compared to normal cells. This could result in viral-viral or viral-cellular interactions that can generate new viruses and result to pathological consequences, including autoimmunity and cancer. (22) Even the US FDA recognized this danger. In a paper published in its website, it stated: “In some cases the cell lines that are used might be tumorigenic, that is, they form tumors when injected into rodents. Some of these tumor-forming cell lines may contain cancer-causing viruses that are not actively reproducing. Such viruses are hard to detect using standard methods. These latent, or ‘quiet,’ viruses pose a potential threat, since they might become active under vaccine manufacturing conditions.” (23)
Still another concern, not only in terms of safety issues but also on moral grounds, is the use of aborted fetal cells in vaccine manufacture. Vaccines produced from human fetal cells contain cell debris and contaminating fetal DNA (together with its epigenetic modification) which cannot be fully eliminated during downstream purification. This could cause insertional mutagenesis (potentially causing cancer) and autoimmunity in the vaccinated. At least six of the COVID-19 candidate vaccines (Cansino, AstraZeneca/Oxford, Janssen, ImmunityBio/NantKwest, University of Pittsburgh and Altimmune) use one of two human fetal cell lines: HEK-293, a kidney cell line that comes from a fetus aborted in about 1972; and PER. C6, a proprietary cell line owned by Janssen, developed from retinal cells from an 18-week-old fetus aborted in 1985. (24)
There are many plausible biological mechanisms for potential adverse effects of all the vaccines in the pipeline for COVID-19. The history of vaccination is replete with scientific evidence of adverse effects through enhanced pathogenicity, mutation, recombination, induced immune system dysfunction, and various non-specific effects following vaccination despite regulatory approval and prior clinical trials and other corporate sponsored studies that were claimed to be proof of safety. The inherent danger of injecting microbial protein fragments, contaminants, DNA and other foreign materials into the human body is well documented in the scientific literature. Practically all vaccines contain such hazardous foreign fragments and materials and are unavoidably unsafe. Furthermore, exposure of the vaccinee to other environmental hazards (pesticides, air pollutants, 5G radiation, ionizing radiation, etc.) resulting to synergistic adverse effects not captured by corporate sponsored “safety” studies is also another plausible mechanism that may result in acute or long-term injury, including death.
Safety assessments under the corporate dominated scientific milieu are grossly inadequate and oftentimes erroneous. Pre-clinical studies and clinical trials are done or sponsored by the very corporations who sell the vaccines and they do not adequately address the plausible adverse effects that cannot be detected by the corporate sponsored studies. There are no independent studies that could validate the claims of the vaccine manufacturers. Therefore, there is no reason to believe that the potential benefits from an upcoming COVID-19 vaccine would outweigh the potential adverse effects, despite assurances of safety by the vaccine industry, international institutions, governments and the mainstream medical science groups.
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(12). Lipid Nanoparticles Entails a Biphasic Humoral Response
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