Review of COVID-19 Vaccines & the Risk of Chronic Adverse Events
IntroductionUse of all pharmaceuticals, including vaccines, is associated with acute and long term/chronic risks. The acute risk of immunization against COVID-19 has been studied by others. Data from clinical trials and case reports sent to databases like the VAERs database in the USA have been analyzed to estimate the acute risk of immunization against COVID-19. Unfortunately, there is insufficient data, because immunization started so recently, to estimate the long term/chronic risk of immunization against COVID-19.
Vaccines have been found to cause a host of chronic, late developing, adverse events. Some adverse events including type 1 diabetes may not occur until 3-4 years after a vaccine is administered [1]. In the example of type 1 diabetes, the frequency of cases of vaccine induced type 1 diabetes can surpass the frequency of cases of severe infectious disease the vaccine was designed to prevent.
Given that type 1 diabetes is only one of many immune mediated diseases potentially caused by vaccines, chronic late occurring adverse events are a serious public health issue. Vaccines for COVID-19, like other vaccines, have the potential to induce autoimmune diseases, such as type 1 diabetes, as well as the opposing condition metabolic syndrome. There is an old saying in medicine that “the cure may be worse than the disease.”
The phrase can be applied to vaccines. In the current paper the concern is raised that the COVID-19 specific vaccines have the potential to cause more disease than the epidemic of COVID-19. This paper focuses on a novel potential adverse event mechanism causing prion disease which could be even more common and debilitating than the COVID-19 infection the vaccines were designed to prevent.
COVID-19 vaccines can potentially induce catastrophic novel chronic adverse events because they contain or induce production of spike protein, an alleged bioweapon. Modulations related to the spike protein including mRNA sequence changes, amino acid sequence changes, rout of entry, amount received, coadministration with adjuvants or other excipients, and placing the spike protein in other viruses (adenovirus vaccine vectors) could create chronic disease more severe and or more common than with the natural COVID-19 infection.
There is also risk of shedding of the adenovirus based COVID-19 vaccine and the potential for contamination of animals in the food supply. All of these potential risks, which are elaborated below, suggests that marketing/ regulatory approval of the COVID-19 specific vaccines was premature.
Protein Based Vaccines for COVID-19 Risk of autoimmunity
One method of immunization against COVID-19 involves injection of purified genetically engineered spike protein into the recipient in order to induce an immune response against the virus. There are several long-term risks associated with this approach. The spike protein found in these vaccines may induce autoimmune disease. One author has found amino acid sequences coded by the spike protein to be identical to sequences in human proteins including proteins found in the CNS [2].
The identification of amino acid sequence homology between viral/vaccine antigens with self-proteins helps explain the rise in autoantibodies in patients recovering from COVID-19 infections [3]. Vaccines against group A beta hemolytic streptococcus have failed because historically they induced the same autoimmune disease as the wild type infection. Autoimmunity can also be induced by epitope spreading when a foreign antigen, like the spike protein, is presented by an antigen presenting cell that also has self-molecules attached to its MHC molecules.
Risk of prion disease
COVID-19 vaccines containing spike proteins are concerning because of the potential for the spike proteins to cause prion disease. Tetz and Tetz [4] have reported that the spike protein from the virus that causes COVID-19 has prion regions that are not found in the spike proteins from other coronaviruses.
Theoretically the spike protein can induce the formation of other prion molecules. A separate group [5] showed that the spike protein binding site binds “to a number of aggregation-prone, heparin binding proteins including Aβ, α-synuclein, tau, prion, and TDP 43 RRM. These interactions suggests that the heparin-binding site on the S1 protein might assist the binding of amyloid proteins to the viral surface and thus could initiate aggregation of these proteins and finally leads to neurodegeneration in brain.”
The spike protein in the vaccine can bind angiotensin converting enzyme 2 (ACE2), a zinc containing enzyme [6]. This interaction has the potential to increase intracellular zinc. Zinc ions have been shown to cause the transformation of TDP-43 to its pathologic prion configuration [7]. The folding of TDP-43 and FUS into their pathologic prion confirmations is known to cause ALS, frontotemporal lobar degeneration, Alzheimer’s disease and other neurological degenerative diseases [8].
Many believe the outbreak of COVID-19 is the result of the release of a viral bioweapon. It is more than just possible that the novel spike protein and its nucleic acid sequence are actually complex weapons. This is a concern because all approved COVID-19 vaccines either contain or code for a spike protein. The vaccines generally incorporate small changes in the spike protein amino acid sequence or its mRNA sequence.
It is not known if these changes could induce more chronic disease including prion disease than the wild type spike protein. Because the vaccines were all created before the risk of the spike proteins was known it is doubtful this concern was addressed before development and marketing of the vaccines.
Nanotechnology and the risk of blood brain barrier penetration
Another risk of the protein-based vaccines is they use relatively novel nanotechnology. The small nanoparticles that comprise some of the new purified spike protein COVID-19 vaccines have an increased potential to cross the blood brain barrier. The blood brain barrier excludes particles that are too large. Nanotechnology has been used in the past to successfully get drugs across the blood brain barrier as referenced below.
The concern is the nanotechnology used in the vaccines may increase spike protein penetration into the brain which could then lead to chronic neurological damage. The endothelial cells of the brain express ACE-2 (angiotensin converting enzyme-2), the receptor for the spike protein, leading some to believe that this could allow virus or the spike protein alone to cross the blood brain barrier [9]. ACE-2 is however not the only receptor that can potentially transport spike protein across the blood brain barrier.
Apolipoprotein E (APOE) molecules have also been discussed as possible transport proteins as well. A large British study found the biggest risk factor for fatal COVID-19 infections is preexisting dementia [10]. The same group further identified the gene for APOE4, in the absence of dementia, as a leading risk factor for fatal COVID-19 infections [11]. The APOE4 gene is the gene associated with the greatest risk of developing Alzheimer’s disease.
A separate group [12] using cell cultures found that neuronal cells containing APOE4 on their surface, as compared to other variants such as APOE3, were more likely to be infected with the virus that causes COVID-19. These observations are further supported by earlier experiments using APOE molecules to transport nanoparticles containing drugs across the blood brain barrier [13].
Risk of novel adjuvants
Novel adjuvants found in protein based COVID-19 vaccines, such as Novavax’s vaccine, create another source of risk. Adjuvants are known to cause a plethora of different adverse events. Aluminum for example can cause chronic inflammation [14]. The adjuvant used in Novavax’s COVID-19 vaccine, Matrix-M, has limited human use and thus little is known about its ability to cause chronic adverse events.
It is possible this oil-based adjuvant could increase permeability through the blood brain barrier leading to slowly progressing neurological degenerative disorders. Traditional aluminum-based adjuvants will inactivate prions by making them insoluble until they can be phagocytized, broken down in the phagosomes, and presented on MHC molecules.
By contrast Matrix-M appears to help vaccine particles, such as the spike protein, enter cells where some of the molecules can go on and induce a cellular immune response (15). The Matrix-M adjuvant, by helping the spike protein enter cells, may have an increased risk of inducing prion disease.
RNA Based Vaccines
A previous peer reviewed paper [16] described in detail the risk of the mRNA based COVID-19 vaccines. The paper specifically evaluated Pfizer’s vaccine mRNA sequence but expressed concern with the Moderna’s mRNA vaccine due in part to sequence homology between the vaccines. The mRNA sequence of the Pfizer vaccine was analyzed for its potential to convert intracellular RNA binding proteins, TAR DNA binding protein (TDP-43) and Fused in Sarcoma (FUS), into their pathologic prion conformations.
The results indicate that the vaccine mRNA has specific sequences that may induce TDP-43 and FUS to fold into their pathologic prion confirmations. A simple manual reading of the vaccine mRNA sequence found a total of sixteen UG tandem repeats (ΨGΨG) in addition to UG (ΨG) rich sequences in the vaccine nucleic acid sequence. Two GGΨA sequences were also found. Once the vaccine mRNA is translated into spike protein, the spike protein is associated with many of the risks described above.
The Pfizer and Moderna vaccines contain mRNA with different sequences from each other and from the mRNA sequence of the native spike protein. It is unclear if these mRNA sequence differences or the resulting amino acid sequence differences result in different risk levels for developing prion disease.
Adenovirus Based COVID-19 Vaccines
Adenoviral vector vaccines against COVID-19 have many of the same potential risks as mRNA and protein-based vaccines as well as having unique risks. The adenovirus vector apparatus facilitates mRNA production which is translated to spike protein. The risks of mRNA and spike protein are discussed above. The adenoviral vector vaccines lack adjuvants or other related excipients present in the protein and mRNA vaccines but the adenoviral based COVID-19 vaccines pose unique health risks due to the presence of the adenovirus.
Three approved and widely used adenoviral based COVID-19 vaccines include the Johnson and Johnson vaccine, the AstraZeneca vaccine and the Russian Sputnik V vaccine. These vaccines were created from strains of the adenovirus where the DNA sequence of the spike protein was added to the adenoviral genome and genes needed for replication were removed from the adenoviral genome [17-19]. The vaccines all use different adenovirus vectors. The Russian vaccine, Sputnik V, is comprised of two different adenoviral strains.
The nucleic acid sequences coding for the spike protein are similar in the three vaccines. The unique risks of these adenoviral vector vaccines result in part from their potential to recombine genetically with DNA from other viruses infecting the recipient or human host DNA, and from their potential to mutate. The risks are significant in part because of the large number of vaccine virus particle injected in each recipient, 5-10 billion viral particles per dose and their potential use in billions of people.
The risk of genetic recombination and mutation have been acknowledged by manufacturers [20] but the risk is simply downplayed. This lack of concern is not scientifically founded as evidenced by the fact that adenoviral vectors have been documented to integrate in liver cell DNA in vivo at a rate of 7 x 10 E-5 [21] and adenoviral vectors are actually being used for recombinant based gene-editing [22]!
Several obvious risks of the adenoviral based COVID-19 vaccines are described below and are based on the principals of molecular biology which have been developed following careful scientific observations.
Mutation, recombination and contamination
As with all replicating matter, including the virus causing COVID-19, mutations occur as part of errors in replication. Adenovirus based vaccines are at risk for mutation in part due to the large number of virus particles needed for each dose, 5 to 10 billion virus particles per dose. Adenoviral based COVID-19 vaccines have been depleted of specific genes to keep the adenovirus from replicating.
The genes needed for viral replication have been inserted in designated host cells to allow the adenovirus to replicate during manufacturing of the vaccines. However, on occasions the deficient viral vector genome has undergone recombination with the DNA in the host cell leading to the adenovirus vaccine vector regaining its ability to reproduce in cells other that the designated host cell.
The designated host cells needed for reproduction of the adenoviral vaccine can become infected/contaminated with other viruses including other adenoviruses or non-adenoviruses. The contamination can occur at any time in the lifecycle of the vaccine product and can be limited to a single batch of vaccine from a mishap in production. The vaccine strain of the adenovirus can recombine with the DNA of the contaminating virus leading to creation of pathogenic viruses.
For example, the live polio vaccine was contaminated with an cancer causing monkey virus called SV-40 when the vaccine strain of the live polio vaccine was cultured in green monkey cells during manufacturing. There are reports that the live polio vaccine used in the USA contained the cancer-causing virus until the day the vaccine was pulled from the US market.
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