COVID-19: Impact of Genetic Vaccines on Public Health and Blood Transfusion Safety

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On March 11, 2020, the coronavirus pandemic was officially declared by the Director-General of the World Health Organization (WHO), prompting nations worldwide to adopt public health measures like quarantine, isolation, disinfection, and lockdowns. Amid these measures, the race for a vaccine intensified, with the consensus leaning towards rapid herd immunity as the most effective strategy to curb the pandemic. By 2021, pharmaceutical giants such as Pfizer-BioNTech, Moderna, and AstraZeneca had rolled out genetic vaccines, leveraging the spike protein of the Wuhan strain of SARS-CoV-2 as an antigen to stimulate immunity. This led to an unprecedented global vaccination campaign.

Simultaneously, intensive virological research on SARS-CoV-2 unfolded, revealing its pathogenesis, notably the spike protein’s interaction with the ACE2 receptor, which facilitates viral entry and replication. This interaction was found to induce blood cell aggregation and microthrombi formation, contributing to the virus’s lethal impact.

However, the narrative around genetic vaccines, particularly mRNA vaccines, took a turn as reports surfaced globally of their association with a broad spectrum of health issues, ranging from thrombosis to nervous system disorders. The underlying issue was traced to the genetic material delivered into cells via lipid nanoparticles (LNPs), which led to the production of spike proteins, causing thrombosis among recipients. This phenomenon, termed “spikeopathy,” represents a comprehensive hypothesis encapsulating the vaccine’s adverse effects.

Further complexity was added by the mechanisms through which the vaccine’s genetic material and resultant antigens disseminated throughout the body. LNPs were found to distribute beyond the injection site, preferentially accumulating in organs like the liver and spleen. Additionally, the release of mRNA and spike proteins via extracellular vesicles facilitated their systemic spread, raising concerns about the vaccine’s far-reaching impact.

Despite the WHO declaring the end of the COVID-19 public health emergency on May 5, 2023, the aftermath of global vaccination efforts, particularly post-vaccination syndrome (PVS), remains a pressing issue. The discourse now necessitates a nuanced evaluation of the genetic vaccines’ global utility, balancing their benefits against potential risks.

The safety of blood products, especially in the context of transfusions, has been under scrutiny since the pandemic’s onset. Initially, the lack of comprehensive data on SARS-CoV-2 led to speculative discussions on the risks associated with genetic vaccines in blood transfusion. Over time, evidence emerged of persistent genetic material and proteins from the vaccines in recipients’ blood, leading to widespread reporting of vaccine-induced adverse events.

Specific studies, such as those by Roubinian et al., attempted to demystify the impact of COVID-19 vaccination on blood component transfusions, suggesting no significant adverse outcomes. However, these studies often focused on specific blood components and lacked long-term follow-up, leaving the broader implications on blood safety and transfusion practices uncertain.

This scenario underscores the need for a reevaluation of blood product usage from genetic vaccine recipients. The categorization of genetic vaccines as biomedicine, rather than traditional vaccines, due to their operational mechanism, has led to mass vaccination on a scale unprecedented in biomedicine history. This mass vaccination raises concerns about the potential impact on blood transfusion safety, given the extensive population exposure.

This article aims to shed light on the intricate relationship between genetic vaccines and public health, particularly in the context of blood transfusion safety, urging a reassessment of practices and policies in light of the evolving evidence on the vaccines’ systemic effects.

Overview of Cases of Blood Abnormalities after Genetic Vaccination

After the global rollout of genetic vaccines, including mRNA-based ones, a surge in various blood-related disorders has been reported. Thrombosis, thrombocytopenia, deep vein thrombosis, and other serious health injuries have been frequently documented. A search in PubMed using terms related to these conditions alongside “COVID-19 vaccine” and “side effects” reveals hundreds of articles published within just two years, pointing to a concerning trend.

Microscopic examinations of blood samples from mRNA-vaccinated individuals have revealed abnormally shaped red blood cells and unidentified amorphous material, hinting at significant blood abnormalities. The spike protein, utilized as an antigen in these vaccines, has been identified as amyloidogenic, neurotoxic, and capable of breaching the blood–brain barrier, establishing its potential toxicity.

Beyond thrombosis, concerns have arisen about the phenomenon of original antigenic sin or immune imprinting, where recipients of multiple vaccine doses develop a skewed immune response towards the spike protein antigen, potentially increasing susceptibility to COVID-19. Concurrently, the risk of antibody-dependent enhancement, where vaccine-induced antibodies facilitate viral infection rather than prevent it, has been highlighted.

Moreover, repeated genetic vaccination might lead to immune tolerance through a shift to non-inflammatory IgG4 antibodies, which could dampen excessive immune responses like cytokine storms. Emerging reports of IgG4-related diseases underscore the potential for genetic vaccines to induce long-term immune system alterations, elevating the risk of severe outcomes from infections that would normally be harmless.

Given these findings, there is a heightened need for caution in handling blood products from genetic vaccine recipients, particularly in contexts like blood transfusion, solid organ transplantation, and surgical procedures. The risk of transmitting blood-borne infections through these medical practices necessitates more stringent scrutiny and handling protocols.

The potential for immune imprinting extends beyond COVID-19 vaccines to other antigens, such as those in influenza vaccines. The intrinsic mechanism of genetic vaccines, which provoke in-body antigen production, likely extends antigen exposure duration, thus increasing the risk of immune imprinting compared to traditional vaccines.

The longevity of vaccine components in the body remains uncertain, with detections of spike protein months post-vaccination suggesting prolonged presence. This prolonged exposure might perpetuate immune dysfunction in vaccine recipients, as some B cells differentiate into long-lasting memory B cells producing IgG4.

Given the ongoing revelations about these immune responses and the toxicity of spike proteins, there is an urgent need for medical and regulatory bodies to collaboratively investigate and mitigate the risks associated with blood products from genetic vaccine recipients. The potential for secondary harm from transfusing such blood products, although currently undetermined, warrants thorough investigation and proactive management.

Concerns are particularly acute regarding the toxic nature of spike proteins and their potential to induce prion-like diseases, a risk underscored by researchers like Seneff and Perez. The prion-like sequences within the spike proteins of various SARS-CoV-2 strains, except for the Omicron variant, suggest a need for continued vigilance and research into the long-term effects of genetic vaccines on blood safety and immune system integrity.

Table 1. Major concerns with the use of blood products derived from gene vaccine recipients.

 ConcernsDescriptionReferences
      1Spike protein contaminationThe spike protein, which is the antigen of SARS-CoV-2 and genetic vaccines, has already been found to have various toxicities, including effects on red blood cells and platelet aggregation, amyloid formation, and neurotoxicity. It is essential to recognize that the spike protein itself is toxic to humans. It has also been reported that the spike protein can cross the blood–brain barrier. Therefore, it is essential to remove the spike protein derived from the gene vaccine itself from blood products.    [22,29,55– 60]
    2Contamination with amyloid aggregates and microthrombi formed by spike proteinsIt is not yet clear how the amyloid aggregates and microthrombi formed by the spike proteins develop into visible thrombi. However, once formed, amyloid aggregates may not be readily cleared and therefore need to be removed from blood products. These amyloid aggregates have also been shown to be toxic.    [51,52,98]
        3Events attributable to decreased donor immune system and immune abnormalities due to immune imprinting or class switch to IgG4, etc. resulting from multiple doses of genetic vaccinesWhen the immune function of a donor is impaired by gene vaccination, there is a risk that the donor has some (subclinical) infectious disease or is infected with a pathogenic virus and has developed viremia or other conditions, even if the donor has no subjective symptoms. For this reason, healthcare professionals who perform surgical procedures, including blood sampling and organ transplantation, as well as using blood products, should manage the blood of genetic vaccine recipients with care to prevent infection through blood. It will also be necessary to inform all healthcare professionals of these risks.      [63–65,68– 71,76–80,82– 87]
        4Lipid nanoparticles (LNPs) and pseudouridinated mRNA (mRNA vaccines only)In the case of mRNA vaccines, LNPs and pseudouridinated mRNA may remain in the blood of recipients if blood is collected without a sufficient deferral period after gene vaccination. LNPs are highly inflammatory and have been found to be thrombogenic themselves, posing a risk to transfusion recipients. LNPs itself has potent adjuvant activity and is at risk of inducing Adjuvant-Induced Autoimmune Syndrome (ASIA syndrome). An additional risk is that if the pseudouridinated mRNA is incorporated into the recipient’s blood while still packaged in LNPs, additional spike protein may be produced in the recipient’s body.      [23,40,44,99– 105]
  5Contamination with aggregated red blood cells or plateletsThe spike protein causes red blood cells and platelets to aggregate and therefore these aggregates will be carried into the recipient’s blood unless they are removed from the blood product.  [7–11,49]
  6Memory B cells producing IgG4 and IgG4 produced from themLarge amounts (serum concentration typically above 1.25–1.4 g/L) of non- inflammatory IgG4-positive plasma cells can cause chronic inflammation such as fibroinflammatory disease.[73– 75,106,107]

Specific Proposals for Blood Sampling and Blood Products from Vaccine Recipients

The emergence of blood-related abnormalities following genetic vaccination necessitates a strategic response to ensure the safety of blood collection and transfusion practices. Given the potential for blood contamination to significantly impact healthcare, a proactive and precautionary approach is essential to prevent any adverse outcomes.

Additional Requirements for Blood Collection (Donation)

In Japan, the Japanese Red Cross Society is at the forefront of blood collection activities, with guidelines allowing the collection of blood from genetic vaccine recipients after specified deferral periods. However, the scientific basis for these deferral periods remains unspecified, highlighting a need for a more data-driven approach. Similar to protocols for HIV and prion diseases, a detailed history of genetic vaccination, including the type of vaccine, timing, and dosage, should be meticulously documented during blood collection. Special attention is required for recent vaccine recipients due to potential blood contamination with lipid nanoparticles (LNPs) and spike protein mRNA, which can induce inflammatory responses. The interaction of negatively charged LNPs with fibrinogen, leading to thrombus formation, further underscores the necessity for caution. Additionally, the history of long COVID should also be recorded, considering the possibility of lingering spike proteins in such individuals.

Handling of Existing Blood Products

The genetic vaccination status of blood donors is currently neither confirmed nor managed effectively, posing risks to transfusion recipients. To mitigate these risks, rigorous testing for spike protein or modified mRNA should be mandated, utilizing methodologies like ELISA, immunophenotyping, mass spectrometry, exosome-based liquid biopsy, or PCR. Given the challenges in developing specific anti-spike protein antibodies and controls, mass spectrometry is recommended as a preliminary step for identifying and quantifying spike protein in blood samples. Additionally, analyzing the components of spike protein-induced amyloid aggregates could provide valuable biomarkers. If blood products are found to contain spike protein or modified genes, the current lack of reliable removal methods necessitates the disposal of these products, despite the ethical and logistical challenges this may entail. In situations where immediate disposal is not feasible, the potential for contamination should be clearly communicated to patients through informed consent processes.

The Need for Regular Checkups and Cohort Studies

The long-term residual status of spike protein or modified genetic fragments in the body is still unknown, necessitating their inclusion in routine health screenings and medical checkups. Comprehensive testing should be extended to all individuals, irrespective of their vaccination status, to obtain a holistic view of spike protein prevalence and its health implications. The transmission of spike protein through exosomes in vaccinated individuals further justifies the need for extensive testing and cohort studies to ascertain the full extent of blood contamination risks. These studies are crucial for developing diagnostic criteria for COVID-19 post-vaccination syndrome (PVS) and for understanding the long-term effects of genetic vaccination, including in individuals with long COVID.

The Need for Early Development of Clinical Practice Guidelines and Diagnostic Criteria for COVID-19 PVS

The varied manifestations of COVID-19 PVS, particularly those related to hematologic and immune system disorders, underscore the importance of establishing robust diagnostic and clinical guidelines. Prompt development of accurate testing methods, especially blood tests, is essential for diagnosing and treating PVS effectively. Collaborative international efforts and meta-analyses of existing data will be vital in creating unbiased diagnostic criteria and clinical practice guidelines that can address the complexities of COVID-19 PVS.

Figure . Summary of items and procedures required for management of blood products derived from gene vaccine recipients or contaminated with spike protein and modified genes. As with any risk management exercise, it is important to constantly revise policies and procedures as risks and problems are identified. PVS, post-vaccination syndrome.

 ConcernsDescriptionReferences
  1  Spike protein content in bloodImmunochemical techniques include enzyme-linked immunosorbent assay, immunophenotyping, mass spectrometry, liquid biopsy, and a combination of liquid biopsy and proteomics. First, we propose mass spectrometry that can directly measure the protein itself.  [28,29,122– 126]
2Spike protein mRNAPCR and/or liquid biopsy are the options. If mRNA for the spike protein is detected, LNPs may be present (mRNA vaccines only).[124,127,128 ]
  3  Spike protein DNAPCR and liquid biopsy are the options. This test is necessary because AstraZeneca’s viral vector is a DNA vaccine. For mRNA vaccines, it is believed that pseudouridinated mRNA is not reverse transcribed, but this test is required if the spike protein remains for a prolonged period.  [124,128]
    4  Markers associated with autoimmune disordersLong-term persistence of the spike protein in the blood increases the risk of autoimmune disease. Therefore, it would be useful to test for autoimmune disease using antinuclear antibodies as biomarkers in people who are positive for the spike protein, taking into account the results of interviews regarding the subjective symptoms.  [27,105,129,1 30]
      5      InterviewA history of genetic vaccination and COVID-19, current and previous medical history, and subjective symptoms (e.g. headache, chest pain, shortness of breath, malaise) should be obtained from blood donors and formally recorded. The types of questions included in the interview are critical to facilitate diagnosis and treatment of COVID-19 PVS, as more people are complaining of psychiatric and neurological symptoms after genetic vaccination.      [15,131,132]
  6Proteins resulting from frameshifting of pseudouridinated mRNAAlthough it is not yet clear whether proteins other than the spike protein are translated from pseudouridinated mRNAs, mass spectrometry may be useful in confirming this.  [133]
    7    Components of amyloid aggregates and thrombiCommon markers of thrombosis, such as D-dimer, are used first. Once the major components of amyloid aggregates and thrombi have been identified, their use as biomarkers is proposed. Understanding the composition of amyloid aggregates will be important in the future, as amyloid aggregates have been reported to be toxic. Understanding the composition of amyloid aggregates may provide clues to how amyloid is broken down.    [51,52,98,134 ]
  8Components of SARS-CoV-2 other than the spike protein geneThis test will help determine whether the spike protein is from the genetic vaccine or from SARS-CoV-2. Potential candidates include nucleocapsid.  [4,5,41,128]
  9  Immunoglobulin subclassesIt may be necessary to analyze immunoglobulin subclasses (the amount of IgG4) if immunosuppression from multiple doses of the genetic vaccine is a concern.  [68–71]
  10  Anti-nucleocapsid antibodiesThe presence or absence and amount of anti-nucleocapsid antibodies as well as antibody isotypes may be an indicator(s) in distinguishing whether genetic vaccination or long COVID is the cause.  [135–137]
  11  OtherMyocarditis and pericarditis after genetic vaccination have been reported in various countries. Therefore, those with subjective symptoms may also be tested for myocarditis marker, such as cardiac troponin T.[18,19,29,138 –140]
Table : Tests needed to confirm the safety of blood products.

Conclusion: Assessing the Impacts of Genetic Vaccination

The use of genetic vaccines, such as those employing pseudouridinated mRNAs and mRNA-LNP platforms, presents ongoing risks, as detailed throughout this review. The scope of these concerns extends beyond blood products to encompass all forms of organ transplants, including bone marrow transplants. The full extent of the damage caused by genetic vaccines to blood products remains largely unexplored, necessitating an urgent reassessment of the continued deployment of these vaccines.

Given the severity of health injuries attributed to genetic vaccination, a moratorium on the vaccination campaign utilizing these genetic vaccines is advocated. This pause is crucial to facilitate a comprehensive harm–benefit analysis, echoing the sentiments of researchers like Fraiman et al. and Polykretis et al. The call for such an assessment underscores the pressing need to address and mitigate the risks associated with genetic vaccines.

This review, driven by the collective effort of researchers J.U., M.F., A.F., H.M., Y.M., and Y.H., aims to highlight the serious implications of genetic vaccination and urge a collaborative international response to evaluate and manage the potential risks. Supported by contributions from the Japanese Society for Vaccine-related Complications and the Volunteer Medical Association, this work represents a significant step towards understanding and addressing the complex issues surrounding genetic vaccines and their impact on public health.


REFERENCE LINK : https://www.preprints.org/manuscript/202403.0881/v1

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