{"id":35163,"date":"2024-03-21T09:33:38","date_gmt":"2024-03-21T09:33:38","guid":{"rendered":"https:\/\/evaggelatos.com\/?p=35163"},"modified":"2024-03-21T12:48:14","modified_gmt":"2024-03-21T12:48:14","slug":"%ce%b1%cf%85%cf%84%ce%ad%cf%82-%ce%b5%ce%af%ce%bd%ce%b1%ce%b9-%ce%bf%ce%b9-%cf%83%cf%85%ce%bd%ce%ad%cf%80%ce%b5%ce%b9%ce%b5%cf%82-%ce%b1%ce%bd-%cf%83%ce%b1%cf%82-%ce%ba%ce%ac%ce%bd%ce%bf%cf%85%ce%bd","status":"publish","type":"post","link":"https:\/\/evaggelatos.com\/?p=35163","title":{"rendered":"\u0391\u03c5\u03c4\u03ad\u03c2 \u03b5\u03af\u03bd\u03b1\u03b9 \u03bf\u03b9 \u03c3\u03c5\u03bd\u03ad\u03c0\u03b5\u03b9\u03b5\u03c2 \u03b1\u03bd \u03c3\u03b1\u03c2 \u03ba\u03ac\u03bd\u03bf\u03c5\u03bd \u03bc\u03b5\u03c4\u03ac\u03b3\u03b3\u03b9\u03c3\u03b7 \u03b1\u03c0\u03cc mRNA \u03b5\u03bc\u03b2\u03bf\u03bb\u03b9\u03b1\u03c3\u03bc\u03ad\u03bd\u03bf\u03c5\u03c2!"},"content":{"rendered":"
Review Not peer-reviewed version
\nConcerns regarding Transfusions of Blood Products Derived from Genetic Vaccine Recipients and \u00a0 for Specific Measures<\/strong><\/span>
\nJun Ueda * , Hideyuki Motohashi , Yuriko Hirai , Kenji Yamamoto , Yasufumi Murakami , Masanori Fukushima , Akinori Fujisawa *<\/div>\n
Posted Date: 15 March 2024
\ndoi: 10.20944\/preprints202403.0881.v1<\/div>\n
<\/div>\n
Keywords: COVID-19 vaccine; genetic vaccine; blood product; blood transfusion; spike protein; post-
\nvaccination syndrome; harm\u2013benefit assessment; prion; spikeopathy; inspection standard; diagnostic
\ncriteria<\/div>\n
<\/div>\n
Preprints.org is a free multidiscipline platform providing preprint service that
\nis dedicated to making early versions of research outputs permanently
\navailable and citable. Preprints posted at Preprints.org appear in Web of
\nScience, Crossref, Google Scholar, Scilit, Europe PMC.
\nCopyright: This is an open access article distributed under the Creative Commons
\nAttribution License which permits unrestricted use, distribution, and reproduction in any
\nmedium, provided the original work is properly cited.<\/div>\n
<\/div>\n
Review<\/strong><\/span><\/div>\n
<\/div>\n
Concerns regarding Transfusions of Blood Products
\nDerived from Genetic Vaccine Recipients and
\nProposals for Specific Measures<\/div>\n
<\/div>\n
Jun Ueda 1,*, Hideyuki Motohashi 2, Yuriko Hirai 3, Kenji Yamamoto 4, Yasufumi Murakami 5,
\nMasanori Fukushima 6 and Akinori Fujisawa 7,*<\/div>\n
<\/div>\n
1 Department of Advanced Medical Science, Asahikawa Medical University, Asahikawa 078-8510,
\nHokkaido, Japan; junueda@asahikawa-med.ac.jp
\n2 Pre-Clinical Research Center, Tokyo Medical University Hospital, 6-7-1 Nishi-Shinjuku, Shinjuku-ku,
\nTokyo 160-0023, Tokyo, Japan; moto@tokyo-med.ac.jp
\n3 MCL Corporation, Jimukino-Ueda bldg. 603, 21 Sakaimachi Gojo-Takakurakado, Shimogyo-Ku, Kyoto 600-
\n8191, Kyoto, Japan; hirai@mcl-corp.jp
\n4 Department of Cardiovascular Surgery, Center of Varicose Veins, Okamura Memorial Hospital, 293-1
\nKakita Shimizu-cho, Sunto-gun, Shizuoka 411-0904, Japan; yamamoto@okamura.or.jp
\n5 Department of Biological Science and Technology, Faculty of Advanced Engineering, Tokyo University of
\nScience, 6-3-1 Niijuku, Katsushika-ku, Tokyo 125-8585, Japan; yasufumi@rs.tus.ac.jp
\n6 Foundation of Learning Health Society Institute, Nagoya 450-0003, Aichi, Japan; mfukushima@imrd.jp
\n7 Kokoro Medical Corporation, Honbetsu Cardiovascular Medicine Clinic, Honbetsu 089-3314, Hokkaido,
\nJapan; fujisawa.peace@mac.com
\n* Correspondence: junueda@asahikawa-med.ac.jp (J.U.); fujisawa.peace@mac.com (A.F.);
\nTel.: +81-166-68-2385 (J.U.); +81-156-22-8888 (A.F.)<\/div>\n
<\/div>\n
Abstract:<\/strong> The coronavirus pandemic was declared by the World Health Organization (WHO) in
\n2020, and a global genetic vaccination program has been rapidly implemented as a fundamental
\nsolution. However, many countries around the world have reported that so-called genetic vaccines,
\nsuch as those using modified mRNA encoding the spike protein and lipid nanoparticles as the drug
\ndelivery system, have resulted in post-vaccination thrombosis and subsequent cardiovascular
\ndamage, as well as a wide variety of diseases involving all organs and systems, including the
\nnervous system. In this article, based on these circumstances and the volume of evidence that has
\nrecently come to light, we call the attention of medical professionals to the various risks associated
\nwith blood transfusions using blood products derived from people who have suffered from long
\nCOVID and from genetic vaccine recipients, including those who have received mRNA vaccines,
\nand we make proposals regarding specific tests, testing methods, and regulations to deal with these
\nrisks. We expect that this proposal will serve as a basis for discussion on how to address post-
\nvaccination syndrome and its consequences following these genetic vaccination programs.
\nKeywords: COVID-19 vaccine; genetic vaccine; blood product; blood transfusion; spike protein;
\npost-vaccination syndrome; harm\u2013benefit assessment; prion; spikeopathy; inspection standard;
\ndiagnostic criteria<\/div>\n
<\/div>\n
1. Introduction<\/strong><\/div>\n
<\/div>\n
On March 11, 2020, the coronavirus pandemic was declared by the Director-General of the World
\nHealth Organization (WHO) [1], and countries actively implemented classical public health
\nmeasures, including quarantine, isolation, disinfection, and lockdowns. However, hopes for a vaccine
\ngrew as the general consensus was that rapid herd immunity was the best solution to overcome the
\npandemic. Since 2021, as a means to combat SARS-CoV-2 infection, several global pharmaceutical
\ncompanies including Pfizer-BioNTech, Moderna, and AstraZeneca have developed various genetic
\nvaccines that use the spike protein of the Wuhan strain of SARS-CoV-2 as an antigen, and rapid
\nDisclaimer\/Publisher\u2019s Note: The statements, opinions, and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and\/or the editor(s). MDPI and\/or the editor(s) disclaim responsibility for any injury to people or property resulting
\nfrom any ideas, methods, instructions, or products referred to in the content.<\/div>\n
<\/div>\n
Preprints.org (www.preprints.org) | NOT PEER-REVIEWED | Posted: 15 March 2024 doi:10.20944\/preprints202403.0881.v1 <\/strong>\u00a9 2024 by the author(s). Distributed under a Creative Commons CC BY license.<\/strong><\/div>\n
<\/div>\n
page2
\nvaccination has been promoted on a global scale [2,3]. During this period, virological studies of SARS-
\nCoV-2 have been intensively conducted, and the pathogenic mechanism of this virus has been
\nelucidated in detail [4,5]. In brief, the key pathogenic processes include the binding of the spike
\nprotein of SARS-CoV-2 to the angiotensin-converting enzyme 2 (ACE2) receptor on vascular
\nendothelial cells, allowing viral entry and amplification [6]; the triggering of red blood cell and
\nplatelet aggregation by the spike protein [7\u201311]; and the formation of microthrombi [12,13].
\nHowever, it has been reported from various countries around the world that genetic vaccines
\nsuch as mRNA vaccines encoding spike proteins have also caused a wide variety of diseases in all
\norgans and systems, including the nervous system, in addition to thrombosis and resulting
\ncardiovascular disorders in vaccine recipients [14\u201321]. This is because when the foreign gene was
\nintroduced into autologous cells using gene-transfer capable lipid nanoparticles (LNPs) or other
\nmeans, the spike proteins produced from the mRNA or DNA introduced via the gene vaccine
\ninduced thrombosis in the vaccine recipient. While evidence for specific problems has been reported
\nindividually, Parry et al. have proposed the theory of spikeopathy (spike disease) as a hypothesis
\nthat synthesizes all of the evidence for this problem [22]. Furthermore, there are two general
\nmechanisms by which a modified gene introduced into the body by genetic vaccination and some of
\nthe antigens produced because of the expression of that gene can be transmitted throughout the body.
\nFirst, LNPs encapsulating mRNA can spread through the body via the bloodstream from the injection
\nsite. It has already been shown that LNPs have a tendency to accumulate in specific organs, such as
\nthe liver, spleen, ovaries, testes, and bone marrow [22,23]. The other is the release of
\npseudouridinated mRNA molecules and synthesized spike proteins as extracellular vesicles, or
\nexosomes, from cells that have incorporated LNPs. These exosomes are transported in the circulation
\nthroughout the body to reach various organs [24\u201327]. And it has already been proven that spike
\nproteins produced by cells that have taken up the modified gene travel throughout the body in the
\nbloodstream [28,29]. Thus, it must be emphasized that the transport, distribution, and expression of
\nthe components of the genetic vaccine beyond the administration site to organs and tissues of the
\nwhole body after vaccination involve the risk of inducing various conditions.
\nAlthough the Director-General of the WHO declared the end of the COVID-19 public health
\nemergency on May 5, 2023, post-vaccination syndrome (PVS), caused by genetic vaccines that have
\nbeen promoted worldwide and have been given to billions of people, has become a major global
\nproblem [19,21,27,30] requiring a reasonable harm\u2013benefit assessment of the global use of genetic
\nvaccines [27,31\u201333]. Since the beginning of the coronavirus pandemic and genetic vaccination, there
\nhas been much debate about the safety of blood products and their use in transfusions [34\u201339].
\nHowever, because the pathology of SARS-CoV-2 was not fully understood at the beginning, there
\nwas no specific discussion based on data or analysis of what was a problem and what could be a risk;
\nonly concerns were expressed, and no clear conclusions or policies were drawn. For example, Jacobs
\net al. argued that there was no requirement to collect or share the genetic vaccination status of blood
\ndonors and that hospitals were not required to inform patients about the genetic vaccination status
\nof blood donors [37], because there were no reports of health issues from genetic vaccination in 2021.
\nHowever, this argument was not based on data. Contrary to initial expectations, it was found that
\ngenes and proteins from genetic vaccines persist in the blood of vaccine recipients for prolonged
\nperiods of time [22,28,40\u201344], and a variety of adverse events resulting from genetic vaccines are now
\nbeing reported worldwide. Roubinian et al. reported that transfusions of plasma and platelet blood
\ncomponents collected before and after COVID-19 vaccination were not associated with increased
\nadverse outcomes in transfusion recipients who did not develop COVID-19 [39]. However, they
\nevaluated only plasma and platelet preparations, not red blood cell or whole blood preparations. The
\nlong-term effects remain unclear, as the study only followed up recipients to the point of 30-day
\nreadmission rates.
\nConsidering the current situation and the volume of evidence that has recently come to light,
\nthe purpose of this article is to raise awareness among relevant parties and point toward future
\ndirections by making specific recommendations regarding the use of blood products derived from
\ngenetic vaccine recipients, including those who have received mRNA vaccines. To be more precise,
\ngenetic vaccines are the equivalent of biomedicine (i.e. immune therapeutics) rather than
\nconventional vaccines in terms of their mechanism of action [45,46]. The various genetic vaccines now
\ntreated as vaccines should originally have been treated as biomedicine, but because they were
\nclassified as vaccines, huge numbers of people were inoculated with them [2,3]. As a result, extensive
\nareas of medicine are now beginning to be affected because most of the population in many countries
\nhas been vaccinated [19,21,27,30,47]. This has never happened before in the history of biomedicine,
\nand consequently, it is highly suspected that blood products for transfusion have been affected by
\nthese so-called genetic vaccines. Therefore, this review was prepared to examine the risks of blood
\ntransfusions at the current stage when genetic vaccines are administered in large quantities. The
\nvaccine recipients described in this proposal are limited to genetic vaccine recipients.<\/div>\n
<\/div>\n
2. Overview of Cases of Blood Abnormalities after Genetic Vaccination<\/strong><\/div>\n
<\/div>\n
A wide variety of diseases related to blood and blood vessels, such as thrombosis, have
\ndeveloped after genetic vaccination, including with mRNA vaccines, and many cases of serious
\nhealth injuries have been reported. For example, a PubMed search on diseases such as
\nthrombocytopenia, thrombotic disorders with thrombocytopenia, deep vein thrombosis,
\nthrombocytopenic purpura, cutaneous vasculitis, and sinus thrombosis combined with the essential
\nkeywords \u201cCOVID-19 vaccine\u201d and \u201cside effects\u201d yielded several hundred articles in only about two
\nyears since the rollout of genetic vaccines [14,17,20,21,48]. In addition to abnormally shaped red blood
\ncells, amorphous material has been found floating in the blood of mRNA-vaccinated individuals
\nunder microscopic observation, some of which has shown grossly abnormal findings (Table 1, point
\n5) [7\u201310,49]. Recent studies have also reported that the spike protein has amyloidogenic potential [50\u2013
\n54], is neurotoxic [55\u201357], and can cross the blood\u2013brain barrier [58\u201360]. Thus, there is no longer any
\ndoubt that the spike protein used as an antigen in genetic vaccines is itself toxic [22,61,62].
\nIn addition to thrombosis, individuals who have received multiple doses of a genetic vaccine
\nmay have multiple exposures to the same antigen within a brief period, thereby being imprinted with
\na preferential immune response to that antigen [63,64]. This phenomenon, called original antigenic
\nsin or immune imprinting, has caused COVID-19 vaccine recipients to become more susceptible to
\ncontracting COVID-19 [65].<\/div>\n
In addition, antibody-dependent enhancement of infection is also known;
\nantibodies produced by vaccination may rather promote viral infection and symptoms [66,67]. On
\nthe other hand, it has also been suggested that repeated administration of genetic vaccines may result
\nin immune tolerance because of a class switch to non-inflammatory immunoglobulin G4 (IgG4) [68\u2013
\n71], whereby the immune system of the recipient does not mount an excessive response such as
\ncytokine storm [27,72], and case reports of IgG4-related disease have begun to appear [73\u201375]. This
\nraises concern that alterations in immune function due to immune imprinting and immunoglobulin
\nclass switching to IgG4 may also occur in genetic vaccine recipients. This may increase the risk of
\nserious illness due to opportunistic infections or pathogenic viruses that would not normally be a
\nproblem if the immune system were normal [76\u201382]. For example, cases of suspected viremia have
\nbeen reported [82]. Therefore, from the perspective of traditional containment of infectious diseases,
\ngreater caution is required in the collection of blood from genetic vaccine recipients and the
\nsubsequent handling of blood products, as well as during solid organ transplantation and even
\nsurgical procedures [83\u201387] in order to avoid the risk of accidental blood-borne infection (Table 1,
\npoint 3) [84\u201387]. The phenomenon of immune imprinting can occur even when spike protein is not
\nused as an antigen or when another antigen is used (e.g. inactivated influenza vaccine) [88]. However,
\ncompared to conventional inactivated vaccines, genetic vaccines, which produce an antigen within
\nthe body, are expected to prolong the period of exposure to the same antigen, and as a result, the risk
\nof immune imprinting may be higher than with conventional vaccines. It is not actually known how
\nlong the vaccine components remain in the body after a person has received a genetic vaccine
\n[22,40,43], but it is expected that they will remain in the body for a longer period than originally
\nthought, in part because spike protein has been detected in the bodies of people several months after
\nvaccination (Table 1, point 1) [22,28,41,42]. In addition, since long-term exposure to a specific identical
\nantigen (in this case, spike protein) causes immunoglobulins to become IgG4 [68,70] and some of thepage4
\nB cells that produce them are likely to differentiate into memory B cells that survive in the body for
\na sustained period [70,89], the immune dysfunction of genetic vaccine recipients is expected to be
\nprolonged (Table 1, point 3 & 6). More details on these points are expected to be revealed in the future.
\nIn summary, there is an undeniable risk that patients may experience some problems if they
\nreceive blood products derived from blood collected in, at least, a brief deferral period after genetic
\nvaccination. Although it is unknown at present whether secondary damage is caused by transfusion
\nof blood products derived from genetic vaccine recipients, it is necessary for medical institutions and
\nadministrative organizations to respond and investigate cooperatively, keeping various possibilities
\nin mind, because mechanisms such as the toxicity of the spike protein itself and the effects of LNPs
\nand modified mRNA on the immune response have not been fully elucidated and are still under
\nstudy. It should be emphasized that a significant proportion of the COVID-19 PVS in mRNA vaccine
\nrecipients is due to toxic spike proteins, and the inclusion of structures in the receptor-binding
\ndomain within these proteins that may induce prion disease is particularly alarming, as Seneff et al.
\nand Perez et al. have warned [50,90\u201396]. Furthermore, it has been shown that prion similarity in the
\nreceptor-binding domain exists not only in the spike protein of the Wuhan strain, which is still used
\nas an antigen in genetic vaccines, but also in the spike protein of variants of SARS-CoV-2, such as the
\nDelta strain, with the exception of the Omicron strain [93,97]. Whether we should be uniformly
\nvigilant for the spike protein of the coronavirus or just the spike protein of certain variants, such as
\nthe Wuhan strain, awaits further analysis.<\/div>\n
<\/div>\n
Table 1. Major concerns with the use of blood products derived from gene vaccine recipients.
\nConcerns Description References<\/div>\n
<\/div>\n
1 Spike protein contamination
\nThe spike protein, which is the antigen of SARS-CoV-2 and genetic vaccines,
\nhas already been found to have various toxicities, including effects on red
\nblood cells and platelet aggregation, amyloid formation, and neurotoxicity.
\nIt is essential to recognize that the spike protein itself is toxic to humans. It
\nhas also been reported that the spike protein can cross the blood\u2013brain
\nbarrier. Therefore, it is essential to remove the spike protein derived from
\nthe gene vaccine itself from blood products.
\n[22,29,55\u2013
\n60]
\n2
\nContamination with amyloid
\naggregates and microthrombi
\nformed by spike proteins
\nIt is not yet clear how the amyloid aggregates and microthrombi formed by
\nthe spike proteins develop into visible thrombi. However, once formed,
\namyloid aggregates may not be readily cleared and therefore need to be
\nremoved from blood products. These amyloid aggregates have also been
\nshown to be toxic.
\n[51,52,98]
\n3
\nEvents attributable to
\ndecreased donor immune
\nsystem and immune
\nabnormalities due to immune
\nimprinting or class switch to
\nIgG4, etc. resulting from
\nmultiple doses of genetic
\nvaccines
\nWhen the immune function of a donor is impaired by gene vaccination,
\nthere is a risk that the donor has some (subclinical) infectious disease or is
\ninfected with a pathogenic virus and has developed viremia or other
\nconditions, even if the donor has no subjective symptoms. For this reason,
\nhealthcare professionals who perform surgical procedures, including blood
\nsampling and organ transplantation, as well as using blood products,
\nshould manage the blood of genetic vaccine recipients with care to prevent
\ninfection through blood. It will also be necessary to inform all healthcare
\nprofessionals of these risks. [63\u201365,68\u201371,76\u201380,82\u201387]
\n4
\nLipid nanoparticles (LNPs) and
\npseudouridinated mRNA
\n(mRNA vaccines only)
\nIn the case of mRNA vaccines, LNPs and pseudouridinated mRNA may
\nremain in the blood of recipients if blood is collected without a sufficient
\ndeferral period after gene vaccination. LNPs are highly inflammatory and
\nhave been found to be thrombogenic themselves, posing a risk to
\ntransfusion recipients. LNPs itself has potent adjuvant activity and is at risk
\nof inducing Adjuvant-Induced Autoimmune Syndrome (ASIA syndrome).
\nAn additional risk is that if the pseudouridinated mRNA is incorporated
\ninto the recipient\u2019s blood while still packaged in LNPs, additional spike
\nprotein may be produced in the recipient\u2019s body.
\n[23,40,44,99\u2013
\n105]
\n5
\nContamination with
\naggregated red blood cells or
\nplatelets
\nThe spike protein causes red blood cells and platelets to aggregate and
\ntherefore these aggregates will be carried into the recipient\u2019s blood unless
\nthey are removed from the blood product.
\n[7\u201311,49]
\n6
\nMemory B cells producing IgG4 and IgG4 produced from them
\nLarge amounts (serum concentration typically above 1.25\u20131.4 g\/L) of non-
\ninflammatory IgG4-positive plasma cells can cause chronic inflammation
\nsuch as fibroinflammatory disease. [73\u201375,106,107]<\/div>\n
<\/div>\n
\n
3. Specific Proposals for Blood Sampling and Blood Products from Vaccine Recipients<\/strong><\/div>\n
<\/div>\n
In the previous section, we discussed a variety of blood-related abnormalities that have occurred
\nfollowing genetic vaccination. In this section, we provide specific proposals on how to respond to
\nthese circumstances. Because blood contamination affects so many areas of health care, it is especially
\nimportant to anticipate the worst [95,96,108\u2013110] and to plan and act from the start to ensure that
\nthere are no lapses or omissions.<\/div>\n<\/div>\n
<\/div>\n
3.1. Additional Requirements for Blood Collection (Donation)<\/strong><\/div>\n
<\/div>\n
Currently, in Japan, the Japanese Red Cross Society (https:\/\/www.jrc.or.jp\/english\/) plays a
\ncentral role in blood collection activities, and its blood products are used for blood transfusions and
\nother purposes. The Japanese Red Cross Society has a rule that blood can be collected from genetic
\nvaccine recipients after a deferral period (48 hours for mRNA vaccine recipients and 6 weeks for
\nAstraZeneca DNA vaccine recipients), but the data and rationale for the rule have not been specified.
\nAs with infections such as human immunodeficiency virus (HIV) and prion diseases, a history of
\ngenetic vaccination (DNA and\/or mRNA type), including timing and number of doses, should be
\nobtained by interview, and kept in the official record when blood is collected (Figure 1, Table 2).
\nAdditional caution is needed, particularly if not many days have passed since the genetic vaccine
\nwas administered, because LNPs [23,101\u2013103] and spike protein mRNA, which can induce
\ninflammation, may remain in the blood (Table 1, point 4) [22,40,43,44]. If certain events such as
\nanaphylactic shock occur immediately after genetic vaccination, the effects of LNPs should also be
\nsuspected [100]. It has also been reported that negatively charged LNPs themselves interact with
\nfibrinogen to form thrombi [99]. Therefore, the presence of LNPs may itself be a factor in the need for
\ncaution with transfusion products.
\nOn the other hand, even if a person has not received a genetic vaccine, if they have had long
\nCOVID, it is possible that the spike protein remains in their body, and thus it would be better to keep
\nan official record of whether they have long COVID or not [51,111\u2013113]. As the degradation rates of
\npseudouridinated mRNA and spike protein in the body are unknown at present, blood products
\nderived from genetic vaccine recipients should be used with extreme caution, being conscious of the
\ncases of AIDS, bovine spongiform encephalopathy (BSE), and variant Creutzfeldt-Jakob disease
\n(vCJD) caused by the use of contaminated blood products in the past [110,114\u2013121]<\/div>\n
<\/div>\n
page6<\/div>\n
<\/div>\n
Figure 1. Summary of items and procedures required for management of blood products derived<\/strong>
\nfrom gene vaccine recipients or contaminated with spike protein and modified genes<\/strong>. As with any
\nrisk management exercise, it is important to constantly revise policies and procedures as risks and
\nproblems are identified. PVS, post-vaccination syndrome.<\/div>\n
<\/div>\n
Table 2. Tests needed to confirm the safety of blood products.<\/div>\n
<\/div>\n
Concerns Description References<\/div>\n
<\/div>\n
1 Spike protein content in blood
\nImmunochemical techniques include enzyme-linked immunosorbent assay,
\nimmunophenotyping, mass spectrometry, liquid biopsy, and a combination
\nof liquid biopsy and proteomics. First, we propose mass spectrometry that
\ncan directly measure the protein itself.[28,29,122\u2013126]<\/div>\n
<\/div>\n
2 Spike protein mRNA PCR and\/or liquid biopsy are the options. If mRNA for the spike protein is
\ndetected, LNPs may be present (mRNA vaccines only).[124,127,128]<\/div>\n
<\/div>\n
3 Spike protein DNA<\/div>\n
<\/div>\n
PCR and liquid biopsy are the options. This test is necessary because AstraZeneca\u2019s viral vector is a DNA vaccine. For mRNA vaccines, it is believed that pseudouridinated mRNA is not reverse transcribed, but this
\ntest is required if the spike protein remains for a prolonged period. [124,128]<\/div>\n
<\/div>\n
4 Markers associated with autoimmune disorders<\/div>\n
<\/div>\n
Long-term persistence of the spike protein in the blood increases the risk of
\nautoimmune disease. Therefore, it would be useful to test for autoimmune
\ndisease using antinuclear antibodies as biomarkers in people who are
\npositive for the spike protein, taking into account the results of interviews
\nregarding the subjective symptoms. [27,105,129,130]<\/div>\n
<\/div>\n
5 Interview<\/div>\n
<\/div>\n
\n

A 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]<\/p>\n

page 7<\/p>\n<\/div>\n

<\/div>\n
6Proteins resulting from frameshifting of pseudouridinated mRNA<\/div>\n
<\/div>\n
Although it is not yet clear whether proteins other than the spike protein
\nare translated from pseudouridinated mRNAs, mass spectrometry may be
\nuseful in confirming this.
\n[133]<\/div>\n
<\/div>\n
7 Components of amyloid aggregates and thrombi<\/div>\n
<\/div>\n
Common markers of thrombosis, such as D-dimer, are used first. Once the
\nmajor components of amyloid aggregates and thrombi have been identified,
\ntheir use as biomarkers is proposed. Understanding the composition of
\namyloid aggregates will be important in the future, as amyloid aggregates
\nhave been reported to be toxic. Understanding the composition of amyloid
\naggregates may provide clues to how amyloid is broken down.
\n[51,52,98,134
\n]
\n8
\nComponents of SARS-CoV-2
\nother than the spike protein
\ngene<\/div>\n
<\/div>\n
This test will help determine whether the spike protein is from the genetic
\nvaccine or from SARS-CoV-2. Potential candidates include nucleocapsid. [4,5,41,128]
\n9 Immunoglobulin subclasses<\/div>\n
<\/div>\n
It may be necessary to analyze immunoglobulin subclasses (the amount of
\nIgG4) if immunosuppression from multiple doses of the genetic vaccine is a
\nconcern.[68\u201371]<\/div>\n
<\/div>\n
10 Anti-nucleocapsid antibodies
\nThe presence or absence and amount of anti-nucleocapsid antibodies as well
\nas antibody isotypes may be an indicator(s) in distinguishing whether
\ngenetic vaccination or long COVID is the cause. [135\u2013137]<\/div>\n
<\/div>\n
11 Other<\/div>\n
<\/div>\n
Myocarditis 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\u2013140]<\/div>\n
<\/div>\n
3.2. Handling of Existing Blood Products<\/strong><\/div>\n
<\/div>\n
At present, the genetic vaccination status of blood donors is not confirmed or controlled by
\norganizations including medical institutions, and the use of blood collected from these donors for
\ntransfusions may pose risks to patients. Therefore, when blood products derived from gene vaccine
\nrecipients are used, it is necessary to confirm the presence or absence of spike protein or modified
\nmRNA as in other tests for pathogens (Figure 1, Table 2). These should be quantified by an
\nimmunochemical enzyme-linked immunosorbent assay (ELISA), by immunophenotyping, by direct
\nmass spectrometry of the protein itself, by an exosome-based liquid biopsy as used in cancer
\nscreening, or by PCR [28,29,122\u2013128]. For protein assays, as it may take time to generate a good-
\nquality anti-spike protein antibody or a positive control for a recombinant spike protein to be
\ncompared with, and to sort and distribute them to each laboratory, we suggest that mass
\nspectrometry be used as an initial step to identify and quantify the spike protein itself in blood
\n[28,125]. In parallel with this, an analysis of the components of the spike protein-induced amyloid
\nmaterial will be needed [51,98]. Once the components of amyloid aggregates are identified, they can
\nbe used as biomarkers in the future. Exosome analysis will also be useful as a test as it has already
\nbeen shown that spike proteins and their genes are transported in the circulation around the body by
\nexosomes [24\u201327].<\/div>\n
If the blood product is found to contain the spike protein or a modified gene derived from the
\ngenetic vaccine, it is essential to remove them. However, there is currently no reliable way to do so.
\nAs noted above, the prion-like structure within the spike protein molecule [91,95,96] suggests that
\nthis molecule may be a persistent, sparingly soluble, heat-resistant, and radiation-resistant protein
\n[141,142]. The prion protein can be inactivated by thiocyanate, hydroxide, and hypochlorite [143\u2013
\n145], but it is not yet known whether these can be applied to the spike protein and the resulting
\namyloid materials. Therefore, as there is no way to reliably remove the pathogenic protein or mRNA,
\nwe suggest that all such blood products be discarded until a definitive solution is found. Discarding
\nblood products prepared from blood collected from many dedicated blood donors can be very
\npainful, but it is necessary because the spike protein itself has been shown to induce thrombosis and
\nsimilar diseases. However, some medical facilities may have difficulty disposing of blood products
\nimmediately, in which case it is essential to add the possibility of contamination with spike protein
\nor other foreign substances to the transfusion consent form and to fully explain this to the patient. In
\nany case, to prevent and reduce medical accidents caused by contaminated blood, it is imperative to
\nunderscore the importance of confirming the history and frequency of genetic vaccination at the time
\nof blood collection and this information should be documented as an official record, managed and
\nstored by both medical and governmental organizations (see Figure 1, Table 2)fe.<\/div>\n
<\/div>\n
page 8
\n3.3. The Need for Regular Checkups and Cohort Studies to Gain a Complete Picture of Blood Contamination<\/strong><\/div>\n
<\/div>\n
As the residual status of spike protein or modified gene fragments derived from genetic vaccines
\nis currently unknown, it will be necessary in the future to include measurement of these amounts in
\nroutine health checkups. It is also necessary to include a section in the routine medical checkup
\nquestionnaire to check genetic vaccination status and the number of vaccinations to obtain an overall
\npicture of the residual status of spike proteins in the blood. This is because a variety of conditions
\nfollowing genetic vaccination involve thrombosis and immunological conditions [12,14,16,17,21,22,68,70]. Therefore, abnormalities in blood components related to these events shouldalso be analyzed.<\/div>\n
<\/div>\n
On the other hand, when exosomes collected from vaccine recipients were administered to mice
\nthat had not been vaccinated with the genetic vaccine, the spike protein was transmitted [25].
\nTherefore, it cannot be denied that the spike protein and its modified genes can be transmitted
\nthrough exosomes. For this reason, we suggest that full testing be done initially, regardless of genetic
\nvaccination status, and that a cohort study be conducted to quickly capture the full picture (Figure
\n1). This is a steady, labor-intensive effort that requires collaboration between all parties involved, but
\nsuch analyses may lead to the development of diagnostic criteria and testing for COVID-19 PVS. In
\naddition, as mentioned above, it cannot be ruled out that even those who have not been vaccinated
\nwith the genetic vaccine, but have had long COVID, may have residual spike proteins or fibrin-
\nderived microthrombi in their bodies, so it would be advisable to conduct the same testing and
\nfollow-up as for genetic vaccine recipients [51,52,111\u2013113]. The presence or absence and amount of
\nanti-nucleocapsid antibodies as well as antibody isotypes may be an indicator(s) in distinguishing
\nwhether genetic vaccination or long COVID is the cause (Table 2, point 10) [135\u2013137]. In any case,
\nthese cohort studies are expected to help establish cutoff values for blood levels of spike protein and
\nother substances to determine the safety of blood products. Faksova et al. conducted a large cohort
\nstudy of 99 million people using a multinational Global Vaccine Data Network\u2122 (GVDN \u00ae) and found
\na significantly increased risk of myocarditis, pericarditis, Guillain-Barre syndrome, and cerebral
\nvenous sinus thrombosis in genetic vaccine recipients [140]. This type of study will be increasingly
\nnecessary in the future.<\/div>\n
<\/div>\n
3.4. The Need for Early Development of Clinical Practice Guidelines and Diagnostic Criteria for COVID-19<\/strong>
\nPVS<\/strong>
\nAlthough the spectrum of COVID-19 PVS is diverse, it is characterized by a high prevalence of
\nhematologic and immune-related diseases [21]. Considering this, regardless of the transfusion issues
\ndiscussed in this review, blood tests are likely to be the first step in the diagnosis of COVID-19 PVS.
\nThe ability to rapidly develop highly accurate testing systems, particularly blood tests, in
\ncollaboration with other countries will be critical in treating patients suffering from PVS due to the
\nCOVID-19 vaccine. Additional meta-analysis of data from systematic reviews and cohort analyses
\nwill be needed to prevent bias in diagnostic criteria and to develop appropriate clinical practice
\nguidelines (Figure 1) [146\u2013148].<\/div>\n
<\/div>\n
4. Problems following Blood Transfusion Using Blood Products Prepared from Donated Blood<\/strong>
\nof Genetic Vaccine Recipients and the Need for Traceability of Blood Products for Transfusion<\/strong><\/div>\n
<\/div>\n
With the advent of genetic vaccination, there has been considerable debate about the safety of
\nblood products prepared from donated blood of the vaccine recipients and their use in blood
\ntransfusion [36\u201339]. However, what happens in the body when a genetic vaccine such as an mRNA
\nvaccine is administered in the first place is not well understood at this stage, and as mentioned above,
\nthe results of tests on the vaccine recipient\u2019s blood need to be evaluated. Cases of encephalitis caused
\nby blood from dengue vaccine recipients have been reported as recently as 2023 [149], indicating that
\nthe current system for managing and tracking blood products is not adequate. Unless accurate tests
\nare established, no conclusions can be drawn about the risk or safety of blood transfusions using
\nblood products from gene vaccine recipients. Thorough and continuous investigation is therefore9
\nnecessary. To accomplish this, all potential donors should be registered, traceability of blood
\nproducts should be ensured, and rigorous recipient outcome studies and meta-analysis should be
\nmaintained. Furthermore, as we have repeatedly stated, it is essential to rigorously obtain from
\ndonors a history of vaccination and COVID-19 infection, preserve official records, and store samples
\nof blood products for later detection and verification of substances such as spike proteins and
\nexosomes (Figure 1). Given the wide variety of tests and records, the movement of people around the
\nworld, and the import\/export of blood products, it may be necessary in the future to establish
\ntraceability by introducing blockchain technology into the management of blood products while
\nmaintaining anonymity [150,151].<\/div>\n
<\/div>\n
5. The Need for the Development of Relevant Legislation<\/strong><\/div>\n
<\/div>\n
The issue of blood products derived from genetic vaccine recipients described in this review is
\nexpected to affect a very wide range of areas in countries around the world. In Japan, the \u201cAct on
\nPrevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases\u201d
\n(https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/2830\/en) has been enacted to prevent the
\nspread of infectious diseases through blood products, and the \u201cAct on Organ Transplantation\u201d has
\nbeen enacted to handle organ transplants. The Ministry of Health, Labour and Welfare (MHLW) has
\nissued the \u201cGuidelines for Blood Transfusion Therapy\u201d regarding blood transfusions. These laws and
\nguidelines specify the responsibilities of the public, physicians, and national and local governments
\nand protect their rights. However, as the spike protein used as an antigen or its gene is not an
\norganism, there are likely to be number of difficult issues, such as how to legally define its
\npathogenicity. From this point of view, when the risks of and health injuries caused by blood
\nproducts derived from genetic vaccination recipients have been roughly clarified (Table 2), it will be
\nessential to formulate regulations to reduce and prevent risks and contamination, by developing
\nrelated laws with the participation of the legislative branch, legal experts, medical administration
\npersonnel, healthcare providers, and medical researchers, and by taking measures such as checking
\nvaccination status and dates, and legally regulating the import\/export of blood products (Figure 1).
\nThe wide range of issues makes coordination between agencies and healthcare professionals essential
\nfrom the outset.
\nSecond, it is expected that the situation will already be complicated because, in contrast to
\nprevious drug disasters, genetic vaccination was implemented on a global scale and simultaneously
\nfor a substantial number of people [2,3]. This means, as in the context of the coronavirus pandemic,
\nor even more critically, that there is an urgent necessity for legislation and international treaties
\nexplicitly elucidating bilateral and multilateral agreements concerning the management of blood
\nproducts. These legal frameworks should delineate regulations governing the handling of blood
\nproducts and establish protocols for governmental compensation and response to issues and hazards
\nassociated with these products, including penalties and prohibitions. For example, the International
\nHealth Regulations (IHR) 2005 may be helpful [152,153], but given the WHO\u2019s strong push for genetic
\nvaccination [154], another framework may be needed. In relation to the cohort studies described in
\nSection 3.3 of this article, it will also be necessary for countries to conduct active epidemiological
\nsurveys [155], as was the case with COVID-19, to compile the results of these surveys, and to establish
\nan international organization tasked with monitoring response efforts and assessing damages within
\neach country (Figure 2). It is expected that it will be important to incorporate not only the perspective
\nof infectious diseases but also biosafety and biosecurity [153,156].
\nAs for Japan, Article 15 (2) of the Infectious Disease Act
\n(https:\/\/www.japaneselawtranslation.go.jp\/ja\/laws\/view\/2830\/en#je_ch3at5) stipulates that the
\nJapanese government is responsible for conducting epidemiological studies. Given the significant
\nhealth risks associated with COVID-19 PVS, we urge the Japanese government to prioritize the
\nanalysis and safety verification of blood products derived from gene vaccine recipients. This is
\nimperative given the urgent nature of the situation.<\/div>\n
<\/div>\n

age 10<\/p>\n

Figure 2. An example of a system for managing health injuries among genetic vaccine recipients.
\nGiven the global nature of genetic vaccination and the movement of vaccine recipients and blood
\nproducts between countries, there will be a need for an international surveillance network to
\ncoordinate countries.<\/p>\n

6. Other Important Considerations<\/p>\n

There is an urgent need to develop methods to identify as well as remove spike proteins and
\nmodified genes derived from gene vaccines in blood products. In order to develop a uniform
\ninspection standard, there is an urgent need in Japan for the Japanese Society of Hematology
\n(http:\/\/www.jshem.or.jp\/modules\/en\/index.php?content_id=1), the Japanese Society of Transfusion
\nand Cell Therapy (http:\/\/yuketsu.jstmct.or.jp\/en\/), and their related organizations to develop
\nguidelines on how to handle blood products that contain residual spike proteins or their modified
\ngenes. Also, as noted earlier, gene vaccination has been promoted on a global scale [2,3], which will
\nnecessitate coordination and exchange of information with national administrations and relevant
\ninternational medical societies (Figure 1). International guidelines on the handling of blood products
\nand the establishment of an international investigatory organization will be necessary (Figure 2).
\nHowever, there is an urgent need to share the risks of transfusion of blood products derived from
\ngenetic vaccine recipients among the parties concerned, and prompt investigation and response by
\nall parties concerned is essential. The most important initial action is to make the relevant medical
\npersonnel aware of this situation.<\/p>\n

In the development of various guidelines, it will be helpful to refer to the response of each
\ncountry when the transmission of BSE and vCJD, also through blood transfusion, became a problem
\n(e.g. the Creutzfeldt-Jakob Disease International Surveillance Network in<\/p>\n

page 11<\/p>\n

https:\/\/www.eurocjd.ed.ac.uk\/) [110,114,115,121,157]. For example, in the United Kingdom, when
\nBSE became a social problem and the mode of transmission of prion protein was unknown,
\nleukodepletion of blood products was conducted universally. Whether this was effective in
\npreventing transmission of BSE and vCJD through blood products is controversial [110,120,121,158],
\nbut it was not common at the time to remove white blood cells from all blood products, as is now
\nroutinely done with collected blood. However, because of leukodepletion, the safety of blood
\nproducts has increased [159]. In the case of the spike protein, which causes abnormalities such as
\nagglutination of red blood cells and platelets [8\u201311,49], we do not expect the problem to be eliminated
\nby leukodepletion alone. However, it is worth confirming whether washing of red blood cells can be
\neffective [160,161]. In urgent cases, autotransfusion may be an option [162].<\/p>\n

Recent studies have shown that RNA pseudouridylation can result in frameshifting [133]. It is
\nnot yet clear whether a portion of the pseudouridinated mRNA for the spike protein is translated into
\nanother protein of unknown function in vaccine recipients. If these proteins are also pathogenic,
\nadditional testing for such frameshift proteins may be needed in the future. Even if a frameshift
\nprotein is not toxic, it must be foreign to the body and could cause autoimmune disease. In addition,
\nLNPs themselves are highly inflammatory substances [23,100\u2013102], as described in Section 3.1, but
\nLNPs have been found to have stronger adjuvant activity than the adjuvants used in conventional
\nvaccines [104], and there is also concern about autoimmune diseases resulting from this aspect (Table
\n1, point 4) [105,163]. Thus, although it is not clear what the causative agent of autoimmune disease
\nis, the large number of reported cases of autoimmune disease following genetic vaccination is
\nextremely concerning [15,21,27,30,105,164]. The very mechanism of gene vaccines that causes one\u2019s
\nown cells to produce the antigens of pathogens carries the risk of inducing autoimmune diseases,
\nwhich cannot be completely avoided even if mRNA pseudouridylation technology is used. In this
\ncontext, individuals with a positive blood test for spike protein may need to have interviews and
\nadditional tests for autoimmune disease indicators, such as antinuclear antibodies (Table 2, point 4)
\n[27,105,129,130]. Alternatively, if the amino acid sequence of the protein resulting from the frameshift
\nis predictable, these candidate proteins could be included in the initial mass spectrometry assay
\n(Table 2, point 6). In any case, it is particularly important to develop tests and establish medical care
\nsettings in anticipation of these situations.<\/p>\n

7. Conclusion<\/span><\/strong><\/span><\/p>\n

Finally,<\/span> we<\/span> would<\/span> like<\/span> to<\/span> state<\/span> that<\/span> if<\/span> we<\/span> continue<\/span> to<\/span> use<\/span> genetic<\/span> vaccines<\/span> such<\/span> as<\/span>
pseudouridinated mRNAs and mRNA-LNP platforms [46,103], there will be further risks like those<\/span>
described in this review. It should also be stressed that the issues discussed here are matters that<\/span>
pertain to all organ transplants, including bone marrow transplants, and not just blood products. The<\/span>
impact of these genetic vaccines on blood products and the actual damage caused by them are<\/span>
unknown at present. Therefore, in order to avoid these risks and prevent further expansion of blood<\/span>
contamination and complication of the situation, we strongly request that the vaccination campaign<\/span>
using genetic vaccines be suspended and that a harm\u2013benefit assessment be carried out as early as<\/span>
possible, as called for by Fraiman et al. and Polykretis et al. [27,31\u201333]. As we have repeatedly stated,<\/span>
the health injuries caused by genetic vaccination are already extremely serious, and it is high time<\/span>
that countries and relevant organizations take concrete steps together to identify the risks and to<\/span>
control and resolve them.<\/span><\/p>\n

Author Contributions<\/strong>:<\/span> Conceptualization, J.U. M.F. and A.F.; investigation, J.U. H.M. Y.M. M.F. and A.F.;<\/span>
resources, Y.H.; data curation, J.U. H.M. M.F. and A.F.; writing\u2014original draft preparation, J.U.; writing\u2014<\/span>
review and editing, J.U. H.M. Y.H. K.Y. M.F. and A.F.; visualization, J.U.; supervision, J.U. M.F. and A.F.; project<\/span>
administration, J.U. M.F. and A.F.; funding acquisition, M.F. and A.F. All authors have read and agreed to the<\/span>
published version of the manuscript.<\/span>
Funding:<\/span> <\/strong>The study was supported by donations from members of the Japanese Society for Vaccine-related<\/span>
Complications and the Volunteer Medical Association.<\/span>
Institutional Review Board Statement:<\/span> Not applicable.<\/span>

Acknowledgments:<\/span> We would like to express our deep appreciation to the members of the Volunteer Medical <\/span>Association for their help in the discussions that led to the preparation of this review.<\/span>
Conflicts of Interest:<\/span> The authors declare no conflict of interest in connection with this research.<\/span><\/p>\n

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of the individual author(s) and contributor(s) and not of MDPI and\/or the editor(s). MDPI and\/or the editor(s) <\/span>disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or<\/span>products referred to in the co ntent.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Review Not peer-reviewed version Concerns regarding Transfusions of Blood Products Derived from Genetic Vaccine Recipients and \u00a0 for Specific Measures Jun Ueda * , Hideyuki Motohashi , Yuriko Hirai , Kenji Yamamoto , Yasufumi Murakami , Masanori Fukushima , Akinori Fujisawa * Posted Date: 15 March 2024 doi: 10.20944\/preprints202403.0881.v1 Keywords: COVID-19 vaccine; genetic vaccine; blood … <\/p>\n

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