{"id":2022467,"date":"2023-09-05T16:52:01","date_gmt":"2023-09-05T20:52:01","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/a-deeper-dive-into-the-role-of-spike-protein-in-myocarditis-and-blood-clotting-after-covid-19-vaccination\/"},"modified":"2023-09-05T17:02:26","modified_gmt":"2023-09-05T21:02:26","slug":"a-deeper-dive-into-the-role-of-spike-protein-in-myocarditis-and-blood-clotting-after-covid-19-vaccination","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/a-deeper-dive-into-the-role-of-spike-protein-in-myocarditis-and-blood-clotting-after-covid-19-vaccination\/","title":{"rendered":"Exploring Spike Protein&#8217;s Impact on Myocarditis &#038; Blood Clotting Post COVID-19 Vaccination"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">24<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fa-deeper-dive-into-the-role-of-spike-protein-in-myocarditis-and-blood-clotting-after-covid-19-vaccination%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2022467&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div class=\"post_content\">\n<div class=\"aplayer_app\" data-source=\"https:\/\/vs1.youmaker.com\/assets\/2023\/0905\/d2c1051f-8c74-408e-a3dd-4e37482036ff\/audio.mp3?length=36547533&#038;duration=3046\"><\/div>\n<\/p>\n<p style=\"padding-left: 30px;\"><em>In <a href=\"https:\/\/www.theepochtimes.com\/health\/promise-or-peril-covid-19-mrna-vaccine-issues-series\">this \u200dseries, \u201cPromise or Peril: Alarming COVID-19 mRNA Vaccine Issues<\/a>,\u201d we \u2064explore how \u200dthe\u200b introduction of mRNA technology lacked an adequate regulatory framework, setting the stage \u200dfor serious adverse events \u2063and other concerns related\u2064 to inadequate safety testing of lipid \u2062nanoparticles, spike\u2062 protein, and residual DNA- and lipid-related impurities, as well as truncated\/modified mRNA species.<\/em><\/p>\n<p style=\"padding-left: 30px;\"><em>Previously: \u200bIn \u200dPart 1, we introduced how the U.S. Food \u2062and Drug Administration (FDA) relaxed the rules \u2064for \u2064mRNA \u2063vaccines compared\u2064 to mRNA therapies and discussed the available data regarding LNP distribution throughout the body based \u200bon \u200banimal\u2062 testing, the fact that\u200d human testing was not done, and the \u2063lack of mRNA or spike protein biodistribution\u200c data. In Parts 2 and\u2064 3, we explored how the LNPs are constructed and how they behave \u200bin\u2064 the body and affect\u2063 health.<\/em><\/p>\n<p><em>Health Viewpoints<\/em><\/p>\n<p>Now we turn to another problem\u2014the cargo contained in\u200d the LNP\u200b capsules: the mRNA\u200d and its encoded spike \u2063protein. We introduce the inflammatory response to the \u200bspike protein and one of its subunit proteins and how they may contribute to serious adverse \u200bevents such as\u200c myocarditis and blood clotting.<\/p>\n<p>Rochelle Walensky, former director of the U.S. Centers for\u2064 Disease Control\u2063 and Prevention (CDC), <a href=\"https:\/\/www.goodmorningamerica.com\/news\/video\/cdc-director-talks-delta-variant-rare-heart-inflammation-78354466\">stated on \u201cGood Morning America\u201d in June 2021<\/a> that myocarditis cases are \u201creally quite rare \u2026 minor, self-limited, they generally resolve \u200bwith \u2062rest and\u2064 standard medications.\u201d However, this assertion was\u2063 made based on a preliminary review of 300 cases and \u2062before\u200b conducting long-term follow-up.<\/p>\n<p>A study published \u200don Aug. 1 followed \u200c <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC10373639\/\">40 adolescents\u2064 in Hong Kong<\/a> for up to a year. Follow-up testing performed in 26 patients with initial abnormal findings revealed that 58 percent of those with vaccine-associated myocarditis had persistent heart muscle\u200d scarring. The authors concluded: \u201cThere exists \u200da <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/should-be-no-risk-world-economic-forum-pushes-space-bubbles-to-block-out-the-sun-stop-climate-change\/\" title=\"\u2018Should Be No Risk\u2019: World Economic Forum Pushes \u2018Space Bubbles\u2019 To Block Out The Sun, Stop Climate Change\">potential long-term effect<\/a> on exercise \u200dcapacity and cardiac functional reserve during stress.\u201d<\/p>\n<p>This series demonstrates how exposure to the spike protein results in downstream cardiovascular issues. \u2064Given that vaccination causes the body to produce more spike protein,\u2064 it\u200b is clear that additional research was needed to understand the health impacts \u200dof vaccination prior to licensure.<\/p>\n<h2>Summary of\u200b Key Facts<\/h2>\n<ul>\n<li>The SARS-CoV-2 spike protein and \u200bits S1 subunit \u2063have known impacts on the cardiovascular system, such as an increased risk of blood clotting.<\/li>\n<li>The vaccine-induced spike \u2063protein and\u2064 its\u2064 S1 subunit have been found\u2064 in the blood\u2064 following vaccination.<\/li>\n<li>In lab studies, the spike protein activates white blood\u200d cells and may \u200ctrigger an inflammatory\u2062 response\u200c or clotting.<\/li>\n<li>Free spike protein was found in the blood of\u2062 adolescents and young adults with \u2063post-mRNA vaccine myocarditis\u2064 but not in \u200bhealthy control \u200csubjects without myocarditis.<\/li>\n<li>The S1 subunit \u200bcan interact with ACE2, platelets, \u2064and fibrin and\u2063 may be what leads to \u2064an inflammatory response driving serious \u200badverse events, including\u200d clots,\u2063 myocarditis, and neurological problems.<\/li>\n<li>As discussed in \u2062Part 3, lipid nanoparticles (LNPs) act as adjuvants, stimulating\u2062 the immune \u2063system. This innate immune\u2063 response peaks within six hours of vaccination and returns to baseline by about \u2063day nine, temporally corresponding to \u200bthe \u200donset of myocarditis, which typically occurs\u200b within the first seven days following mRNA COVID-19 vaccination.<\/li>\n<li>Studies have not \u2063been done to evaluate how vaccination affects those who have already\u2062 been infected with\u200b SARS-CoV-2.<\/li>\n<li>The spike protein was implicated in \u200dsmall vessel microclots during COVID-19 illness; thus, postvaccination cardiovascular\u2063 effects should have \u2063been anticipated.<\/li>\n<li>The first\u2064 deadline for FDA-mandated post-authorization safety studies has passed, yet to the best \u2064of\u200d our knowledge, \u2063the full report has\u200b not been \u2063made available \u200cto the public.<\/li>\n<\/ul>\n<p>The spike\u200d protein protrudes from the SARS-CoV-2 virus\u200c like a crown of sticky handles. The job of the spike protein is to grab onto the ACE2 receptor so the virus can enter the cell. The ACE2\u200d receptor is found in\u200d many human \u2064cells \u2063in \u2062the lungs, kidneys, gut, \u2064heart, and the\u200d lining of the blood vessels.<\/p>\n<p>Spike protein is comprised of two parts: the S1 and S2 subunits. The S1 subunit protein\u200b sits at the tip of the spike protein and is responsible for\u2063 attaching to the ACE2 receptor. Once bound to\u2063 the receptor, the spike protein \u2062changes shape to allow the virus to enter.\u2063 Having accessed the\u200d inside of the cell, the SARS-CoV-2 virus uses the \u2062cell\u2019s\u2063 own \u2063protein manufacturing process to make \u2062new viral \u200bproteins.<\/p>\n<p>Effective\u200c vaccines\u2063 select recognizable antigens that \u2064induce a robust immune response. The spike \u2063protein was\u2064 chosen for the mRNA COVID-19 vaccine because it is responsible for attaching \u200dto cells\u200d and gaining\u200c entry. However, research \u2063suggests that the spike protein and its S1 subunit may also be responsible for cardiovascular complications\u2064 following both \u200cinfection and \u200bvaccination.<\/p>\n<p>The S2 subunit\u200c may also <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7324311\/\">interfere with tumor suppression<\/a>, potentially explaining why COVID-19 can be\u2063 more severe for cancer patients.<\/p>\n<figure id=\"attachment_5389843\" style=\"width: 4000px\" class=\"wp-caption alignnone\">\n    <a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2023\/07\/11\/id5389843-sars-cells-1200x1200.jpeg\"><figcaption class=\"wp-caption-text\"><noscript><\/noscript><\/figcaption><\/a><br \/>\n  <\/figure>\n<p>Research shows that the spike protein is found in the\u2064 blood following COVID-19 infection and vaccination.\u200c The spike protein modifies blood clotting and \u200bcan stimulate an overactive\u200c immune response. A \u2063better understanding of \u200dthese findings and the specific roles the \u2062spike protein \u2062and its \u2062S1 subunit\u2062 play will help us determine who is \u2062most at risk\u200c for severe disease or vaccine adverse events.<\/p>\n<h2>Cardiovascular \u2064Effects of \u200dSpike Protein Following Infection<\/h2>\n<p>Although \u2062the studies are \u200bsmall,\u200d the spike protein has been found in the blood and clots \u200cof severely ill COVID-19 patients. The <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/five-benefits-of-ashwagandha-that-can-improve-your-training\/\" title=\"Five Benefits of Ashwagandha That Can Improve Your Training\">clinical evidence suggests<\/a> a fingerprint of the spike protein\u2019s cardiovascular effects.<\/p>\n<p>In a study of\u2062 41 patients\u2063 published in Frontiers in Immunology, <a href=\"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2022.827146\/full\">30.4\u200c percent<\/a> \u200bof the 23 hospitalized were found to have significant levels of spike protein in their circulation. None\u200b of the\u200d remaining 18 uninfected or mildly ill individuals had circulating spike protein.<\/p>\n<p>A\u2063 small <a href=\"https:\/\/jhoonline.biomedcentral.com\/articles\/10.1186\/s13045-022-01329-w\">case-control study<\/a> detected the\u2064 spike protein in clots retrieved \u2063from COVID-19 patients with acute ischemic stroke \u2063and myocardial \u200binfarction.<\/p>\n<p>Another study detected\u2062 the S1 subunit in the plasma\u200d of <a href=\"https:\/\/academic.oup.com\/clinchem\/article\/66\/12\/1562\/5902449\">64 percent<\/a> of COVID-19-positive patients, and S1 levels were \u200csignificantly associated \u2063with disease severity. The nucleocapsid (N) protein, a marker for COVID-19 infection, was \u200balso \u200cdetected. \u2063The authors speculated that the presence of S1 and \u2063N \u2062in plasma suggests\u2063 that virus\u200b fragments\u200c enter the bloodstream, potentially\u2064 due to tissue damage.<\/p>\n<p>The exact chain of\u200b events is not fully understood. Still, laboratory, clinical, and <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/a-deeper-dive-into-the-role-of-spike-protein-in-myocarditis-and-blood-clotting-after-covid-19-vaccination\/\" title=\"Exploring Spike Protein's Impact on Myocarditis &#038; Blood Clotting Post COVID-19 Vaccination\">biopsy findings offer converging \u200cevidence suggesting<\/a> a role for \u2063the spike protein and \u2062its\u2062 S1\u2063 subunit\u2064 in blood clotting\u2063 and heart injury.<\/p>\n<h2>Blood Clots Associated \u2064With Spike S1 Subunit<\/h2>\n<p>In laboratory experiments\u200d like those performed in the Frontiers in Immunology study, the spike protein S1 subunit causes a chain reaction that sets up the right conditions for\u200b clots to form. \u2063In \u2063this chain\u2064 reaction, the \u200cS1 \u2064protein binds to the ACE2 receptor on the cells lining the blood vessels. Binding to ACE2 then activates \u2063immune cells.<\/p>\n<p>This domino\u200c effect can also stimulate platelet binding, increasing clotting risk. Platelets are essential \u2062clotting\u200c agents that stop blood loss following \u2062injury\u2063 by clumping together. The authors further noted that \u2062in vitro, \u201cour\u200d group recently documented that exposing sera from severe COVID-19 patients to endothelial cells induced platelet aggregation.\u201d<\/p>\n<p>In \u2064other words, the S1 \u2062subunit is of interest because, in vitro (in a test tube), it appears\u2063 to cause changes\u2063 to clotting mechanisms. If the S1 subunit can affect\u200b clotting agents like fibrin,\u2063 complement 3, and prothrombin, this may be a mechanism through\u2062 which SARS-CoV-2 can cause cardiovascular complications. Clotting \u200ccauses changes\u200d in\u200c blood flow, potentially leading to thrombosis, stroke, \u200band heart attack.<\/p>\n<h2>Atypical Blood \u2063Clots<\/h2>\n<p>Providing blood thinners\u200d to\u200b decrease the risk of clot formation did not appear to reduce the\u200d clotting risk in COVID-19 <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2103417\">inpatients<\/a> or <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2785218\">outpatients<\/a>. This may be because the clots formed after exposure to the S1 subunit may \u2063not be typical blood clots. Three\u200c findings suggest that the S1 \u2063subunit is important to clotting risk.<\/p>\n<h3><strong>1. Clots Resist Normal Breakdown<\/strong><\/h3>\n<p>First, when the S1 subunit was \u2063added to healthy blood in the lab, it created <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8380922\/\">dense, \u200bfibrous clot deposits<\/a>. These fibrous \u201camyloid\u201d clots\u2064 formed even\u200c when blood taken from\u200b healthy people\u2064 was exposed to the \u200cS1 \u2063subunit.<\/p>\n<p>The S1 subunit \u2062appears \u200bto be\u200b associated with clotting resistant to fibrinolysis\u2014the normal breakdown of clots necessary to restore\u200b blood flow\u2064 after injury. These amyloid clots are shown \u2063in\u200b Figure 1 below.<\/p>\n<p>Amyloid clots \u200doccur when a protein is\u2063 damaged and begins to\u200d fold abnormally on itself. When these abnormal amyloid proteins accumulate \u2064in the body, they can interfere with normal function.<\/p>\n<h3><strong>Figure 1. Amyloid Clots \u200dFormed in Response to Spike Protein\u200c S1<\/strong><\/h3>\n<figure id=\"attachment_5367743\" style=\"width: 387px\" class=\"wp-caption aligncenter\">\n    <a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2023\/06\/30\/id5367743-Part-4-Fig-2.png\"><figcaption class=\"wp-caption-text\"><noscript><\/noscript><\/figcaption><\/a><br \/>\n  <\/figure>\n<h3><strong>2. S1 Subunit Can Induce Amyloid \u200bSubstances<\/strong><\/h3>\n<p>Second, these dense clots may be caused by certain protein segments on the S1 subunit. The spike protein has seven \u2063protein segments (peptides) that \u200bcan <a href=\"https:\/\/pubs.acs.org\/doi\/10.1021\/jacs.2c03925\">induce fibrous (amyloid)\u2063 substances<\/a>. While the \u2062fully \u200cintact\u2064 spike protein \u2064(S1 and \u2063S2 subunits attached to form the full \u2064spike) did not\u2064 form this \u200camyloid, the S1 subunit did. This finding is interesting \u2063because it suggests that the subunits of the spike protein\u200c may\u2062 have unique effects on cells.<\/p>\n<h3><strong>3. Spike Blocks Other Clot-Inhibiting Proteins<\/strong><\/h3>\n<p>Third, \u2062spike \u2062protein can \u200coutcompete \u200cother\u200d proteins,\u2064 which \u200cprevent clots from \u200cforming. In another\u2062 laboratory experiment designed to understand \u2063how this process plays \u2064out, scientists found that the\u200d spike protein <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8553634\/\">blocks \u200bproteins<\/a> important\u2063 to breaking down clots.<\/p>\n<p>In summary, the in vitro (laboratory-based) research suggests that the spike protein subunit S1 can\u200d induce clot formation and impair clot \u200cdissolution. \u200cWhile we do not know precisely how this translates to\u2063 processes in the body, Epoch Times\u2019 Jan\u200b Jekielek explored clotting and the \u200crole of spike\u2064 protein with pathologist <a href=\"https:\/\/www.theepochtimes.com\/epochtv\/how-humans-were-used-as-lab-rats-in-the-covid-pandemic-dr-ryan-cole-on-fragmented-mrna-spike-messages-and-the-vaccine-ego-5300734?utm_source=open&#038;utm_medium=search\">Dr. Ryan Cole on June\u200c 3<\/a> \u2064 and <a href=\"https:\/\/www.theepochtimes.com\/the-spike-goes-to-every-organ-system-dr-paul-marik-on-mrna-in-the-covid-19-vaccine-vs-natural-infection-cheap-and-effective-treatments-and-interventions_5281130.html?utm_source=open&#038;utm_medium=search\">Dr. Paul Marik on May 23<\/a>. In the interview, Dr. Cole explained\u200d that the spike\u200b protein \u2063persists in the body longer, inflames\u200d tissues wherever\u200d it lands, and acts as an irritant \u2064or toxin in the body.<\/p>\n<h2>Spike Protein\u2064 Found in COVID-19-Vaccinated Myocarditis Patients<\/h2>\n<p>Studies of COVID-19-vaccinated patients diagnosed with myocarditis found spike protein in the patients\u2019 blood and heart muscles \u200bbut not in those without myocarditis.<\/p>\n<h3><strong>Found in Blood<\/strong><\/h3>\n<p>The full-length spike\u2062 protein has been found in the blood of\u2062 <a href=\"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCULATIONAHA.122.061025\">vaccinated \u200badolescents with myocarditis<\/a> but \u200dnot in\u2063 the blood of those without myocarditis.<\/p>\n<p>It\u200d is unclear why the \u2062spike protein was circulating \u2064freely\u2064 or unbound by antibodies. The adolescents who developed myocarditis\u200c had similar immune markers \u200bto those who did not develop myocarditis. In\u200c other\u200b words, the group with myocarditis did not\u200b appear to\u200d have any immune problems.<\/p>\n<p>Rather, \u2063these adolescents may have had\u2064 an overactive natural immune response. Strong natural \u2064(\u201cinnate\u201d) immunity \u2063helps the \u2062body fight off disease without any \u2062prior exposure. However,\u200d the first\u200b responders (inflammatory cytokines) \u2062can sometimes\u2063 be exuberant. \u200cIf \u200bthe innate immune response overreacts, it may trigger myocarditis.<\/p>\n<h3><strong>Found in Heart \u200bMuscle<\/strong><\/h3>\n<p>The spike protein coded by mRNA \u200chas also been\u200b found\u200c in heart \u2063muscle cells. \u2064An \u2064endomyocardial (heart muscle) <a href=\"https:\/\/www.mdpi.com\/1422-0067\/23\/13\/6940\">biopsy study<\/a> \u2064 was\u2064 conducted among 15 patients\u200d with myocarditis\u2062 following \u2063vaccination. No other viral infection could be found that might have caused the myocarditis.<\/p>\n<p>The investigators found SARS-CoV-2 spike protein in nine of the \u206315 patients. Immune cells (CD4+ T) \u200bwere \u2062also detected in \u200dthe \u2064biopsy samples.\u2063 These observations suggest an \u2063inflammatory reaction \u200bto\u200b the spike protein.<\/p>\n<p>The authors concluded: \u201cAlthough a\u2064 causal relationship between vaccination and the occurrence of myocardial inflammation cannot be established\u2063 based on the findings, the cardiac detection of\u200c spike\u2064 protein, the CD4+ \u2063T-cell-dominated inflammation, and the close\u200c temporal relationship argue for a vaccine-triggered autoimmune reaction.\u201d<\/p>\n<p>A <a href=\"https:\/\/www.mdpi.com\/1999-4915\/14\/7\/1415\">2022 modeling study<\/a> also suggests that\u2064 the spike protein can\u200c cause an autoimmune\u2064 response by mimicking human\u2063 molecules, causing antibodies to bind\u200b to \u201cself\u201d proteins.<\/p>\n<h2>Spike S1 Detected in the Blood\u200b of Vaccinated\u200c Adults<\/h2>\n<p>Another study found\u200c that 11 of \u200c13 adults vaccinated with Moderna\u2019s mRNA-1273 had the \u200c <a href=\"https:\/\/academic.oup.com\/cid\/article\/74\/4\/715\/6279075?login=false\">S1 subunit<\/a> in their blood as early as one day after\u200c vaccination.<\/p>\n<p>Plasma was\u200c collected from 13 participants at various times during the first month after each dose. The antigens S1 and spike were measured to estimate the amount of mRNA translation into \u2063protein products.<\/p>\n<p>After the first 100-microgram dose, S1 antigen was detected in the \u200cplasma \u2062of 11 participants. In contrast, the spike antigen \u200dwas detected in \u200dthree of 13 participants. The S1 antigen peak was detected on average five days after vaccination. \u2063Again, the timing of this peak for S1 seems to add to the clues\u200b suggesting an autoimmune \u2063response in the week after vaccination.<\/p>\n<h2>mRNA Detected in the Blood and Lymph Nodes After \u200cVaccination<\/h2>\n<p>Vaccine mRNA, which encodes the spike protein and its S1 subunit, also \u2063persists in the blood and lymph nodes. Following vaccination, spike-encoded mRNA has been found in the <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9313234\/\">blood for 15 days<\/a> and \u2062in <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0092867422000769\">lymph nodes<\/a> for up to 60 days. <a href=\"https:\/\/journals.aai.org\/jimmunol\/article\/207\/10\/2405\/234284\/Cutting-Edge-Circulating-Exosomes-with-COVID-Spike\">Spike-laden exosomes<\/a> \u200b have been found circulating in \u2062the blood for up to four months. This finding is important because it refutes\u200d the CDC\u2019s claim \u2064that \u200dthe mRNA is so fragile that it dissolves quickly at the injection site (see\u200b <a href=\"https:\/\/www.theepochtimes.com\/health\/fda-overhaul-needed-for-new-vaccines-and-mrna-therapies_5157904.html\">Figure 2a\u2063 in Part 1<\/a>).<\/p>\n<p>The lymph nodes continue creating better-fitting antibodies after any viral infection. This\u200c is a critical way that our bodies\u2064 prepare for new variants naturally. \u200bHowever, persistently high levels\u200d of vaccine-induced mRNA and spike \u2062protein\u2064 may not\u200c be helpful\u200c when the immune system \u200bis asked to respond to future variants. In \u2063other words, if the \u200cimmune system is tasked with\u200b continuing to pump\u2064 out antibodies to\u200b a \u200dprevious\u2063 variant,\u200c it\u2062 may be \u2062less nimble when asked to \u2063create a high-quality antibody for a new variant.<\/p>\n<h2>Inadequate Clinical Trials Leave Unresolved Questions<\/h2>\n<p>Given what we \u200dknow about \u200dthe harmful effects of\u2064 the SARS-CoV-2 virus, we should not have\u2064 assumed \u2063that\u2062 the vaccine-encoded spike\u2064 protein would be harmless.<\/p>\n<p>And, given what we know about \u2063clotting issues following COVID-19 infection, future studies should\u200d test whether the S1 subunit produced in response\u200b to vaccination\u2062 can \u2064also \u2064cause clotting issues via the same pathway. These studies should \u200dinclude both lab experiments and human observations.<\/p>\n<p>In addition,\u2063 we do not know the relative amounts of free spike protein\u200b in circulation following infection \u200cversus vaccination.<\/p>\n<p>In the case of the COVID-19 vaccines, the active ingredient was\u200d not studied prior to authorization. The manufacturers used mRNA that encodes for a substitute\u2063 protein (luciferase) to test the safety and biodistribution of the mRNA vaccines.<\/p>\n<p>Pfizer submitted animal biodistribution data to\u200d regulatory agencies using \u2064the surrogate \u2063RNA encoding for luciferase, as discussed in <a href=\"https:\/\/www.theepochtimes.com\/health\/fda-overhaul-needed-for-new-vaccines-and-mrna-therapies_5157904.html\">Part 1<\/a> of this series.<\/p>\n<p>However, these studies were inadequate\u2063 in describing how mRNA, the \u2064spike protein, its S1 subunit, and the\u2063 LNP carrier \u2063would affect the human body.<\/p>\n<p>In this article, we described laboratory findings showing clotting associated with the S1 subunit. Studies\u200d like these reinforce why thorough\u200d preclinical studies are so \u2064crucial. The studies conducted by pharmaceutical companies were\u200d not sufficient\u2064 to \u2064address these questions.<\/p>\n<p>We had very little information about how people would respond to vaccination depending on age, sex, immune \u200cstatus, \u2064overall health,\u2063 or history of prior\u200d SARS-CoV-2 infection. The\u2063 <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fauci-rejects-communication-error-people-who-dont-want-covid-shot-fundamentally-against-vaccination\/\" title=\"Fauci Rejects 'Communication Error' -- People Who Don't Want COVID Shot 'Fundamentally Against Vaccination'\">original clinical trials<\/a> did not \u2063enroll enough people who had already \u2064recovered from COVID-19; they \u2063were not designed to provide an\u200c understanding of how \u2064prior infection would affect a person\u2019s\u2062 response to vaccination.<\/p>\n<h2>Required Pfizer Post-Authorization Safety Study \u200cUnavailable to Public<\/h2>\n<p>Pre-authorization studies were clearly \u200binadequate. Post-authorization, the FDA has only acknowledged that passive\u2064 surveillance is insufficient to establish\u200c safety. The agency responded to adverse event reports by \u200drequiring Pfizer to conduct additional studies, with the first monitoring report \u2064due October 2022.<\/p>\n<p>On <a href=\"https:\/\/www.fda.gov\/media\/151710\/download\">page 6 of the approval letter<\/a>, the FDA acknowledges \u200bthis fact (see Figure 2 below):<\/p>\n<blockquote>\n<p>\u201cWe\u200d have determined that an analysis\u200d of \u2064spontaneous \u200bpostmarketing adverse events reported under section 505(k)(1) of the FDCA will \u2062not be\u200d sufficient to assess \u2064known serious\u2062 risks of\u200c myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.<\/p>\n<p>\u201cFurthermore, the pharmacovigilance system that the\u2064 FDA\u200d is required to \u2062maintain under section \u2064505(k)(3) of the FDCA is\u200c not sufficient to assess these serious risks. Therefore,\u200b based on appropriate scientific data,\u2062 we have \u200cdetermined \u2063that you are required to conduct the following studies. \u2026\u201d<\/p>\n<\/blockquote>\n<p>Has the FDA \u2062received the <a href=\"https:\/\/twitter.com\/RxRegA\/status\/1671576467791126540?s=20\">monitoring \u200breport \u200dfrom Pfizer<\/a>, which was due by Oct. \u206431, 2022? The next report, the interim report, will be due in October.<\/p>\n<h3><strong>Figure 2.\u200d FDA Postmarketing Safety Study Requirements<\/strong><\/h3>\n<figure id=\"attachment_5367705\" style=\"width: 605px\" class=\"wp-caption aligncenter\">\n    <a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2023\/06\/30\/id5367705-Part-4-FDA-image.jpg\"><figcaption class=\"wp-caption-text\"><noscript><\/noscript><\/figcaption><\/a><br \/>\n  <\/figure>\n<blockquote>\n<p><em><span style=\"font-weight: 400;\">Read \u200cPart \u20641: <\/span><a href=\"https:\/\/www.theepochtimes.com\/health\/fda-overhaul-needed-for-new-vaccines-and-mrna-therapies_5157904.html?utm_source=open&#038;utm_medium=search\">FDA Overhaul Needed for New \u2062Vaccines and mRNA Therapies<\/a><\/em><\/p>\n<p><em><span style=\"font-weight: 400;\">Read Part 2:<\/span><a href=\"https:\/\/www.theepochtimes.com\/health\/health-implications-of-poor-covid-19-mrna-testing-miscarriage-vision-loss-immunotoxicity_5201116.html?utm_source=open&#038;utm_medium=search\">Health Implications of Poor COVID-19 mRNA \u200bTesting: Miscarriage, Vision Loss,\u200d Immunotoxicity<\/a><\/em><\/p>\n<p><em>Read Part \u20643: <a href=\"https:\/\/www.theepochtimes.com\/health\/pulling-back-the-curtain-mrna-lipid-nanoparticle-design-created-potential-for-clotting-and-triggering-immune-overdrive-5201297\">Pulling Back the Curtain: mRNA Lipid Nanoparticle Design Created Potential \u2064for Clotting and Triggering Immune Overdrive<\/a><\/em><\/p>\n<p><span style=\"color: #000000;\"><i><span style=\"font-weight: 400;\">Next: In Part 5, we will discuss the\u2064 mRNA manufacturing issues affecting \u2064contamination with \u200ddouble-stranded DNA and \u200cthe \u2063potential for\u2062 genome integration.<\/span><\/i><\/span><\/p>\n<\/blockquote>\n<h3><strong>\u25ca References<\/strong><\/h3>\n<p>Addgene. Molecular Biology Reference. <a href=\"https:\/\/www.addgene.org\/mol-bio-reference\/#introduction\">https:\/\/www.addgene.org\/mol-bio-reference\/#introduction<\/a><\/p>\n<p>Alana F Ogata, Chi-An Cheng, Micha\u00ebl Desjardins, \u2064Yasmeen Senussi, Amy C Sherman, Megan Powell, Lewis Novack, Salena Von, Xiaofang Li,\u200c Lindsey\u2062 R Baden, David R Walt, Circulating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine\u200d Antigen Detected in the \u200cPlasma of \u2062mRNA-1273 Vaccine Recipients, Clinical Infectious Diseases, Volume 74, Issue 4, 15 February 2022, Pages 715\u2013718, <a href=\"https:\/\/doi.org\/10.1093\/cid\/ciab465\">https:\/\/doi.org\/10.1093\/cid\/ciab465<\/a><\/p>\n<p>Ald\u00e9n M, Olofsson Falla F, Yang D, Barghouth M, Luan\u2064 C, Rasmussen M, De Marinis\u200b Y. Intracellular Reverse Transcription of Pfizer BioNTech \u200bCOVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. Curr Issues Mol Biol. 2022 Feb\u2064 25;44(3):1115-1126. doi: 10.3390\/cimb44030073. PMID: 35723296; \u200dPMCID: PMC8946961. <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35723296\/\">https:\/\/pubmed.ncbi.nlm.nih.gov\/35723296\/<\/a><\/p>\n<p>Allergic Reactions Including Anaphylaxis \u200bAfter Receipt \u2062of the First Dose of Pfizer-BioNTech COVID-19 Vaccine \u2014 United States, \u200cDecember 14\u201323, 2020. MMWR Morb Mortal Wkly\u200b Rep 2021;70:46\u201351. DOI: <a href=\"http:\/\/dx.doi.org\/10.15585\/mmwr.mm7002e1\">http:\/\/dx.doi.org\/10.15585\/mmwr.mm7002e1<\/a><\/p>\n<p>Anderson \u2064EJ, Rouphael NG, Widge AT, et al. \u2064Safety and Immunogenicity \u200cof SARS-CoV-2 mRNA-1273 Vaccine in \u2064Older Adults N Engl J Med 2020; 383:2427-2438 <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2028436\">https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2028436<\/a><\/p>\n<p>Anderson \u2064S. CBER Plans for Monitoring COVID-19\u200d Vaccine Safety and Effectiveness. <a href=\"https:\/\/stacks.cdc.gov\/view\/cdc\/97349\">https:\/\/stacks.cdc.gov\/view\/cdc\/97349<\/a> \u2062October \u206220, 2020. Accessed 3\/20\/23.<\/p>\n<p>Angeli F, Spanevello A, Reboldi G, Visca D, Verdecchia P. SARS-CoV-2 vaccines: Lights and shadows. Eur J Intern Med. 2021\u200d Jun;88:1-8. doi: 10.1016\/j.ejim.2021.04.019. Epub 2021 Apr 30. PMID: 33966930; PMCID: PMC8084611.\u2062 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8084611\/#bib0043\">https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8084611\/#bib0043<\/a><\/p>\n<p>Baker, A. T., Boyd,\u200c R. J., Sarkar, D., Teijeira-Crespo, \u200dA., \u2062Chan, C. K., Bates, E., Waraich,\u2063 K.,\u200b Vant, J., Wilson, E., Truong, C. D.,\u2064 Lipka-Lloyd, M., Fromme, P., Vermaas,\u200b J., Williams, D., Machiesky, L., Heurich, M., Nagalo, B. M.,\u200c Coughlan, L., Umlauf, S., Chiu, P. L., \u2026 Borad, M. J. (2021). ChAdOx1 interacts with\u2064 CAR and PF4 with implications for thrombosis with\u200c thrombocytopenia syndrome. \u2062Science Advances. \u200c7(49), eabl8213. <a href=\"https:\/\/doi.org\/10.1126\/sciadv.abl8213\">https:\/\/doi.org\/10.1126\/sciadv.abl8213<\/a><\/p>\n<p>Baumeier C, Aleshcheva G,\u2063 Harms D, Gross U, Hamm C,\u200b Assmus\u2062 B, \u2064Westenfeld R, Kelm M, \u2062Rammos S,\u200b Wenzel P, M\u00fcnzel T, Els\u00e4sser A, Gailani M, Perings C, Bourakkadi\u2063 A, Flesch M, Kempf<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In &#8220;Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues,&#8221; we delve into the risks posed by the introduction of mRNA technology. Insufficient regulations have led to serious adverse events and concerns regarding safety testing of lipid nanoparticles, spike protein, residual DNA, lipid impurities, and modified mRNA.<\/p>\n","protected":false},"author":2387,"featured_media":2022468,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[543],"tags":[],"class_list":["post-2022467","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-epoch-times"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2022467","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/2387"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2022467"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2022467\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2022468"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2022467"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2022467"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2022467"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}