{"id":11146,"date":"2025-01-05T18:00:00","date_gmt":"2025-01-05T23:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=11146"},"modified":"2025-01-05T10:42:54","modified_gmt":"2025-01-05T15:42:54","slug":"fda-led-peer-reviewed-study-by-high-school-students-uncovers-alarming-dna-contamination-in-pfizers-mrna-covid-19-vaccine-at-fdas-own-lab","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=11146","title":{"rendered":"FDA-Led Peer-Reviewed Study by High School Students Uncovers Alarming DNA Contamination in Pfizer\u2019s mRNA COVID-19 Vaccine at FDA\u2019s Own Lab"},"content":{"rendered":"\n<p class=\"has-small-font-size\">by\u00a0Jim H\u1d0fft\u00a0Jan. 5, 2025 TGP<\/p>\n\n\n\n<p>A group of high school students from Centreville High School in Virginia, in collaboration with the FDA, has uncovered alarming DNA contamination in both Pfizer\u2019s experimental and commercial mRNA COVID-19 shots.<\/p>\n\n\n\n<p>Their&nbsp;<a href=\"https:\/\/jhss.scholasticahq.com\/article\/127890-a-rapid-detection-method-of-replication-competent-plasmid-dna-from-covid-19-mrna-vaccines-for-quality-control\">peer-reviewed study,<\/a>&nbsp;published in the&nbsp;<a href=\"https:\/\/jhss.scholasticahq.com\/article\/127890-a-rapid-detection-method-of-replication-competent-plasmid-dna-from-covid-19-mrna-vaccines-for-quality-control\"><em>Journal of High School Science<\/em><\/a>&nbsp;on December 29th, has sparked renewed debate over vaccine manufacturing standards and quality control processes.<\/p>\n\n\n\n<p>The researchers, led by Tyler Wang, Alex Kim, and Kevin Kim, developed a novel method to detect replication-competent DNA impurities at FDA\u2019s own research facility at the White Oak Campus,&nbsp;<a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-study-high-school-lab-dna-contamination-pfizer-covid-vaccine\/\">Children\u2019s Health Defense<\/a>&nbsp;reported.<\/p>\n\n\n\n<p>Their technique involves extracting DNA from vaccine samples, ligating it into a circular form, and then transforming it into&nbsp;Escherichia coli&nbsp;cells.<\/p>\n\n\n\n<p>If transformation results in antibiotic-resistant bacterial colonies, it indicates the presence of replication-competent DNA, which should ideally be absent or minimal in the final vaccine product.<\/p>\n\n\n\n<p>The findings were based on analyses of two separate lots of Pfizer\u2019s mRNA vaccines, including monovalent and bivalent formulations.<\/p>\n\n\n\n<p>The students uncovered significant levels of DNA contamination in the vaccines, with some samples exceeding the WHO threshold by up to 470 times, the amount of residual DNA detected ranged between 40 to 110 nanograms per dose.<\/p>\n\n\n\n<p>While no replication-competent DNA was detected in commercial Pfizer vaccine batches, smaller DNA fragments\u2014approximately 35 base pairs in length\u2014were consistently present.<\/p>\n\n\n\n<p>Interestingly, the study reported sporadic instances of replication-competent DNA in an in-house mRNA vaccine and a biosimilar vaccine.<\/p>\n\n\n\n<p>Investigative medical reporter,&nbsp;<a href=\"https:\/\/blog.maryannedemasi.com\/p\/exclusive-fda-lab-uncovers-excess\">Maryanne Demasi, Ph.D.<\/a>&nbsp;first reported:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Kevin McKernan, a former director of the Human Genome Project, described the findings as a \u201cbombshell,\u201d criticising the FDA for its lack of transparency.<\/p>\n\n\n\n<p>\u201cThese findings are significant not just for what they reveal but for what they suggest has been concealed from public scrutiny. Why has the FDA kept these data under wraps?\u201d McKernan questioned.<\/p>\n\n\n\n<p>While commending the students\u2019 work, he also noted limitations in the study\u2019s methods, which may have underestimated contamination levels.<\/p>\n\n\n\n<p>\u201cThe Qubit analysis can under-detect DNA by up to 70% when enzymes are used during sample preparation,\u201d McKernan explained. \u201cAdditionally, the Plasmid Prep kit used in the study does not efficiently capture small DNA fragments, further contributing to underestimation.\u201d<\/p>\n\n\n\n<p>[\u2026]<\/p>\n\n\n\n<p>Nikolai Petrovsky, a Professor of Immunology and director of Vaxine Pty Ltd, described the findings as a \u201csmoking gun.\u201d<\/p>\n\n\n\n<p>\u201cIt clearly shows the FDA was aware of these data. Given that these studies were conducted in their own labs under the supervision of their own scientists, it would be hard to argue they were unaware,\u201d he said.<\/p>\n\n\n\n<p>Prof Petrovsky praised the quality of work carried out by the students at the FDA labs.<\/p>\n\n\n\n<p>\u201cThe irony is striking,\u201d he remarked. \u201cThese students performed essential work that the regulators failed to do. It\u2019s not overly complicated\u2014we shouldn\u2019t have had to rely on students to conduct tests that were the regulators\u2019 responsibility in the first place.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>It can be recalled that in 2023, Florida Surgeon General, Dr. Joseph A. Ladapo, demanded answers from Dr. Robert M. Califf, the Commissioner of the U.S. Food and Drug Administration (FDA), regarding the&nbsp;<a href=\"https:\/\/www.thegatewaypundit.com\/2023\/12\/developing-floridas-surgeon-general-joseph-ladapo-confirms-detection\/\">detection of host cell DNA fragments in mRNA COVID-19 vaccines<\/a>&nbsp;developed by Pfizer and Moderna.<\/p>\n\n\n\n<p>The Florida Surgeon General&nbsp;<a href=\"https:\/\/www.floridahealth.gov\/about\/_documents\/12-06-2023-DOH-Letter-to-FDA-RFI-on-COVID-19-Vaccines.pdf\">sent a letter<\/a>&nbsp;to FDA Commissioner Califf and CDC Director Mandy Cohen on December 6, pressing for greater transparency about the potential for DNA integration into the human genome\u2014a concern that could have far-reaching implications.<\/p>\n\n\n\n<p>Ladapo raised alarms about potential nucleic acid contaminants in the Pfizer and Moderna COVID-19 mRNA vaccines, particularly those in combination with lipid nanoparticles and the identified Simian Virus 40 (SV40) promoter\/enhancer DNA.<\/p>\n\n\n\n<p>\u201cLipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells, and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter\/enhancer DNA may also pose a unique and heightened risk of DNA integration into host cells,\u201d wrote in the letter.<\/p>\n\n\n\n<p>The Gateway Pundit reported in 2022 that researchers in Sweden&nbsp;<a href=\"https:\/\/www.mdpi.com\/1467-3045\/44\/3\/73\/htm\">published<\/a>&nbsp;an alarming study showing that Pfizer\u2019s mRNA Covid vaccine can modify DNA within the human genome.<\/p>\n\n\n\n<p>The&nbsp;<a href=\"https:\/\/www.mdpi.com\/1467-3045\/44\/3\/73\/htm\">study<\/a>, which was published in the Journal of Clinical Medicine (MDPI), found that the SARS-CoV-2 RNA within the Pfizer vaccine can reverse-transcribe itself and install itself within the DNA of the human genome within a matter of just six hours following exposure to the vaccine.<\/p>\n\n\n\n<p>Aside from the self-explanatory issues of modifying DNA in humans without their knowledge, the changes can cause \u201cgenotoxic side effects,\u201d according to the&nbsp;<a href=\"https:\/\/www.mdpi.com\/1467-3045\/44\/3\/73\/htm\">study<\/a>.<\/p>\n\n\n\n<p>From the&nbsp;<a href=\"https:\/\/www.mdpi.com\/1467-3045\/44\/3\/73\/htm\">study<\/a>, titled \u201cIntracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line:\u201d<\/p>\n\n\n\n<p><em>\u201cOur study shows that BNT162b2&nbsp;can be reverse transcribed to DNA in liver cell line&nbsp;Huh7,&nbsp;and this may give rise to the concern if&nbsp;BNT162b2-derived DNA may be integrated into the host genome and affect the integrity of genomic DNA, which&nbsp;may potentially mediate genotoxic side effects.\u201d<\/em><\/p>\n\n\n\n<p>Researchers&nbsp;<a href=\"https:\/\/www.mdpi.com\/1467-3045\/44\/3\/73\/htm\">determined<\/a>&nbsp;that the mRNA concoction is able to enter the human cell lining at \u201chigh efficiency\u201d after observing the phenomenon happen within human liver cells in vitro (a lab setting). They detected \u201chigh levels\u201d of the foreign DNA within the liver cell after just a few hours. There were also rapid changes in gene expression within the affected cells.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>by\u00a0Jim H\u1d0fft\u00a0Jan. 5, 2025 TGP A group of high school students from Centreville High School in Virginia, in collaboration with the FDA, has uncovered alarming DNA contamination in both Pfizer\u2019s [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11148,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[669,761,854,337,914,974,607,608,1028],"tags":[],"class_list":["post-11146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-adenovirus-vector-vaccines","category-concerns","category-leaky-vaccines","category-mrna","category-pfizer-vaccine","category-vaccine-long-term-safety","category-vaccine-news","category-vaccine-safety","category-vaccine-shedding"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11146","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11146"}],"version-history":[{"count":3,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11146\/revisions"}],"predecessor-version":[{"id":11150,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11146\/revisions\/11150"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/11148"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}