{"id":11524,"date":"2025-02-12T12:00:00","date_gmt":"2025-02-12T17:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=11524"},"modified":"2025-02-12T11:56:51","modified_gmt":"2025-02-12T16:56:51","slug":"fda-lab-uncovers-excess-dna-contamination-in-covid-19-vaccines","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=11524","title":{"rendered":"FDA Lab Uncovers Excess DNA Contamination In COVID-19 Vaccines"},"content":{"rendered":"\n<p class=\"has-small-font-size\"><em>Authored by Maryanne Demasi via The Brownstone Institute,<\/em><\/p>\n\n\n\n<p>An explosive new study conducted within the US Food and Drug Administration\u2019s (FDA) own laboratory has revealed excessively high levels of DNA contamination in Pfizer\u2019s mRNA Covid-19 vaccine.<\/p>\n\n\n\n<p>Tests conducted at the FDA\u2019s White Oak Campus in Maryland found that residual DNA levels\u00a0<strong>exceeded regulatory safety limits by 6 to 470 times.<a href=\"https:\/\/www.zerohedge.com\/s3\/files\/inline-images\/Shutterstock_146497574-800x469.jpg?itok=5pJCkhQ9\"><\/a><\/strong><\/p>\n\n\n\n<p>The study was undertaken by student researchers under the supervision of FDA scientists. The vaccine vials were sourced from BEI Resources, a trusted supplier affiliated with the National Institute of Allergy and Infectious Diseases (NIAID), previously headed by Anthony Fauci.<\/p>\n\n\n\n<p>Recently&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\">published<\/a>&nbsp;in the&nbsp;<em>Journal of High School Science<\/em>, the peer-reviewed study challenges years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless.<\/p>\n\n\n\n<p>The FDA is expected to comment on the findings this week. However, the agency has yet to issue a public alert, recall the affected batches, or explain how vials exceeding safety standards were allowed to reach the market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-the-methods\">The Methods<\/h2>\n\n\n\n<p>The student researchers employed two primary analytical methods:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NanoDrop Analysis<\/strong>\u00a0\u2013 This technique uses UV spectrometry to measure the combined levels of DNA and RNA in the vaccine. While it provides an initial assessment, it tends to overestimate DNA concentrations due to interference from RNA, even when RNA-removal kits are utilised.<\/li>\n\n\n\n<li><strong>Qubit Analysis<\/strong>\u00a0\u2013 For more precise measurements, the researchers relied on the Qubit system, which quantifies double-stranded DNA using fluorometric dye.<\/li>\n<\/ul>\n\n\n\n<p>Both methods confirmed the presence of DNA contamination far above permissible thresholds. These findings align with earlier reports from independent laboratories in the&nbsp;<a href=\"https:\/\/osf.io\/preprints\/osf\/b9t7m\">United States<\/a>,&nbsp;<a href=\"https:\/\/osf.io\/preprints\/osf\/mjc97\">Canada<\/a>,&nbsp;<a href=\"https:\/\/www.dropbox.com\/scl\/fi\/sb20elb520v6a1saxg9lj\/240909-D-Speicher-Report.pdf?rlkey=dutcvd85gh80ebfs2ucdmorba&amp;e=2&amp;st=0jpsw84f&amp;dl=0\">Australia<\/a>,&nbsp;<a href=\"https:\/\/www.mdpi.com\/2409-9279\/7\/3\/41\">Germany<\/a>,&nbsp;and&nbsp;<a href=\"https:\/\/hal.science\/hal-04778576v1\">France<\/a>.<\/p>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"h-expert-reaction\">Expert Reaction<\/h1>\n\n\n\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><em><strong>\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<\/strong><\/em>\u00a0McKernan questioned.<a href=\"https:\/\/www.zerohedge.com\/s3\/files\/inline-images\/image-7-800x452.jpg?itok=Uk9jgp0K\"><\/a><\/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><em><strong>\u201cThe Qubit analysis can under-detect DNA by up to 70% when enzymes are used during sample preparation,\u201d<\/strong><\/em>&nbsp;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>In addition to genome integration, McKernan highlighted another potential cancer-causing mechanism of DNA contamination in the vaccines.<\/p>\n\n\n\n<p>He explained that plasmid DNA fragments entering the cell\u2019s cytoplasm with the help of lipid nanoparticles could&nbsp;<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/31852718\/\">overstimulate<\/a>&nbsp;the&nbsp;<strong>cGAS-STING pathway<\/strong>, a crucial component of the innate immune response.<\/p>\n\n\n\n<p>\u201cChronic activation of the cGAS-STING pathway could paradoxically fuel cancer growth,\u201d McKernan warned. \u201cRepeated exposure to foreign DNA through COVID-19 boosters may amplify this risk over time, creating conditions conducive to cancer development.\u201d<\/p>\n\n\n\n<p>Adding to the controversy, traces of the SV40 promoter were detected among the DNA fragments. While the authors concluded that these fragments were \u201cnon-replication-competent\u201d meaning they cannot replicate in humans, McKernan disagreed.<\/p>\n\n\n\n<p><em><strong>\u201cTo assert that the DNA fragments are non-functional, they would need to transfect mammalian cells and perform sequencing, which wasn\u2019t done here,\u201d<\/strong><\/em>&nbsp;McKernan stated.<\/p>\n\n\n\n<p>\u201cMoreover, the methods used in this study don\u2019t effectively capture the full length of DNA fragments. A more rigorous sequencing analysis could reveal SV40 fragments several thousand base pairs long, which would likely be functional,\u201d he added.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-oversight-under-scrutiny\">Regulatory Oversight under Scrutiny<\/h2>\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.<a href=\"https:\/\/www.zerohedge.com\/s3\/files\/inline-images\/image-6-800x449.jpg?itok=cVrPIxOZ\"><\/a><\/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><em><strong>\u201cThe irony is striking,\u201d<\/strong><\/em>&nbsp;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\n\n\n<p>The Australian Therapeutic Goods Administration (TGA), which has consistently defended the safety of the mRNA vaccines,&nbsp;<a href=\"https:\/\/blog.maryannedemasi.com\/p\/tga-releases-data-on-residual-dna?utm_source=publication-search\">released<\/a>&nbsp;its own batch testing results, claiming they met regulatory standards. However, Prof Petrovsky criticised the TGA\u2019s testing methods.<\/p>\n\n\n\n<p><em><strong>\u201cThe TGA\u2019s method was not fit for purpose,\u201d&nbsp;<\/strong><\/em>he argued. \u201cIt didn\u2019t assess all the DNA in the vials. It only looked for a small fragment, which would severely underestimate the total amount of DNA detected.\u201d<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Implications for Manufacturers and Regulators<\/h3>\n\n\n\n<p>Now that DNA contamination of the mRNA vaccines has been verified in the laboratory of an official agency and published in a peer-reviewed journal, it becomes difficult to ignore.<\/p>\n\n\n\n<p><strong>It also places vaccine manufacturers and regulators in a precarious position.<\/strong><\/p>\n\n\n\n<p>Addressing the contamination issue would likely require revising manufacturing processes to remove residual DNA, which Prof Petrovsky explained would be impractical.<\/p>\n\n\n\n<p><em><strong>\u201cThe only practical solution is for regulators to require manufacturers to demonstrate that the plasmid DNA levels in the vaccines are safe,\u201d<\/strong>&nbsp;Prof Petrovsky stated.<\/em><\/p>\n\n\n\n<p><em>\u201cOtherwise, efforts to remove the residual DNA would result in an entirely new vaccine, requiring new trials and effectively restarting the process with an untested product.\u201d<\/em><\/p>\n\n\n\n<p>Now the onus is on regulators to provide clarity and take decisive action to restore confidence in their oversight. Anything less risks deepening the scepticism of the public.&nbsp;<\/p>\n\n\n\n<p>Both the US and Australian drug regulators have been approached for comment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Authored by Maryanne Demasi via The Brownstone Institute, An explosive new study conducted within the US Food and Drug Administration\u2019s (FDA) own laboratory has revealed excessively high levels of DNA [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11526,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[68,126,854,337,914,1203,973,974,607,608],"tags":[],"class_list":["post-11524","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cancer","category-dna","category-leaky-vaccines","category-mrna","category-pfizer-vaccine","category-sv-40","category-vaccine-failure","category-vaccine-long-term-safety","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11524","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=11524"}],"version-history":[{"count":1,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11524\/revisions"}],"predecessor-version":[{"id":11525,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11524\/revisions\/11525"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/11526"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11524"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11524"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11524"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}