Yet Another Validation of DNA Contaminants in COVID-19 mRNA Vaccines
TrialSite recently covered the unfolding “plasmidgate” controversy involving DNA contamination found in same of COVID-19 mRNA vaccine product. To date, this media reported on four such studies featuring what some experts are declaring are unacceptable amounts of DNA contamination in the mRNA vaccines, with an emphasis on the Pfizer-BioNTech product.
A new study has been uploaded to OSF Preprints, and one of the authors is a regular TrialSite contributor, David Wiseman, Ph.D., but also includes none other than Kevin McKernan of Medicinal Genomics in Beverly, Massachusetts, the investigator leading the first study verifying that DNA contaminants in the mRNA vaccine vials exceeded the European Medicines Agency 330ng/mg requirement and the Food and Drug Administration (FDA) 10g/dose requirements.
The new study is titled “DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.” While this study is not yet peer reviewed, meaning as a matter of scientific practice the findings should not be cited as evidence, the combination of seriousness, relevance and timeliness of findings merit high level introductory overview in the TrialSite.
Representing the study as corresponding author is Dr. David J. Speicher, Ph.D., DTM, a molecular virologist and clinical epidemiologist whose Ph.D. thesis in 2012, on the detection and characterization of HHV-8 led to the first HHV-8 quantitative PCR assay in Australia. He currently teaches and does research at University of Guelph.
Other authors involved with this study include Jessica Rose, Ph.D. and Maria Gutschi, a research pharmacist and drug assessor in Canada.
The study team acknowledges in their study paper the recent studies covered by TrialSite pointing to significant levels of plasmid DNA in both mRNA COVID-19 vaccine products (Pfizer-BioNTech and Moderna). But the authors acknowledge that the previous study findings were based on output based on a limited number of lots, as well as questions linked to variance and quality of the underlying samples used in those studies.
The Study
In vitro transcription employed to generate nucleoside RNA (modRNA) for SARS-CoV-2 vaccines to date relies on an RNA polymerase transcribing from a DNA template, meaning DNA is required in the mRNA production process.
In this context, as an example, the manufacture of the modRNA used in the original Pfizer randomized clinical trial was based on such PCR-generated DNA template.
In fact, by generating clones into a bacterial plasmid vector for amplification in Escherichia coli before linearization, part of the second process making up this study, the team can expand the size and complexity of possible residual DNA, while bringing sequences not present in the template mentioned above.
Articulating that Moderna’s vaccine, both clinical trials and post authorization mRNA product, is based on a comparable plasmid-based set of processes, the present authors used quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry as part of a process to test the additional 27 vials of mRNA COVID-19 vaccine product obtained in Canada.
With the samples drawn from 12 unique lots including:
5 lots of Moderna child/adult monovalent
1 lot of Moderna adult bivalent BA.4/5
1 lot of Moderna child/adult bivalent BA.1
1 lot of Moderna XBB.1.5 monovalent
3 lots of Pfizer adult monovalent
1 lot of Pfizer adult bivalent BA.4/5
To better understand safety profile, the authors queried the U.S. Vaccine Adverse Event Reporting System (VAERS) database for the number and categorization of adverse events (AEs) reported for each of the lots tested. Using Oxford Nanopore sequencing, this helped the team investigate the content of one of the previously studied Pfizer COVID-19 vaccine vials as part of the quest in this study to determine the size distribution of DNA fragments.
Speicher and team also used the sample to verify if the “residual DNA is packaged in the lipid nanoparticles (LNPs) and thus resistant to DNaseI or if the DNA resides outside of the LNP and is DNaseI labile.”
Findings
Based on the dose response model established, Speicher and team conducted an exploratory analysis, finding at least early evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). Could it be that COVID-19 mRNA vaccine safety as reflected in the number of safety incidences could be predicted based on this model?
The study authors report that the Pfizer and Moderna products differed based on size distribution analysis---mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively.
Disturbingly, the study authors write, “The plasmid DNA is likely inside the LNPs and is protected from nucleases.”
Takeaway
Of course, this study output needs to be vetted via peer review, but the authors demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the studied Pfizer and Moderna mRNA 19 vaccines.
The study team was able to verify using fluorometry that “all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”
During this study, Speicher et al. point to the need for methodological clarity and consistency when interpreting quantitative guidelines based on observations for instance, that the qPCR residual DNA content in all vaccines were below established guidelines.
They point out, “The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation.”
Perhaps most importantly is the overall mounting unease about the COVID-19 mRNA vaccines. This concern is expressed by the present authors:
“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection.”
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Ivermectin/Hydroxychloroquine Lawsuits Continue On
Physicians in Iowa are suing the state’s licensing boards to overturn restrictions associated with repurposed drugs used for COVID-19, including Hydroxychloroquine and Ivermectin. The physician has filed a civil lawsuit seeking a court order to force pharmacies to fill prescriptions for these drugs.
This news was reported by the Des Moines Register and other sources. Why is Iowa doctor David Hartsuch pursuing a lawsuit against the Iowa Board of Medicine and Iowa Board of Pharmacy? He is accusing them of dissuading members against use of hydroxychloroquine and ivermectin as a regimen for COVID-19.
Citing one study published in the Journal of the American Medical Association, the plaintiff points out that despite the fact that the FDA doesn’t authorize the drugs for COVID-19, approximately 1 in 20 U.S. adults are identified as using hydroxychloroquine or ivermectin for COVID-19 treatment.
Briefly authorized as an emergency medicine during COVID-19, Hydroxychloroquine’s status was revoked when ensuing research suggested the potential for harm. Although conflict ensued thereafter over the research, with some studies showing efficacy and others not. Ivermectin was never authorized in the United States although at least a dozen nations, mostly in low-and middle-income countries, authorized ivermectin on an emergency basis against COVID-19.
While some prominent larger studies (TOGETHER, COVID-OUT, ACTIV-6) showed no efficacy, many others have shown promise. For example, a website tracks ongoing studies which now total 99 studies covering 137,255 patients across 28 countries. The takeaway: the drug can statistically lower risk for mortality, ventilation, ICU and other targeted outcomes. But critics in institutions such as the NIH suggest these studies are not trustworthy, with poor design, questionable data, and the like.
Regardless, by 2021, weekly ivermectin prescriptions, according to one study, skyrocketed from 3,000 per week to nearly 90,000 per week!
The FDA joined in on an information war against the drug, labeling it only as an animal drug, when of course hundreds of millions of doses are administered to humans per year.
Iowa Clash
Dr. Hartsuch’s conflict with the Iowa licensing boards emerged in March 2020. While during summer and late 2020 growing ivermectin use across America was generally accommodated, as Biden entered the White House, the conditions changed.
This market demand triggered a massive industry, government and academic medical system response. TrialSite examined how the federal government went after doctors indirectly in December 2021. In “Feds coming after Doctors & Pharmacies that Market Ivermectin as Safe & Effective for COVID-19” for example, the FDA wrote letters to group such as the Federation of State Medical Boards (FSMB) warning state groups to monitor members for espousing misinformation involving ivermectin.
This campaign spooked doctors and pharmacists around the nation. By the fall of 2021, it was becoming harder for doctors such as Hartsuch to prescribe the off-label drug to his patients. Pharmacies were increasingly on alert.
So, a patient of Dr. Hartsuch for example, could not get ivermectin prescriptions filled, which led to investigations by the Board of Medicine into the doctor’s ivermectin prescribing trends.
But the Iowa physician points out in his complaint that warning letters received by the Iowa Board of Medicine were violative of core free speech rights, during his professional brand reputation.
Now seeking the court to expunge the warning letter from his record, he demands an injunction requiring pharmacies to fill prescriptions for the off-label drugs.
The Iowa physician’s point of view: doctors’ rights to consider and prescribe repurposed off-label drugs is a basic physician right, as long as they follow their professional standards (e.g., consent, etc.).
In other states such as Nebraska, the attorney general doesn’t enforce disciplinary measures should physicians prescribe drugs like ivermectin or hydroxychloroquine for COVID-19.
Before COVID-19 physicians routinely would prescribe off label drugs typically with little to no problems.
https://www.trialsitenews.com/a/ivermectinhydroxychloroquine-lawsuits-continue-on-81c1b8ee
********************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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