TruthArchive.ai - Tweets Saved By @joshg99

@joshg99 - Josh Guetzkow

What?!? In 2022 & 2023, the FDA cited significant violations at an EU facility where Pfizer's mRNA 'drug substance' is purified prior to LNP encapsulation. Violations including failure to assure compliance w/specifications & standards for endotoxin testing. But there's more! 🧵

@joshg99 - Josh Guetzkow

Background: Pfizer used a new process scale up production for the commercial product (different from the one it tested). Using plasmids grown in E.coli bacteria, the new process introduced DNA & endotoxin contamination that required thorough purification. https://x.com/joshg99/status/1658421192326365185

@joshg99 - Josh Guetzkow

Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch? There were >44,000 people in the trial, but only ~250 of them were given doses made with a new manufacturing method ('process 2') that was used to make enough doses to sell around the world.

@joshg99 - Josh Guetzkow

In Oct. 2020, Rentschler Biopharma announced its contract w/Pfizer for "downstream processing to provide highly purified drug substance" where process-related "impurities will be effectively removed" at its Laupheim, Baden-Württemberg facility in Germany. https://www.rentschler-biopharma.com/news/press-releases-and-announcements/detail/view/joining-forces-against-sars-cov-2

News - Press Releases and Announcements - Detail - Rentschler Biopharma SE Rentschler Biopharma SE is your biopharmaceutical CDMO partner specializing in bioprocess development, drug production, biopharmaceutical manufacturing and regulatory support. We’ve been leading the way in the biopharmaceutical industry since 1927. rentschler-biopharma.com

@joshg99 - Josh Guetzkow

In Feb '22 the FDA notified the facility of 9 violations including the endotoxin testing problem above, their samples for testing were not representative of the final product & no system to alert them to ultracold storage freezer failures they found. https://www.fiercepharma.com/manufacturing/rentschler-slapped-form-483-citing-lax-manufacturing-procedures

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. fiercepharma.com

@joshg99 - Josh Guetzkow

In March '23 the FDA again notified the facility of 5 new violations, including poor monitoring of endotoxin contamination of equipment and other procedures inadequate to prevent microbial contamination. https://www.fiercepharma.com/manufacturing/manufacturing-operations-eli-lilly-rentschler-reprimanded-fda-form-483-filings

Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the United States' drug regulator is making concerns about the facilities public. fiercepharma.com

@joshg99 - Josh Guetzkow

Why does this matter? In 2021 Pfizer started a study to compare multiple production lots of its COVID vaccine for safety, tolerability, and immunogenicity. It seems they were all lots made with process 2, which was used for commercial supply.

@joshg99 - Josh Guetzkow

The study compared 3 lots made in the US to 1 lot made in the EU. This table from a leaked FDA document indicates that all purification of drug substance made in Europe was done at the Rentschler site.

@joshg99 - Josh Guetzkow

The comparability study found the EU lot had double the rate of adverse events as the combined US lots -- a difference which is statistically significant. The EU lot had 1 serious AE out of 173 subjects compared with 1 SAE from US lots with 1,049 participants (0.1% vs. 0.6%).

@joshg99 - Josh Guetzkow

In short, Pfizer's own lot-to-lot comparison study shows a significant difference in the safety of doses made in the US vs. doses made in the EU that passed through this manufacturing plant in Germany for purification prior to being encapsulated in LNPs at a different site.

@joshg99 - Josh Guetzkow

The tests Pfizer used to check for DNA and endotoxin are not suited to detect contamination encapsulated in the LNPs. That's why purification prior to encapsulation is so important. And may explain at least in part the increased dangers of the EU-manufactured lots.

@joshg99 - Josh Guetzkow

For more on the dangers of DNA contamination in the mRNA vaccines, see this pre-print: https://osf.io/mjc97/ For more on the dangers of endotoxin contamination see Geoff Pain's blog (endotoxins are pieces of E.coli membranes): https://geoffpain.substack.com/

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. Background: In vitro transcription (IVT) reactions used to generate nucleoside modified RNA (modRNA) for SARS-CoV-2 vaccines currently rely on an RNA polymerase transcribing from a DNA template. Production of modRNA used in the original Pfizer randomized clinical trial (RCT) utilized a PCR-generated DNA template (Process 1). To generate billions of vaccine doses, this DNA was cloned into a bacterial plasmid vector for amplification in Escherichia coli before linearization (Process 2), expanding the size and complexity of potential residual DNA and introducing sequences not present in the Process 1 template. It appears that Moderna used a similar plasmid-based process for both clinical trial and post-trial use vaccines. Recently, DNA sequencing studies have revealed this plasmid DNA at significant levels in both Pfizer-BioNTech and Moderna modRNA vaccines. These studies surveyed a limited number of lots and questions remain regarding the variance in residual DNA observed internationally. Methods: Using previously published primer and probe sequences, quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry was performed on an additional 27 mRNA vials obtained in Canada and drawn from 12 unique lots (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, and 1 lot of Pfizer adult bivalent BA.4/5). The Vaccine Adverse Events Reporting System (VAERS) database was queried for the number and categorization of adverse events (AEs) reported for each of the lots tested. The content of one previously studied vial of Pfizer COVID-19 vaccine was examined by Oxford Nanopore sequencing to determine the size distribution of DNA fragments. This sample was also used to determine 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.  Results: Quantification cycle (Cq) values (1:10 dilution) for the plasmid origin of replication (ori) and spike sequences ranged from 18.44 - 24.87 and 18.03 - 23.83 and for Pfizer, and 22.52 – 24.53 and 25.24 – 30.10 for Moderna, respectively. These values correspond to 0.28 – 4.27 ng/dose and 0.22 - 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR, and 1,896 – 3,720 ng/dose and 3,270 – 5,100 ng/dose measured by Qubit® fluorometry for Pfizer and Moderna, respectfully. The SV40 promoter-enhancer-ori was only detected in Pfizer vials with Cq scores ranging from 16.64 – 22.59. In an exploratory analysis, we found preliminary evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). This relationship was different for the Pfizer and Moderna products. Size distribution analysis found mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively. The plasmid DNA is likely inside the LNPs and is protected from nucleases. Conclusion: These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry, all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold. However, qPCR residual DNA content in all vaccines were below these guidelines emphasizing the importance of methodological clarity and consistency when interpreting quantitative guidelines. The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation. Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection using LNPs. With several obvious limitations, we urge that our work is replicated under forensic conditions and that guidelines be revised to account for highly efficient DNA transfection and cumulative dosing. osf.io

Geoff Pain PhD | GeoffPainPhD | Substack Tromethamine aka Tris, THAM and many other names is biologically active. Click to read Geoff Pain PhD, by GeoffPainPhD, a Substack publication with thousands of subscribers. geoffpain.substack.com

@joshg99 - Josh Guetzkow

Big thanks to @Quo_vadis_BRD for bringing the FDA reports to my attention & @a_nineties for clarifying important issues related to Pfizer's comparability study.

@joshg99 - Josh Guetzkow

Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch? There were >44,000 people in the trial, but only ~250 of them were given doses made with a new manufacturing method ('process 2') that was used to make enough doses to sell around the world.

@joshg99 - Josh Guetzkow

To our knowledge, the safety and efficacy comparison they planned to do with those 250 subjects has never been published and has not been released in the FOIA'd documents that Pfizer submitted to the FDA. Was the comparison ever done? Where are the results?

@joshg99 - Josh Guetzkow

@RetsefL and I explore the importance of this comparison and the potential impact of variability in the the production process of COVID-19 mRNA vaccines on efficacy and safety in a newly published rapid response in the @bmj_latest. https://www.bmj.com/content/378/bmj.o1731/rr-2

Effect of mRNA Vaccine Manufacturing Processes on Efficacy and Safety Still an Open Question bmj.com

@joshg99 - Josh Guetzkow

Keep in mind that one of the major changes in the new production process was using bacterial cDNA to upscale production of mRNA. @Kevin_McKernan's analysis of vaccine vials found unacceptably high levels of leftover bacterial DNA. https://www.rebelnews.com/genomics_expert_discovers_concerning_contents_in_covid_vaccine_vials

Genomics expert discovers concerning contents in COVID vaccine vials Former research and development leader at the Human Genome Project has taken citizen science into his own hands to learn more about what exactly lurks in the vials of the novel COVID-19 injections. rebelnews.com

@joshg99 - Josh Guetzkow

Pfizer's 6-month report to the FDA doesn't include the process 2 comparison, but it does show a significantly higher serious adverse event rate in placebo subjects after they were given the vaccine compared to the original vaccine group, "as expected." Why was it expected?

@joshg99 - Josh Guetzkow

We know from FOIA'd documents that about 70% of the trial sites received new batches with distinct Pfizer lot numbers after Nov. 19. Were these intended for the crossover placebo subjects? Were they different than the doses given to the original treatment group? And if so, how?

@joshg99 - Josh Guetzkow

In addition, a recent Danish study found significant variability in the rate of serious adverse events across 52 different lots of Comirnaty. https://onlinelibrary.wiley.com/doi/10.1111/eci.13998

@joshg99 - Josh Guetzkow

Taken together, evidence from trial documents and existing research underscores the need to better understand the potential impact of variability in the production process of COVID-19 mRNA vaccines on efficacy and safety.

@joshg99 - Josh Guetzkow

I forgot to add: The two process 2 lots sent to 8 trial sites were also given to the public. There are 1,149 reports in VAERS for these lots, including 307 serious adverse events and 23 deaths.

@joshg99 - Josh Guetzkow

This thread is also highly relevant to manufacturing standards and batch toxicity:

@Jikkyleaks - Jikkyleaks 🐭

HOLY CHEESE 🧀🧀🧀 I have discovered something that should lead to the immediate investigation of the TGA and every drug regulator Two FOIs prove that there were batches of #Pfizer vaccine that had killed people and should have failed the batch analysis. But they kept jabbing.

@joshg99 - Josh Guetzkow

Somebody asked if study C4591017 was the process 2 comparison trial: https://clinicaltrialsregister.eu/ctr-search/trial/2021-005903-11/results It isn't though it does compare 5 (unidentified) lots & found a 2x rate of subjects experiencing at least one AE and AEs judged related to the vaccine in one lot & variation in SAEs.

@joshg99 - Josh Guetzkow

In case it isn't clear, the 2 production processes were radically different and yielded different quality products! You can't just test it on 250 people and say it's all the same. They could not be assumed to be bio-similar, like name-brand and generic.

@joshg99 - Josh Guetzkow

@joshg99 - Josh Guetzkow

My 30 min. discussion with Dr. Paul Thomas on the Pfizer/BioNTech COVID vaccine bait-and-switch is live! Starts 5:30. Second half of video is an interview of Paul about his book, The Vaccine-Friendly Plan & how his views have changed since he wrote it. https://rumble.com/v2sp3wa-bait-and-switch-with-josh-guetzkow.html

Bait-and-Switch With Josh Guetzkow Josh Guetzkow, this week’s guest, is an investigative journalist. In this episode of ‘With the Wind,’ he explains Pfizer’s BioNTech COVID vaccine clinical trial bait-and-switch scheme and its effects rumble.com

@joshg99 - Josh Guetzkow

@joshg99 - Josh Guetzkow

This article has excellent coverage of this issue. It also points out the fact that the manufacturer was never required to test process 2 jabs on lab animals. Or at least we've never seen results of such tests. https://www.conservativewoman.co.uk/how-hancock-and-the-fiercely-independent-mhra-helped-pfizer-game-the-vaccine-approval-process/

How Hancock and the ‘fiercely independent’ MHRA recklessly rolled out a vaccine tested on only 500 people - The Conservative Woman How Hancock and the ‘fiercely independent’ MHRA recklessly rolled out a vaccine tested on only 500 people conservativewoman.co.uk

@joshg99 - Josh Guetzkow

Genomics expert, professor @P_J_Buckhaults U of South Carolina, testifies on the potential risks of the DNA contamination he found in vials of mRNA vaccine entirely that was entirely due to the switch to process 2. https://x.com/TheChiefNerd/status/1703544942004478251

@joshg99 - Josh Guetzkow

However I suspect that the endotoxin contamination is likely a bigger problem, both because it is probably a major factor in many adverse events and because it is basically impossible to purify. For more on endotoxin risks: https://geoffpain.substack.com/

Geoff Pain PhD | GeoffPainPhD | Substack Tromethamine aka Tris, THAM and many other names is biologically active. Click to read Geoff Pain PhD, by GeoffPainPhD, a Substack publication with thousands of subscribers. geoffpain.substack.com

@joshg99 - Josh Guetzkow

See this thread for a further update showing that Pfizer/BioNTech never did the planned study comparing process 2 v 1 for safety and immunogenicity: https://x.com/joshg99/status/1705177305499279525

@joshg99 - Josh Guetzkow

A professor and expert in cancer genetics at U of South Carolina testifies on risks posed by process 2 jabs due to the plasmid DNA contamination: https://www.youtube.com/watch?v=IEWHhrHiiTY

@joshg99 - Josh Guetzkow

And a transcript of his interview with Maryanne Demasi: https://maryannedemasi.substack.com/p/exclusive-an-interview-with-buckhaults

EXCLUSIVE: An interview with Buckhaults about DNA contamination in covid vaccines... and the FDA responds Earlier this year, genomics expert Kevin McKernan first discovered DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots. He published his findings in a pre-print, but the research received little attention from the mainstream media. maryannedemasi.substack.com

@joshg99 - Josh Guetzkow

Great talk by @hedleyrees discussing the intricacies and challenges of biologic drug manufacturing: https://rumble.com/v3fqujk-challenges-in-manufacturing-and-distributing-products-derived-from-biologic.html

Challenges in manufacturing and distributing products derived from biologics | Hedley Rees The pharmaceutical industry was founded on small molecule products, where active ingredients were manufactured by fine chemical companies using long-established industrial processing. That meant the f rumble.com

@joshg99 - Josh Guetzkow

Our new pre-print on COVID-19 vaccine safety in pregnancy is out! Women vaccinated in early pregnancy (weeks 8-13) had a higher-than-expected number of fetal losses: Dose 1 = 3.9 more per 100 women Dose 3 = 1.9 more per 100 women Based on data on >200K pregnancies in Israel 🧵

@joshg99 - Josh Guetzkow

2/ Late pregnancy losses were a *big* part of the signal. Among all women: 1.1% lost their pregnancy after week 24. Compared to: 2.7% of women who received dose 1 in early weeks. 1.8% of women who received dose 3 in early weeks.

@joshg99 - Josh Guetzkow

3/ In fact, most of the excess losses occurred later in pregnancy, including nearly half after week 24. In Israel, abortions after week 24 are rare and must be medically justified and are very rare. This strongly suggests biological, not behavioral, mechanisms are involved.

@joshg99 - Josh Guetzkow

4/ In stark contrast, women vaccinated for influenza in the same weeks (8-13) saw *FEWER* fetal losses than expected, about 5 per 100 women vaccinated. What's the significance of that?

@joshg99 - Josh Guetzkow

5/ Comparing both types of vaccines helps control for bias in who chooses to get vaccinated. For example, if women vaccinate in early pregnancy because they have health problems, the elevated fetal loss risk for COVID-19 vaccines could simply be due to that bias.

@joshg99 - Josh Guetzkow

6/ But people who get vaccinated are usually healthier & more health conscious to begin with. This is called healthy vaccinee bias & can make vaccines look safer than they really are. It's a known – but often ignored -- issue in vaccine safety research based on real-world data.

@joshg99 - Josh Guetzkow

7/ Influenza vaccination during pregnancy showed lower-than-expected fetal losses—likely due to healthy vaccine bias. So it's even more striking that mRNA COVID-19 vaccination in early pregnancy showed higher-than-expected fetal losses—despite healthy vaccinee bias.

@joshg99 - Josh Guetzkow

8/ Our findings don’t prove causation. But they point to a clear safety signal—one that calls for further investigation, especially given the vulnerability of this population.

@joshg99 - Josh Guetzkow

9/ So why hasn’t this been seen before? Most other studies compare vaccinated vs. unvaccinated women during vaccination campaigns. That approach is vulnerable to bias—especially if healthier women are more likely to vaccinate (a.k.a. “healthy vaccinee bias”).

@joshg99 - Josh Guetzkow

10/ Our approach was different. We used detailed medical records to estimate expected fetal loss rates for each vaccinated woman—based on her individual risk factors and pregnancy timing—using data from pre-COVID years.

@joshg99 - Josh Guetzkow

11/ Here is a link to the pre-print: https://medrxiv.org/cgi/content/short/2025.06.18.25329352v1 This was of course a team effort with my amazing co-authors: @RetsefL, @TalPatalon, Sivan Gazit, @TracyBethHoeg, @JosephFraiman and Yaakov Segal.

Observed-to-Expected Fetal Losses Following mRNA COVID-19 Vaccination in Early Pregnancy medRxiv - The Preprint Server for Health Sciences medrxiv.org

@joshg99 - Josh Guetzkow

https://t.co/se1GOqkvtl

@RetsefL - Retsef Levi

BREAKING: Analysis of over 220K pregnancies in Israel during 2016- 2022 found that mRNA COVID-19 vaccination during gestational weeks 8-13 was associated with a higher-than-expected number of eventual fetal losses (miscarriages, abortions & stillbirths)! Pregnant women vaccinated with dose 1 during weeks 8-13 had nearly 3.9 (95% CI: [2.55-5.14]) additional fetal losses above expected per 100 pregnancies. Most of the excess fetal losses occurred after gestational week 20 and nearly half occurred after gestational week 25. In contrast, pregnant women vaccinated for influenza during weeks 8-27 exhibited a consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias. Women vaccinated for COVID-19 or influenza prior to pregnancy exhibited according-to-expected or lower-than-expected numbers of fetal losses. The study used innovative observed-to-expected methodology, where data from prior years were leveraged to determine the expected number of fetal losses based on the individual characteristics of the pregnant women who vaccinated and their week of vaccination.

@joshg99 - Josh Guetzkow

@JesslovesMJK nails the coffin on the placebo theory. Great work! Age and date profile is totally different and SAEs abound. Yellow dots prob. used for boosters?@ChrisEd16512812@FluoridePoison@EdV1694@TheChiefNerd @denisrancourt https://open.substack.com/pub/jessicar/p/debunking-the-yellow-dot-lot-placebo

Debunking the yellow dot lot placebo theory... What do the VAERS reports look like for the yellow (and blue) lots in the Schmeling, Manniche, Riis Hansen study? jessicar.substack.com

@joshg99 - Josh Guetzkow

What?!? In 2022 & 2023, the FDA cited significant violations at an EU facility where Pfizer's mRNA 'drug substance' is purified prior to LNP encapsulation. Violations including failure to assure compliance w/specifications & standards for endotoxin testing. But there's more! 🧵

@joshg99 - Josh Guetzkow

Background: Pfizer used a new process scale up production for the commercial product (different from the one it tested). Using plasmids grown in E.coli bacteria, the new process introduced DNA & endotoxin contamination that required thorough purification. https://x.com/joshg99/status/1658421192326365185

@joshg99 - Josh Guetzkow

Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch? There were >44,000 people in the trial, but only ~250 of them were given doses made with a new manufacturing method ('process 2') that was used to make enough doses to sell around the world.

@joshg99 - Josh Guetzkow

In Oct. 2020, Rentschler Biopharma announced its contract w/Pfizer for "downstream processing to provide highly purified drug substance" where process-related "impurities will be effectively removed" at its Laupheim, Baden-Württemberg facility in Germany. https://www.rentschler-biopharma.com/news/press-releases-and-announcements/detail/view/joining-forces-against-sars-cov-2

News - Press Releases and Announcements - Detail - Rentschler Biopharma SE Rentschler Biopharma SE is your biopharmaceutical CDMO partner specializing in bioprocess development, drug production, biopharmaceutical manufacturing and regulatory support. We’ve been leading the way in the biopharmaceutical industry since 1927. rentschler-biopharma.com

@joshg99 - Josh Guetzkow

In Feb '22 the FDA notified the facility of 9 violations including the endotoxin testing problem above, their samples for testing were not representative of the final product & no system to alert them to ultracold storage freezer failures they found. https://www.fiercepharma.com/manufacturing/rentschler-slapped-form-483-citing-lax-manufacturing-procedures

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. fiercepharma.com

@joshg99 - Josh Guetzkow

In March '23 the FDA again notified the facility of 5 new violations, including poor monitoring of endotoxin contamination of equipment and other procedures inadequate to prevent microbial contamination. https://www.fiercepharma.com/manufacturing/manufacturing-operations-eli-lilly-rentschler-reprimanded-fda-form-483-filings

Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the United States' drug regulator is making concerns about the facilities public. fiercepharma.com

@joshg99 - Josh Guetzkow

Why does this matter? In 2021 Pfizer started a study to compare multiple production lots of its COVID vaccine for safety, tolerability, and immunogenicity. It seems they were all lots made with process 2, which was used for commercial supply.

@joshg99 - Josh Guetzkow

The study compared 3 lots made in the US to 1 lot made in the EU. This table from a leaked FDA document indicates that all purification of drug substance made in Europe was done at the Rentschler site.

@joshg99 - Josh Guetzkow

The comparability study found the EU lot had double the rate of adverse events as the combined US lots -- a difference which is statistically significant. The EU lot had 1 serious AE out of 173 subjects compared with 1 SAE from US lots with 1,049 participants (0.1% vs. 0.6%).

@joshg99 - Josh Guetzkow

In short, Pfizer's own lot-to-lot comparison study shows a significant difference in the safety of doses made in the US vs. doses made in the EU that passed through this manufacturing plant in Germany for purification prior to being encapsulated in LNPs at a different site.

@joshg99 - Josh Guetzkow

The tests Pfizer used to check for DNA and endotoxin are not suited to detect contamination encapsulated in the LNPs. That's why purification prior to encapsulation is so important. And may explain at least in part the increased dangers of the EU-manufactured lots.

@joshg99 - Josh Guetzkow

For more on the dangers of DNA contamination in the mRNA vaccines, see this pre-print: https://osf.io/mjc97/ For more on the dangers of endotoxin contamination see Geoff Pain's blog (endotoxins are pieces of E.coli membranes): https://geoffpain.substack.com/

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. Background: In vitro transcription (IVT) reactions used to generate nucleoside modified RNA (modRNA) for SARS-CoV-2 vaccines currently rely on an RNA polymerase transcribing from a DNA template. Production of modRNA used in the original Pfizer randomized clinical trial (RCT) utilized a PCR-generated DNA template (Process 1). To generate billions of vaccine doses, this DNA was cloned into a bacterial plasmid vector for amplification in Escherichia coli before linearization (Process 2), expanding the size and complexity of potential residual DNA and introducing sequences not present in the Process 1 template. It appears that Moderna used a similar plasmid-based process for both clinical trial and post-trial use vaccines. Recently, DNA sequencing studies have revealed this plasmid DNA at significant levels in both Pfizer-BioNTech and Moderna modRNA vaccines. These studies surveyed a limited number of lots and questions remain regarding the variance in residual DNA observed internationally. Methods: Using previously published primer and probe sequences, quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry was performed on an additional 27 mRNA vials obtained in Canada and drawn from 12 unique lots (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, and 1 lot of Pfizer adult bivalent BA.4/5). The Vaccine Adverse Events Reporting System (VAERS) database was queried for the number and categorization of adverse events (AEs) reported for each of the lots tested. The content of one previously studied vial of Pfizer COVID-19 vaccine was examined by Oxford Nanopore sequencing to determine the size distribution of DNA fragments. This sample was also used to determine 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.  Results: Quantification cycle (Cq) values (1:10 dilution) for the plasmid origin of replication (ori) and spike sequences ranged from 18.44 - 24.87 and 18.03 - 23.83 and for Pfizer, and 22.52 – 24.53 and 25.24 – 30.10 for Moderna, respectively. These values correspond to 0.28 – 4.27 ng/dose and 0.22 - 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR, and 1,896 – 3,720 ng/dose and 3,270 – 5,100 ng/dose measured by Qubit® fluorometry for Pfizer and Moderna, respectfully. The SV40 promoter-enhancer-ori was only detected in Pfizer vials with Cq scores ranging from 16.64 – 22.59. In an exploratory analysis, we found preliminary evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). This relationship was different for the Pfizer and Moderna products. Size distribution analysis found mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively. The plasmid DNA is likely inside the LNPs and is protected from nucleases. Conclusion: These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry, all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold. However, qPCR residual DNA content in all vaccines were below these guidelines emphasizing the importance of methodological clarity and consistency when interpreting quantitative guidelines. The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation. Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection using LNPs. With several obvious limitations, we urge that our work is replicated under forensic conditions and that guidelines be revised to account for highly efficient DNA transfection and cumulative dosing. osf.io

Geoff Pain PhD | GeoffPainPhD | Substack Tromethamine aka Tris, THAM and many other names is biologically active. Click to read Geoff Pain PhD, by GeoffPainPhD, a Substack publication with thousands of subscribers. geoffpain.substack.com

@joshg99 - Josh Guetzkow

Big thanks to @Quo_vadis_BRD for bringing the FDA reports to my attention & @a_nineties for clarifying important issues related to Pfizer's comparability study.

@joshg99 - Josh Guetzkow

Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch? There were >44,000 people in the trial, but only ~250 of them were given doses made with a new manufacturing method ('process 2') that was used to make enough doses to sell around the world.

@joshg99 - Josh Guetzkow

To our knowledge, the safety and efficacy comparison they planned to do with those 250 subjects has never been published and has not been released in the FOIA'd documents that Pfizer submitted to the FDA. Was the comparison ever done? Where are the results?

@joshg99 - Josh Guetzkow

@RetsefL and I explore the importance of this comparison and the potential impact of variability in the the production process of COVID-19 mRNA vaccines on efficacy and safety in a newly published rapid response in the @bmj_latest. https://www.bmj.com/content/378/bmj.o1731/rr-2

Effect of mRNA Vaccine Manufacturing Processes on Efficacy and Safety Still an Open Question bmj.com

@joshg99 - Josh Guetzkow

Keep in mind that one of the major changes in the new production process was using bacterial cDNA to upscale production of mRNA. @Kevin_McKernan's analysis of vaccine vials found unacceptably high levels of leftover bacterial DNA. https://www.rebelnews.com/genomics_expert_discovers_concerning_contents_in_covid_vaccine_vials

Genomics expert discovers concerning contents in COVID vaccine vials Former research and development leader at the Human Genome Project has taken citizen science into his own hands to learn more about what exactly lurks in the vials of the novel COVID-19 injections. rebelnews.com

@joshg99 - Josh Guetzkow

Pfizer's 6-month report to the FDA doesn't include the process 2 comparison, but it does show a significantly higher serious adverse event rate in placebo subjects after they were given the vaccine compared to the original vaccine group, "as expected." Why was it expected?

@joshg99 - Josh Guetzkow

We know from FOIA'd documents that about 70% of the trial sites received new batches with distinct Pfizer lot numbers after Nov. 19. Were these intended for the crossover placebo subjects? Were they different than the doses given to the original treatment group? And if so, how?

@joshg99 - Josh Guetzkow

In addition, a recent Danish study found significant variability in the rate of serious adverse events across 52 different lots of Comirnaty. https://onlinelibrary.wiley.com/doi/10.1111/eci.13998

@joshg99 - Josh Guetzkow

Taken together, evidence from trial documents and existing research underscores the need to better understand the potential impact of variability in the production process of COVID-19 mRNA vaccines on efficacy and safety.

@joshg99 - Josh Guetzkow

I forgot to add: The two process 2 lots sent to 8 trial sites were also given to the public. There are 1,149 reports in VAERS for these lots, including 307 serious adverse events and 23 deaths.

@joshg99 - Josh Guetzkow

This thread is also highly relevant to manufacturing standards and batch toxicity:

@Jikkyleaks - Jikkyleaks 🐭

HOLY CHEESE 🧀🧀🧀 I have discovered something that should lead to the immediate investigation of the TGA and every drug regulator Two FOIs prove that there were batches of #Pfizer vaccine that had killed people and should have failed the batch analysis. But they kept jabbing.

@joshg99 - Josh Guetzkow

Somebody asked if study C4591017 was the process 2 comparison trial: https://clinicaltrialsregister.eu/ctr-search/trial/2021-005903-11/results It isn't though it does compare 5 (unidentified) lots & found a 2x rate of subjects experiencing at least one AE and AEs judged related to the vaccine in one lot & variation in SAEs.

@joshg99 - Josh Guetzkow

In case it isn't clear, the 2 production processes were radically different and yielded different quality products! You can't just test it on 250 people and say it's all the same. They could not be assumed to be bio-similar, like name-brand and generic.

@joshg99 - Josh Guetzkow

@joshg99 - Josh Guetzkow

My 30 min. discussion with Dr. Paul Thomas on the Pfizer/BioNTech COVID vaccine bait-and-switch is live! Starts 5:30. Second half of video is an interview of Paul about his book, The Vaccine-Friendly Plan & how his views have changed since he wrote it. https://rumble.com/v2sp3wa-bait-and-switch-with-josh-guetzkow.html

Bait-and-Switch With Josh Guetzkow Josh Guetzkow, this week’s guest, is an investigative journalist. In this episode of ‘With the Wind,’ he explains Pfizer’s BioNTech COVID vaccine clinical trial bait-and-switch scheme and its effects rumble.com

@joshg99 - Josh Guetzkow

@joshg99 - Josh Guetzkow

This article has excellent coverage of this issue. It also points out the fact that the manufacturer was never required to test process 2 jabs on lab animals. Or at least we've never seen results of such tests. https://www.conservativewoman.co.uk/how-hancock-and-the-fiercely-independent-mhra-helped-pfizer-game-the-vaccine-approval-process/

How Hancock and the ‘fiercely independent’ MHRA recklessly rolled out a vaccine tested on only 500 people - The Conservative Woman How Hancock and the ‘fiercely independent’ MHRA recklessly rolled out a vaccine tested on only 500 people conservativewoman.co.uk

@joshg99 - Josh Guetzkow

Genomics expert, professor @P_J_Buckhaults U of South Carolina, testifies on the potential risks of the DNA contamination he found in vials of mRNA vaccine entirely that was entirely due to the switch to process 2. https://x.com/TheChiefNerd/status/1703544942004478251

@joshg99 - Josh Guetzkow

However I suspect that the endotoxin contamination is likely a bigger problem, both because it is probably a major factor in many adverse events and because it is basically impossible to purify. For more on endotoxin risks: https://geoffpain.substack.com/

Geoff Pain PhD | GeoffPainPhD | Substack Tromethamine aka Tris, THAM and many other names is biologically active. Click to read Geoff Pain PhD, by GeoffPainPhD, a Substack publication with thousands of subscribers. geoffpain.substack.com

@joshg99 - Josh Guetzkow

See this thread for a further update showing that Pfizer/BioNTech never did the planned study comparing process 2 v 1 for safety and immunogenicity: https://x.com/joshg99/status/1705177305499279525

@joshg99 - Josh Guetzkow

A professor and expert in cancer genetics at U of South Carolina testifies on risks posed by process 2 jabs due to the plasmid DNA contamination: https://www.youtube.com/watch?v=IEWHhrHiiTY

@joshg99 - Josh Guetzkow

And a transcript of his interview with Maryanne Demasi: https://maryannedemasi.substack.com/p/exclusive-an-interview-with-buckhaults

EXCLUSIVE: An interview with Buckhaults about DNA contamination in covid vaccines... and the FDA responds Earlier this year, genomics expert Kevin McKernan first discovered DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots. He published his findings in a pre-print, but the research received little attention from the mainstream media. maryannedemasi.substack.com

@joshg99 - Josh Guetzkow

Great talk by @hedleyrees discussing the intricacies and challenges of biologic drug manufacturing: https://rumble.com/v3fqujk-challenges-in-manufacturing-and-distributing-products-derived-from-biologic.html

Challenges in manufacturing and distributing products derived from biologics | Hedley Rees The pharmaceutical industry was founded on small molecule products, where active ingredients were manufactured by fine chemical companies using long-established industrial processing. That meant the f rumble.com

@joshg99 - Josh Guetzkow

Remember how the COVID vaccines contaminated with endotoxin & plasmid DNA that Pfizer/BioNTech sold to the world were only tested on 252 people, but they said they'd compare them w/the ~20K subjects who got higher quality ones? New FOIA proves they never did that! But I did.🧵 https://t.co/ONgaR2OxgU

@joshg99 - Josh Guetzkow

The adverse event rate among the subjects who got the new 'Process 2' doses was 2.5x higher than the AE rate of all other treatment subjects in the same age group & 2x higher than other treatment subjects at the same sites -- controlling for sex, obesity and comorbidities. https://t.co/EqKIoRSfq6

@joshg99 - Josh Guetzkow

Only 4 of the process 2 subjects were tested for neutralizing antibody titers (aka immunogenicity) -- all of them aged 22 and younger. Only 3 out of the 4 showed presence of antibody titers 1 month after second jab. None were tested for neutralizing titers before vaccination. https://t.co/aGqFjgjy4o

@joshg99 - Josh Guetzkow

What was the excuse Pfizer/BioNTech gave in Sep. 2022 for shirking their responsibility to do the comparison study by Feb 2021 as stated in their protocol? No need due to the "extensive usage of vaccines manufactured via 'Process 2'" as of Sept 2022. Make it make sense! https://t.co/uW3hKo7uMY

@joshg99 - Josh Guetzkow

For background and more information on the Pfizer/BioNTech bait-and-switch scandal, see this thread. 👇 https://x.com/joshg99/status/1658421192326365185

@joshg99 - Josh Guetzkow

The FOIA was obtained by Perseus Group member @NickHunt5, who also writes for the Daily Sceptic. Here is the cover page of the MHRA response to his request (FOI# 23/510): https://t.co/YgvJh2ZbFc

@joshg99 - Josh Guetzkow

An easy way to remember the key difference between process 1 and 2: https://t.co/H8HCYZ54xb