The Unfinished Safety Audit

Imagine you test a prototype car with meticulous care, then send a completely different manufacturing version to dealerships—without telling buyers about the changes. This isn't just about cars; it's what happened with Pfizer's COVID-19 vaccine.

The vaccine used in clinical trials—the one that demonstrated safety and efficacy—was manufactured under "Process 1." The version billions received came from "Process 2." The fundamental question remains: Were they actually the same product?

A Tale of Two Factories

The Clinical Trial Version (Process 1)

  • Setting: Laboratory-scale production
  • Methods: Research-grade purification, small-batch DNA templates
  • Purpose: Generate data for regulatory approval
  • Testing: Used in the randomized trials that secured Emergency Use Authorization

The Mass Production Version (Process 2)

  • Setting: Industrial-scale fermentation
  • Methods: Revised purification, different enzymes, scaled DNA production
  • Purpose: Supply global demand
  • Timeline: Dominated the market by late 2021

The Critical Gap: Pharmaceutical regulations require proof that process changes don't affect product quality or safety (WHO Guidelines). This proof was never made public.

The Disappearing Safety Check

Pfizer's original trial design included a crucial safeguard: a cohort of participants would receive both Process 1 and Process 2 material for direct comparison. This wasn't an optional extra—it was fundamental science.

Then, in September 2022, Protocol Amendment 20 removed this objective (Archive of Protocol C4591001 Amendment 20). The planned safety comparison vanished just as Process 2 dominated global supply.

When researchers filed Freedom of Information requests asking how equivalence was demonstrated, regulators acknowledged the question but provided no analytical data (MHRA FOI 23/510).

The DNA Contamination Mystery: From Theory to Regulatory Crisis

The Safety Standard

International guidelines set a clear limit: no more than 10 nanograms of residual DNA per injection (WHO TRS 978). This isn't arbitrary—foreign DNA can trigger immune reactions or, in theory, integrate into human cells.

The Global Laboratory Consensus

Multiple independent laboratories across North America, Europe, and Asia have now confirmed DNA contamination in Process 2 vaccine lots:

  • Kevin McKernan (USA): Found residual plasmid DNA at 10-843 ng/dose with SV40 promoter confirmation
  • Tomonori Nitta (Japan): Peer-reviewed study finding 1-18 ng/dose with SV40 detection
  • Phillip Buckhaults (USA): 1-6 ng/dose confirmed in Senate testimony
  • David Speicher et al.: Analysis of 27+ vials showing 0.22-510 ng/dose range
  • König/Kirchner (Germany): Reported 3,600-5,340 ng/dose (500x regulatory limit)

Health Canada's Internal Alarm: The Regulatory Smoking Gun

Internal emails obtained through investigative work by Scoops McGoo reveal a regulatory crisis directly connected to Process 2 manufacturing:

The Unplanned Discovery

  • Pfizer's Admission: "Yes, because Pfizer did not identify the presence of SV40 promoter enhancer on the plasmid template used to produce mRNA" (Email Pg. 235 )
  • Process 2 Connection: This admission directly implicates the commercial manufacturing process where quality controls failed

Regulatory Alarm Bells

  • "SV40 must be avoided!" (Email Pg. 66 ) - Clear safety principle violation
  • "Remedy the situation before Fall 2024 vax campaign" (Pg. 141 ) - Urgent timeline for Process 2 resolution
  • "They do not seem to care much at this moment" (Pg. 151 ) - Frustration with Pfizer's response

Scientific Concern

  • "Fragment size is related to the probability of integration" (Pg. 205 ) - fragment size is related to the probability of integration with the human genome
  • "References: None" beside "minimal safety risk" claim (Pg.203 ) - Unsubstantiated safety assurance minimal safety risk … “References: None”

This regulatory crisis context makes the removal of the Process 1 vs Process 2 safety comparison even more concerning.

For detailed laboratory findings on DNA contamination, see SV40 DNA Signals in COVID-19 mRNA Vaccine Vials: What These Independent Labs Reported

The SV40 Enigma: From Cancer Risk to Immune System Threat

Pfizer's manufacturing plasmid included SV40 sequences—fragments from a virus once linked to cancer in early polio vaccines. The company says they're "inert" (Pfizer FAQ), but emerging research reveals a more immediate concern than theoretical cancer risk.

A January 2024 preprint demonstrates that the SV40 enhancer functions as a somatic hypermutation (SHM) targeting element - meaning it can directly interfere with the fundamental process our immune system uses to create effective antibodies (bioRxiv Preprint).

What This Means for Immune Function:

  • Somatic hypermutation is the process where B-cells "fine-tune" antibodies to better recognize pathogens
  • AID enzyme is the "master catalyst" that makes this possible
  • SV40 enhancer can hijack this process, potentially causing:
  1. Impaired Antibody Responses: Disruption of normal SHM could lead to reduced ability to fight infections
  2. Oncogenic Mutations: Aberrant targeting of AID could introduce cancer-causing mutations
  3. Autoimmune Potential: Misdirected hypermutation might generate antibodies that attack the body's own tissues

As immunologist Jessica Rose notes in her analysis of this mechanism: "If we have impaired antibody responses, we have a broken immune system."

This represents a potential immune system threat that was never assessed in the Process 1 vs Process 2 comparability that was never conducted.

For comprehensive analysis of biological mechanisms, see The Stability Trap: How mRNA Vaccine Engineering and DNA Contamination Created a Perfect Storm

Manufacturer Prior Knowledge: Moderna's Patent Admissions

Manufacturers had long recognized the theoretical risks of residual DNA in mRNA production. Moderna's patent filings explicitly discuss:

  • "DNA fragments resulting from the mRNA production process need to be removed"
  • "Because the remaining DNA fragments may cause a patient to develop cancer"
  • "qPCR can't measure small DNA fragments, yet we have to use another method to quantify them"
  • "Some of the introduced DNA may be incorporated into the genome of the cell and inherited by the offspring"

Moderna patent excerpt acknowledging DNA contamination risks

These admissions show the risks were well-understood years before the pandemic rollout, making the discovery of these same contaminants in Process 2 vaccine lots particularly alarming.

The Manufacturing Knowledge Gap

The discovery that manufacturers understood DNA contamination risks years before the pandemic raises critical questions about Process 2 quality control:

Moderna's Patent Warnings Included:

  • "DNA fragments... may cause a patient to develop cancer"
  • "Introduced DNA may be incorporated into the genome... inherited by offspring"
  • Explicit acknowledgment that qPCR cannot adequately measure small DNA fragments

Moderna patent excerpt

Given this prior knowledge, the failure to implement adequate DNA contamination controls in Process 2 manufacturing—and the subsequent removal of Process 1 vs Process 2 safety comparisons—represents a significant breakdown in pharmaceutical quality assurance.

For complete reference documentation, see DNA Contamination & mRNA Vaccine Biology: Curated Reference Roadmap

Safety Signals: Coincidence or Consequence?

The Trial Data Reanalysis

When Dr. Joseph Fraiman re-analyzed the original Pfizer and Moderna trials, he found a 36% increase in serious adverse events in vaccine recipients versus placebo (Vaccine 2022). These weren't sore arms—they were events serious enough to require medical intervention.

The Biological Evidence

  • Spike Protein Detection: Dr. Lael Yonker found circulating spike protein in teens with post-vaccine myocarditis (Circulation 2023)
  • Spike Persistence: Multiple studies detected spike protein lingering in tissues months after vaccination (Cell Reports Medicine 2024)
  • DNA Inflammation Pathways: Research confirms foreign DNA can activate inflammatory responses through cGAS-STING pathways (Front Immunol 2023)

Traffic-Light Snapshot: Claims vs Reality

"The manufacturing change was rigorously validated"

  • Company Claim: Process 2 equivalent to Process 1
  • Evidence: Comparison cohort removed from trial; FOI requests yield no data; SV40 sequence was unexpected finding; Multiple independent labs find DNA contamination in Process 2 vials
  • Verdict: ❌ Validation failure - No public proof despite global lab confirmations

"DNA levels are within safe limits"

  • Regulatory Standard: 10 ng/dose maximum
  • Independent Findings: Up to 60 ng/dose reported; SV40 sequences present; Health Canada emails show internal alarm; SV40 disrupts somatic hypermutation
  • Verdict: ❌ Unacceptable risk - mechanism identified for immune system harm

"Safety signals are coincidental"

  • Dismissal: Billions administered safely
  • Evidence: 36% serious adverse event increase in trials; biological mechanisms identified; Moderna patents acknowledge cancer risk from DNA fragments
  • Verdict: ❌ Requires proper investigation, not dismissal

The Human Cost of Technical Decisions

Behind the manufacturing specifications and quality control documents are real people:

  • The trial participants who volunteered for what they believed was rigorous science
  • The billions who received injections based on trial data of a different product
  • The doctors seeing unexplained inflammatory conditions in previously healthy patients
  • The families who trusted that "safe and effective" meant the product was thoroughly characterized

What Transparency Would Look Like

  1. Release the Data: Publish all comparability studies submitted to regulators
  2. Independent Testing: Multi-laboratory analysis of retained Process 1 vs Process 2 vials
  3. Clinical Correlation: Examine adverse event rates by manufacturing lot
  4. Full Disclosure: Document all process changes and their justifications

🔗 Related Investigations

For readers seeking deeper analysis of specific aspects:

The Core Question

When you received your Pfizer COVID-19 vaccine, did you get the carefully tested clinical trial version—or something fundamentally different that was never directly compared for safety?

The discovery of unexpected DNA contaminants that caused significant internal alarm at Health Canada, combined with manufacturers' own prior knowledge of these risks, suggests the answer is not reassuring. The fact that these fundamental questions remain unanswered represents a failure of scientific transparency at the highest levels.

The removal of Process 1 vs Process 2 safety comparisons, combined with the subsequent discovery of DNA contamination that regulators were privately alarmed about, suggests we may never know what differences existed between the vaccine that was tested and the vaccine that was delivered to billions.

see the very latest discussions over on substack Dr Jessica Rose (https://substack.com/home/post/p-175987412) Kevin McKernan (https://anandamide.substack.com/p/pfizers-failure-to-linearize-the) and Dr David Speicher (https://substack.com/@drdavidspeicher/note/p-159309301?utm_source=notes-share-action&r=15i0bd) follow them all on X support their work on substack these guys are literally the tip of the spear.

This investigation exists because independent scientists refused to accept that manufacturing changes don't require rigorous validation. In a properly functioning regulatory system, these questions would have been answered before products reached the public.