In this compelling interview, consultant pharmacist Maria Gutschi, BScPhm, PharmD, delivers a thorough analysis of the numerous manufacturing “red flags” tied to the COVID-19 mRNA injections, spotlighting what she terms Pfizer’s “hard fraud.” She reveals her deep concerns about the mRNA COVID-19 vaccines, particularly regarding manufacturing issues, contamination, and regulatory oversight.

Before diving into her insights, it’s important to revisit the DNA/SV40 contamination scandal, which underscores the Chemistry, Manufacturing, and Controls (CMC) concerns raised by Maria in the interview.

Over the last two years, numerous independent labs across the United States, Canada, Germany, Japan, France and more recently the Czech Republic, have verified the presence of plasmid DNA—significantly exceeding the regulatory cap of 10 ng/dose—in Pfizer/BioNTech and Moderna’s COVID-19 injections with SV40 promoter/enhancer sequence specifically identified in the Pfizer/BioNTech’s product. This alarming discovery was initially uncovered by Kevin McKernan in April 2023.

My earlier investigations on this scandal can be read below.

Manufacturing red flags

In early 2021, Maria Gutschi began her own research on what she calls Moderna and Pfizer/BioNTech’s “gene-therapy products.” While digging though the European Medicine Agency’s EPARs (European Public Assessment Reports) on the mRNA vaccines, she was shocked at its content. Unlike typical EPARs she had reviewed over a decade, this one listed numerous "specific obligations"- legally binding requirements for manufacturers, particularly around manufacturing quality- that were unprecedented in scope and focus. Maria emphasized that for biologics like mRNA vaccines, "the process is the product," meaning manufacturing flaws directly affect safety and efficacy.

Whenever you manufacture a biologic, it is always a problem getting the purity right, because the process is the product.

The process on how you make a biological is what you end up with.

The EPAR highlighted significant manufacturing concerns, including:

* Purity and Consistency: The EMA flagged multiple unresolved issues, such as ensuring the spike protein produced was authentic and consistent across batches.

* Specific Obligations: Unlike usual clinical trial follow-ups, five or six obligations focused on manufacturing, which Maria found unusual and indicative of deeper problems.

DNA contamination findings

Maria became involved in investigating DNA contamination in the vaccine vials. Notably, she was co-author of the preprint paper by Speicher et al., published in October 2023, which confirmed Kevin McKernan’s troubling findings of DNA/SV40 contamination in the Moderna and Pfizer/BioNTech vials vastly exceeeding the regulatory cap. The presence of plasmid DNA with regulatory sequences (e.g., SV40 in Pfizer) and lipid nanoparticles (LNPs) enabling cellular entry raised concerns about genomic integration and biological activity.

Other key issues explored

* Blotgate Scandal: Maria discussed how BioNTech dismissed Western blot anomalies (unusual spike protein sizes) as glycosylation (sugar attachments), a claim the EMA accepted without sufficient follow-up. This specific obligation remains unmet as of 2025. (My investigation into this scandal can be read here.)

* Ribosomal Frameshifting: A Cambridge study (December 2023) confirmed mRNA vaccines could cause frameshifting, leading to aberrant proteins with unknown effects (e.g., toxicity, autoimmunity).

* SV40 Contamination: Found in Pfizer vaccines, the SV40 promoter/enhancer sequence (with an origin of replication) can amplify itself, block the p53 tumor suppressor gene, and potentially promote oncogenes, raising cancer risks. Health Canada was shocked by this undisclosed contamination but took no decisive action after Pfizer resisted accountability.

* Lipid Nanoparticles: Maria criticized their classification as excipients (inactive ingredients), noting their reactive nature and ability to deliver contaminants (DNA, RNA, metals) into cells, bypassing normal regulatory mechanisms- a "Trojan horse" effect increasing risks like DNA integration.

Canadian Open Letter

Maria has spearheaded an open letter that will be sent on March 31 to Canadian MPs, senators, and provincial health officers, highlighting:

* Health Canada’s Findings: FOI requests (ATIPs) revealed regulators’ concerns about DNA variability, SV40, LNPs, frameshifting, and IgG4 immune tolerance, yet action was stifled.

* Demands: Recall the vaccines due to risk outweighing benefits, reclassify them as gene therapies (not vaccines), and fund independent lab studies to investigate mechanisms and adverse events.

* SV40 Cover-Up: Pfizer’s failure to disclose SV40 violated WHO guidelines, constituting "hard fraud," with Health Canada’s response squashed internally despite initial efforts to address it.

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