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Health Canada has sidestepped detailed parliamentary questions about the manufacturing oversight of the plasmid DNA template used in the modified RNA-based COVID-19 vaccines, prompting renewed criticism over the depth of regulatory scrutiny applied to these novel products.

In an Order Paper response to Conservative MP Ted Falk, the department provided limited specifics on key aspects of the production process for the shots. Falk’s questions focused on the foundational DNA blueprint, that is, the plasmid DNA template, including who manufactured it, which facilities were involved, who performed linearization (the process of cutting circular plasmid DNA into linear form for mRNA production), and what quality control testing occurred.

Additional queries could have addressed whether Health Canada itself inspected manufacturing sites, provided any oversight directly or relied on foreign regulators, and whether any concerns, such as incomplete linearization, residual DNA issues, or manufacturing deviations, were identified and resolved.

The questions also probed compliance with international standards from the International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) regarding residual DNA, genetic characterization, and viral safety.

Health Canada’s reply largely deferred to blanket statements around authorization itself being proof that the agency did its regulatory due diligence.

The department stated that authorized products meet regulatory requirements, but did not name specific facilities, inspection details, or provide concrete responses on linearization processes, master cell banks, or lot-specific investigations.

Similarly, no confirmation or denial was given on adherence (or otherwise) to the cited ICH and USP standards for residual DNA testing.

This approach aligns with the department’s broader reliance model, where much of the foundational manufacturing oversight for these novel products rests with sponsors (such as Pfizer and Moderna) and international regulatory partners (such as the US CDC and the EU’s EMA).

Given the public investment into Health Canada – roughly $9 billion last year – taxpaying Canadians should be curious as to why the agency doesn’t appear to have conducted any independent verification of the shots’ DNA starting material.

Instead, independent researchers and citizen scientists have largely filled that void.

Genomics researcher Kevin McKernan raised concerns as early as 2022 about plasmid DNA instability and possible contamination. Later, peer-reviewed independent analyses — including work by virologist Dr. David Speicher examining vaccine vials — showed high levels of DNA fragments, in some cases above regulatory guidelines.

The detection of previously undisclosed elements, such as the controversial SV40 promoter sequence in some Pfizer samples, has also reinforced concerns raised by pharmacist and former regulatory specialist Maria Gutschi, who questioned whether sufficient scrutiny had been given to the shift from the manufacturing process used in clinical trials (called Process 1) to the one later adopted for large-scale distribution (called Process 2).

Taken together, all of this paints a picture of lacking quality controls applied by Health Canada, both pre- and post-approval.

Health Canada has previously acknowledged the presence of the undisclosed SV40 sequence but maintained that residual DNA levels posed no significant risk.

However, the agency’s response provided no new information regarding deviation reports, corrective or preventive actions, or regulatory assessments related to manufacturing irregularities, and failed to acknowledge any issues associated with incomplete plasmid linearization or the use of shared plasmid stocks across multiple jurisdictions.

These manufacturing questions should be at the heart of quality assurance for a biotechnology platform deployed at such an unprecedented scale, yet Health Canada evades and deflects.

Canadians who ‘trusted the science’ deserve clarity on how that science, and specifically the building blocks of these products, were controlled and monitored.