Health Canada Had Questions About SV40 DNA in Pfizer’s COVID Vaccine. Why Didn’t Parliament Demand an Explanation?

Health Canada had questions. Canadians are entitled to ask how those questions were resolved.

Newly circulated documents show staff examining an SV40-associated DNA element in Pfizer’s vaccine manufacturing plasmid in July 2023. A draft recommended asking the company to replace it. Taking no action was not the recommended option. [1]

Yet when Parliament sought answers in June 2024, the government said the issue summary had ultimately been deemed unnecessary. Manufacturing correspondence remained confidential. [2]

That is the gap Ottawa should explain, document by document.

A media question set the review in motion

The July 2023 draft traces the review to a July 17 media inquiry. Staff subsequently identified the SV40 promoter and enhancer sequence through an alignment check. The supplied plasmid maps had not annotated the element. [1]

The reviewers considered it unnecessary for production in bacterial cells. Their recommended option was to seek a replacement that worked only in those cells. The covering email from Michael Wall said human-health analysis needed more detailed work and had been left outside this draft, which focused on regulatory issues and public perception. [1]

That makes the next question unavoidable: where is the complete account of the work that followed?

The answer Parliament received

Conservative MP Dean Allison asked about the review, Pfizer’s responses, DNA fragment sizes and independent verification. The government grouped the questions into one answer on June 19, 2024.

Yasir Naqvi, then parliamentary secretary to the health minister, said manufacturer measurements using approved methods were consistently below 10 nanograms per dose, commercial batches met quality requirements and residual DNA did not change Health Canada’s safety assessment. He also said the issue summary had been deemed unnecessary. The response did not supply the requested fragment-size results. [2]

A threshold and an assurance are not a public account of how a particular recommendation was handled. Who reviewed the response? What was accepted? What changed between the draft and the final position?

The records came through a disclosure fight

McGoo reports that further disclosure followed an access-to-information dispute and Federal Court proceedings, with a consent judgment ending the case in October. Those procedural details are his account of obtaining the records. [3]

His September report described a later quality review strongly recommending removal of unnecessary plasmid elements. Pfizer agreed to evaluate the request, according to the disclosed passages. The review nevertheless supported approval. [4]

Regulators can accept a product while recommending a manufacturing change. But when the recommendation concerns material that was not annotated in the supplied maps, the reasoning deserves more than a blanket appeal to confidentiality.

Publish the decision trail

The sequence discussed here is not the intact SV40 virus. In a December 2023 letter, the FDA said the vaccines contained no SV40 proteins and did not encode them, and that its assessment, including lipid nanoparticles, animal studies and monitoring, had not identified the alleged genetic harm. [5]

The July draft itself did not undertake the health analysis. Its significance is what it reveals about the review process and the questions left for the public.

Canadians should be able to see what Pfizer supplied, what reviewers concluded and why an issue considered worth investigating was later described as unnecessary. Release the decision trail with dates and explanations.

Public confidence is not something a department can demand while keeping the reasoning out of public view. If the review answered the questions, show the answers.