Health Canada knew about contamination issues in Pfizer’s shots but rubber-stamped the booster doses anyway

The agency tasked with drug regulation colluded with other regulators to develop cohesive messaging as independent investigations revealed Canadians were injected with materials not initially disclosed by the manufacturer.

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Newly released Health Canada emails show that the agency sought guidance from Pfizer on impurities discovered in the novel mRNA shots and scrambled to unify messaging across regulatory agencies when the public became aware of this contamination.

Amid reports of DNA contaminants and undisclosed plasmid DNA known as the SV40 promoter in Pfizer’s novel mRNA COVID-19 injections, Health Canada sought clarification from Pfizer regarding the products under its regulatory responsibility.

The emails were obtained through access to information requests to determine how and when Canada’s drug regulator became aware of these undisclosed contaminants as the agency repeatedly assured Canadians that the shots are “safe and effective.”

Michael Wall, a biologist and evaluator at Health Canada, sent an email on July 23, 2023 to seek clarification from Pfizer. The email requested information on the sequence analysis of plasmids, the presence and function of the SV40 promoter, and details regarding the size analysis conducted on residual DNA contaminants.

By the beginning of August, it was determined that this contamination was still present in the XBB1.5 booster injections Pfizer was about to seek authorization for. Later that month, Dean Smith, immunologist and Senior Scientific Evaluator of Vaccines at Health Canada, emailed about an “Ad-hoc cluster meeting” with the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA). Smith proposed including the SV40 topic for discussion and sought alignment among regulators, asking “what they plan to do” and “if they are all on the same page.”

“This is a public topic now and we are approaching the next vaccination season for these vaccines,” he writes, hinting at the fact that the agency is concerned and does not want to compromise the safe and effective narrative.

Someone from the FDA thanks Smith for “facilitating a global discussion among NRAs,” referring to the national regulatory authorities.

Those NRAs are the gatekeepers of medical products. They are responsible for ensuring the quality, safety and efficacy of medical products, and should inform the public – who funds and relies on their oversight for safety – when there are concerns

Smith further explains that he “understands that there have been internal discussions regarding the presence of an SV40 enhancer/promoter sequence,” and notes that its presence is unrelated to the purpose of Pfizer's plasmid as a transcription template for their mRNA COVID-19 vaccine.

“Pfizer has communicated to Health Canada recently, that they apparently chose not to mention this information to EMA, FDA or Health Canada at the time of their initial or subsequent submissions. However, as of April of this year, this information was independently made public, which has resulted to questions coming to agencies,” he writes.

Indeed, that was Rebel News’ interview in April with genomics expert Kevin McKernan, who was sounding the alarm on this undisclosed plasmid as an independent scientist.

The email continues, “At [Health Canada] we do not view this an urgent risk topic. However, given the fall COVID-19 vaccination campaigns, it may be useful to be on the same page on this topic between agencies. Time permitting, a brief exchange at the end of tomorrow's Cluster Meeting could also help inform potential exchanges between Agencies and Pfizer on the SV40 topic, as well as future actions we may collectively consider taking subsequently to encourage Pfizer to remedy the situation prior to a potential fall 2024 COVID-19 vaccine campaign. It would be unfortunate if the information circulating had a negatively impact on public acceptance of the vaccine this year or in the future."

A pre-print from McKernan’s paper sequencing bivalent Moderna and Pfizer mRNA vaccines is attached at the end of the communication.

The “Vaccine Cluster Meeting" took place on August 24 between the FDA, Health Canada, and EMA. It appears they were discussing booster strategies, including aligned recommendations on intervals between COVID-19 vaccine doses.

All titles of those in attendance are listed but their names are redacted, except Health Canada co-chair Co Pham, executive director.

After the meeting, Smith relayed that Pfizer replied and acknowledged “minimal risk,” but the rest of the communication is redacted.

When it came to the SV40 sequence, apparently Pfizer didn’t commit and the three agencies did not want to tell Pfizer about their cluster meeting because the pharma behemoth “does not seem to care.”

Why would Pfizer be concerned? Manufacturer liability was waived for these novel products to expedite their market release and inject them into the arms of Canadians, including babies and children. Pfizer received billions, delivering approximately 185 million doses by the year-end, with taxpayer-funded premiums for the mRNA products. Pfizer profited while remaining unaccountable for any repercussions. Of course, they don’t care.

According to these emails, Health Canada says they will continue to work with international partners to remove the sequence elements from the plasmid for future strain changes despite repeatedly stating it isn’t a cause for concern.

On September 5 2023, Dr. Tong Wu from Health Canada submitted Pfizer’s Quality Evaluation Executive Summary to Dr. Co Pham, seeking authorization for the XBB1.5 booster formulation by mid-September (as requested by Pfizer). Health Canada reminded Pfizer of its commitment to providing additional data on residual DNA by December 1 2023, including on-going stability monitoring of the vaccines.

Interestingly, the drug submission report states that stability data for the injection was “unavailable… due to the expedited development of the Omicron XBB.1.5 vaccine.”

As these novel bivalent booster injections were being authorized, an email from Tong Wu to Co Pham said that these commitments and comments are “not considered critical to product quality.”

This makes sense when the background of the submission says that “the Omicron XBB.1.5 was developed to prevent COVID-19 caused by infection with the SARS-CoV-2 virus,” yet real-world data has repeatedly shown that these injections are ineffective at doing just that.

Despite this, Health Canada rubber-stamped the XBB booster on September 28, 2023, less than a month after Pfizer submitted for authorization.

There was a summary of key quality issues but it’s redacted so the general public is not allowed to know what the issues were.

Those responsible for the review were Elizabeth Davis and Michael Wall.

The reviewers required a Submission Review, which had the quality review report but they did not require a Drug Master File (DMF) review, consistency testing, an OSE (on-site evaluation) or anything else.

By October, the EMA planned to take the issue to Pfizer directly and asked for the other agencies' perspectives, or if they had taken any action.

The EMA emailed that they had been contacted by “different media” and “fact checker groups from the US,” so they sought an “aligned position” to “navigate the communication challenge.”

In response to Health Canada asking for residual DNA and plasmid clarification, Pfizer attempts to gaslight the regulator.

Pfizer claimed that the data was “not readily available” and would “require time to generate,” asking Health Canada to “note that to date, they have not been requested to provide these characterization data across global markets.”

Throughout this process, the regulator asserts that there is “minimal safety risk” and that elements like the SV40 promoter are “non-functional,” yet no references for these assertions are listed.

Some notes were taken from what appears to be a discussion with Supriya Sharma, the chief medical advisor to the deputy minister and senior medical advisor at Health Canada, where it was stated that it was “unexpected” to find the SV40 promoter sequence in the injections because Pfizer didn’t disclose it.

By the end of October last year, the agency was scrambling to have internal meetings about this. The urgency was heightened when Conservative MP Ted Falk filed an order paper question in the House of Commons asking questions about Health Canada’s authorization of the Pfizer injections and the disclosure of contaminants.

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