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Pfizer and BioNTech have forcefully denied any wrongdoing in the heartbreaking death of 17-year-old Sean Hartman following his first COVID-19 vaccination in September 2021.

The duo filed near-identical defences on December 5, 2025, that reject all liability and seek outright dismissal of the landmark wrongful death lawsuit brought by his father, Dan Hartman, in Ontario's Superior Court of Justice.

The companies insist their COVID-19 vaccine played no role in the teen's fatal myocarditis 33 days after his shot, brushing aside claims of negligence, inadequate warnings, and untested manufacturing changes as the grieving family demands justice and accountability.

Pfizer frames their Comirnaty vaccine as a heroic response to a pandemic that (they say) killed over seven million globally and 60,000 in Canada, justifying the rush for "diagnosis, treatment, mitigation, and prevention options." They tout "rigorous" trials with 44,000 participants starting in April 2020 — yet these trials still lack a clean quality control review after four rejections or fixes.

Health Canada greenlit the shots in December 2020 amid ongoing trials, but Pfizer now urges the court that their product is safe despite unresolved issues, years later. They defend changes in their manufacturing processes partway through their clinical trials, insisting both were comparable and disclosed to regulators, countering Hartman's allegations of untested changes.

This echoes warnings from pharmaceutical regulatory specialist Maria Gutschi, who in October 2023 detailed adulterations, impurities, regulatory lapses, and process shifts in the manufacturing process of these novel shots.

In November of 2021, Gutschi similarly revealed how the components of these injections, namely the lipid nanoparticles, had never been used in humans before.

Genomics expert Kevin McKernan has similarly raised alarms about these novel products for years.

Pfizer clings to the assertion that myocarditis warnings in the product monograph by June 2021 – which was two months before Sean's vaccination — were sufficient. They say that cases, although more common in young males, were rare and often resolved.

Yet long-term data to support that conclusion is limited, at best.

They invoke the "learned intermediary" doctrine, arguing that alerts to healthcare professionals were enough to mitigate the damage. They deny causation, asserting higher risks from COVID-19 itself, and claim no provable damages.

Most shockingly, the defendants direct Hartman to Canada's Vaccine Injury Support Program (VISP), where he has been languishing for years awaiting an appeal decision.

Previous access-to-information probes expose VISP's failures in assessing compensation, especially for child victims, which speaks precisely to this case.

Pfizer adds that the suit is time-barred under Ontario's two-year Limitations Act.

BioNTech, the German firm holding Canadian market authorization, mirrors these defences: denying direct distribution as that was Pfizer's role, rejecting "common design" torts in an attempt to emphasize their corporate independence from Pfizer. They laud mRNA safety, repeat clinical and manufacturing details, and highlight Health Canada's rolling review safety process.

Both portray the vaccine as a lifesaver, with billions of doses given worldwide, citing benefits as trumping ‘rare’ risks. This clashes with Canada's Chief Medical Officer Theresa Tam's March 2021 admission that the full scope of vaccine harms wouldn't emerge until after mass rollout.

March '21: Chief Public Health Officer of Canada Theresa Tam confirmed that side effects of the novel COVID-19 mRNA shots would not be picked up until the experiment was unleashed onto millions of people

She promoted these injections to children anywayhttps://t.co/Pi3CfkFqWI pic.twitter.com/myYNT2eylG

— Tamara Ugolini 🇨🇦 (@TamaraUgo) May 28, 2024

It also ignores Pfizer executive Janine Small's 2022 European Parliament testimony: they didn't test for stopping transmission, moving "at the speed of science," and taking risks.

A key point in the defence is that Pfizer inadvertently spotlights a hidden manufacturing switch. While claiming Processes 1 and 2 are comparable, Phase 1/2 trials skipped Process 2 entirely.

The Comirnaty vaccine was initially produced by Process 1, a smaller-scale method using PCR to amplify DNA templates, for early clinical trials. After securing Emergency Use Authorization (EUA) in late 2020, Pfizer scaled up to Process 2, utilizing E. coli bacteria to mass-produce plasmid DNA, enabling cheaper and larger output of the novel products for global distribution.

While Pfizer conducted lab tests claiming the two processes yielded comparable vaccines, the early Phase 1/2 trials tested only Process 1.

Process 2 was introduced late in the Phase 3 trial, with limited testing on a few hundred participants post-EUA. Yet the pivotal trial data supporting approval relied almost entirely on Process 1, not the version ultimately administered to billions. Pfizer’s own Protocol Amendment 20 axed the Process 1 cohort, substituting "real-world data" in the aftermath of mass distribution.

Yet public assurances cited early trial data for safety, which can be said is inapplicable to the injected version, as the product that reached the public remained largely untested.

While Pfizer and BioNTech seek excuses due to urgency, scale, and approvals for unfinished trials, the case of Sean Hartman and his father's quest for accountability seeks a hard truth: When a rushed product claims a child's life, with risks revealed only after billions are exposed, who bears the blame?