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Health Canada asked Pfizer for a pregnancy registry. Pfizer declined. Health Canada accepted. That exchange -- documented in internal records -- is one of four negotiated decisions that shaped what Canadians were and were not told about their COVID-19 vaccines.
By Chris Allen | The Old Guardian | September 2026
Primary source: ATI Release A-2025-001410, Health Canada, July 15, 2026
On August 3, 2021, Health Canada sent a formal request to Pfizer-BioNTech.
The request was specific. Given that serious pregnancy outcomes were being reported to Canadian surveillance databases following Comirnaty vaccination -- 64 spontaneous abortion reports by that point, 290 pregnancy-related adverse events total -- Health Canada asked Pfizer to implement a pregnancy registry for Canada and reference it in the Canadian Product Monograph.
Pfizer declined. The company cited existing post-authorization studies already underway. It stated it had no plans to update the Canadian Product Monograph to include information on pregnancy registries.
Health Canada accepted this response. No further action was taken.
That exchange -- a regulator asking, a manufacturer declining, the regulator standing down -- is documented in 2,460 pages of internal Health Canada pharmacovigilance records obtained by The Old Guardian under federal Access to Information request A-2025-001410.
It is not the only exchange of its kind in those documents.
Post-market vaccine surveillance is not a passive monitoring system sitting quietly in the background recording what happens. It is an active negotiation between regulator and manufacturer -- over what gets studied, what gets labeled, what gets reported, and when. The ATI documents provide a granular record of that negotiation for Comirnaty across multiple formulations and age group extensions.
Several findings in that record are not consistent with the public description of rigorous independent oversight.
The Pregnancy Registry: A Request Declined
The August 3, 2021 pregnancy registry request did not emerge from nowhere. It was the product of months of internal monitoring that Health Canada had been conducting since early 2021.
By August 2021, Health Canada’s internal pharmacovigilance reviewers had already flagged pregnancy as a special monitoring category. The internal documents show that MHPD -- the Marketed Health Products Directorate -- had been tracking pregnancy outcomes since the earliest SMSR review periods.
The monitoring was warranted. The documents confirm that Canada was not tracking vaccination status by pregnancy at the population level. The internal review stated explicitly: ‘this information is not tracked in Canada.’ The 64 spontaneous abortion reports in the Canadian database were from a passive surveillance system with acknowledged underreporting. The denominator -- how many pregnant Canadians were actually vaccinated -- was not known with precision.
Against that backdrop, Health Canada made a reasonable request. A pregnancy registry would have allowed prospective tracking of vaccinated pregnant Canadians and their outcomes -- filling the data gap the internal documents acknowledged existed.
Pfizer said no.
Health Canada’s internal BBRS Signal Tracking document records the exchange without editorial comment. The request was made. The response was received. No further action was taken. The data gap that prompted the request remained unfilled.
Canada was not tracking vaccination by pregnancy status at the population level. Health Canada asked Pfizer to help fill that gap. Pfizer declined. Health Canada accepted that answer.
The public communication during this same period continued to characterize COVID-19 vaccination as safe for pregnant people. The internal documents confirm that characterization was made in the absence of the registry data that would have actually supported it.
Source: ATI Release A-2025-001410, BBRS Signal Tracking document, August 3, 2021 entry. ATI p.271. ATI p.229.
Bell’s Palsy: A Label Negotiation on the Record
The pregnancy registry was not the only documented negotiation between Health Canada and Pfizer in this period.
Running parallel to the pregnancy monitoring thread was a signal Health Canada internally tracked across multiple Summary Monthly Safety Report review periods: Bell’s Palsy and facial paralysis cases following Comirnaty vaccination.
By the fifth and sixth SMSR review periods, 434 serious facial paralysis cases had been recorded in a single reporting interval. Health Canada formally disagreed with Pfizer’s assessment that this signal could be closed. The internal documents record Health Canada’s position in writing: the signal warranted product monograph -- label -- updates. Health Canada requested Pfizer make those updates.
Pfizer resisted including Bell’s Palsy in the clinical trial section of the product monograph. The internal BBRS Signal Tracking document records the disagreement explicitly. An advisement letter was issued to Pfizer on July 14, 2021. Pfizer’s response characterized the evidence as inconclusive.
Health Canada’s documented position: ‘Health Canada’s position remains the same and the need for further risk mitigation will be discussed with our pre-market colleagues.’
This is not a regulator passively accepting whatever a manufacturer provided. Health Canada pushed back. The disagreement is in writing. What is also in writing is that the resolution of that disagreement -- what ultimately appeared on the label, and when -- took place in a process that the public had no visibility into.
434 serious facial paralysis cases. A documented negotiation between regulator and manufacturer over whether and how to disclose them. The outcome of that negotiation determined what Canadian healthcare practitioners read on the product label when advising their patients.
Source: ATI Release A-2025-001410, SMSR review pages 62-63. BBRS Signal Tracking document, July 12-14, 2021 entries.
Children Six Months to Four Years: Authorized Before Terms Were Final
The authorization of Comirnaty for children six months to four years old is where the internal documents produce their most significant finding in this negotiation record.
Health Canada proposed Terms and Conditions to Pfizer governing post-market safety commitments for this age group. Pfizer’s response to those proposed terms was documented internally as ‘not acceptable.’ The content of the Terms and Conditions was described as ‘under negotiation.’
A meeting was held September 8, 2022 to work through the disagreement.
The authorization for children six months to four years proceeded before the Terms and Conditions were finalized. Comirnaty was authorized for the youngest Canadians before the safety commitments governing post-market monitoring for that age group were fully agreed upon between the regulator and the manufacturer.
A separate internal memo makes a related finding explicit. For the Comirnaty Original and Omicron BA.4/BA.5 bivalent vaccine authorized as a primary series for children six months to under five years, the internal review states: ‘While clinical data for the use of Comirnaty Original and Omicron BA.4/BA.5 vaccine as a primary series is not yet available, based on extrapolation of clinical data from its use as a booster dose.’
The youngest Canadians eligible for Comirnaty were authorized on extrapolated data from booster dose studies in older populations. No primary series clinical trial data existed for this age group at the time of authorization. That is documented in Health Canada’s own internal review memo.
Comirnaty was authorized for children six months to four years before the Terms and Conditions governing their safety monitoring were finalized. The internal documents say so directly.
The public communication around pediatric authorization did not reflect this. Parents making decisions about vaccinating their youngest children were not told that the authorization preceded finalization of safety commitments, or that it rested on extrapolated rather than primary series data.
Source: ATI Release A-2025-001410, ATI p.296. ATI p.392. Internal RMP review memo, pediatric extension.
Product Monograph corroboration: The current authorized Comirnaty Product Monograph (August 10, 2026, Control Number 300388) independently confirms this finding. Section 8.1.3 states that the safety of the bivalent primary series for children 6 months to 4 years is “inferred primarily from the safety profile of COMIRNATY at 3 mcg” -- the same extrapolation language documented in ATI p.392. The product label itself uses the word “inferred” to describe the evidentiary basis for authorizing the youngest Canadians. That is now on the public record in two independent primary sources.
Fatal Reports Removed: The Bivalent Surveillance Reduction
As successive bivalent formulations were authorized -- BA.1, then BA.4/BA.5, then XBB.1.5 -- the surveillance architecture that had governed the original Comirnaty authorization progressively relaxed.
The most significant documented reduction involved fatal reports.
For the original Comirnaty formulation, monthly safety reports included observed versus expected analyses of fatal adverse events -- a systematic comparison of reported deaths against the statistical baseline that would be expected in a population of similar size and demographics. That analysis was the core tool for detecting whether vaccine-associated death rates exceeded background rates.
For the BA.4/BA.5 bivalent vaccine, Pfizer proposed removing the fatal reports observed versus expected analysis requirement from monthly reporting. The internal BBRS Signal Tracking document records what happened next: ‘Accepted as removed by MAH.’
Health Canada accepted Pfizer’s proposal. Fatal report tracking for the bivalent vaccines was moved from monthly reports to the less frequent six-monthly Periodic Safety Update Reports.
The frequency of fatal report monitoring was reduced at the manufacturer’s request, and the regulator agreed.
Health Canada’s internal documentation frames this as a risk-based approach: ‘adopting a risk-based approach in the post-market surveillance strategy by reducing the oversight on indications where the safety profile has been better characterized.’
Whether the bivalent vaccine’s safety profile had been sufficiently characterized to warrant reducing fatal report monitoring frequency is a question the public was never asked. The decision was made internally, documented in the BBRS tracking log, and not communicated as a change in surveillance intensity to Canadians who continued receiving bivalent doses.
Source: ATI Release A-2025-001410, BBRS Signal Tracking document, BA.4/BA.5 bivalent entries. ATI p.349. ATI p.329.
The Surveillance Wind-Down: A Documented Timeline
The four negotiations documented above did not occur in isolation. They occurred within a broader trajectory of declining surveillance intensity that the ATI documents allow reconstruction of with precision.
In December 2020, when Comirnaty was first authorized, the surveillance architecture was intensive. Daily Canada Vigilance database searches. Monthly summary safety reports. Active signal monitoring across all authorized DINs. Observed versus expected analyses for fatal reports.
By late 2021, the scope of required analyses was under active negotiation between Health Canada and Pfizer. By 2022, bivalent authorizations began proceeding with Terms and Conditions negotiated post-authorization. Fatal reports observed versus expected analysis was removed from monthly bivalent reporting.
By December 2022, the monthly reporting requirement was removed for most DINs and replaced with six-monthly Periodic Safety Update Reports.
By May 29, 2023, Health Canada issued a formal memo to BRDD closing the monthly safety report requirement entirely and amending Terms and Conditions across all Comirnaty DINs. The exact internal language: ‘Repeal/close the following Ts&Cs: The requirement to submit monthly safety reports for all DINs within the authorized Comirnaty product line.’
By 2023, standard COVID-19 specific reporting was replaced with standard drug reporting requirements -- the same framework that governs routine medications that have been on the market for decades.
Comirnaty went from the most intensively monitored pharmaceutical product in Canadian regulatory history to a standard marketed drug in approximately three years. That transition was managed through a documented negotiation process. It was not publicly communicated as a reduction in oversight.
In three years, Comirnaty went from the most intensively monitored pharmaceutical in Canadian regulatory history to a standard marketed drug. The transition was negotiated. It was not announced.
Source: ATI Release A-2025-001410, BBRS Signal Tracking document, May 29, 2023 entry. ATI p.329. ATI p.365.
What This Means
The negotiation record documented in these ATI files does not describe a corrupt regulator or a dishonest manufacturer. It describes something more systemic and in some ways more difficult to address: a post-market surveillance architecture that operated as a bilateral negotiation between regulator and manufacturer, largely invisible to the public it was designed to protect.
Health Canada asked for a pregnancy registry. Pfizer said no. Health Canada accepted that.
Health Canada disagreed with Pfizer’s assessment of the Bell’s Palsy signal. The disagreement was documented. The resolution happened behind closed doors.
Pfizer’s response to proposed Terms and Conditions for the youngest Canadians was ‘not acceptable.’ Authorization proceeded while the negotiation continued.
Pfizer proposed removing fatal report monitoring from monthly bivalent reporting. Health Canada accepted.
None of these decisions were communicated to Canadians as decisions. They were administrative determinations made within a regulatory process that operates without public visibility. Canadians receiving subsequent doses, making decisions for their children, asking their doctors whether the vaccines were still being monitored with the same rigour as when they were first authorized -- none of them had access to the negotiation record that would have answered that question.
The documents do not tell us what the right decisions were. Reasonable regulatory experts could disagree about whether each of these outcomes was appropriate given the evidence available at the time. What the documents tell us is that these decisions were made, that they were documented, and that the public was not told they had been made.
That gap -- between the documented internal negotiation and the public’s assumed understanding of rigorous independent oversight -- is the accountability record this series is building.
Editor’s Notes and Primary Sources
All findings in this piece are drawn directly from ATI Release A-2025-001410, released by Health Canada to The Old Guardian on July 15, 2026. Specific documents cited:
ATI p.271
August 3, 2021 pregnancy registry request to Pfizer -- Pfizer declined, Health Canada accepted, no further action taken.
ATI p.229
Health Canada internal review confirming vaccination status by pregnancy not tracked at population level in Canada.
ATI p.62-63
Bell’s Palsy/facial paralysis -- 434 serious cases in one reporting interval, documented Health Canada / Pfizer disagreement on signal closure and label language.
ATI p.296
6-month to 4-year authorization -- Pfizer response to Terms and Conditions ‘not acceptable,’ content ‘under negotiation,’ authorization proceeded.
ATI p.392
Internal memo confirming bivalent authorized as primary series for 6-month to 4-year age group on extrapolated booster data -- no primary series clinical trial data available.
ATI p.349
BA.4/BA.5 bivalent -- fatal reports O/E analysis requirement removed from monthly reporting at Pfizer’s request, ‘Accepted as removed by MAH.’
ATI p.329
Health Canada formal documentation of reduced monitoring intensity -- ‘adopting a risk-based approach...reducing oversight on indications where safety profile has been better characterized.’
ATI p.365
By 2023 -- standard COVID-19 specific reporting framework replaced with standard drug reporting requirements.
BBRS Signal Tracking (ATI Excel file)
Internal project tracking log 2020-2023 -- complete chronological record of all advisement letters, memos, Terms and Conditions negotiations, and surveillance changes across the full Comirnaty authorization period. May 29, 2023 entry documents formal closure of monthly safety report requirements.
Comirnaty Product Monograph (August 10, 2026, Control Number 300388)
Section 8.1.3 -- Safety of bivalent primary series for children 6 months to 4 years is “inferred primarily from the safety profile of COMIRNATY at 3 mcg.” Independently corroborates ATI p.392 finding on extrapolated pediatric authorization. Section 7 Cardiovascular -- Myocarditis and pericarditis warning added, October 2024. Independently corroborates ATI p.62 myocarditis signal timeline.
The Old Guardian’s six-part series What They Knew examines Health Canada’s internal COVID-19 vaccine pharmacovigilance records. The series publishes in September 2026 in conjunction with the Allison Inquiry hearings at Parliament Hill. ATI file: A-2025-001410.
If you or a family member experienced a serious adverse event following COVID-19 vaccination, contact The Old Guardian at tips@theoldguardian.ca. Source confidentiality is protected. Verification is required.
The Old Guardian | theoldguardian.ca | tips@theoldguardian.ca | ATI File: A-2025-001410