THE OLD GUARDIAN
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Pregnant women were excluded from Pfizer’s COVID-19 clinical trials. Then they were vaccinated on extrapolated evidence while Health Canada internally flagged their population for special monitoring. The gap between what was known and what was tracked is documented in federal records -- and in the lives of Canadian women who were never told.
By Chris Allen | The Old Guardian | September 2026
Primary source: ATI Release A-2025-001410, Health Canada, July 15, 2026
Three words appear in Health Canada’s own internal pharmacovigilance review of Comirnaty. They appear on page 208 of a 2,460-page document obtained by The Old Guardian under federal Access to Information request A-2025-001410.
The words are: protection by exclusion.
The full sentence reads: ‘The safety and efficacy of COVID-19 vaccines have been demonstrated in adults across a range of demographics, except on pregnant and lactating women due to the protection by exclusion during the clinical development stages.’
Protection by exclusion. It is a phrase from the regulatory world meaning that a population is protected from the risks of a clinical trial by not being included in it. It is a standard practice in early-stage drug development for good reasons -- pregnant women are a vulnerable population and trial risks are unknown.
But protection by exclusion is not the same as evidence of safety. It means the opposite. It means no data exists. It means the question was not answered in the controlled setting that would answer it definitively. It means that when those same excluded women were subsequently vaccinated -- in the millions, across Canada, under varying degrees of social and institutional pressure -- they were vaccinated on the basis of extrapolation, not evidence.
Health Canada’s own internal documents say so directly. The product monograph authorized August 10, 2026 says so publicly. And the consequences of that gap -- between what was studied and what was assumed, between what was tracked and what was communicated -- are documented in the lives of Canadian women who were never told that the protection extended to them was not evidence. It was an absence of data dressed as reassurance.
The Clinical Trial Exclusion: Confirmed in Internal Documents
Health Canada’s internal pregnancy ad-hoc review, conducted in 2022, is explicit on this point. Beyond the page 208 passage already quoted, page 225 of the same ATI release states:
‘Despite their higher risk of SARS-CoV-2 infection, pregnant and lactating women were not included in any initial COVID-19 vaccine trials.’
Higher risk of severe COVID-19 outcomes. Excluded from the trials designed to establish safety. Then vaccinated as part of the population for whom vaccination was recommended.
This sequence -- exclusion, then authorization, then vaccination -- is not a secret. It was acknowledged in regulatory language at the time. What was not communicated with equivalent clarity was what exclusion actually meant for the evidence base. The public messaging in Canada characterized COVID-19 vaccination as safe for pregnant people. The internal documents confirm that characterization was made in the absence of the controlled clinical data that would have supported it.
The current authorized Comirnaty Product Monograph, dated August 10, 2026, independently confirms this. Section 7.1.1 states: ‘There are limited clinical study data from the use of COMIRNATY (Original) in pregnant women.’ For the variant-adapted formulations that Canadians received in 2022 and beyond: ‘No clinical study data are available regarding the use of variant-adapted COMIRNATY during pregnancy.’
No clinical study data. For the formulations that pregnant Canadians received. That language is on the official product label right now.
Source: ATI Release A-2025-001410, Health Canada internal pregnancy ad-hoc review, pages 208, 225. Comirnaty Product Monograph, August 10, 2026, Section 7.1.1, p.14.
No Observed Versus Expected Analysis: The Missing Calculation
When Health Canada monitors post-authorization adverse events for a vaccine, one of its primary tools is the observed versus expected analysis. It compares the rate of adverse events actually reported against the rate that would be statistically expected in a comparable unvaccinated population of similar size and demographics. A rate above the expected range is a signal. A signal triggers investigation.
For the myocarditis signal documented in Part 2 of this series, an observed versus expected analysis existed. It was the tool that allowed Health Canada’s internal reviewers to conclude a ‘possible link’ between the second dose and myocarditis in young males.
For Comirnaty pregnancy outcomes, no such analysis existed.
Page 242 of the ATI release states it directly: ‘Comirnaty: No observed versus expected analysis.’
For comparison, Spikevax -- Moderna’s mRNA vaccine -- had an observed versus expected analysis for pregnancy outcomes during the same period. For Pfizer’s product, which was the primary vaccine administered to the majority of Canadians, it did not exist.
Without an observed versus expected analysis, Health Canada’s internal reviewers were working without the primary statistical tool that would have allowed them to detect whether adverse pregnancy outcomes were occurring at a rate above background. They were monitoring a population they had no baseline to compare against, for a drug they had no primary trial data for, using a surveillance system that -- as documented elsewhere in these records -- was itself operating with incomplete data.
No observed versus expected analysis existed for Comirnaty pregnancy outcomes. The primary statistical tool for detecting adverse signals was absent for the vaccine most Canadians received.
Source: ATI Release A-2025-001410, Health Canada internal pregnancy ad-hoc review, page 242.
Canada Was Not Tracking: The Population-Level Data Gap
Beyond the absence of an observed versus expected analysis for Comirnaty specifically, there was a more fundamental data gap documented in these records.
Page 229 of the ATI release states: ‘This was not restricted to pregnancy status of the females as the data for this subpopulation is not available; this information is not tracked in Canada.’
Canada was not tracking vaccination status by pregnancy at the population level. The country administered millions of doses to women of reproductive age without a systematic mechanism to identify which of those women were pregnant at the time of vaccination, what their pregnancy outcomes were, and whether those outcomes differed from the unvaccinated pregnant population.
The 290 pregnancy-related adverse event reports recorded in Canada to May 31, 2022 -- including 127 classified as serious and 72 spontaneous abortion reports -- came from a passive surveillance system. Passive surveillance means healthcare providers and patients submit reports voluntarily. The literature consistently documents that passive surveillance systems capture a fraction of actual adverse events -- estimates typically range from five to ten percent of events being reported.
The 72 spontaneous abortion reports in the Canadian database were assessed against Brighton Collaboration case definitions. The median time to onset was eleven days. The range was two hours to sixty-three days.
But those reports existed in a denominator vacuum. The total number of pregnant Canadians who were vaccinated during this period was not precisely known. The rate of spontaneous abortion in vaccinated pregnant Canadians compared to unvaccinated pregnant Canadians was not calculable from available data. Health Canada’s own evaluators noted in their review that Canadian AEFI reports ‘lacked clinical evaluation and medical confirmation’ -- that the data quality was insufficient to draw conclusions even from the reports that were submitted.
The surveillance system was passive, incomplete, and operating without a population-level denominator. That is not a conspiracy. It is a documented failure of data architecture that predates COVID. But it is a failure that had direct consequences for the ability of Canadian regulators to detect rare adverse events in pregnant women even if those events were occurring.
Source: ATI Release A-2025-001410, pages 229, 273-274, 281. Health Canada internal pregnancy ad-hoc review.
Pfizer Declined the Registry: A Request on the Record
Health Canada identified this gap. On August 3, 2021, Health Canada sent a formal request to Pfizer-BioNTech asking the company to implement a pregnancy registry for Canada and reference it in the Canadian Product Monograph.
A pregnancy registry would have allowed prospective tracking of vaccinated pregnant Canadians and their outcomes. It would have created the denominator that passive surveillance lacked. It would have generated the data that would have made an observed versus expected analysis possible.
Pfizer declined. The company cited existing post-authorization studies already underway internationally. It stated it had no plans to update the Canadian Product Monograph to include information on pregnancy registries.
Health Canada accepted this response. The 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. The absence of an observed versus expected analysis for Comirnaty pregnancy outcomes remained. Canada remained unable to track vaccination status by pregnancy at the population level. And the public messaging continued to characterize COVID-19 vaccination as safe for pregnant people -- a characterization made in the absence of the registry data that would have actually supported it.
Health Canada asked Pfizer to build the data infrastructure that would have allowed proper pregnancy safety monitoring. Pfizer said no. Health Canada accepted that answer. The data gap remained.
Source: ATI Release A-2025-001410, BBRS Signal Tracking document, August 3, 2021 entry. ATI page 271.
What Fauci Texted Walensky: A Cross-Border Parallel
On January 25, 2021 -- seven months before Health Canada formally requested and was denied a Canadian pregnancy registry -- the director of the National Institute of Allergy and Infectious Diseases sent a text message to the director of the Centers for Disease Control and Prevention.
The text was from Anthony Fauci to Rochelle Walensky. It was released by Senators Ron Johnson and Rand Paul on August 10, 2026, from Fauci’s government-issued iPhone, produced by HHS.
Fauci wrote: ‘Since many people have significant cytokines storm and fever after the 2nd dose, this theoretically could be associated with miscarriage in the 1st trimester.’
Walensky’s response called it ‘definitely a good point, especially after dose two.’
Days later, Fauci publicly stated that thousands of vaccinated pregnant women had shown ‘no red flags.’ Seven months later, Health Canada was still trying to get Pfizer to build the data infrastructure that would have allowed detection of rare adverse pregnancy events.
The Fauci text does not prove vaccines caused miscarriages. It establishes that the senior American public health official who was the dominant voice of the pandemic response privately acknowledged a theoretical first trimester miscarriage risk at the same time his public messaging said no red flags existed. That gap -- between private concern and public reassurance -- ran on both sides of the border simultaneously.
Canadian public health messaging was downstream of American guidance. When Fauci said no red flags, Canadian health authorities reflected that position. The internal documents on both sides of the border show the picture was more complicated than the public was told.
Source: Fauci text messages, released by Senators Ron Johnson and Rand Paul, August 10, 2026. Primary source: ronjohnson.senate.gov. CBS News confirmation August 10, 2026.
The Breastfeeding Gap: Six Years Later
There is one line in the current authorized Comirnaty Product Monograph -- the document that governs how Canadian healthcare practitioners advise patients on this vaccine right now, in September 2026 -- that captures the scope of what remains unknown.
Section 7.1.2, under Breastfeeding, states: ‘No data are available yet regarding the use of COMIRNATY during breast-feeding.’
No data are available yet. Six years after initial authorization. Six years after Canadian nursing mothers made decisions about vaccination based on the reassurance that it was safe. The word ‘yet’ implies the data is coming. After six years, it has not arrived.
This is not a claim that vaccination harmed nursing mothers or their infants. It is a documented fact that six years after Comirnaty was first authorized in Canada, the product label still acknowledges the absence of breastfeeding safety data. The public messaging during the vaccination campaign did not communicate equivalent uncertainty. Nursing mothers were not routinely told that the safety data for their specific situation did not exist.
Source: Comirnaty Product Monograph, August 10, 2026, Control Number 300388. Section 7.1.2, p.14.
The Human Cost: Two Ontario Women
The data gaps documented in this piece are not abstract. They have faces.
Kayla Pollock is an Ontario woman who received a Moderna booster shot in February 2022. Within days she developed acute transverse myelitis -- inflammation of the spinal cord -- that left her paralyzed from the chest down with limited function in her arms. While hospitalized, she was offered MAiD twice. She refused both times. Her VISP claim remained unfinalized as of the most recent available reporting. Her case was reported by CBC News in April 2026.
Jamie Daniel spent her career as a medical professional helping people in emergencies. Following COVID-19 vaccination she developed severe neurological symptoms. She was repeatedly dismissed by healthcare providers. Called a drug seeker. Eventually diagnosed with transverse myelitis. While hospitalized, in severe pain, asking for help, a psychologist was brought in to discuss MAiD. She was in her early thirties. She had two young children at home. She testified publicly at the Allison Inquiry on September 11, 2026.
‘I was asking for help,’ Jamie told the inquiry panel. ‘And instead, they offered to euthanize me.’
Transverse myelitis is documented in Health Canada’s internal pharmacovigilance records as one of the neurological adverse events tracked in Canada. The ATI documents show 759 neurological events recorded for Comirnaty in Canada by June 2022. The surveillance system tracked the category. It did not have the data architecture to track the denominators that would have allowed detection of a population-level signal.
Whether vaccination caused Kayla Pollock’s or Jamie Daniel’s transverse myelitis is not a question this series can answer. What this series can document is that the data infrastructure that might have answered that question -- the pregnancy registry Pfizer declined to build, the observed versus expected analysis that didn’t exist for Comirnaty, the population-level tracking that Canada didn’t do -- was absent. And in that absence, two women were left without answers. One was told to start her compensation claim over after three years of waiting. The other was offered death while asking for help.
The data infrastructure that might have detected rare adverse events in vulnerable populations was documented as absent. Two Ontario women were left in that absence without answers.
Source: Kayla Pollock case -- CBC News, April 2026. Jamie Daniel -- public testimony, Allison Inquiry, September 11, 2026. Neurological adverse events -- ATI Release A-2025-001410, page 198.
What This Means
This piece does not argue that COVID-19 vaccines harmed pregnant women, nursing mothers, or women of reproductive age as a population. The evidence does not support that claim and TOG does not make it.
What the evidence supports is precise and documented. Pregnant women were excluded from the clinical trials that established Comirnaty’s safety profile. They were subsequently vaccinated on extrapolated evidence while Health Canada internally flagged their population for special monitoring. No observed versus expected analysis existed for Comirnaty pregnancy outcomes. Canada did not track vaccination status by pregnancy at the population level. Pfizer declined to build the registry that would have filled that gap. Health Canada accepted that answer. The public was not told that the evidence base for vaccination in pregnancy rested on extrapolation rather than direct clinical data.
Three words in Health Canada’s own internal documents describe what happened to pregnant women in the clinical development of Comirnaty. Protection by exclusion.
The protection of exclusion from a trial is real. It means pregnant women were not exposed to the risks of an experimental drug in a controlled setting. That is a genuine form of protection.
But exclusion from a trial is not the same as evidence of safety. And in the gap between those two things -- between the protection of not being studied and the assumption of safety that followed -- millions of Canadian women made decisions about vaccination that the evidence base, honestly communicated, would have allowed them to make differently.
That gap is the accountability record this piece documents.
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, and from the current authorized Comirnaty Product Monograph dated August 10, 2026. Specific documents cited:
ATI p.208
Health Canada internal pregnancy ad-hoc review -- ‘protection by exclusion during the clinical development stages.’ Verbatim internal language.
ATI p.225
‘Despite their higher risk of SARS-CoV-2 infection, pregnant and lactating women were not included in any initial COVID-19 vaccine trials.’ Verbatim internal language.
ATI p.242
Comirnaty: ‘No observed versus expected analysis’ for pregnancy outcomes. For Spikevax, an O/E analysis existed.
ATI p.229
‘This information is not tracked in Canada.’ Canada not tracking vaccination status by pregnancy at population level.
ATI p.271
August 3, 2021 pregnancy registry request to Pfizer -- Pfizer declined, Health Canada accepted, no further action taken.
ATI p.273-274
290 pregnancy-related adverse event reports in Canada to May 31, 2022. 127 serious. 72 spontaneous abortion reports. Median onset: 11 days. Range: 2 hours to 63 days.
ATI p.281
Health Canada evaluators -- Canadian AEFI reports ‘lacked clinical evaluation and medical confirmation.’ Data quality insufficient to draw conclusions.
ATI p.198
759 neurological events tracked in Canada for Comirnaty by June 2022.
Comirnaty Product Monograph (August 10, 2026, Control Number 300388)
Section 7.1.1: ‘limited clinical study data’ for COMIRNATY Original in pregnant women. ‘No clinical study data’ for variant-adapted formulations in pregnancy. Section 7.1.2: ‘No data are available yet regarding the use of COMIRNATY during breast-feeding.’
Fauci text messages (August 10, 2026)
January 25, 2021 text to Walensky: ‘this theoretically could be associated with miscarriage in the 1st trimester.’ Source: ronjohnson.senate.gov. Confirmed by CBS News, The Hill, Newsweek.
Kayla Pollock
CBC News, April 2026. Transverse myelitis following Moderna booster, February 2022. MAiD offered twice during hospitalization.
Jamie Daniel
Public testimony, Allison Inquiry, September 11, 2026. Transverse myelitis following COVID-19 vaccination. MAiD offered while hospitalized with two young children at home.
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. 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.
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