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COVID-19

Emails obtained by CHD reveal government’s failure to monitor COVID vaccine injury reports

Published

9 months ago

19 minute read

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

By Risa Evans, The Defender and Karl Jablonowski, Ph.D., The Defender

Newly posted email records on the U.S. Food and Drug Administration (FDA) website reveal that in the first 18 months after COVID-19 vaccines were rolled out to the public, the agency’s data monitoring of the Vaccine Adverse Event Reporting System (VAERS) showed consistent alerts for serious adverse events (including death) for the Janssen vaccine.

Meanwhile, the FDA’s monitoring found almost no safety signals for the Moderna and Pfizer shots, failing to detect signals even for widely recognized risks like myocarditis, pericarditis, and anaphylaxis.

The information is contained in emails sent by the FDA to key personnel in the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office between Jan. 12, 2021 and July 5, 2022.

Each email is accompanied by a list of adverse events for which the FDA says its weekly data analysis of VAERS yielded a statistical “alert” indicating a potential safety issue with the COVID-19 shots that may have required action on the agencies’ part.

The FDA posted the emails — under the banner “Empirical Bayesian Data Mining Records” — one day after the agency objected to a motion filed by Children’s Health Defense (CHD) in federal court pertaining to a 2023 Freedom of Information Act (FOIA) lawsuit.

The motion asks the court to order the FDA to disclose VAERS safety-monitoring records that CHD requested from the agency in July 2022.

According to Ray Flores, senior outside counsel to CHD, “The emails are further evidence of the federal government’s failure to make good on its promises to use VAERS as an ‘early warning system’ to detect and act on risks associated with the new vaccines.”

CDC claimed vaccines were ‘safe’ despite record number of VAERS reports

The emails show that despite these numbers, the FDA noted a steadily increasing number of alerts for adverse events associated with the Janssen vaccines, while noting just a handful of alerts for Moderna and Pfizer, mostly for product administration issues.

Due to concerns about six instances of severe blood clotting, the CDC and FDA “paused” the Janssen vaccine’s authorization on April 13, 2021. However, the agencies lifted the pause 10 days later, based on a “review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices [ACIP].”

The agencies wrote that they had “confidence that this vaccine is safe,” and promised they would “continue with these efforts to closely monitor the safety of these vaccines.”

However, after the pause was lifted, the FDA emails show that the agency consistently noted EB-mining alerts for Janssen vaccines for various types of thrombotic and other serious adverse events, including death.

For example, an alert for “deep vein thrombosis” was noted on May 11, 2021, and in every subsequent email. An alert for “death” was noted on March 8, 2022, and in every subsequent email.

READ: Cancer drug pioneer praises RFK Jr., suggests link between childhood cancer and COVID shots

In December 2021, the ACIP recommended “preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine.” However, Janssen remained available in the U.S. until May 22, 2023, when the company requested a withdrawal of the emergency use authorization (EUA).

For the Pfizer and Moderna shots, the FDA emails show that in 18 months of EB mining, the FDA noted alerts for various types of product administration issues and a handful of clinical outcomes, but failed to note alerts for myocarditis, pericarditis and anaphylaxis.

Yet as of June 30, 2022, VAERS had received 8,333 anaphylaxis reports (including 1,656 for Moderna, 6,427 for Pfizer, and 227 for Janssen), 10,166 pericarditis reports (including 1,879 for Moderna, 8,084 for Pfizer, and 181 for Janssen), and 15,353 myocarditis reports (including 3,607 for Moderna,11,487 for Pfizer, and 215 for Janssen), according to the CDC’s database.

CDC anticipated deluge of vaccine injury reports following COVID shots

According to the CDC, COVID-19 shots “underwent the most intensive safety analysis in U.S. history” and “continue to be monitored for safety.” A key component of that monitoring is VAERS, which the agency refers to as the “nation’s early warning system that monitors the safety” of vaccines, and “can often quickly detect an early hint or warning of a safety problem with a vaccine.”

VAERS, which is co-managed by the Centers for Disease Control (CDC) and Prevention and the FDA, is a “passive” monitoring system that accepts reports of adverse events experienced after vaccination.

Months before the FDA granted emergency use authorizations for the COVID-19 shots, the CDC anticipated that VAERS would be deluged with reports of adverse events following COVID-19 vaccination.

READ: Canadian parents wary of COVID, flu shots for children despite government propaganda: report

In a July 2020 multimillion-dollar VAERS-management contract between the CDC and General Dynamics Information Technologies (GDIT), the CDC predicted that the “total number of reports received during periods of peak activity (which are not expected to reflect sustained activity) is expected to be 1,000 reports per day, with up to 40% of the reports serious.”

As it turned out, the GDIT contract underestimated the number of adverse events. According to monthly status reports from GDIT, in January 2021, the number of incoming reports rose to over 2,500 per day.

By April 2021, GDIT indicated it would begin processing 25,000 reports per week to keep up with new and backlogged reports.

FDA, CDC promised to use 2 types of data analysis to detect safety signals in VAERS

Despite the unprecedented volume of adverse event reports for COVID-19 shots, the CDC and FDA have consistently noted that a report to VAERS does not, on its own, prove that a vaccine caused the reported adverse event — nor does a high number of adverse events reported for a particular type of vaccine prove causation.

Rather, to determine whether there could be a causal link between a vaccine and a particular type of adverse event, the CDC and FDA monitor VAERS in various ways, including by using data mining to look for statistical “signals” indicating a higher-than-expected number of reports for a given type of adverse event.

When the data analysis yields a signal, further investigation is required to determine if the vaccine poses a safety risk.

The agencies’ VAERS safety-monitoring duties for the COVID-19 shots are spelled out in the VAERS “Standard Operating Procedures (SOP) for COVID-19 (as of 29 January 2021),” which states that the agencies would conduct “routine VAERS surveillance to identify potential new safety concerns for COVID-19 vaccines.”

The VAERS SOP describes how the agencies would detect potential safety signals, stating:

“Two main approaches to data mining are Proportional Reporting Ratios (PRRs) and Empirical Bayesian Geometric Means. Both have published literature suggesting criteria for detecting “signals.” PRR will be used at CDC for potential signal detection; Empirical Bayesian data mining will be performed by FDA.”

The SOP specifies that PRR analysis would be conducted on a weekly basis or “as needed” and EB mining would be conducted at least bi-weekly.

Under the VAERS SOP, the agencies would “share and discuss results of data mining analyses and signals” and investigate potential signals as necessary to determine whether they indicated genuine safety concerns.

The process is also described in a March 2023 letter from the FDA and CDC to Florida Surgeon General Joseph Ladapo:

“FDA and CDC physicians continuously screen and analyze VAERS data for possible safety concerns related to the COVID-19 vaccines. For signals identified in VAERS, physicians from FDA and CDC screen individual reports, inclusive of comprehensive medical record review.”

The VAERS SOP also promised that the VAERS contractor (GDIT) would provide daily emails to the CDC and the FDA with lists of VAERS ID numbers for “adverse events of special interest” (AESIs), and that FDA would routinely conduct “manual review” of AESIs.

Agencies relied solely on FDA analysis, even after confirming failure to detect key signals

According to Brian J. Hooker, Ph.D., CHD’s chief scientific officer:

“PRR and EB mining provide complementary methods of ‘disproportionality analysis.’ Essentially, PRR compares the rate of adverse events in the vaccine being studied with the rate in another vaccine (typically of older vintage), looking for statistical signals that the rate in the studied vaccine exceeds expectations.

“EB mining also looks for statistical signs of a disproportionately high number of adverse events. However, the basis for comparison is the expected rate of the event in question, typically in the general population.”

Potential safety signals that are eventually highlighted by both approaches may be highlighted earlier by PRR, according to the Council for International Associations of Medical Societies.

In June 2022, responding to a FOIA request from CHD, the CDC admitted it did not conduct the PRR analysis described in the VAERS SOP.

In 2023, responding to additional FOIA requests from CHD and the Epoch Times — and a lawsuit brought by CHD — the CDC said the agencies relied solely on the FDA’s EB mining to analyze “disproportionate reporting” because PRR is “prone to false signals” and EB mining is “a more robust data mining technique.”

Despite the CDC’s decision not to conduct the weekly analysis described in the VAERS SOP, the agency did conduct some PRR analysis for a brief period, from March 25, 2022 through July 31, 2022.

The CDC told CHD it did this for the purpose of “corroborating” the FDA’s EB mining results.

According to PRR records that the CDC eventually provided to CHD as part of the FOIA lawsuit, for the first six weeks of the PRR analysis, the CDC simply compared the adverse event rates between Moderna and Pfizer shots. However, on May 6, the CDC started comparing Pfizer and Moderna mRNA shots to non-COVID vaccines.

According to the CDC, the results of the PRR analysis were “generally consistent with empirical Bayesian data mining, revealing no additional unexpected safety signals.” However, unlike the few alerts detected through the EB mining, the PRR analyses comparing mRNA shots to non-COVID vaccines revealed hundreds of potential safety signals.

For example, the May 6, 2022 analysis, covering reports received by VAERS on or before that date, flagged 777 symptoms, of which 171 are serious, including death, cardiac arrest, and stroke.

For 5-to-11 year-olds, the analysis flagged 56 symptoms, of which 20 are serious, including myo- and pericarditis. For 12-to-17 year-olds, the analysis flagged 95 symptoms, of which 45 are serious, also including myo- and pericarditis.

In stark contrast to these PRR flags, the EB mining runs for Pfizer and Moderna shots on May 10 yielded alerts for nine events related to vaccine administration and a mere three clinical outcomes (‘mechanical urticaria’, ‘exposure via breast milk’, and ‘drug ineffective’).

Despite the apparent failure of the FDA’s EB mining to detect signals that the CDC detected through PRR, the CDC told CHD in June 2023 that the agencies would continue to rely solely on the EB mining, “[g]iven that it is a ‘gold standard’ mining technique.”

“The results of these two methods are simply not ‘generally consistent,’ and a pharmacovigilance system that detects a mere three clinical outcomes while failing to detect the most serious adverse events certainly does not qualify as a ‘gold standard.’” Hooker said. “The CDC’s conclusion that the PRR results support the agencies’ exclusive reliance on EB mining cannot possibly have been made in good faith.”

Agencies have yet to disclose key records of activities under VAERS SOP

Through FOIA requests submitted to the FDA and CDC in the summer of 2022, and the lawsuits filed against both agencies in early 2023, CHD has been attempting to obtain records of the agencies’ activities and findings under the VAERS SOP during the first 18 months after the COVID shots became publicly available in the U.S.

CHD also seeks records of the FDA’s manual review of AESIs; communications and consults between the agencies regarding data mining results and signals; follow-up investigation done in connection with any signals detected; and the daily email reports of adverse events sent to CDC and FDA by the VAERS contractor.

Although the CDC provided some records after CHD sued the agency and the FDA recently posted the emails containing EB-mining results where an alert was generated, many key records are still outstanding.

In connection with the EB mining, the FDA has yet to provide the records of data-mining runs that did not result in alerts, and full data for any of the runs, which should include variables such as the expected rates of adverse events that formed the basis for the FDA’s comparisons.

Additionally, the agencies have not provided records of discussions or consults regarding signals, or records of follow-up investigations they may have conducted when a signal was detected.

The delay in producing records is due in part to court-ordered stays of both lawsuits. The stays were granted after the FDA told courts it does not have ability to process CHD’s FOIA requests because its resources are devoted to fulfilling orders from a Texas court requiring the agency to produce licensing documents for the COVID-shots.

Despite recent calls for “transparency” by a top FDA vaccine official, Dr. Peter Marks, the FDA says it has requested similar stays in at least 10 other FOIA lawsuits, and has received stays in seven of those, including a second CHD lawsuit, which seeks records of the FDA’s safety monitoring of COVID-19 vaccines through its “active surveillance” system.

This article was originally published by The Defender 

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COVID-19

The Trials of Liberty: What the Truckers Taught Canada About Power and Protest

Published on October 13, 2025

By

Half the country still believes the convoy was a menace; the other half thinks it was a mirror that showed how fragile our freedoms had become.

This Thanksgiving I am grateful for many things. The truckers who stood up to injustice are among them.

When the first rigs rolled toward Ottawa in January 2022, the air was sharp, but not as sharp as the mood of the men and women behind the wheels. They were not radicals. Seeing a CBC a campaign of disinformation about them begin as soon as their trek started, even when Ottawa political operatives hadn’t yet heard, I started following several of them on their social media.

They were truckers, small business owners, independent contractors, and working Canadians who had spent two years hauling the essentials that kept a paralyzed nation alive. They were the same people politicians, including Prime Minister Trudeau, had called “heroes” in 2020. By 2022, they had become “threats.”

The Freedom Convoy was born from exhaustion with naked hypocrisy. The federal government that praised them for risking exposure on the road now barred the unvaccinated from crossing borders or even earning a living. Many in provincial governments cheered Ottawa on. The same officials who flew to foreign conferences maskless or sat in private terraces to dine, let’s recall, still forced toddlers to wear masks in daycare. Public servants worked from home while police fined citizens for walking in parks.

These contradictions were not trivial; they were models of tyrannical rule. They told ordinary people that rules were for the ruled, not for rulers.

By late 2021, Canada’s pandemic response had hardened into a hysterical moral regime. Compliance became a measure of virtue, not prudence. Citizens who questioned the mandates were mocked as conspiracy theorists. Those who questioned vaccine efficacy were treated as fools; those who refused vaccination were treated as contagious heretics. Even science was no longer scientific. When data showed that vaccines did not prevent transmission, officials changed definitions instead of policies. The regime confused authority with truth. One former provincial premier just this week was still hailing the miracle of “life-saving” COVID vaccines.

For truckers, the breaking point came with the federal vaccine mandate for cross-border transport. Many had already complied with provincial rules and workplace testing. Others had recovered from COVID and had natural immunity that the government refused to recognize. To them, the new rule was not about safety; it was about humiliation. It said, “Obey, or you are unfit to work.”

So they drove.

Donna Laframboise, one of the rare journalists who works for citizens instead of sponsors, described the convoy in her book Thank You, Truckers! with gratitude and awe. She saw not a mob but a moral statement. She showcased for us Canadians who refused to live by lies. Their horns announced what polite society whispered: the emergency had become a creepy habit, and the habit had become a tool of control.

When the convoy reached Ottawa, it was messy, loud, and human. There was singing, prayer, laughter, dancing and some foolishness, but also remarkable discipline. For three weeks, amid frigid temperatures and rising tension, there were no riots, no arsons, no looting. In a country that once prized civility, that should have earned respect.

Instead, it attracted the media’s and government’s contempt.

The Trudeau government, rattled by its own public failures, sprung to portray the protest as a national security threat. Ministers invoked language fit for wartime. The Prime Minister, who had initially fled the city claiming to have tested positive, returned to declare that Canadians were under siege by “racists” and “misogynists.” The accusations were as reckless as they were false. The government’s real grievance was not chaos but defiance.

Then came the Emergencies Act. Designed for war, invasion, or insurrection, it was now deployed against citizens with flags and thermoses. Bank accounts were frozen without charge or trial. Insurance policies were suspended. Police weilding clubs were unleashed against unarmed citizens. The federal government did not enforce the law; it improvised it.

A faltering government declared itself the victim of its citizens. The Emergency declaration was not a reaction to danger; it was a confession of political insecurity. It exposed a leadership that could not tolerate dissent and recast obedience for peace.

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The convoy’s organizers, who kept the protest largely peaceful, were arrested and prosecuted as though they had plotted sedition. They were charged for holding the line, not for breaking it. The state’s behaviour was vindictive, not judicial. Prosecutors went along with it, and so did courts.

In a healthy democracy, such political trials would have shaken Parliament to its core. Legislators would have demanded justification for the use of emergency powers. The press would have asked precisely which law had been broken. Citizens would have debated the limits of government in times of fear, times which seem to continue just under the radar.

Not much of that happened.

Canada’s institutions have grown timid. The press is subsidized and more subservient. The courts happily defer to the administrative state. Law enforcement has learned to follow politics before principle. Academics have been lost for about generation. Under such conditions, how can citizens object to unscientific and coercive policies? What options remain when every channel of dissent—media, science, judiciary, and law enforcement—is captured or cowed?

The convoy’s protest, let’s remember, was not the first major disruption in the Trudeau years. A year earlier, Indigenous activists blocked rail lines and highways in solidarity with Wet’suwet’en hereditary chiefs opposed to a pipeline. The blockades cost the economy millions. They were called “a national conversation.” Few arrests, no frozen accounts, no moral panic.

In 2020, Black Lives Matter marches were cheered by politicians and news anchors. Some protests were peaceful, others destructive. Yet they were treated as expressions of justice, not extremism.

Even today, pro-Hamas Palestinian demonstrations that include violence and intimidation of Jewish citizens are tolerated with a shrug. The police stand back, bring them coffee, citing “the right to protest.”

Why, then, was the Freedom Convoy treated as a crisis of state?

In a liberal democracy, protest is not rebellion. It is a civic instrument, a reminder that authority is contingent. When a government punishes peaceful protest because it disapproves of the message, it turns democracy into décor.

The trials of the convoy organizers are therefore not about law but about legitimacy. Each conviction signals that protest is permitted only when it pleases the powerful. This is the logic of every soft tyranny: it criminalizes opposition while decorating itself with the vocabulary of rights. I see this daily in Nicaragua, my native land.

The truckers’ protest revealed what the pandemic concealed. The COVID regime was unscientific and incoherent. It punished truckers who worked alone in their cabs while allowing politicians to mingle maskless at conferences. It barred unvaccinated Canadians from air travel but allowed infected citizens to cross borders with the proper paperwork. It closed playgrounds and churches while keeping liquor stores open.

These contradictions were not mistakes; they were instruments of obedience. Each absurd rule tested how much submission people would endure.

The truckers said, “Enough.” I am grateful that they did.

For that, Chris Barber (Big Red) and Tamara Lich 🇨🇦 are still being punished. Their trials have now concluded, save for possible appeals, yet their quiet defiance remains one of the few honest moments in recent Canadian history. It showed that courage is still possible, even the state seems to forbid reason.

The government’s response revealed the opposite: that fear, once politicized, is never surrendered willingly. The state that learned to rule through emergency will not soon unlearn it. They cling to its uses still.

Canada lives with the legacy of that winter today. The trials are finished, but the divisions persist. Half the country still believes the convoy was a menace; the other half thinks it was a mirror that showed how fragile our freedoms had become.

Trudeau’s government is no more, yet the spirit of his politics lingers. He did not create the divisions by accident. He cultivated them as a strategy of control. The country that left him behind is also less free, less trusting, and less united than it was before the horns sounded in Ottawa. Carney’s government is Trudeau’s heir.

The trials and sentencing measure the distance between the Canada we imagined and the one we inhabit.

The truckers’ convoy was imperfect, yet profoundly democratic. It stood for the right of citizens to say no to a government that had forgotten how to hear them. The echo of that refusal still moves down the Trans-Canada Highway. It is the sound of liberty idling in the cold, waiting for a green light that will not soon come.

This Thanksgiving, I am grateful for the abounding love and understanding in my life. I am grateful for my spirited children and their children. I am grateful for my nonagenarian father and for my siblings. I’m grateful for the legion of aunts, uncles, cousins, nieces and nephews on all sides of the family. I am grateful for loyal friendships and for my colleagues and coworkers who share the quest for a freer country. I’m grateful to my adoptive Alberta, and Albertans, also struggling to be strong and free.

I am grateful for the Truckers, wherever they came from, for their courage.

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COVID-19

Tamara Lich says she has no ‘remorse,’ no reason to apologize for leading Freedom Convoy

Published on October 10, 2025

By

From LifeSiteNews

By Anthony Murdoch

‘To whom shall I apologize? Thousands of Canadians who stopped planning to take their own lives or were able to return to their jobs, kiss dying loved ones or have families over for Thanksgiving?’

Freedom Convoy leader Tamara Lich, reflecting on her recent house arrest verdict, said she has no “remorse” and will not “apologize” for leading a movement that demanded an end to all COVID mandates.

Lich revealed in an X post this week that in conversations with her lawyer, Lawrence Greenspon, over the past few months, she told him, “I would not, and could not, express remorse as it would be dishonest and disingenuous.”

“To whom shall I apologize? The thousands of Canadians who stopped planning to take their own lives when the convoy started? To the thousands of Canadians who were able to return to their jobs? Or should I apologize to all the Canadians who can kiss their dying loved ones or have their families over for Thanksgiving?” she observed.

On October 7, Ontario Court Justice Heather Perkins-McVey sentenced Lich and Chris Barber to 18 months’ house arrest after being convicted earlier in the year convicted of “mischief.”

As reported by LifeSiteNews, the Canadian government was hoping to put Lich in jail for no less than seven years and Barber for eight years for their roles in the 2022 protests against COVID mandates.

Interestingly, Perkins-McVey said about Lich and Barber during the sentencing, “They came with the noblest of intent and did not advocate for violence.”

In Lich’s X post, she noted that while she has “no doubt” some citizens of Ottawa “felt afraid, threatened and terrorized” by the protests, she blamed the Liberal government under former Prime Minister Justin Trudeau.

“How could they not when their mayor and politicians were labeling us as an angry mob coming to overthrow the government before we even left Alberta?” she wrote.

“Do I feel bad for these people? Of course I do. I wish no ill will upon anyone. However, it was their very own leaders who lied to them and misled them. There are citizens in Ottawa genuinely afraid of working-class Canadians, who had never met a trucker or an oil patch worker.”

Specifically, Barber was handed an 18-month conditional sentence, with a concurrent three-month sentence for counseling disobedience of a court order that can be served in the community.

Lich was given 18 months less time already spent in custody, amounting to 15 1/2 months.

Both Lich and Barber must remain in their house for the first 12 months except for medical emergencies and certain appointments. They are allowed to work and can leave their house for certain permitted activities for up to five hours once a week. They were also given a curfew and 100 hours of community service.

As reported by LifeSiteNews, Barber thanked Conservative MP Leslyn Lewis for “speaking up” in support of him and Canadians’ freedom rights after he and Lich were sentenced.

LifeSiteNews reported that Conservative Party leader Pierre Poilievre offered his thoughts on the sentencing, wishing them a “peaceful” life while stopping short of blasting the sentence as his fellow MPs did.

In early 2022, the Freedom Convoy saw thousands of Canadians from coast to coast come to Ottawa to demand an end to COVID mandates in all forms. Despite the peaceful nature of the protest, Trudeau’s government enacted the never-before-used Emergencies Act (EA) on February 14, 2022.

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