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COVID-19

Is FDA ‘covering for Pfizer’? Court orders agency to release a million more pages of COVID vaccines documents

Published

6 months ago

12 minute read

From LifeSiteNews

By Dr. Michael Nevradakis for The Defender

“The reluctance to release these data proves to me that there is fear that the public will become even more aware that the FDA has failed and continues to fail in its duty to protect us.”

A federal court last week ordered the U.S. Food and Drug Administration (FDA) to release one million pages of documents related to the Pfizer-BioNTech COVID-19 vaccine, despite the agency’s efforts to block their release. The FDA has approximately six months to provide the documents.

The ruling stems from a lawsuit Public Health and Medical Professionals for Transparency (PHMPT) filed against the FDA in 2021. PHMPT sued the agency after it rejected a Freedom of Information Act (FOIA) request for expedited processing of documents relating to the Pfizer-BioNTech COVID-19 vaccine clinical trials.

In January 2022, a federal court sided with PHMPT, ordering the agency to release internal documents. According to PHMPT, the FDA didn’t provide all the clinical trial documents, prompting the organization to file a motion for their release.

In an opposing motion, the FDA claimed PHMPT’s initial request sought only those documents pertaining to its licensing of the Pfizer-BioNTech vaccine, not the emergency use authorization (EUA) that preceded licensure. The FDA asked the court to release the agency from any obligation to provide additional documents.

The Dec. 6 ruling by U.S. District Judge Mark T. Pittman rejected the FDA’s claim, ordering the FDA to “produce the responsive EUA file on or before June 30, 2025.”

Pittman’s ruling quoted Patrick Henry, a key figure in the American Revolution: “The liberties of a people never were, nor ever will be, secure, when the transactions of their rulers may be concealed from them.”

“The Covid-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer Vaccine,” Pittman added.

Medical, legal experts welcome the ruling

 

“FDA clearly lacks confidence in the review it conducted to license Pfizer’s Covid-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri posted on X.

Naomi Wolf, CEO of Daily Clout and author of “The Pfizer Papers: Pfizer’s Crimes Against Humanity,” analyzed the initial batch of FDA documents. She told The Defender the ruling is “another important victory in securing the immediate release of a million new documents from Pfizer.”

Writing on Substack, Dr. Meryl Nass, founder of Door to Freedom, said, “It turned out FDA was hanging on to … the entire EUA file. The juiciest materials had not been released. The EUA file contained FDA’s evaluation (and probably all other materials) of the Pfizer clinical trial, which we now know bent a lot of rules.”

Noting that the initial tranche of documents the FDA released contained many duplicate documents and suggesting the FDA was trying to “pull a fast one,” Nass asked, “Why would it need an official release from further production … unless there was further production that it was withholding?”

FDA ‘obviously covering for Pfizer’

According to Pittman’s ruling, “Vaccines are approved for marketing through applications known as Biologics License Applications (‘BLA’).” It stated:

BLAs include various information and data, including: (1) nonclinical and clinical data; (2) information about manufacturing methods and locations; (3) data establishing stability of the product through the dating period; (4) summaries of results from tests performed on the lots of representative samples of the product; and (5) mockups of the labels, enclosures, medication guide if proposed, and containers as applicable. …

If the FDA determines that the BLA meets the statutory and regulatory requirements, the FDA will issue a biologics license for the product, authorizing the sponsor of that particular BLA to market that new product.

The BLA process is distinct from the process of granting an EUA, the ruling noted. This process is governed under the Project BioShield Act of 2004 and gives the FDA authority to grant emergency approval to “certain medical products – such as vaccines – during public health emergencies, according to the ruling.

“The level of scrutiny afforded to a vaccine seeking EUA approval varies significantly from what is considered normal for FDA approval,” Pittman said in his ruling. “Generally, EUA applications require data supporting – not proving – safety and effectiveness, with lower standards and faster reviews than normal FDA approval.”

In its motion opposing the release of the documents, the FDA claimed, “the EUA file does not fall within Plaintiff’s FOIA request because the BLA and EUA are separate applications that are subject to different standards and, thus, a FOIA request for one does not necessitate production of the other.”

Pittman rejected this argument. Conceding that the FDA is correct that the two applications are distinct, he wrote it is nevertheless evident that the documents PHMPT requested included “‘all data and information submitted with or incorporated by reference in any [BLA],’ as well as ‘other related submissions.’”

According to the court, the BLA the FDA granted to Pfizer-BioNTech “incorporated and relied heavily on the EUA.” As such, the ruling stated that the BLA and EUA documents are “related.”

Ray Flores, senior outside counsel to Children’s Health Defense, told The Defender that after the declaration of a public health emergency, “safety and efficacy shortcuts for medical countermeasures are permitted via EUA.”

“By withholding and redacting, the FDA is obviously covering for Pfizer while trying to cover itself, since FDA maintains sole power to revoke the Pfizer-BioNTech EUA,” Flores said. “The reluctance to release these data proves to me that there is fear that the public will become even more aware that the FDA has failed and continues to fail in its duty to protect us.”

Documents may bring us ‘a step closer to learning who rules America’

In late 2021, the FDA argued that it needed 75 years to redact and produce the documents PHMPT requested. A federal court rejected this argument, approving their expedited release and giving Pfizer eight months to furnish the documents. A total of 1,200,874 pages of records have since been released, according to the ruling.

PHMPT, a group of more than 60 medical and public health professionals and scientists from institutions such as Harvard, Yale and UCLA, has published those documents on its website.

“FDA wanted 75+ years to produce these documents and … has worked very hard to get there, this time by hiding a million pages from the Court and the plaintiff,” Siri tweeted.

Nass told The Defender the FDA “attempted a fraud on the court” by “failing to produce documents it knew it was required to make public, based on the original court ruling and FDA law” and “tried to trick the court into acquiescing with its partial production.”

Nass accused the FDA of being “desperate” to conceal documents that indicated it expedited the licensure of the Pfizer-BioNTech vaccine to facilitate the Biden administration’s desire, in August 2021, to impose vaccine mandates.

“Immediately after the Comirnaty” – the fully licensed version of Pfizer’s COVID-19 shot – “license was issued (within days) mandates were issued,” Nass said.

“The only scientific – and ethical – justification to impose a vaccine mandate is to stop transmission,” Nass said. Yet, the FDA “knew the vaccine did not stop transmission when the vaccine was licensed and when it was mandated” – and is now attempting to cover up this information, Nass added.

According to Nass, the FDA might also have been trying to conceal information about the problematic clinical trials of the COVID-19 shots, its inaction on serious adverse events and DNA contamination in the shots.

“As Judge Pittman noted, the language in the original ruling was crystal clear,” Nass wrote on Substack. “And I would point out that the law is also clear regarding the requirement to put the entire package of documents used in a licensing decision in the public domain, once a product is licensed.”

Wolf, whose book, “The Pfizer Papers,” contains an analysis of the previously released FDA documents, previously told The Defender that Pfizer and the FDA were aware of the inadequacies of the COVID-19 vaccine trials and the prevalence of serious side effects, but the FDA tried to hide the data.

In an interview last month on “The Defender In-Depth,” Wolf said the documents revealed evidence of “catastrophic” vaccine injuries, including turbo cancers, and serious side effects that many pregnant women experienced, including miscarriages.

Wolf assembled a team of scientists who volunteered to analyze the previously released documents. She told The Defender that, for the new documents, “We will of course be able in principle to review these documents and issue the historic, politically significant reports as in the past.”

However, to accomplish this, Wolf said “We must solicit resources from the administration or from the public or from our potential partners, or all three,” as analyzing these documents is “extremely labor-intensive.”

Nass questioned whether the FDA will “fully release all its records in response to this second court order.” She said if the documents are fully released, this will bring us “a step closer to learning who rules America.”

This article was originally published by The Defender – Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

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Pentagon agency to simulate lockdowns, mass vaccinations, public compliance messaging

Published on June 12, 2025

By

From LifeSiteNews

By Tim Hinchliffe

With lockdowns, mass vaccination campaigns, and social distancing still on the table from the last around, it appears that AI and Machine Learning will play a much bigger role in the next.

DARPA is getting into the business of simulating disease outbreaks, including modeling interventions such as mass vaccination campaigns, lockdowns, and communication strategies.

At the end of May, the U.S. Defense Advanced Research Projects Agency (DARPA) put out a Request for Information (RFI) seeking information regarding “state-of-the-art capabilities in the simulation of disease outbreaks.”

The Pentagon’s research and development funding arm wants to hear from academic, industry, commercial, and startup communities on how to develop “advanced capabilities that drive technical innovation and identify critical gaps in bio-surveillance, diagnostics, and medical countermeasures” in order to “improve preparedness for future public health emergencies.”

As if masks, social distancing, lockdowns, and vaccination mandates under the unscientific guise of slowing the spread and preventing the transmission of COVID weren’t harmful enough, the U.S. military wants to model the effects of these exact same countermeasures for future outbreaks.

The RFI also asks participants “Fatality Rate & Immune Status: How are fatality rates and varying levels of population immunity (natural or vaccine-induced) incorporated into your simulations?“

Does “natural or vaccine-induced” relate to “population immunity” or “fatality rates” or both?

Moving on, the RFI gets into modeling lockdowns, social distancing, and mass vaccination campaigns, along with communication strategies:

Intervention Strategies: Detail the range of intervention strategies that can be modeled, including (but not limited to) vaccination campaigns, social distancing measures, quarantine protocols, treatments, and public health communication strategies. Specifically, describe the ability to model early intervention and its impact on outbreak trajectory.

The fact that DARPA wants to model these so-called intervention strategies just after the entire world experienced them suggests that these exact same measures will most likely be used again in the future:

“We are committed to developing advanced modeling capabilities to optimize response strategies and inform the next generation of (bio)technology innovations to protect the population from biological threats. We are particularly focused on understanding the complex interplay of factors that drive outbreak spread and evaluating the effectiveness of potential interventions.” — DARPA, Advanced Disease Outbreak Simulation Capabilities RFI, May 2025.

“Identification of optimal timelines and capabilities to detect, identify, attribute, and respond to disease outbreaks, including but not limited to biosensor density deployment achieving optimal detection timelines, are of interest.” ­— DARPA, Advanced Disease Outbreak Simulation Capabilities RFI, May 2025.

With lockdowns, mass vaccination campaigns, and social distancing still on the table from the last around, it appears that AI and Machine Learning will play a much bigger role in the next.

For future innovation, the DARPA RFI asks applicants to: “Please describe any novel technical approaches – or applications of diverse technical fields (e.g., machine learning, artificial intelligence, complex systems theory, behavioral science) – that you believe would significantly enhance the state-of-the-art capabilities in this field or simulation of biological systems wholistically.”

Instead of putting a Dr. Fauci, a Dr. Birx, a replaceable CDC director, a TV doctor, a big pharma CEO, or a Cuomo brother out there to lie to your face about how they were all just following The ScienceTM, why not use AI and ML and combine them with behavioral sciences in order to concoct your “public health communications strategies?”

When you look at recently announced DARPA programs like Kallisti and MAGICS, which are aimed at creating an algorithmic Theory of Mind to model, predict, and influence collective human behavior, you start to get a sense of how all these programs can interweave:

“The MAGICS ARC calls for paradigm-shifting approaches for modeling complex, dynamic systems for predicting collective human behaviour.” — DARPA, MAGICS ARC, April 2025

On April 8, DARPA issued an Advanced Research Concepts (ARC) opportunity for a new program called “Methodological Advancements for Generalizable Insights into Complex Systems (MAGICS)” that seeks “new methods and paradigms for modeling collective human behavior.”

Nowhere in the MAGICS description does it mention modeling or predicting the behavior of “adversaries,” as is DARPA’s custom.

Instead, it talks at length about “modeling human systems,” along with anticipating, predicting, understanding, and forecasting “collective human behavior” and “complex social phenomena” derived from “sociotechnical data sets.”

Could DARPA’s MAGICS program be applied to simulating collective human behavior when it comes to the next public health emergency, be it real or perceived?

“The goal of an upcoming program will be to develop an algorithmic theory of mind to model adversaries’ situational awareness and predict future behaviour.” — DARPA, Theory of Mind Special Notice, December 2024.

In December 2024, DARPA launched a similar program called Theory of Mind, which was renamed Kallisti a month later.

The goal of Theory of Mind is to develop “new capabilities to enable national security decisionmakers to optimize strategies for deterring or incentivizing actions by adversaries,” according to a very brief special announcement.

DARPA never mentions who those “adversaries” are. In the case of a public health emergency, an adversary could be anyone who questions authoritative messaging.

The Theory of Mind program will also:

… seek to combine algorithms with human expertise to explore, in a modeling and simulation environment, potential courses of action in national security scenarios with far greater breadth and efficiency than is currently possible.

This would provide decisionmakers with more options for incentive frameworks while preventing unwanted escalation.

We are interested in a comprehensive overview of current and emerging technologies for disease outbreak simulation, how simulation approaches could be extended beyond standard modeling methods, and to understand how diseases spread within and between individuals including population level dynamics.

They say that all the modeling and simulating across programs is for “national security,” but that is a very broad term.

DARPA is in the business of research and development for national security purposes, so why is the Pentagon modeling disease outbreaks and intervention strategies while simultaneously looking to predict and manipulate collective human behavior?

If and when the next outbreak occurs, the same draconian and Orwellian measures that governments and corporations deployed in the name of combating COVID are still on the table.

And AI, Machine Learning, and the military will play an even bigger role than the last time around.

From analyzing wastewater to learning about disease spread; from developing pharmaceuticals to measuring the effects of lockdowns and vaccine passports, from modeling and predicting human behavior to coming up with messaging strategies to keep everyone in compliance – “improving preparedness for future public health emergencies” is becoming more militaristically algorithmic by the day.

“We are exploring innovative solutions to enhance our understanding of outbreak dynamics and to improve preparedness for future public health emergencies.” — DARPA, Advanced Disease Outbreak Simulation Capabilities RFI, May 2025.

Reprinted with permission from The Sociable.

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Audit report reveals Canada’s controversial COVID travel app violated multiple rules

Published on June 11, 2025

By

From LifeSiteNews

By Anthony Murdoch

Canada’s Auditor General found that government procurement rules were not followed in creating the ArriveCAN app.

Canada’s Auditor General revealed that the former Liberal government under Prime Minister Justin Trudeau failed multiple times by violating contract procurement rules to create ArriveCAN, its controversial COVID travel app.

In a report released Tuesday, Auditor General Karen Hogan noted that between April 2015 to March 2024, the Trudeau government gave out 106 professional service contracts to GC Strategies Inc. This is the same company that made the ArriveCAN app.

The contracts were worth $92.7 million, with $64.5 million being paid out.

According to Hogan, Canada’s Border Services Agency gave four contracts to GC Strategies valued at $49.9 million. She noted that only 54 percent of the contracts delivered any goods.

“We concluded that professional services contracts awarded and payments made by federal organizations to GC Strategies and other companies incorporated by its co-founders were not in accordance with applicable policy instruments and that value for money for these contracts was not obtained,” Hogan said.

She continued, “Despite this, federal government officials consistently authorized payments.”

The report concluded that “Federal organizations need to ensure that public funds are spent with due regard for value for money, including in decisions about the procurement of professional services contracts.”

Hogan announced an investigation of ArriveCAN in November 2022 after the House of Commons voted 173-149 for a full audit of the controversial app.

Last year, Hogan published an audit of ArriveCAN and on Tuesday published a larger audit of the 106 contracts awarded to GC Strategies by 31 federal organizations under Trudeau’s watch.

‘Massive scandal,’ says Conservative leader Pierre Poilievre

Conservative Party leader Pierre Poilievre said Hogan’s report on the audit exposed multiple improprieties.

“This is a massive scandal,” he told reporters Tuesday.

“The facts are extraordinary. There was no evidence of added value. In a case where you see no added value, why are you paying the bill?”

ArriveCAN was introduced in April 2020 by the Trudeau government and made mandatory in November 2020. The app was used by the federal government to track the COVID jab status of those entering the country and enforce quarantines when deemed necessary.

ArriveCAN was supposed to have cost $80,000, but the number quickly ballooned to $54 million, with the latest figures showing it cost $59.5 million.

As for the app itself, it was riddled with technical glitches along with privacy concerns from users.

LifeSiteNews has published a wide variety of reports related to the ArriveCAN travel app.

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