COVID-19
Is FDA ‘covering for Pfizer’? Court orders agency to release a million more pages of COVID vaccines documents
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
Aaron Siri, an attorney representing PHMPT, called the ruling “Another giant win for transparency.”
“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.
From the Brownstone Institute
“Authorities have attacked, detained, prosecuted, and in some cases killed critics, broken up peaceful protests, closed media outlets, and enacted vague laws criminalizing speech that they claim threatens public health”
Didn’t give much thought to freedom until four years ago, at age 63. Freedom was just there, like the water surrounding a goldfish. And then the Covid-19 pandemic blew in, the world locked down, and admonitions to “stay the ‘$^#&’ home” blazed through social media. No freedom was too important to discard in the name of public safety: jobs, family businesses, artistic endeavours, public meetings, social connections that kept despair at bay, all took a backseat to the grim business of saving grandma (who ended up getting Covid anyway). No discussion of moral or practical trade-offs, no pushback from the press, nothing. It felt wrong to me on a cellular level.
Apparently I was the only one in my middle-class liberal circle to harbour misgivings about this astonishing new world. If I tried, ever so timidly, to articulate my concerns on Facebook or Twitter, the online warriors shot back with a string of epithets. “Go lick a pole and catch the virus,” said one. “Crawl back into your cave, troglodyte,” said another. And my all-time favourite: “You’re nothing but a mouth-breathing Trumptard.”
From the get-go, I perceived Covid as more of a philosophical problem than a scientific one. As I wrote on more than one occasion, science can inform our decisions, but not dictate them. What ultimately powers our choices are the values we hold. I saw Covid as a morality play, with freedom and safety cast as the duelling protagonists, and it looked like safety was skipping to an easy victory.
It was a heady time for the health bureaucrats, whose increasingly arcane rules betrayed a naked impulse to control: the Canadian high-school students required to use masks on both their faces and their wind instruments during band practice, the schoolchildren forced (for hygiene reasons) to study on their knees for hours in an Alaska classroom, the “glory-hole” sex advised by the British Columbia Centre for Disease Control. The lack of public pushback against these absurdities heightened my awareness of the fragility of our freedoms.
One of the earliest memes to surface during the pandemic was “muh freedumb.” The locution became a shorthand for a stock character – a tattooed man wearing camo gear and a baseball cap, spewing viral particles while yelling about his rights. A selfish idiot. The memes kept coming: “Warning, cliff ahead: keep driving, freedom fighter.” “Personal freedom is the preoccupation of adult children.” Freedom, for centuries an aspiration of democratic societies, turned into a laughing stock.
Eventually, pro-freedom voices began trickling into the public arena. I wasn’t alone, after all. There were others who understood, in the words of Telegraph writer Janet Daley, that the institutional response to Covid-19 had steamrolled over “the dimension of human experience which gives meaning and value to private life.” Lionel Shriver decried how “across the Western world, freedoms that citizens took for granted seven months ago have been revoked at a stroke.” And Laura Dodsworth brought tears to my eyes when she wrote, in her 2021 book A State of Fear, that she feared authoritarianism more than death.
Once the vaccines rolled out, the war on freedom of conscience went nuclear. If you breathed a word against the products, or even the mandates, you were “literally killing people.” The hostility towards the “unvaxxed” culminated in a Toronto Star front page showcasing public vitriol, splashed with such sentiments as: “I honestly don’t care if they die from Covid. Not even a little bit.”
This, too, felt viscerally wrong. I knew several people who had refused the vaccine, and they all had well-articulated reasons for their stance. If they didn’t fully trust the “safe and effective” bromide recycled by all government and pharmaceutical industry spokespeople, I could hardly blame them. (And I say this as someone who writes for Big Pharma and got five Covid shots.)
One of the most deplorable casualties of Covid culture was freedom of expression, a core principle in the United Nations’ Universal Declaration of Human Rights. Experts speaking publicly about the harms of lockdown faced systematic ostracism from mainstream media, especially left-wing news outlets. By early 2021, Human Rights Watch estimated that at least 83 governments worldwide had used the Covid-19 pandemic to violate the lawful exercise of free speech and peaceful assembly.
“Authorities have attacked, detained, prosecuted, and in some cases killed critics, broken up peaceful protests, closed media outlets, and enacted vague laws criminalizing speech that they claim threatens public health,” the group wrote in a media release. “The victims include journalists, activists, healthcare workers, political opposition groups, and others who have criticized government responses to the coronavirus.”
But what about misinformation? Doesn’t it kill people? Newsflash: misinformation has always existed, even before TikTok. It’s up to each of us to sift the credible folks from the cranks. The best defence against misinformation is better information, and it’s the policy wonks’ job to provide it. Modern science itself depends on this tug-of-war of ideas, which filters out weaker hypotheses and moves stronger ones ahead for further testing.
Besides, misinformation comes not just from cranks, but from “official sources” – especially those tasked with persuading the public, rather than informing it. Remember when Rochelle Walensky, former director of the Centers for Disease Control and Prevention in the US, asserted that “vaccinated people do not carry the virus?” Or when Anthony Fauci maintained that getting vaccinated makes you a “dead end” in the chain of transmission? I rest my case.
The marketplace of ideas is like a souk, with a lot of hollering and arguing and the odd snatched purse – and that’s exactly how it should be. It’s an ingenious and irreplaceable process for getting to the truth. There are few ideas too sacrosanct to question or too ridiculous to consider. That’s why, unlike just about everyone in my left-leaning circle, I take no issue with Elon Musk’s shakedown of the old Twitter, now the Wild West of X.
Under Musk’s algorithms, my feed has become a true philosophical souk, with wildly disparate views smashing into each other, leaving me to sift through the rubble in search of a gold nugget or two. Love him or hate him, Musk offers a much-needed counterweight to the ideological lockstep in much of the mainstream media. And when it comes to free speech, Musk has put his money where his mouth is: when media personality Keith Olbermann recently hopped on X, where he boasts a million followers, to call for Musk’s arrest and detainment, Musk made no move to censor him. Works for me.
While the “old normal” has thankfully returned to our daily lives, save the odd mask in a shopping mall or subway car, the stench of censorship that blew in with the pandemic has yet to dissipate. An obsession with disinformation permeates the zeitgeist, spurring lawmakers in several Western countries to censor the flow of thoughts and ideas that gives a free society its pulse.
We cannot excise personal freedom from a democratic society, even in the interests of the “public good,” without poisoning the roots of democracy itself. Article 3 of UNESCO’s 2005 Universal Declaration of Bioethics and Human Rights states this plainly: “The interests and welfare of the individual should have priority over the sole interest of science or society.” In our post-pandemic reality, the statement seems almost quaint. Nonetheless, it expresses an enduring truth: that a democracy must never discard the idea of freedom – even in a pandemic.
Freedom desperately needs a comeback from its current incarnation as an expendable frill. In my own small way I’m trying to make this happen: never much of an activist before Covid, I’m now part of a small group preparing to launch a Free Speech Union in Canada, modelled after the highly successful one in the UK. The organisation will offer legal advice to individuals facing censorship, cancellation, or job loss because of their words. I look forward to supporting people caught in this anti-freedom web, including those whose words I heartily disagree with.
My newfound respect for free speech is also what propels me to keep talking about Covid. The response to the pandemic exceeded the bounds of public health, and we need to expose the forces that drove it. Here’s Daley again: “The world went crazy. There is no other way to account for what was an almost nihilistic dismantling not just of particular liberties and rights, but of the very idea of liberty.” We can’t let it happen again.
Republished from Perspective Media
Author
From LifeSiteNews
Tamara Lich says her and co-leader Chris Barber’s verdict for their involvement in 2022 protests against Canada’s COVID mandates will be revealed on March 12. Lich and Barber face up to 10 years in prison.
Freedom Convoy leader Tamara Lich says her and co-leader Chris Barber’s verdict for being the face of the protests in 2022 that called for an end to all COVID mandates in Canada will be made on March 12, 2025.
Lich made the announcement in an X post on December 4, relaying her dissatisfaction that pro-Hamas protestors, who had swarmed and occupied government buildings in the first week of the month, got away more or less without charges.
“On the same day protestors swarmed, overcame and occupied a government building in our nations capital, joined & even supported by some elected officials, @ChrisBarber1975 and I received news of a verdict date for The Longest Mischief Trial of All Time,” she wrote.
Lich blasted the fact that the protests that occurred in Ottawa resulted in no apparent “charges” nor “threats of ten years in prison.”
“No snipers. No frozen bank accounts. No threats to take their pets or children, their business or vehicle insurance or their drivers licenses. No trampling horses, no battered senior citizens, no police beating protestors with their firearms. Nothing,” she wrote.
Lich said she lamented the fact that their verdict is still some three months away. However, she said that “Vindication is coming!”
In another post on X, Lich blasted Prime Minister Justin Trudeau’s Canada, saying there is a double standard of justice on display.
“In Trudeau’s Canada, it’s ok to violently take over and occupy a government building if you’re wearing approved scarves and shouting approved slogans,” she wrote.
Lich observed that if one is a “regular” hard-working “Canadian” who simply wants the “return of your God given rights and freedoms, and do so in a peaceful manner,” it’s off to “jail for you, two and a half years of crippling lawfare, and the longest mischief trial of all time.”
Lich and Barber’s trial concluded back in September more than a year after it began. It was only originally scheduled to last 16 days.
As reported by LifeSiteNews, Lich and Barber face a possible 10-year prison sentence for their role in the 2022 Freedom Convoy. LifeSiteNews reported extensively on their over-year-long trial.
As reported by LifeSiteNews, some protesters charged for participating in the Freedom Convoy have seen their charges dropped.
In early 2022, thousands of Canadians from coast to coast came to Ottawa to demand an end to COVID mandates in all forms. Despite the peaceful nature of the protest, Trudeau’s government invoked the Emergencies Act on February 14. Trudeau revoked the EA on February 23.
The EA controversially allowed the government to freeze the bank accounts of protesters, conscript tow truck drivers, and arrest people for participating in assemblies the government deemed illegal.
COP29 was a waste of time
WHO Director-General Tedros Adhanom Ghebreyesus Must Resign. Now
Luxury Vancouver Homes at the Center of $100M CAD Loan and Chinese Murder Saga
World War Syria: The outcome in Syria is so important Trump may reach out to Assad
Sajjan shouldn’t let taxpayers pay for his Taylor Swift tickets
Energy Security in a Turbulent World: Canada’s Moment to Lead
Federal government out of touch with economic reality in Canada
-
National1 day agoJD Vance sounds alarm over slew of Canadian church burnings: ‘Anti-Christian bigotry’
-
Crime2 days agoAs Trump 2.0 Scrutinizes Canadian Fentanyl Networks, British Columbia Advances Forfeiture on 14 Properties Linked to Alleged PRC Triad Associate
-
COVID-191 day ago
Verdict for Freedom Convoy leaders Tamara Lich and Chris Barber coming next spring
-
Automotive1 day agoForeign Companies Think Twice About Pouring Billions Into US EVs As Trump Return Looms
-
Christopher Rufo15 hours agoAmerica’s Verdict
-
Daily Caller1 day agoYou Say You Want A Revolution? Watch Trump
-
National1 day agoTrudeau government bans even more guns, wants to send them to Ukraine
-
Censorship Industrial Complex1 day agoBiden admin used banks to spy on Americans’ financial data, targeted Trump supporters: House report