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COVID-19

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

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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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COVID-19

Trump’s new NIH head fires top Fauci allies and COVID shot promoters, including Fauci’s wife

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From LifeSiteNews

By Doug Mainwaring

“During the pandemic Fauci’s bioethicist wife, Christine Grady, offered nurses a choice: Get vaccinated, or lose your job,” noted The COVID-19 History Project on X. “Yesterday, she was offered a choice: Transfer to an office in Alaska, or lose your job. What’s fair is fair. Everyone deserves a choice,” explained the COVID watchdog account.

On day one of his new job as head of the National Institutes of Health (NIH), Dr. Jay Bhattacharya removed four powerful agency heads, including Dr. Anthony Fauci’s wife, Christine Grady, and others associated with the questionable handling of the COVID-19 shots.

Grady, who had served as chief of the agency’s Department of Bioethics, and other longtime Fauci allies in top posts at the NIH involved in the development and distribution of the untested COVID shots produced by Big Pharma were offered jobs in Alaska and other remote locales far away from the NIH’s sprawling Bethesda, Maryland, complex just outside Washington, D.C.

The purge came amid massive layoffs in health-related agencies under the umbrella of Health and Human Services (HHS), now headed by the Make America Healthy Again (MAHA) movement’s founder, Robert F. Kennedy Jr., who has long questioned vaccine safety and American medicine’s focus on treating disease rather than preventing it.

A total of about 20,000 personnel – mostly bureaucrats – or about 25 percent of the HHS workforce have been or will be handed pink slips amid Kennedy’s realignment of the agency.

MAHA critics were quick to call Tuesday’s axing of Fauci confederates as “one of the darkest days in modern scientific history” fueled by Kennedy’s desire to exact revenge on Fauci’s former trusted associates who represent the antithesis of the MAHA movement.

However, the revamping of the federal government’s side of the health industry is no more harsh than the treatment meted out by those formerly in control who, at best, suppressed, and worst, punished those who questioned their iron grip on health-industry regulations and standards.

For years, Kennedy’s critics have dismissed his quest to revamp healthcare and his questioning of the efficacy of the COVID-19 mRNA jabs as anti-science, labeling him as an “anti-vaxxer” in order to suppress his messaging.

Dr. Francis Collins – whom Bhattacharya replaced as head of NIH – in an October 2020 email to Fauci condemned Bhattacharya as a “fringe epidemiologist” because he had co-authored the Great Barrington Declaration, which criticized harmful COVID lockdown policies.

“During the pandemic Fauci’s bioethicist wife, Christine Grady, offered nurses a choice: Get vaccinated, or lose your job,” noted The COVID-19 History Project on X.

“Yesterday, she was offered a choice: Transfer to an office in Alaska, or lose your job. What’s fair is fair. Everyone deserves a choice,” explained the COVID watchdog account.

“We spend 4X more than Italy on healthcare — and live 7 years less. Dead last in cancer rates. This isn’t science — it’s a system profiting off sick kids,” explained Calley Means, RFK Jr. HHS advisor during an interview with Laura Ingraham following the NIH firings.

“Firing the people who oversaw this? That’s step one,” declared Means.

Other NIH officials who were offered reassignments were Dr. Jeanne Marrazzo, who succeeded Fauci as head of the National Institute of Allergy and Infectious Diseases (NIAID), Dr. Clifford Lane, a close Fauci ally who served as deputy director for clinical research at NIAID, and Dr. Emily Erbelding, NIAID’s microbiology and infectious diseases director.

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Freedom Convoy

Freedom Convoy leaders Tamara Lich, Chris Barber found guilty of mischief

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From LifeSiteNews

By Anthony Murdoch

Despite the peaceful nature of the protest, Prime Minister Justin Trudeau and his Liberal government invoked the Emergencies Act to clear-out protesters, an action a federal judge has since said was “not justified.”

Freedom Convoy leaders Tamara Lich and Chris Barber have been found guilty of mischief for their roles as leaders of the 2022 protest and as social media influencers, a Canadian federal judge has ruled.

“The Crown has proven beyond a reasonable doubt that Lich and Barber have committed mischief,” said Justice Heather Perkins-McVey, the federal judge overseeing the pair’s mischief trial, during the verdict hearing Thursday. 

The Democracy Fund, who has been helping the defense in the case, also noted on X, “Mischief is proven beyond a reasonable doubt here. Both Lich and Barber are guilty of mischief.”

 

“When freedom of expression collides with the need to uphold public order is when the line is crossed,” the judge said during court.

Perkins-McVey seemed to agree with the Crown’s case that Lich and Barber’s influence on the Freedom Convoy constituted public mischief but did dismiss the Crown’s Carter Application accusing Lich and Barber of conspiracy outright.

The government’s “Carter Application” asked that the judge consider “Barber’s statements and actions to establish the guilt of Lich, and vice versa.”

A “Carter Application” requires that the government prove “beyond a reasonable doubt” that there was a “conspiracy or plan in place and that Lich was a party to it based on direct evidence.”

Lawyer Eva Chipiuk noted that Perkins-McVey “acknowledged that there was disruption on Ottawa and said its citizens and that downtown was jammed, loud and busy.”

Court will reconvene later today for additional information to be revealed.

Lich and Barber both face a possible 10-year prison sentence. LifeSiteNews reported extensively on their trial.

The Lich and Barber trial concluded in September of 2024, more than a year after it began. It was only originally scheduled to last 16 days.

Lich and Barber were arrested on February 17, 2022, in Ottawa for their roles in leading the popular Freedom Convoy protest against COVID mandates. During COVID, Canadians were subjected to vaccine mandates, mask mandates, extensive lockdowns and even the closure of churches.

Despite the peaceful nature of the protest, Prime Minister Justin Trudeau and his Liberal government invoked the Emergencies Act to clear-out protesters, an action a federal judge has since said was “not justified.” During the clear-out, an elderly lady was trampled by a police horse and many who donated to the cause had their bank accounts frozen.

As reported by LifeSiteNews, Lich recently spelled out how much the Canadian government has spent prosecuting her and Barber for their role in the protests. She said at least $5 million in “taxpayer dollars” has been spent thus far, with her and Barber’s legal costs being above $750,000.

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