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Pfizer, FDA Ask Court to Further Delay Release of COVID Vaccine Safety Data

By Michael Nevradakis, Ph.D. | The Defender | January 31, 2022

Days prior to today’s scheduled release of a tranche of documents related to the Pfizer COVID vaccine, the pharmaceutical company asked a federal court to let it intervene before any information is released.

It’s the latest development in an ongoing court case that began with a Freedom of Information Act (FOIA) request filed in August 2021 by Public Health and Medical Professionals for Transparency (PHMPT).

PHMPT asked the U.S. Food and Drug Administration (FDA) to release all documents related to its Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine and full approval of the Pfizer-Comirnaty COVID vaccine.

Judge Mark Pittman of the U.S. District Court for the Northern District of Texas on Jan. 6 issued an order requiring the FDA to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter, until the release of the nearly 400,000 pages of documents is complete.

Pfizer claims to support the disclosure of the documents, but asked to intervene in the case to ensure that information exempt from disclosure will not be “disclosed inappropriately.”

In a memorandum it submitted to the court, Pfizer said it:

“[S]eeks leave to intervene in this action for the limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.”

Attorneys for Pfizer also claimed while it was not asking the court to reconsider the Jan. 6 order, it would consider challenging the order at an unspecified later date, telling the court:

“Pfizer does not presently intend to move the Court to reconsider its January 6, 2022 order, but Pfizer is not in a position at this time to waive its ability to do so if circumstances change such that there is good cause at a later time to do so.”

Pfizer did not clarify what such a change of circumstances might entail.

Lawyers for PHMPT, in a brief submitted Jan. 25 to the court, asked Pittman to reject Pfizer’s motion and requested the judge ask Pfizer to clarify how, exactly, its intervention would help expedite the release of the documents, arguing that Pfizer:

“… provides no reason why it needs to intervene in this matter to render that purported assistance. Nor can Plaintiff discern why Pfizer needs to intervene in this matter to assist the FDA with expediting release of the requested documents—it can render this assistance without intervening.”

PHMPT, a group of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, in September 2021 filed a lawsuit against the FDA when the agency denied its original FOIA request.

In that request, PHMPT asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.

The first batch of documents released in November 2021, which totaled a mere 500 pages, revealed there were more than 1,200 vaccine-related deaths within the first 90 days following the release of the Pfizer-BioNTech COVID vaccine.

Arguments regarding Pfizer’s motion are scheduled to be heard in court on Jan. 28, though as of this writing, no further updates regarding the case or this scheduled hearing have been publicly disclosed.

Pfizer represented by world’s third-largest law firm

Pfizer on Jan. 21 submitted two filings to the court: a motion to intervene in the case “for a limited purpose,” and an accompanying “memorandum of points and authorities” supporting the motion.

It remains unclear how Pfizer defines “inappropriately” or “for a limited purpose,” or why it waited two weeks after Judge Pittman’s order, and only days before the Jan. 31 scheduled release of 12,000 pages to file its motion.

Pfizer claims it was unaware of the case until executives read news reports about it in December 2021, despite the fact that the case garnered coverage from major news outlets, including Reuters, in November of that year.

Still, the company hired DLA Piper LLP, one of the world’s most high-powered law firms, to represent it. DLA Piper is headquartered in London and maintains offices in 40 countries.

In 2014, the firm had revenues totaling $2.48 billion, making it the third-largest law firm in the U.S. by revenue.

DLA Piper was the 12th largest donor to President Obama’s 2012 re-election campaign and the 9th largest donor to Hillary Clinton between 1999 and 2018.

Douglas Emhoff, spouse of U.S. Vice President Kamala Harris, was employed at the firm until 2020, earning $1.2 million in partnership income that year.

FDA supports Pfizer’s motion, requests extension

In a response to Pfizer’s motion, the FDA said it welcomed Pfizer’s “help,” claiming that this is “due to the unprecedented speed with which the Court has ordered [the] FDA to process the records at issue.”

In addition to supporting Pfizer’s motion, the FDA also requested an extension from the court that would further delay the scheduled release of the documents.

Aaron Siri of the Siri & Glimstad law firm, who is representing PHMPT in its lawsuit against the FDA, explained:

“The FDA now insists it must delay its first 55,000-page production until May 1, 2022 – four months after the Court entered its order.

“However, the FDA’s own papers seeking this delay make plain it can produce at a rate of 55,000 pages per month in February and March.”

The FDA claimed Pfizer is entitled to intervene in the case and the process of redacting the documents in question, due to the “Trade Secrets Act,” signed into law by President Obama in 2016, stating:

“FDA anticipates that coordination with Pfizer to obtain the company’s views as to which portions of the records are subject to Exemption 4, the Trade Secrets Act, 18 U.S.C. § 1905, or other statutory protections will be a necessary component of the agency’s endeavors to meet the extraordinary exigencies of this case.”

However, according to The Gateway Pundit, the Trade Secrets Act is being misinterpreted by the FDA and Pfizer:

“[T]he protections provided under that law allow for an owner of a trade secret to sue in federal court when its trade secrets have been misappropriated and does not even imply that a company could intervene in a public records request through the FOIA.”

PHMPT, in its Jan. 25 brief, also rejected the FDA’s continued claim that it cannot adhere to the disclosure schedule Pittman ordered on Jan. 6, arguing “the FDA has more than sufficient resources to expeditiously produce the requested documents.”

Siri, on his blog, also questioned this aspect of FDA’s argument, writing:

“The FDA … attests that over the coming weeks, it will have 28.5 full-time people reviewing the documents. Working 7.5 hours per day for 20 business days per month, 28.5 people reviewing 50 pages per hour can review a total of approximately 213,750 pages per month.

“The FDA affirms it has already ‘allocated the equivalent of nearly 11 full-time staff to this project’ and that ‘a review speed of 50 documents per hour was within the normal range for document review in a complex matter’ in private practice; and here the 50 document per hour rate would be faster since there is only a need to review for personally identifying information (‘PII’) for most pages. Hence, if the FDA’s 11 full-time reviewers work only 7.5 hours per day and review 50 pages (not documents) per hour, the FDA could review over 88,000 pages per month in February and March. That is more than sufficient to produce the 55,000 pages per month currently ordered for these two months.”

Instead of complying with this court’s “reasoned order,” Siri Wrote, the FDA claims these 11 reviewers can only review a total of 10,000 pages per month.

What the FDA does not say, and what basic math shows, according to Siri, is that a rate of 10,000 pages a month for 11 full-time reviewers amounts to only 5 pages per hour.

Siri also questioned the FDA’s commitment to transparency and hinted at a cover-up, stating:

“The Court is, other than Congress, the only check on the FDA.  In a free country, transparency is paramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests.

“It is also incredible for the FDA to claim that compliance here would harm its health policy objectives. Even if the FDA really does need to spend $4 to $5 million which … is an absurd overestimate, that is an inconsequential amount of its overall $3.41 billion discretionary budget.

“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues.”

Siri said the FDA’s “potential embarrassment” over its decision to license the Pfizer vaccine must take a back seat to the transparency demanded by FOIA and “the urgent need and interests of the American people to review that licensure data.”

Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

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January 31, 2022 Posted by | Deception | , , , , | 1 Comment

Pfizer, FDA Dodge Media Questions About Pfizer Comirnaty Vaccine

By Seth Hancock | The Defender | December 22, 2021

Two media outlets last week requested, but failed to obtain, clarity from Pfizer on whether its fully licensed Comirnaty COVID vaccine is available in the U.S.

Reporting by The Ohio Star and National File highlighted the ongoing debate over whether the vaccine can legally be mandated, and whether Pfizer can be held liable for injuries related to the vaccine.

The Star reported that despite asking multiple times whether the Comirnaty vaccine is in use, Pfizer would not answer the question.

The U.S. Food and Drug Administration (FDA) in August granted full approval, or Biological License Application Approval (BLA) — for the Comirnaty vaccine for individuals age 16 and older.

The approval, granted without a formal advisory committee meeting or public comments, prompted a number of questions including:

  1. What, if any, differences exist between the formulations used in the fully licensed Comirnaty vaccine and the Pfizer-BioNTech vaccine being distributed under Emergency Use Authorization (EUA).
  2. If/when the fully licensed vaccine would be available in the U.S.

Seeking an answer to the latter question, The Star reached out to Pfizer, the FDA and to Ohio’s largest health system, OhioHealth.

A spokeswoman for OhioHealth confirmed the system’s 12 hospitals “are currently distributing the Pfizer vaccine that does not have the Comirnaty branding label.”

In response to whether the Comirnaty vaccine is being used elsewhere in the U.S., Pfizer told The Star in an email:

“The Pfizer-BioNTech COVID-19 Vaccine (EUA labeled product) is currently being shipped; however, please be advised that the COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. They are made using the same processes, and there are no differences between them in safety or effectiveness.”

Pfizer’s claim that the two vaccines can “be used interchangeably” is inconsistent with FDA statements, The Star said, citing an FDA Q&A page that states the two vaccines are “legally distinct.”

The FDA reaffirmed that distinction, telling The Star the “statutory authorities governing BLAs and EUAs are distinct and provide different legal requirements.”

The FDA “did not directly address” The Star’s initial question about the specific difference between Comirnaty and the EUA vaccine, or why Pfizer is not shipping Comirnaty if the formulas are “interchangeable.”

However, in a Dec. 9 notice of reissuance of the EUA for the original Pfizer vaccine to give booster shots to 16 and 17-year-olds, the FDA said:

“[a]lthough COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”

The Star also reached out to Ohio Attorney General Dave Yost, asking if Ohio’s public universities are following the state’s law, HB 244, which prohibits public institutions from mandating a vaccine that is not fully approved.

Bethany McCorkle, Yost’s communications director, responded that HB 244 does not apply because “the FDA fully approved the vaccines.”

National File, following up on The Star’s reporting, also contacted Pfizer to ask if Comirnaty is in use. Pfizer told National File the “EUA-labeled product will still be shipped and usable until its expiry date.”

Pfizer did not respond to National File’s follow-up requests for additional clarification.

Comirnaty ‘not available at this time’

According to the Centers for Disease Control and Prevention (CDC), a chart showing the current procedural terminology description for the Comirnaty BLA-licensed vaccine states Comirnaty is “not orderable at this time.”

The current procedural terminology description includes a statement from Pfizer:

“At present, Pfizer does not plan to produce any product with these new NDCs (National Drug Code) and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA (American Medical Association), and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”

According to a Dec.16 letter from the FDA’s acting chief scientist, Jacqueline A. O’Shaughnessy, Pfizer-BioNTech vaccines exported from the U.S. are allowed only if “the regulatory authorities of the country in which the vaccine will be used are fully informed that this vaccine is subject to an EUA and is not approved or licensed by FDA.”

O’Shaughnessy’s letter states there is “a significant amount of Pfizer-BioNTech COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization. The authorization remains in place with respect to the Pfizer-BioNTech COVID-19 Vaccine for this population.”

In a Twitter exchange last weekend, Rep. Thomas Massie (R-Ky.) cited O’Shaughessy’s letter to refute a tweet by Joe Gerth, a columnist for the Louisville Courier-Journal, who claimed Comirnaty is available.

Can vaccines be ‘interchangeable’ and ‘legally distinct’ at the same time?

Misrepresentations by media and public officials — like those of the Louisville Courier-Journal and Ohio attorney general claiming the Pfizer vaccines in use in the U.S. are FDA-approved — coupled with the FDA’s own ambiguous documents and public statements have given rise to public confusion and legal questions.

Pfizer’s refusal to directly address questions posed by The Ohio Star and National File only adds to the lack of clarity. As political commentator and attorney Robert Barnes told The Star :

“It is an illicit bait and switch. There is no FDA-approved COVID-19 vaccine available in the U.S. The unavailable FDA biologic license approved drug is not medically identical and has to abide different manufacturing standards. As important, you have fewer legal rights and fewer legal remedies when you take an EUA drug than a biologic licensed drug. This directly impacts the legal rights of all Americans.”

The FDA’s assertion that the Comirnaty and Pfizer vaccines are “legally distinct” yet “interchangeable” is at the center of legal arguments around whether one, both — or neither — of the two vaccines can be mandated.

A lawsuit brought by members of the military against the U.S. Department of Justice (DOJ) challenging the DOJ’s COVID vaccine mandate for all service members highlights some of the arguments.

A federal judge on Nov. 12 denied plaintiffs’ request for a preliminary injunction against the DOJ mandates.

However, in his ruling, the judge stated — contrary to claims by Pfizer and the FDA — that the FDA-licensed Comirnaty vaccine is not interchangeable with Pfizer-BioNTech’s EUA-labeled vaccine.

Judge Allen Winsor of the U.S. District Court for the Northern District of Florida said the service members showed the U.S. Department of Defense (DOD) is requiring them to submit to EUA-labeled vaccines, yet “defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all.”

Judge Winsor wrote:

“In the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials). According to the DOD’s argument, this means servicemembers are not required to accept ‘a product authorized for emergency use.’ …

“Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. Thus, the DOD argues, the ‘product’ injected is a chemical formulation that has received full FDA licensure — not merely an EUA.”

Judge Winsor called that argument “unconvincing.”

The distinction between an EUA product and one that is fully licensed raises other legal questions. For instance, the FDA fact sheet on the Comirnaty vaccine states:

“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”

The statement appears to suggest the Pfizer-BioNTech and Comirnaty vaccines are EUA, and that both EUAs will end under the conditions noted.

Another key difference between fully licensed and EUA vaccines relates to the issue of liability. Under the 2005 Public Readiness and Preparedness Act (PREP Act), EUA vaccines are accompanied by a far-reaching liability shield that protects all parties involved with the product from lawsuits.

Specifically, if one is injured by an EUA vaccine, the only way to claim damages and receive compensation is to apply to the Countermeasures Injury Compensation Program, an administrative process under the U.S. Department of Health and Human Services (HHS), which authorized the vaccines.

At this time, the Pfizer Comirnaty vaccine may have no liability shield, making it subject to product liability laws that allow those injured by it to potentially sue for damages, although Pfizer asserts the vaccine is protected under the PREP Act as well.

Children’s Health Defense, following the Comirnaty approval, sued the FDA arguing the approval was a “bait in switch” to provide cover for vaccine mandates.

Seth Hancock is a freelance reporter for The Defender.

© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

December 23, 2021 Posted by | Civil Liberties, Deception | , , | 2 Comments