The Food and Drug Administration is asking for 75 years – twenty years more than it originally agreed – in order to comply with demands for basic transparency and accountability over its December 2020 decision to grant Pfizer-BioNTech “Emergency Use Authorization” for its mRNA therapeutic drugs being marketed as “vaccines.”
The FDA says there are 59,000 more pages that were not accounted for in its initial agreed timeline. Now, it is asking the judge in its court case to grant it until 2096 to produce them all – after redaction for alleged proprietary information reasons.
Nonetheless, the FDA says that it can produce more than the allotted 500 pages per month in its first batch in its next batch on January 31, 2022 in order to comply with the FOIA lawsuit from Public Health and Medical Professionals for Transparency. After that release, however, the FDA seeks to return to the 500 pages per installment.
Aaron Siri, who is a lawyer in the case representing PHMPT, explained the FDA’s request for an extension in a lengthy post.
“A prior post explained that the FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine,” Siri writes. “Literally, a 55-year delay. My firm, on behalf of PHMPT, asked that this information be disclosed in 108 days – the same amount of time it took for the FDA to review and license Pfizer’s vaccine.”
“The Court ordered the parties to submit briefs in support of their respective positions by December 6, 2021,” the post continued. “The FDA’s brief, incredibly, doubles down. It now effectively asks to have until at least 2096 to produce the Pfizer documents. Not a typo. A total of at least 75 years.”
“Other than producing an initial ~12,000 pages in around two months, the FDA thereafter only wants to commit to producing 500 pages per month,” the post added. “The FDA also disclosed that it actually has approximately at least 451,000 pages to produce.*
Siri then puts the FDA’s obfuscation in perspective for those who may find it incredible.
“If you find what you are reading difficult to believe—that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure,” Siri said.
The lawyer then explained to the public what comes next in the case.
“Each side gets to file response briefs on December 13, 2021, and then there is oral argument on December 14, 2021 before the Judge,” he said. ” If you want to read the response to the FDA’s position, a copy of the introduction in the brief my firm filed is below. And below that, a downloadable copy of each side’s full briefing is available.”
Siri argued to the court that the demonstration of the Covid virus escaping leaky Pfizer vaccines and the way that the pandemic is dragging out points to more urgency that the FDA’s Pfizer documents be “peer-reviewed” in a publicly transparent way.
“The pandemic is continuing to spiral. Despite over 83% of adults having received a COVID-19 vaccine, cases are on the rise in the most vaccinated states, variants that evade vaccine immunity are rising, the CDC has admitted the COVID-19 vaccines do not prevent transmission, the number of breakthrough cases is increasing exponentially, and boosters are now needed for everyone and will likely continue to be required every six months, if not more frequently, among numerous other issues with the vaccine program,” the advocacy group’s lawyers argued.
“America has some of the greatest institutions of learning and research the world has ever known. We need all these hands on deck, both inside and outside the government, to address these serious, ongoing issues, and failings within the vaccine program. Locking out independent scientists from addressing these issues is dangerous, irresponsible, and unethical,” the argument continued.
“The FDA, in both the prior and current administration, has never been free of political pressure when conducing its work and it has also been widely promoting this vaccine to the public, including before it was licensed,” the argument went on. “This all raises questions about the licensure process and whether the FDA will admit mistakes or failings of the same product, mistakes and failings that will only be identified through outside review. America needs independent scientists, like the ones from our premier universities and medical centers comprising Plaintiff, to review this data and assist with offering solutions and addressing these issues. Not 55 years from now or longer. But today.”
However, it makes perfect sense why the FDA would want to bury its Pfizer authorization documents after what was found in the initial release of 90 pages.
As reported earlier, the FDA did not intend to fully release the clinical trials information used to justify its authorization of the Pfizer-BioNTech ‘vaccine’ for 55 years. The non-partisan advocacy group’s sole mission is pressing for transparency in public health decision-making, such as the vaccine authorization process.
Two months after the lawsuit was filed, the FDA produced the first 91 pages of the “more than 329,000 pages [now, 451,000 pages] potentially responsive to Plaintiff’s FOIA request.” Since this initial release, there have been two more documents added to the stack: Both fairly meaningless documents about clinical sites listed on the PHMPT website.
The initial findings from the FDA’s released documents are concerning.
“It is estimated that approximately [REDACTED] doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021,” the document states.
“Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events,” the FDA document continues. “Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866).”
Below is a General Overview of the reported outcomes to the Adverse Events:
The chart lists 1223 fatal outcomes in the Relevant Cases. Interestingly, the age range with the most relevant cases was 31-50 years old, which is not the age group considered to be at high risk from Covid-19. The figure contains the addendum:
As shown in Figure 1, the System Organ Classes (SOCs) that contained the greatest number (≥2%) of events in the overall dataset, were General disorders and administration site conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and subcutaneuous tissue disorders (8,476), Respiratory, thoracic and mediastinal disorders (8,848), Infections and infestations (4,610), Injury, poisoning and procedural complications (5,590), and Investigations (3,693).
The number of Adverse Events in the following categories are shown below.
The same table, continued:
Aaron Siri points to remarks that Pfizer itself made about “large numbers of spontaneous adverse event reports.”
One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA). This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021. Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases…” and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).” Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.
The remainder of the documents obtained by Public Health and Medical Professionals for Transparency can be obtained here. PHMPT argues that there is an imminent need for the FDA to provide transparency, particularly as Americans are being mandated to take the ‘vaccines.’
“The entire purpose of the FOIA is to assure government transparency,” the plaintiffs argue. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
“It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021,” the court document goes on. “We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.”
“The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe,” the filing adds. “The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make ‘immediately available’ all documents underlying licensure of a vaccine.”
“The FDA knew the intense public interest in that data and information,” the document added. “It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite.”
*Since the Pfizer-BioNTech’s product BNT162b2 does not stop the spread of SARS-CoV-2 and marginally lowers transmission, it is more accurately called a prophylactic therapeutic, and not a “vaccine.”
OPINION: This article contains commentary which reflects the author's opinion.
Author: Kyle Becker