The Food and Drug Administration has provided its first batch of ‘confidential’ documents, in accordance with a FOIA lawsuit by the Public Health and Medical Professionals for Transparency. The redacted documents were the basis of the FDA’s Emergency Use Authorization of the Pfizer-BioNTech “vaccine*,” and subsequent federal vaccine mandates.
As reported earlier, the FDA does 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.
“The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076,” the court filing said. “Until the entire body of documents provided by Pfizer to the FDA are made available, an appropriate analysis by the independent scientists that are members of Plaintiff is not possible.”
Two months after the lawsuit was filed, the FDA has produced the first 91 pages of the “more than 329,000 pages potentially responsive to Plaintiff’s FOIA request.” The findings, taken directly from the produced documents, are cited below.
“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).”
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.
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.”
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