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).”
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 sho…