The Food and Drug Administration has made available its first batch of ‘confidential’ documents, according to a FOIA lawsuit filed by the Public Health Authority and Health Professionals for Transparency. The recompiled documents form the basis of the FDA’s Emergency Use Authorization for the Pfizer-BioNTech “vaccine *” and subsequent federal vaccine regulations.
As previously reported, the FDA does not intend to fully release the clinical trial information used to justify licensing the Pfizer-BioNTech ‘vaccine’ for 55 years. The sole mission of the nonpartisan advocacy group is to promote transparency in public health decision-making, such as the vaccine licensing process.
“The FDA has suggested producing 500 pages per month, based on its calculated page count, which means it will complete production in almost 55 years – 2076,” apply to court speak. “Until the full literature provided by Pfizer to the FDA is made available, proper analysis by independent scientists who are members of the Plaintiffs is not possible.”
Two months later lawsuit has been filed, FDA issued the first 91 of the “more than 329,000 pages likely to satisfy Plaintiff’s FOIA request”. Findings, taken directly from the produced literature, are cited below.
“It is estimated that about [REDACTED] doses of BNT162b2 have been shipped worldwide since receiving the first provisional authorization for an emergency supply on December 1, 2020 through February 28, 2021,” the document states.
The FDA document continues: “Accumulated to February 28, 2021, there were a total of 42,086 reported cases (25,379 medically confirmed cases and 16,707 unconfirmed cases). medical) has 158,893 cases. “Most of the cases (34,762) were received from the United States (13,739), the United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866).
Below is a general overview of reported results for Adverse Events:
The chart lists 1223 fatal outcomes in Related Cases. Interestingly, the age group with the most relevant cases is 31-50 years old, which is not an age group considered to be at high risk of contracting Covid-19. The figure contains the addition:
As shown in Figure 1, the System Organ Classes (SOCs) that had the largest number of events (≥2%) in the overall data set, were General Disorders and Administration Condition (51,335 AEs) , Nervous system disorders (25,957), Musculoskeletal and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and subcutaneous tissue disorders (8,476), Respiratory, thoracic and central nervous system disorders Ventricular infections (8,848), Infections and infections (4,610), Trauma, poisoning and procedural complications (5,590), and Investigations (3,693).
The number of Adverse Events in the following categories is shown below.
Similar table, continue:
Aaron Siri point remarks Pfizer himself made regarding the “large number of spontaneous adverse event reports”.
One of the documents created is Cumulative Analysis of Adverse Event Reports After Licensing of [the Vaccine] Received through February 28, 2021, which is just 2 and a half months after the vaccine received its emergency use authorization (EUA). This document reflects adverse events after Pfizer’s “cycle of work” completed vaccination, both within and outside the United States, through February 28, 2021.
Pfizer explains, on page 6, that “Due to the large number of spontaneous adverse event reports received for the product, [Pfizer] prioritized serious cases… ”and Pfizer“ also did [sic] many actions to help reduce a large increase in adverse event reports “including” an increase in the number of data entry and case-handling colleagues “and” introduced approx. [REDACTED] full-time staff (FTE). Query why Pfizer exclusively shared the number of people Pfizer had to hire to monitor all adverse events reported shortly after the launch of its product.
Rest of the documents obtained by Public Health and Health Professionals on Transparency here. PHMPT argues that there is an imminent need for the FDA to provide transparency, especially when Americans are required to use ‘vaccines.’
“The whole purpose of the FOIA is to ensure government transparency,” the plaintiffs argued. “It is hard to imagine a greater need for transparency than the immediate disclosure of documents the FDA relies on to authorize a product that is currently penalized by more than 100 million Americans for the loss of their trust. their occupation, income, and military service status. , and much worse. ”
“It took the FDA to be precise 108 days from the time Pfizer began production of records for approval on May 7, 2021.14 to product approval on August 23, 2021,” the document said. court continued. “We assume, as the FDA has stated, that they have conducted an intense, robust, thorough and complete review and analysis of such documentation to ensure that the Pfizer vaccine is safe and effective. fruit to be licensed.”
“The FDA now has an equally important duty to make those documents available to Plaintiffs in this case and to the general public within at least the same timeframe,” the filing added. “FDA’s own regulations envision and reflect the importance of making this information public as soon as a vaccine is approved. Its regulations stipulate that it must provide ‘immediately’ all the basic documentation of a vaccine’s license. “
“The FDA is aware of the great public interest in that data and information,” the document adds. “It should have been prepared to release it at the same time as licensing. Instead, it did the opposite.”
* Since Pfizer-BioNTech’s BNT162b2 product does not prevent the spread of SARS-CoV-2 and mitigate transmission, it is more accurately called a prophylactic rather than a ” Vaccine”.
https://smartzune.com/the-fda-produced-first-batch-of-confidential-vaccine-docs-now-we-know-why-it-will-take-55-years/ FDA produced first batch of ‘secret’ vaccine documents – Now we know why it will take 55 years