The first batch of documents , from Pfizer dated November 2021 and totaling just 500 pages, revealed 9 pages of Adverse Events of Special Interest (AESI), many of which match the published VAERS (U.S. Vaccine Adverse Event Reporting System ) database. The listing is a Review of Adverse Events of Special Interest (AESI). The AESI terms are incorporated into a TME (targeted medically event) list and include events of interest for their association with severe COVID-19 and events of interest for vaccines in general.
The U.S. Food and Drug Administration on Tuesday released 10,000 pages of documents related to the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID injection.
The documents provide more information about the FDA’s process for approving the vaccine and may also shed light on the safety and efficacy of the vaccines and the number and nature of adverse effects that were observed during clinical trials and the first few months after the Emergency Use Authorization (EUA) was issued.
The documents were made public as part of a court-ordered release schedule stemming from an expedited Freedom of Information Act (FOIA) request by Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT, a group of medical and public health professionals and scientists from Harvard, Yale, UCLA and other institutions, filed the request in August 2021, see membership listing and details below.
The FOIA request asked that the approximately 400,000 pages of documents related to the approval of Pfizer’s COVID injection be made public, including safety and efficacy data, adverse reaction reports, and a list of the injection’s active and inactive ingredients.
When the FDA ignored the request, PHMPT sued the agency in September 2021 and took the case to the U.S. District Court for the Northern District of Texas. On Feb. 2, federal Judge Mark Pittman issued an order requiring the FDA to release redacted versions of the documents in question according to the following disclosure schedule:
10,000 pages each, due on or before March 1 and April 1, 2022.
80,000 pages each to be produced on or before May 2, June 1 and July 1, 2022.
70,000 pages to be produced on or before August 1, 2022.
55,000 pages per month on or before the first business day of each month thereafter until document release has been completed.
The cache of documents made public on March 1, available on the PHMPT website , represents the first release of such documents following the issuance of Pittman’s order in February.
However, FDA released smaller sets of documents in November and December 2021 and January 2022, while the legal case was ongoing.
The first batch of documents , produced in November 2021 and totaling just 500 pages, revealed safety concerns and the fact that there were more than 1200 injection-related deaths in the first 90 days following the launch of the Pfizer-BioNTech COVID injection.
The documents also revealed a nine-page list of adverse events observed during that same period. Recently, the list circulated widely on social media and was erroneously attributed to the set of documents released on March 1.
Pfizer published its list of Adverse Events of Special Interest (AESI). Starting on page 30 there are 8 pages with events of interest for their association with severe COVID-19 and events of interest for vaccines in general (AESI).
On page 12, cases of side effects in pregnant women, their infants, and nursing infants are reported.
These are the adverse effects to which they pay special attention, they are already known effects that are already reported in the list of vaccine adverse effects in general, accumulated over the years. Downloaded from Public Health and Medical Professionals for Transparency: https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf
This may be because the release of the March 1 paper attracted the attention of those following the issue, which likely sent traffic to the PHMPT website, which catalogs all the papers that have been released so far.
However, the mainstream media have not covered the latest document release and, at the time of this writing, there has been only limited coverage by smaller media outlets. That may be due, at least in part, to the sheer volume of information and data to sort through.
Other documentation concerns Pfizer’s “standard user fee payment of nearly $2.9 million to the FDA” and “confidential nonclinical overview of the vaccine,” Brennan said.
Lots of relatively unrevealing information, but the latest batch of documents may contain additional useful information.
An initial review of the information included in this vast set of recently released documents includes:
Details on the animal studies that were conducted and their findings.
Papers that appear to pertain to specific types of adverse reactions experienced by trial participants and COVID-19 infections in trial participants after vaccination.
Information about the study protocol, as well as any modifications that were made to this protocol.
Information on Pfizer’s internal review committee for the COVID vaccine.
Pfizer-BioNTech’s original application to market the COVID vaccine, submitted to the U.S. Department of Health and Human Services (HHS). (HHS).
The sheer volume of information to be analyzed and processed requires careful review, which will be conducted by The Defender’s editorial team, with more information and any important disclosures to be published in the coming days.
A tortuous legal process and a victory for transparency.
The FDA had previously argued that it did not have enough staff to review, redact and publish hundreds of thousands of pages of documents, claiming it could only process 500 pages per month.
This would have meant that the cache of documents would not be fully disclosed to the public for approximately 75 years .
In his Jan. 6 order , Pittmann rejected FDA’s assertion and instead required the agency to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter.
This decision was then amended by Pittman’s subsequent Feb. 2 order , truncating the release timeline to a matter of months rather than decades.
The Feb. 2 order also granted FDA the ability to “warehouse” excess pages as part of this release schedule, meaning that if the agency exceeds its monthly quota in a given month, it can apply those additional pages to the following month.
Earlier, Pfizer responded to the Jan. 6 order by filing a memorandum with the court asking to intervene in the case to assist FDA with the release of the documents, specifically for the “limited purpose of ensuring that information exempt from disclosure under FOIA (Free Information Act) is adequately protected as FDA complies with this Court’s order.”
Pfizer claimed to support disclosure of the documents, but asked to intervene in the case to ensure that information legally exempt from disclosure is not “improperly disclosed.” Pittman rejected Pfizer’s offer in his Feb. 2 order.
In a related matter, Judge Michael Truncale of the U.S. District Court for the Eastern District of Texas on Feb. 10 unsealed 400 pages of documents related to a lawsuit filed by a whistleblower, Brook Jackson.
Jackson previously worked for Ventavia, a contractor hired by Pfizer to conduct Phase 3 clinical trials of the Pfizer-BioNTech COVID vaccine.
Jackson’s lawsuit alleges multiple irregularities in the clinical trial process during the time she was employed at Ventavia. The FDA declined to intervene in this case.
Some of the documents related to the approval of the Pfizer-BioNTech COVID vaccine that were released on March 1 appear to be directly related to the clinical trials conducted by Ventavia and, therefore, may shed light on Jackson’s allegations.
Public Health and Medical Professionals for Transparency https://phmpt.org/ is a non-profit organization, comprised of public health professionals, medical professionals, scientists and journalists, exists solely to obtain and disseminate the data on which the FDA relies to authorize COVID-19 injections. The organization takes no position on the data, except that it should be publicly available to allow independent experts to conduct their own review and analysis. Any data received will be made public on this website.
Four days after Pfizer’s 16+ injection was approved, https://phmpt.org/ submitted a Freedom of Information Act (FOIA) Request to the FDA for all the data in Pfizer’s COVID-19 injection biologics file. They have now sued the FDA for not releasing the data.