An unredacted document obtained through a Freedom of Information Act (FOIA) request showed Pfizer had to unexpectedly hire 600 additional full-time employees to process a flood of adverse events reported during the three months following emergency use authorization of its COVID vaccine.
According to the newly released documents, Pfizer planned to hire more than 1,800 “additional resources by the end of June 2021.”
The information was part of a 10,000-page document released on April 1 by the U.S. Food and Drug Administration (FDA) and was made public as part of a court-ordered schedule originating from a FOIA request by the Public Health and Medical Professionals for Transparency.
The latest disclosure came from the following document: “Cumulative analysis of post-authorization adverse event reports,” which emphasized adverse events identified through Feb. 28, 2021.
The document was previously released in November 2021 but was redacted to exclude the fact that Pfizer had brought on employees to process vaccine injury reports.
According to the unredacted document released on April 1:
“Pfizer has also taken a multiple actions [sic] to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.
“To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs).
“More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
Dr. Aaron Kheriarty, psychiatrist and Chief of Ethics at Unity Project USA posted an excerpt of the document on Twitter:
Exactly why did Pfizer need to bring on so many additional employees to process adverse events if the only risk to taking their product is the “rare” chance a young male might experience “mild” myocarditis?
Why has Pfizer not published detailed data on adverse events reported, while ignoring thousands of people who experienced vaccine injuries?
Where is the FDA?
“The rollout of the Pfizer vaccine has led to an unprecedented number of adverse events reported — 158,000 adverse events in the first two-plus months of the rollout means that the rate of reported AE [adverse events] was approximately 1:1000, with many of the AEs graded as serious. This is based on a denominator of 125,000,000 vaccines distributed.
“It is no wonder that an army of 1,800 individuals was needed to process all of the information.”
The lifted redactions also revealed the number of Pfizer-BioNTech vaccine doses shipped worldwide between December 2020 and February 2021, offering at least some denominator to assist in understanding the volume of reports following vaccination. Notably, the report does not disclose the number of doses administered by the date of the report.
“It is estimated that approximately 126,212,580 doses of BNT162b2 [the Pfizer EUA vaccine] were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021,” the unredacted document states.
In other words, the number of doses shipped was previously redacted because it would have allowed people to better estimate how many individuals had reported injuries after receiving Pfizer’s COVID vaccine — and it would have shown Pfizer was lying about the safety of its product.
Ideally, you would want to know how many doses were actually administered during that time period and compare it to the number of reported injuries to truly understand the risk of experiencing an adverse event.
According to the latest data from the Vaccine Adverse Events Reporting System, 1,205,755 reports of adverse events from all age groups following COVID vaccines, including 26,396 deaths and 214,521 serious injuries were reported between Dec. 14, 2020, and March 25, 2022.
That’s more than the total number (930,952) of adverse events reported for all vaccines in the 32-year-history of the database.
Pfizer ignored adverse events in pursuit of full FDA approval
The documents released on April 1, included a “request for priority review” Pfizer submitted in May 2021 prior to the FDA’s approval of its Comirnaty vaccine, wherein Pfizer described its vaccine as fulfilling an “unmet medical need.” Pfizer claimed its vaccine was safe and effective against COVID, could alter the trajectory of the pandemic and would prevent deaths.
Pfizer also claimed in the documents it was concerned about lifting COVID measures like lockdowns, social distancing, face masks and limited travel for fear doing so would “counteract the impacts of this vaccination effort.”
Pfizer justified its request for full FDA approval on the following grounds:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course.
“Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (ie, individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.”
The same document completely ignored the adverse events prompting Pfizer to hire hundreds of additional employees to process reported injuries from its vaccine. The company claimed its COVID vaccine was safe and well-tolerated during the trial period with “no unanticipated safety findings,” which the unredacted documents now reveal was a lie.
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 [various vaccines tested during the trial period] were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings.
“Phase 2/3 safety data were generally concordant with safety data in Phase 1 of the study, both overall and with regard to younger and older participants.”
Later in the same document, Pfizer drops some astonishing figures on adverse reactions reported following receipt of its COVID vaccine:
“Through 28 February 2021 (data lock point aligned with Pharmacovigilance Plan), there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Cases were received from 63 countries.
“Consistent with what was seen in Phase 2/3 of Study C4591001, most reported AEs were in System Organ Classes (SOCs) with reactogenicity events: general disorders and administration site conditions (51,335), nervous system disorders (25,957), musculoskeletal and connective tissue disorders (17,283), and gastrointestinal disorders (14,096).
What’s clear from the latest document dump is that Pfizer lied about the safety of its COVID vaccine, ignored reported vaccine injuries and the FDA didn’t want anyone to know about it.
The next set of documents — approximately 80,000 pages — is scheduled to be released by May 1, 2022.