Pfizer hired 600 employees to handle ‘large increase of adverse event reports' 

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Pfizer hired 600 employees to handle ‘large increase of adverse event reports' 

An unredacted document newly released in compliance with a Freedom of Information Act (FOIA) lawsuit indicates that double-dose COVID jab maker Pfizer onboarded some 600 new full-time employees last year “to help alleviate the large increase of adverse event reports” received in connection with the experimental COVID shots.

Dr. Aaron Kheriarty highlighted the information in an April 4 tweet which included a screenshot of the relevant section of the document.

Kheriarty is a member of the Public Health and Medical Professionals for Transparency (PHMPT) organization, the group of over 30 physicians and researchers that filed the FOIA lawsuit against the U.S. Food and Drug Administration (FDA) last year to demand the release of the documents it reviewed prior to greenlighting the Pfizer-BioNTech COVID shots.

“Finally got the unredacted version of this FoIA’d document,” Kheriarty wrote. “Three months after the release of the [COVID-19] vaccine Pfizer had to hire 600 additional full-time employees, with a plan to hire 1800 total, just to process the flood of adverse events reported.”

According to the newly released document, which was made public nearly a year after it was created on April 30, 2021, Pfizer’s marketing authorization holder (MAH) had to prioritize the processing of “serious cases” alone after receiving “large numbers of spontaneous adverse event reports” in connection with the COVID-19 drugs.

The document states the company gave special attention to the serious cases “in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.” 

In an effort “to help alleviate the large increase of adverse event reports,” the massive pharmaceutical company, which has a market cap of over $300 billion, took “multiple actions,” including “increasing the number of data entry and case processing colleagues,” as well as making “significant technology enhancements.”

“To date, Pfizer has onboarded approximately 600 additional fulltime [sic] employees (FTEs),” the unredacted document stated. “More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”

Brian Hooker, chief scientific officer of Children’s Health Defense, told The Defender in a statement that the sheer number of adverse events recorded in mere months following the rollout of the drugs was “unprecedented.”

“It is no wonder that an army of 1,800 individuals was needed to process all of the information,” Hooker said.

The revelations regarding Pfizer’s hiring push to deal with the surge in adverse events come after the FDA in March released roughly 150 documents it reviewed prior to granting approval of Pfizer’s COVID drugs.

In January, U.S. District Judge Mark Pittman of the Northern District of Texas rejected the FDA’s request to stall publication of the crucial safety data for up to 75 years, after the PHMPT filed its FOIA lawsuit.

The FDA had asked the court to significantly delay the release of the Pfizer documents, citing “unduly burdensome” logistical and personnel hurdles.

The PHMPT has since uploaded the extensive trove of documents onto its website.

The data made accessible to the public includes a lengthy priority review request document containing over 100 pages of anonymous safety-related data tables. Another document outlines a $2.9 million user fee payment from Pfizer to the FDA, which Endpoint News called “standard.”

However, the 150 documents merely scratches the surface of the hundreds of thousands of pages currently in the possession of the FDA.

American Greatness reported that in the Texas court order, which has thus far resulted in the release of roughly 10,000 pages of previously unreleased documents, the judge also “directed the FDA to release approximately 12,000 documents immediately, and then 55,000 pages a month until all documents are released — totaling more than 300,000 pages.”

One of the documents included in last month’s data dump was a document entitled “Cumulative analysis of post-authorization adverse event reports,” which detailed adverse events connected with the Pfizer jab which had been identified through Feb. 28, 2021.

While the cumulative analysis had been released back in November, American Greatness pointed out that some of the information contained in the document had been redacted, “including the number of employees Pfizer said it hired and was planning to hire.” 

The 38-page document detailed over 150,000 serious adverse events recorded in the first three months after the FDA granted emergency use authorization (EUA) for the injections.

According to the data, the vast majority of the serious adverse events occurred in women (29,914) compared with men (9,182). The largest proportion of adverse events based on age occurred in people ages 31-50 (13,886), an age range generally at low risk of serious effects from the virus. 

Among reported adverse events were 25,957 cases of nervous system disorders, 17,283 musculoskeletal and connective tissue disorders, 14,096 gastrointestinal disorders, 8,848 respiratory, thoracic and mediastinal disorders, 8,476 skin and subcutaneous tissue disorders, and 4,610 infections and infestations. 

Full or ongoing recovery was reported in 19,582 cases, with 520 having recovered with sequelae (a chronic condition), while at the time of the report some 11,361 cases had not recovered. The status of another 9,400 was unknown. 

1,223 cases were reported to have ended fatally.

Meanwhile, Pfizer’s cumulative analysis report also included troubling data regarding the effects of the jabs on pregnant women. 

Table 6 of the document stated that of 270 “unique pregnancies” that were exposed to the vaccine, “no outcome was provided for 238 pregnancies.” 

Per the document, of 32 pregnancies with known outcomes there were 23 spontaneous abortions (miscarriages), two premature births with neonatal death, two spontaneous abortions with intrauterine death, one spontaneous abortion with neonatal death, and one pregnancy with “normal outcome.” 

In its newly unredacted documents, Pfizer downplayed the reported adverse events, American Greatness noted.

“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,” the document states.

“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.”

The FDA’s reluctance to release the documents has raised the ire of medical freedom advocates and others. Earlier this year, the editors of the prestigious BMJ issued an urgent call for the full release of all data regarding the COVID-19 injections and other treatments, arguing that keeping crucial information hidden from the public is “morally indefensible.”

Since the roll out of the COVID-19 drugs last year, rates of vaccine-related adverse events reported to the government’s Vaccine Adverse Event Reporting System (VAERS) have skyrocketed.

As of March 25, there have been over 1.2 million adverse events reported to VAERS in connection with COVID jabs made by Pfizer, Moderna, and Johnson & Johnson, including 26,396 deaths, 145,781 hospitalizations, and 37,579 cases of myocarditis (heart inflammation).

 

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