Pfizer hired an additional 2,400 staff to handle adverse vaccine reaction events of its COVID-19 vaccine, newly-released 10,000-page documents have revealed. The pharmaceutical company had hired 600 full-time employees and 1,800 additional personnel by June 2021.
The information emerged from the document cache released by the US Food and Drug Administration (FDA) following a court order related to the Freedom of Information Act (FOIA) request on April 1.
"Pfizer has also taken 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," according to the unredacted document released on April 1.
Pfizer's EUA Vaccine's 1,26,212,580 doses Were Supplied
The documents and hiring have suggested that the company's vaccine had complex reactions to humans.
It is estimated that approximately 1,26,212,580 doses of BNT162b2 [the Pfizer EUA vaccine] were shipped worldwide from the receipt of the first temporary authorization for emergency supply on December 1, 2020, through February 28, 2021.
Pfizer Downplayed Adverse Reactions
Previously, Pfizer had downplayed adverse reactions as it made the request for a full FDA license in 2021.
The company described its vaccine as fulfilling an "unmet medical need" and claimed that mass immunization with a safe and effective vaccine against COVID-19 can dramatically alter the trajectory of the pandemic," according to The Defender.
Pfizer justified its request for full licensure of its COVID vaccine on the following basis: Justifying its request for full licensure of its COVID-19 vaccine, Pfizer had stated that "expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control".
Many of the documents released as part of the April 1 tranche appear to include more mundane information and data related to the Pfizer COVID vaccine trials.
The documents have shown a large number of cases of adverse reactions as "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 1,58,893 events and cases were received from 63 countries.