Pfizer hired 600 additional full-time employees to prepare for reports of adverse events related to the COVID-19 vaccines, according to U.S. Food and Drug Administration (FDA) documents released under a Freedom of Information Request (FOIA).
In the 10,000 pages released on April 1, Pfizer disclosed to the agency it hired 600 additional full-time employees to process adverse event reports in the three months following the Emergency Use Authorization (EUA) for its mRNA COVID-19 vaccine, and it anticipated the need to hire an additional 1,800 workers by the end of June 2021. The documents did not reveal how many Pfizer workers were assigned to adverse event reporting at the time the EUA was issued.
Pfizer took a number of steps in response to vaccine reactions, according to a document titled “Cumulative Analysis of Post-Authorization Adverse Event Reports” and marked “confidential,” dated April 30, 2021.
“Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports.” states the internal document. “This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.”
1.2 Million Adverse Events
The nonprofit Public Health and Medical Professionals for Transparency filed the FOIA lawsuit on September 16.
The plaintiffs sought 450,000 pages of material about Pfizer’s vaccine and the FDA’s authorization process. Pfizer initially resisted the FOIA request, claiming it could produce no more than 500 pages per month, which would have meant some 75 years would have been required to satisfy the FOIA request.
U.S. District Judge Mark Pittman of the Northern District of Texas, a Trump appointee, ordered Pfizer to release the documents at a rate of 55,000 pages per month on January 7. The first cache of documents was released on April 1.
The documents also disclose that within the initial three months of the vaccine’s use, a total of 158,893 adverse events were logged from approximately 126,212,580 doses shipped. That means that the adverse event reporting rate was approximately one for every 800 doses.
The running tally of adverse events related to COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS) from December 14, 2020, to March 25, 2022, totals 1,205,755, surpassing the 930,952 total adverse events previously reported for all other vaccines in the 32-year history of the database.
‘Reason to Exercise Caution’
Pfizer’s attempt to forestall disclosure of the documents appears to be part of a pattern of nondisclosure with respect to its brand-name, non-EUA COVID-19 vaccine Comirnaty.
Comirnaty is the same vaccine as the one issued under the EUA, however, Pfizer can advertise it and set a price. Having an approved brand name vaccine in the market could give institutions, like universities, more legal footing to require it. Pfizer, however, would also lose some liability protection it has had with the vaccine under the EUA.
Pfizer appeared to enjoy insulation from the usual ethical requirements of disclosure, says Barbara Loe Fisher, co-founder, and president of the National Vaccine Information Center.
“Pfizer’s published clinical trial data did not provide evidence for the safety or efficacy of administering Comirnaty vaccine simultaneously with other vaccines, but the CDC (Centers for Disease Control and Prevention), and medical trade associations like the American Academy of Pediatrics (AAP) are recommending the vaccine be given at the same time as other vaccines to children and adults,” said Fisher.
“There are almost no CDC or Pfizer approved contraindications to receiving Comirnaty vaccine, even though clinical trial data demonstrate that the majority of clinical adult and child trial participants experienced one or more adverse events, especially after the second dose,” said Fisher. “It has long been recognized that strong reactions to pharmaceutical products can be a reason to exercise caution, especially with repeat doses.”
The documents raise red flags, says Twila Brase president and co-founder of the Citizens Council for Health Freedom.
“Clearly Pfizer didn’t want the data to come out,” said Brase. “It could have shut down the vaccination effort, caused courts to stand up for human rights, put egg on the face of their FDA collaborator, and caused their stockholders to flee. But the way they tried to prevent public access showed they had something to hide. Thankfully, the court refused to let them leave the public in the dark about the facts.”
Americans were not given enough information about the vaccines to make informed decisions about getting the shots, says Brase.
“Given the overwhelming narrative that the vaccines are safe, the right thing to do would have been to stand up and tell the truth,” said Brase. “Having a single statement notifying the patient that the product has not been approved, in a two-to-four-page document at the time of injection is insufficient warning about the realities and possible side effects.”
The widespread use of mRNA vaccines has been unprecedented, says Brase.
“The people of the world have become subjects in the largest experiment ever, and it’s not just an experiment on COVID, it’s an experiment on mRNA,” said Brase. “It’s a genetic trial. Those who refused to take the shot are the controls. Those who got the shots are yet to find out what, if any, impacts they may experience now and in the coming years, or whether it will impact their yet-to-be-born children.”
Kevin Stone (firstname.lastname@example.org) writes from Arlington, Texas.
Worldwide Safety Pfizer, “5.3.6 Cumulative Analysis of post-authorization Adverse Event Reports,” April 30, 2021: https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf
This article was updated on May 25, 2022.