A trove of documents reporting on Pfizer's COVID vaccine has been released by the U.S. Food and Drug Administration (FDA) after a federal court ordered them to comply with a Freedom of Information Act (FOIA) request filed by a government accountability alliance called Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT is composed of over 30 professors and scientists, who requested the federal government to share the documents that helped them decide to grant approval to Pfizer's COVID vaccine. While the FDA initially refused, claiming it would take them 55 years to review all 329,000 pages of documents, a first batch has been released and it reportedly shows some dire statistics.
According to the Gateway Pundit, a document titled "Cumulative Analysis of Post-Authorization Adverse Event Records Reports" showed that within 90 days of the Pfizer COVID vaccine's rollout in the U.S. under the FDA's Emergency Use Approval in December 2020, there were thousands of reported adverse effects and more than 1,200 deaths following inoculation.
The document only included adverse effects to Pfizer's COVID vaccine that researchers believed to be "serious cases," implying that there were thousands more left out of the data. The report said that any cases deemed "non-serious" would be processed within 90 days, but the document was released before 90 days of Pfizer's COVID vaccine being available to the public.
"Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity," the document read. "Non-serious cases are processed as soon as possible and no later than 90 days from receipt. Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports."
The document revealed that globally, there were 42,086 case reports of persons who had an adverse reaction to Pfizer's COVID vaccine. Most of them came from the U.S. with 13,739 and the U.K. with 13,404 where the Pfizer brand of COVID jabs were being widely used. The document said that women were found to be three times more likely to experience a reaction than men, with 29,914 women reporting adverse reactions versus 9,182 men.
The Pfizer document also read, "Reports are submitted voluntarily, and the magnitude of underreporting is unknown." Some factors that may have contributed to an event being reported include "length of time since marketing, market share of the drug, publicity about a drug or an AE, seriousness of the reaction, regulatory actions, awareness by health professionals and consumers of adverse drug event reporting, and litigation."
According to Reuters, PHMPT's lawyers argued that the release of all documents must be the FDA's top priority and they must do so by March 3, 2022. The group said that this is the exact same time it took for the FDA to "review the responsive documents for the far more intricate task of licensing Pfizer's COVID-19 vaccine."
