The US Federal government shields Pfizer from liability. Gives it billions of dollars. US (and other governments) force their citizens take its product. But won’t let you see the data supporting its safety/efficacy. Who does the gov’t work for?
With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from America’s most prestigious universities requested the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine.
The FDA’s response? It produced nothing. So, in September, the law firm Siri and Glimstad filed a lawsuit against the FDA on behalf of this group (Public Health and Medical Professionals for Transparency or PHMPT) to demand this information.
The FDA then asked a US federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. Literally, a 55-year delay. My firm, on behalf of PHMPT, asked that this information be disclosed in 108 days – the same amount of time it took for the FDA to review and license Pfizer’s vaccine.
The Court ordered the parties to submit briefs in support of their respective positions by December 6, 2021. The FDA’s brief, incredibly, doubles down. It now effectively asks to have until at least 2096 to produce the Pfizer documents. Not a typo. A total of at least 75 years.
Other than producing an initial ~12,000 pages in around two months, the FDA thereafter only wants to commit to producing 500 pages per month. The FDA also disclosed that it actually has approximately at least 451,000 pages to produce.
Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product. The production consisted of 91 pdf pages, one xpt file, and one txt file. You can download them here.
While it is for the scientists to properly analyze, let me share one observation. One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA). This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021.
Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized the processing of serious cases…” and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).” Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.
As for the volume of reports, in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 “events.” Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown). There was a reported 1,223 deaths as a result of the vaccine in the first three months of its EUA. Also, 25,957 of the events were classified as “Nervous system disorders”
But no cause for alarm since Pfizer explains to the FDA: “The findings of these signal detection analyses are consistent with the known safety profile of the vaccine.” So if they knew these issues were going to arise, then why didn’t they appear to have enough staff to process this expected volume of reports? The grand conclusion by Pfizer to the FDA: “The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.”
Nothing to see here. Now who do we need to pay off to make sure it stays that way?