Given Safety Concerns, The FDA Owes Us Pfizer's Documents on mRNA Shot Forthwith, Not in Half a Century
It is quintessentially government to keep a promise of transparency...so long as everyone responsible for a major decision is safe from accountability six feet underground.
As you may have heard, the FDA is requesting until the year 2076 to finish releasing all records relating the agency’s decision to approve Pfizer’s covid-19 mRNA shot. (More details on the lawsuit against them for denying an expedited FOIA request in my piece at The Federalist today.) Even if we leave aside the obvious credibility issue Pfizer has, having paid out the nation’s largest ever settlement of $2.3 billion for marketing fraud just twelve years ago, to say the public has an urgent need to see every document related to the FDA’s decision to approve the Pfizer jab forthwith would be an understatement. Assuming this report’s numbers are accurate, The Pfizer vaccine’s VAERS-deaths-per-million-dose rate of 15.38 is far higher than any other regularly scheduled approved vaccine in the U.S.. It’s 19x higher than the MMR (0.81) and more than 44x that of the flu (0.35), using the latest VAERS data (see pages 4 and 11).
Though it’s favorable in comparison to the Janssen vaccine (a whopping 59.51 deaths/dose) and Moderna (21.7), Pfizer-associated death reports (excluding 8,655 foreign reports) to VAERS number nearly 3,900 after less than a year since its Emergency Use Authorization (I added up all VAERS Pfizer death reports from each state and the “location unknown” reports to confirm this number). The existence of VAERS reports do not in themselves prove causality, but the reporting system exists to throw up red flags in patterns and frequency of reports in order to provide a safety signal and let regulators know when a vaccine needs to be investigated for an adverse effect and/or suspended. And it’s thrown up a red flag for the COVID vaccines, including Pfizer’s, the size of Dr. Fauci’s ego.
For context, the 1976 H2N2 flu vaccine program was halted for less than 100 cases of Guillain-Barre in the U.S. and the 2009 Pandemrix flu vaccine was halted in Europe for an association with narcolepsy in some countries - far smaller a safety signals than what VAERS, which is likely not capturing all or even most adverse events, is currently showing for any COVID vaccine, including Pfizer. For the FDA to ask for more than half a century to release information on the vaccine with the highest fatality and injury association by a mile of any approved vaccines in use is unconscionable, even if the shot weren’t creating a devastating medical apartheid for millions of Americans.
Recall also that Pfizer’s trial was just a few months - so short, it conveniently didn’t show the drastic wane in efficacy after ~90 days that now has the FDA and CDC crowing boosters! for months now. Everything this company and the FDA have done so far seems designed to profit Pfizer and circumvent any accountability for vast societal fallout and any significant adverse events from the shot.
Add to that recent disturbing information from a whistleblower who worked on Pfizer’s covid-19 shot trials, who repeatedly tried to alert superiors about “poor laboratory management, patient safety concerns, and data integrity issues,” and we have more than enough justification to demand the FDA implement some ready-made redaction software on the 329,000 pages and release the records in a matter of weeks, not months.
According to Aaron Siri, one of the plaintiffs in the suit to make the record public, the 91 pages the FDA has released so far state that “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). Also, 25,957 of the events were classified as ‘Nervous system disorders.’” Pfizer has added additional personnel for “data entry and case processing” due to the large number of “spontaneous reports” associated with their product.
I’m not a a scientist, but we’re less than 100 pages in, and things are already looking rather concerning. Where there’s a will, there’s a way, as they say. So Congress needs to either legislate or strong-arm the FDA into finding the will to release these documents in weeks, not in half a century when everyone who needs to be held accountable for this monumentally disastrous decision is six feet under.
Anyone who's reading this probably knows about it already, but it looks like we're going to see the FDA records much sooner than Pfizer wants. Read this from Siri: https://aaronsiri.substack.com/p/instead-of-fdas-requested-500-pages
Bless your heart --- please, continue...for the sake of all of us.