Below is a November 17, 2021 post from Aaron Siri, the managing partner in the law firm of Siri & Glimstad. In his post, Siri explains how the FDA has refused to produce any records relied upon by the FDA when approving the Pfizer-BioNTech Comirnity COVID-19 vaccine. Siri brought suit against the FDA to compel compliance with the FOIA and federal regulations, 21 C.F.R. § 601.51(e), that obligate the FDA to release those documents to the public.
The FDA took 108 days to (allegedly) thoroughly review the 329,00 pages of documents provided by Pfizer-BioNTech and approve their COVID-19 vaccine based on the information in those documents. Yet, the FDA claims that it will take them 20,000 days (55 years) to review those same documents before releasing them to the public.
Aaron Siri explained in his court pleadings:
It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021, to when the product was licensed on August 23, 2021. We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. (emphasis added)
Siri’s full post is below:
The FDA has asked a 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. That is not a typo. It wants 55 years to produce this information to the public.
As explained in a prior article, the FDA repeatedly promised “full transparency” with regard to Covid-19 vaccines, including reaffirming “the FDA’s commitment to transparency” when licensing Pfizer’s COVID-19 vaccine.
With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from this country’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, my firm filed a lawsuit against the FDA on behalf of this group to demand this information. To date, almost three months after it licensed Pfizer’s vaccine, the FDA still has not released a single page. Not one.
Instead, two days ago, the FDA asked a federal judge to give it until 2076 to fully produce this information. The FDA asked the judge to let it produce the 329,000+ pages of documents Pfizer provided to the FDA to license its vaccine at the rate of 500 pages per month, which means its production would not be completed earlier than 2076. The FDA’s promise of transparency is, to put it mildly, a pile of illusions.
It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021). Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.
So, let’s get this straight. The federal government shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its product’s safety and efficacy. Who does the government work for?
The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure. Everyone who wants to get vaccinated and boosted should be free to do so. But nobody should be coerced by the government to partake in any medical procedure. Certainly not one where the government wants to hide the full information relied upon for its licensure until the year 2076!