FDA asks judge for 55 years to release data on Pfizer vaccine approval

The FDA wants until the year 2076 to fully release the data that led to its decision to license Pfizer’s Covid vaccine. 

By Donna Rachel Edmunds, World Israel News

The American Food and Drug Administration (FDA) has asked a judge to give the agency until 2076 to fully release the data it used when deciding to grant a license to Pfizer’s Covid vaccine.

If the FDA is successful, it would mean the public having to wait a staggering 55 years to be fully informed on how the decision was made.

The request has come in response to legal action being brought by Public Health and Medical Professionals for Transparency (PHMPT), a nonprofit comprising of public health professionals, medical professionals, scientists, and journalists.

The FDA has repeatedly stated publicly that it has a “commitment to ensuring full transparency, dialogue and efficiency.”

In a statement made November last year in relation to the Moderna vaccine, a spokesman said: “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”

More recently in September of this year, in a statement referring to the use of the Pfizer-BioNTech COVID-19 Vaccine as a booster shot, the FDA again affirmed their “commitment to transparency.”

Taking them at their word, in September the PHMPT filed a freedom of information request to see the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine. That information has not been released. Consequently, the PHMPT has now filed a federal lawsuit against the FDA for access to that data.

On its website, PHMPT states that its mission is “solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines.

“The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data received will be made public on this website.”

A court document filed Monday in Texas reveals that the FDA has responded by requesting that the data be released on a schedule due to the quantity of material – more than 329,000 pages. However, the FDA has requested that the schedule amount to it releasing just 500 pages a month. That would mean the full content of the files would not be made public until 2076, some 55 years from now.

Aaron Siri, managing partner of Siri & Glimstad, whose firm is handling the case on behalf of PHMPT, wrote in a Substack post:

“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.”

The court document notes that the plaintiffs agree with the FDA that a schedule of release is acceptable, but argue that it should be no longer than the FDA itself took to review the data – 108 days.

“Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022,” the document reads.

“Let’s get this straight,” Siri commented. “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?”

He added: “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!”

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