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Federal Judge: FDA Must Release Covid Vaccine “Emergency Use Authorization” Files by June 2025

Federal Judge: FDA Must Release Covid Vaccine “Emergency Use Authorization” Files by June 2025

Judge Mark T. Pittman: “The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine.”

Legal Insurrection readers may recall my 2022 report on a federal judge ordering the Food and Drug Administration (FDA) to expedite the release of Pfizer’s COVID-19 vaccine trial data.

Judge Mark T. Pittman of the Northern District of Texas ruled that the FDA must release the documents much faster than initially proposed. The FDA had wanted to take 75 years to release the data fully.

The FDA tried to put a stop to the public records lawsuit

The judge rejected the FDA’s plea, recognizing the “paramount public importance” of the information.

Now Pittman has ordered the release of records related to “emergency use authorization” (EUA) files.

In a ruling, on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.

“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Donald Trump.

The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.

Under the judge’s order, the FDA must produce the responsive EUA files on or before June 30, 2025.

Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency that brought the case, indicated one million pages of data would be released with this order.

“The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri said.

He said the agency was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”

The FDA has power to grant “emergency use authorization” for vaccines and some other medical products.

The lawsuit said, “the medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of the Pfizer vaccine.”

Public Health and Medical Professionals for Transparency (PHMPT) is a nonprofit organization composed of public health professionals, medical professionals, scientists, and journalists. The organization’s purpose is to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. PHMPT maintains a neutral stance on the data, focusing only on making it publicly available for independent experts to review and analyze.

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Comments

The FDA needs an enema.

The Gentle Grizzly | December 9, 2024 at 9:22 am

That noise you hear is the sound of commercial -grade shredders.

If not already destroyed as mentioned above, come June there will be a new administrator in charge who will comply..

    diver64 in reply to Whitewall. | December 9, 2024 at 3:03 pm

    I think that long before June a new Administrator will be in charge and the files will be released. Anyone trying to slow walk them will be terminated.

Trump cannot allow these bureaucracies to stall and wait him out when he orders things to be declassified / released this time around. Make government transparency great again!

What is the country coming to when even government agencies are forced to obey the laws? A better day…

Courts are only years away, when days count…. I’m so sick of judges.

Dolce Far Niente | December 9, 2024 at 1:16 pm

Critical to the EUA was the deliberate refusal to consider, not to mention demonize ivermectin or HCQ as a therapy. The emergency use authority is ONLY for when there is no other therapy available, which was clearly not the case..

It was and is patently obvious that the money would not flow into the coffers of Big Pharma if the truth were told, so it had to be strangled, stuffed in a trunk and thrown in the ocean.

Maybe there is a chance that trunk will be opened 4 years later.

outsidethebox | December 9, 2024 at 4:50 pm

Emergency Use Authorization should never have been authorized. Ivermectin in combination with a few other drugs worked. We got scammed.

    Ivermectin wasn’t a cure, nor was HCQ. In the first year of Covid, India depended on them heavily and then the results came back showing little if any benefit in hospitalized patients. They may have had some efficacy in the cohort that wasn’t at risk for hospitalization/death but the sickest patients received no benefit.

      Evil Otto in reply to Sanddog. | December 10, 2024 at 6:07 am

      Dishonest argument. He didn’t talk just about hospitalized patients. You added that, and then denied their effectiveness based on it. That was only a small percentage of those with Covid. It’s like saying that bandages don’t work because they’re of limited use for patients with gunshots to the chest.

      Here in the west there was little study of either, and those who advocated for their use were actively suppressed. Instead questionable treatments were used, and even more questionable “vaccines” were pushed.

The FDA has a legitimate need to be able to get drugs on the market fast via the Emergency Use Authorization without having to wait decades and spend billions on trials for certain vaccines and drugs. That comes with a responsibility to immediately release all the data used to justify the EUA.