FDA Ordered to Release Data on Emergency Use Authorization of COVID-19 Shots
- by Carolyn Hendler, JD
- Published
- Vaccines
The U.S. Food and Drug Administration (FDA) has been ordered to disclose data it relied on when authorizing COVID-19 shots. U.S. District Court Judge Mark Pittman in Fort Worth, Texas ordered the FDA to release their file on “emergency use authorization” (EUA) related to the Pfizer/BioNTech Comirnaty COVID biologic to a group of scientists. Accordingly, an additional one million pages of COVID trial data will be released to the public by June 30, 2025.1 2 3
The landmark decision arises out of a 2021 case brought by Public Health and Medical Professionals for Transparency to compel the federal agency to release important vaccine trial data. The FDA had previously said it would not release the COVID shot trial data for 75 years.4 Judge Pitman ordered the FDA to expediate the release of 450,000 pages related to the COVID vaccine trials available to the public. The FDA was required to make 55,000 pages available each month until all documents were released by September 2022. Since that time, 1,200,874 pages have been released to the public by the FDA.5
The remaining issue from the 2021 order was whether the EUA file related to the COVID shots was covered by FOIA request by the plaintiffs and, therefore, must be released by the FDA.6 The FDA contended that their emergency use authorization file should not be part of the trial data previously ordered to be released and that they had already spent 3.5 million dollars complying with the court order to release the trial data. Many public health officials supported the FDA and claimed that releasing the information could lead to misinterpretation and fuel vaccine skeptics.7
Both parties moved for summary judgment on the matter.8 A summary judgment motion is brought when one party alleges that a trial is not necessary as the other side has no valid claims or defenses for the judge or jury to consider. The moving party argues that they are required to a judgment as a matter of law due to there being “no genuine issues as to any material fact.”9
There is a Lower Standard to Approve EUA Vaccines
The FDA granted vaccine manufacturers and EUA to release the COVID biologic to the public after fast tracking it to market. An EUA has a different standard for proof of safety and efficacy than vaccines licensed by FDA under standard licensing guidelines. FDA licensed vaccines approved for regular use by the public generally require randomized clinical trials that prove safety and efficacy, while those approved under EUA have a lower standard and a faster review as they merely require data supporting, rather than proving safety and efficacy.
Judge Pitman explained:
While it is normal for EUA standards to vary from those required for FDA approval the “EUA standards for COVID- 19 products varied considerably” and, in some cases, did “not require[] any FDA review of safety or efficacy.10
Plaintiff’s attorney, Aaron Siri said:
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.11
The court concluded by quoting Patrick Henry…
The liberties of a people were, nor ever will be, secure, when the transactions of their rulers may be concealed from them.12
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