The U.S. Food and Drug Administration (FDA) has been ordered by a federal judge to disclose more information regarding its authorization of COVID-19 vaccines. This decision comes after the agency failed to convince the court to dismiss a public records lawsuit seeking transparency.
U.S. District Judge Mark Pittman in Fort Worth, Texas, ruled on Friday that the FDA must provide its “emergency use authorization” file to a group of scientists who are seeking access to the licensing information that was used to approve the Pfizer-BioNTech coronavirus vaccine.
Pittman stated in his ruling that “the COVID-19 pandemic is long past and there is no legitimate reason to withhold the information relied upon by the government in approving the Pfizer vaccine.” The lawsuit, filed in late 2021, gained attention when the FDA suggested that it could take decades to process and release the requested records to the group known as Public Health and Medical Professionals for Transparency.
The FDA has not provided any comments on the matter. Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency, expressed satisfaction with Pittman’s order. He commented that the FDA appears to lack confidence in its review process for licensing the Pfizer vaccine, as it is making every effort to prevent independent scientists from conducting their own review of the data.
Siri also mentioned that the FDA is withholding one million pages of clinical trial documents from the COVID-19 vaccine trials. The FDA has the authority to grant emergency use authorization for vaccines and other medical products.
Despite the FDA’s argument that the emergency use authorization file did not fall under the scientist group’s records request, the lawsuit asserts that the medical and scientific community, as well as the public, have a significant interest in reviewing the data behind the FDA’s approval of the Pfizer vaccine.
The FDA has disclosed over 1 million pages of records in response to the lawsuit and has allocated more than $3.5 million to expedite the search and delivery of the requested documents. Public Health and Medical Professionals for Transparency, which includes members from prestigious institutions like Yale, Harvard, UCLA, and Brown, has made thousands of records available on its website.
The case, known as Public Health and Medical Professionals for Transparency v. U.S. Food and Drug Administration, is being heard in the U.S. District Court for the Northern District of Texas under case number 4:21-cv-01058-P.
