A federal judge has ordered the Food and Drug Administration to disclose more information about its authorization of the COVID-19 vaccines in 2020.
In a ruling released earlier this month, U.S District Judge Mark Pittman of the Northern District of Texas ordered the agency to produce the relevant documentation on its "emergency use authorization" for Pfizer Inc.'s COVID-19 vaccine after failing to persuade the court to dismiss the public information lawsuit against it.
"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," the ruling read.
In 2021, the Public Health and Medical Professionals for Transparency (PHMPT) sued the FDA to make public the documents relating to its approval of the Pfizer-BioNTech COVID-19 vaccine for people sixteen years old and above. This was after the federal health agency said it could take 55 years for it to review and release the vaccine-related data following a Freedom of Information Act request from the group.
PHMPT is a nonprofit aimed at obtaining access to and disseminating information about data used by the FDA to approve coronavirus vaccines.
"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," Attorney Aaron Siri, who represents PHMPT, told Reuters.
The FDA is required to submit the files on or before June 30, 2025.
The report comes just months after the agency approved the use of updated COVID-19 vaccines from Pfizer/BioNTech and Moderna in August.
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