A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to end the public records lawsuit.
In a ruling, opens new tab 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.
The FDA declined to comment.
Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency, welcomed Pittman’s 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.”
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