FDA MUST disclose more COVID-19 vaccine records, US judge rules
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, 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.”
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.”
The agency has countered that its “emergency use authorization” file did not fall within the scientist group’s records request.
The FDA said in a filing that it has produced more than 1 million pages of records in the lawsuit.
The filing also said that it had set up “unprecedented and extraordinary operations” — spending more than $3.5 million — to comply with Pittman’s directives to speed up the search and delivery of responsive records.
Public Health and Medical Professionals for Transparency, whose members include professors and scientists from Yale, Harvard, UCLA and Brown, has posted thousands of records on its website.
The case is Public Health and Medical Professionals for Transparency v. U.S. Food and Drug Administration, U.S. District Court for the Northern District of Texas, No. 4:21-cv-01058-P.
