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FDA must disclose more COVID-19 vaccine records, US judge rules
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FDA must disclose more COVID-19 vaccine records, US judge rules
Dec 6, 2024 1:53 PM

Dec 6 (Reuters) - 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 ( PFE ) 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 ( PFE ) 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 ( PFE )

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.

For plaintiff: Aaron Siri and Elizabeth Brehm of Siri &

Glimstad

For defendant: Andrew Freidah of the U.S. Justice Department

Read more:

FDA asks Texas court to shut down COVID-19 vaccine records

lawsuit

'Paramount importance': Judge orders FDA to hasten release

of Pfizer ( PFE ) vaccine docs

Wait what? FDA wants 55 years to process FOIA request over

vaccine data

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