financetom
Business
financetom
/
Business
/
FDA must disclose more COVID-19 vaccine records, US judge rules
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
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

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
JAL president says plans to use both Boeing and Airbus aircraft
JAL president says plans to use both Boeing and Airbus aircraft
Apr 24, 2024
TOKYO, April 24 (Reuters) - Japan Airlines ( JPNRF ) will continue using both Airbus and Boeing ( BA ) aircraft, President Mitsuko Tottori said on Wednesday. Tottori told reporters that JAL does not plan to depend only on Airbus aircraft even after it announced a plan last month to buy 21 wide-body A350-900 and 11 A321neo narrow-body jets from...
Humana beats first-quarter profit estimates on strength in Medicare business
Humana beats first-quarter profit estimates on strength in Medicare business
Apr 24, 2024
(Reuters) -Humana beat first-quarter profit expectations on Wednesday, helped by strength in its government-backed insurance business for older adults and boost from certain valuation adjustments in some strategic partnerships. The health insurer also raised its 2024 individual Medicare Advantage growth target by 50,000 members. Shares of the company rose 3.3% in premarket trading. Humana generated revenue of $29.61 billion in...
Korean Air in talks to buy Boeing 777X jets, sources say
Korean Air in talks to buy Boeing 777X jets, sources say
Apr 24, 2024
(Reuters) - Korean Air is in talks over the purchase of at least 10 Boeing 777X jetliners in a potential tilt back towards its traditional U.S. supplier after placing a major order with European rival Airbus, two industry sources said. The sources said discussions between Korean Air and Boeing ( BA ) on a purchase of the 777X, an upgrade...
Update: Weatherford International Q1 Net Income, Revenue Rise; Lifts Adjusted EBITDA Margin Outlook
Update: Weatherford International Q1 Net Income, Revenue Rise; Lifts Adjusted EBITDA Margin Outlook
Apr 24, 2024
06:40 AM EDT, 04/24/2024 (MT Newswires) -- (Updates with the stock move, margin, and revenue guidance in the last three paragraphs.) Weatherford International ( WFRD ) reported Q1 net income late Tuesday of $1.50 per diluted share, up from $0.97 a year earlier. Analysts polled by Capital IQ expected $1.48. Revenue for the quarter ended March 31 rose to $1.36...
Copyright 2023-2026 - www.financetom.com All Rights Reserved