UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF TEXAS

FORT WORTH DIVISION

PUBLIC HEALTH AND MEDICAL 

PROFESSIONALS FOR TRANSPARENCY,

ET AL.,

Plaintiffs,

v. No. 4:22-cv-0915-P

FOOD AND DRUG ADMINISTRATION,

Defendant.

ORDER

In May 2023, the Court ordered the Food and Drug Administration 

(“FDA”) to produce all documents related to the approval of Pfizer’s 12 

to 15-year-olds COVID-19 vaccine and Moderna’s adult COVID-19 

vaccine by June 30, 2025. The Court also ordered the Parties to meet 

and confer about a mutually acceptable production schedule of those 

documents—roughly 4.5 million documents in total. But the Parties 

failed to agree on a production schedule and submitted dueling 

schedules for this Court’s consideration. Having considered the Parties 

proposed production schedules, arguments in support, and applicable 

law, the Court ORDERS the following:

1. The FDA must produce all documents related to Pfizer’s 12 to 15-

year-olds COVID-19 vaccine by January 2, 2024, on a rolling 

basis at a rate no fewer than (1) 35,000 pages per month in July, 

August, and September 2023, (2) 55,000 pages per month in 

October and November 2023, and (3) 180,000 pages per month 

thereafter.

2. The FDA must produce all documents related to Moderna’s adult 

COVID-19 vaccine by June 30, 2025, at a rate no less than 75,000 

pages per month in January 2024 and 180,000 pages per month 

thereafter.

3. The FDA’s rolling productions are due on the first business day of 

each month.

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4. The FDA can “bank” any processed pages it produces in excess of 

its monthly quota. 

5. If the FDA asserts any privilege, exemption, or exclusion as to 

any responsive record or portion of it, the FDA must—concurrent 

with each production required by this Order—produce a redacted 

version of the record, redacting only those portions to which the 

privilege, exemption, or exclusion is asserted.

6. The Parties must submit a Joint Status Report detailing the 

progress of the rolling production by September 1, 2023, and 

every 90 days thereafter. 

The chart below illustrates the minimum rate of production for the two 

vaccines mentioned above and Pfizer’s 16+ COVID-19 vaccine1 based on 

the expected number of documents set to be produced: 

 Minimum # of Documents to be Produced

Pfizer’s 

16+ 

Vaccine

Pfizer’s

12-15 

Vaccine

Moderna’s 

Adult 

Vaccine

Total

July 3, 2023 55,000 35,000 0 90,000

Aug. 1, 2023 55,000 35,000 0 90,000

Sept. 1, 2023 55,000 35,000 0 90,000

Oct. 2, 2023 55,000 55,000 0 110,000

Nov. 1, 2023 55,000 55,000 0 110,000

Dec. 1, 2023 02 180,000 0 180,000

Jan. 2, 2024 0 105,0003 75,000 180,000

Feb. 1, 2024 0 0 180,000 180,000

1st business 

day of every 

month 

thereafter

0 0 180,000 180,000

1 See Pub. Health & Med. Pros. for Transparency v. FDA, No. 4:21-CV-1058-P, 2022 

WL 90237 (N.D. Tex. Jan. 6, 2022) (Pittman, J.). 2 This assumes that all documents related to Pfizer’s 16+ vaccine have been 

produced. If not, the FDA must continue to produce at least 55,000 pages per month 

until completion. 

3 This number reflects the expected number of documents remaining at that time. 

All documents—regardless of the actual number remaining at that time—must be 

produced by January 2, 2024.

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SO ORDERED on this 12th day of June 2023.

Mark T. Pittman

UNITED STATES DISTRICT JUDGE

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