Exhibit 1

Case 3:22-cv-01237-E Document 1-1 Filed 06/07/22 Page 1 of 2 PageID 15
2911 Turtle Creek Blvd.

Suite 1400

Dallas TX 75219 US

DEFENDING THE REPUBLIC

TRAVIS MILLER

Requester reference:

February 09, 2022

FOIA Control #:

2022-908

In Reply refer to

Dear Requester:

This is in reference to your request(s) for record(s) from the Food and Drug Administration (FDA) pursuant to the

Freedom of Information Act (FOIA).

Please provide all data and information submitted by Moderna relating to the FDA review and approval of Spikevax.

This includes, but is not limited to, all safety and effectiveness data and information; all data and information in the

biological product file; and all ingredients.

The Electronic Freedom of Information Act (EFOIA) Amendments of 1996 amended the FOIA by adding section

(a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to consider requests for expedited processing and grant them

whenever a "compelling need" is shown and in other cases as determined by the agency. The term "compelling need" is

defined as (1) involving "an imminent threat to the life or physical safety of an individual," or (2) in the case of a request

made by "a person primarily engaged in disseminating information, urgency to inform the public concerning actual or

alleged Federal Government activity."

I have determined that your request for expedited processing does not meet the criteria under the FOIA. You have not

demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither

have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal

Government activity. Therefore, I am denying your request for expedited processing. The responding agency office will

process your request in the order in which it was received.

You have the right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the

agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90

days from the date of this response, to: Director, Office of the Executive Secretariat, US Food & Drug Administration,

5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov. Please clearly mark both the

envelope and your letter "FDA Freedom of Information Act Appeal."

You may also contact the FDA FOIA Public Liaison, Office of the Executive Secretariat, 5630 Fishers Lane, Room

1050, Rockville, MD 20857; email: FDAFOIA@fda.hhs.gov.

If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information

Services (OGIS), the Federal FOIA Ombudsman’s office, offers mediation services to help resolve disputes between

FOIA requesters and Federal agencies. The contact information for OGIS is: Office of Government Information

Services, National Archives and Records Administration, 8601 Adelphi Road–OGIS, College Park, MD 20740-6001,

Telephone: 202-741-5770, Toll-Free: 1-877-684-6448, E-mail: ogis@nara.gov, Fax: 202-741-5769.

Director

SARAH KOTLER

Sincerely,

Case 3:22-cv-01237-E Document 1-1 Filed 06/07/22 Page 2 of 2 PageID 16