Appendix supporting FDA's motion for summary judgment — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 92 · 2024-10-17 · Docket on CourtListener

Summary

An appendix in support of the defendant's motion for summary judgment, filed October 17, 2024 as Document 92 in Public Health and Medical Professionals for Transparency v. United States Food and Drug Administration, No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas. Its table of contents lists a declaration of Suzann Burk and Exhibit 1, the defendant's November 1, 2023 production letter. The declaration explains the biologics license application process and the confidentiality rules at 21 C.F.R. § 601.50 and § 601.51, and describes handling of the plaintiff's August 27, 2021 FOIA request, assigned control number 2021-5683. It states 13,727 pages were produced before the court's February 2, 2022 order and 1,187,147 pages were processed over twenty-one months at more than $3.5 million, a total of 1,200,874 pages.

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1 
 
IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
___________________________________ 
 
 
 
 
 
 
) 
PUBLIC HEALTH AND MEDICAL 
)    
PROFESSIONALS FOR  
 
 
) 
TRANSPARENCY 
 
 
 
) 
 
 
 
 
Plaintiff, 
) 
 
 
 
 
 
 
) 
v. 
 
 
 
 
)    Civil Action No. 4:21-cv-01058-P 
 
 
 
 
 
 
) 
UNITED STATES FOOD AND DRUG 
) 
ADMINISTRATION, 
 
 
) 
 
 
 
 
 
 
) 
 
 
 
 
Defendant. 
) 
___________________________________  ) 
 
APPENDIX IN SUPPORT OF DEFENDANT’S  
MOTION FOR SUMMARY JUDGMENT 
Table of Contents 
 
 
 
 
 
 
 
 
 
 
 
Page Numbers 
Declaration of Suzann Burk………………………………………………………...App’x 001-017 
 
Exhibit 1: Defendant’s November 1, 2023 Production Letter…………...….App’x 018-021 
 
 
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Dated: October 17, 2024 
 
 
Respectfully submitted, 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant Attorney General 
 
ELIZABETH J. SHAPIRO 
Deputy Director, Federal Programs Branch 
 
  /s/ Andrew F. Freidah 
     
 
 
ANDREW F. FREIDAH 
Trial Attorney 
United States Department of Justice  
 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Washington, DC 20005 
Tel.: (202) 305-0879 
Email: andrew.f.freidah@usdoj.gov 
 
Attorneys for Defendant 
 
OF COUNSEL: 
 
SAMUEL R. BAGENSTOS 
General Counsel 
U.S. Department of Health and Human Services 
 
WENDY S. VICENTE 
Deputy Chief Counsel, Litigation 
 
JACLYN E. MARTINEZ RESLY 
MAGGIE R. REDDEN 
Associate Chief Counsel 
Office of the Chief Counsel 
U.S. Food and Drug Administration 
10903 New Hampshire Ave. 
White Oak 31 
Silver Spring, MD 20993-0002 
 
 
 
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CERTIFICATE OF SERVICE 
 
I hereby certify that on October 17, 2024, I electronically filed this document with the 
Clerk of the Court for the United States District Court for the Northern District of Texas by using 
the CM/ECF system.  Counsel in the case are registered CM/ECF users and service will be 
accomplished by the CM/ECF system. 
 
  /s/ Andrew F. Freidah 
ANDREW F. FREIDAH 
Trial Attorney 
United States Department of Justice 
 
 
 
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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
FORT WORTH DIVISION 
 
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR TRANSPARENCY, 
 
 
Plaintiff, 
 
-against- 
 
FOOD AND DRUG ADMINISTRATION, 
 
 
Defendant. 
 
 
 
 
Civil Action No. 4:21-cv-01058-P 
 
 
 
 
 
DECLARATION OF SUZANN BURK 
I, Suzann Burk, hereby declare as follows: 
1. 
I am the Director of the Division of Disclosure and Oversight Management 
(“DDOM”), Office of Communication Outreach and Development, Center for Biologics 
Evaluation and Research (“CBER”), United States Food and Drug Administration (“FDA” or “the 
agency”), in Silver Spring, Maryland. 
2. 
A summary of my work experience and current job responsibilities is included in 
paragraph 2 of my declaration in this matter dated December 6, 2021. Burk December 2021 Decl., 
ECF No. 23, Ex. A. 
3. 
The statements contained in this declaration are based upon my personal 
knowledge, and upon information I have learned in my official capacity.  
App'x 001
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4. 
As explained in my December 2021 declaration, one of DDOM’s three branches is 
the Access Litigation and Freedom of Information Branch (“ALFOI”), which is primarily 
responsible for the review and disclosure of CBER-maintained records in response to Freedom of 
Information Act (“FOIA”) requests and FOIA litigation. See Burk December 2021 Decl. ¶¶ 3, 5. 
5. 
The purpose of this declaration is to explain the biological product licensing 
process, to explain the confidentiality of biological product licensing files, to explain ALFOI’s 
receipt and handling of the FOIA Request submitted by Plaintiff Public Health and Medical 
Professionals for Transparency (“PHMPT”), and to explain ALFOI’s search for records responsive 
to PHMPT’s FOIA Request.   
THE BIOLOGICAL PRODUCT LICENSING PROCESS 
6. 
Vaccines are biological products that are regulated under the Public Health Service 
Act (“PHSA”), 42 U.S.C. § 262(i)(1); as well as “drugs” subject to regulation under the Federal 
Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 321(g)(1)(B). Vaccines are approved for 
marketing through applications known as Biologics License Applications (“BLA”). 42 U.S.C. 
§ 262(a). A vaccine that is the subject of an approved BLA need not also obtain approval via a 
new drug application under 21 U.S.C. § 355. 42 U.S.C. § 262(a), (j). 
7. 
A sponsor of a biological product usually begins the process of studying an 
investigational product by performing a variety of laboratory tests on it, including certain safety 
tests in animals. The sponsor’s focus at this stage is to collect the data and information necessary 
to establish that the investigational product will not expose humans to unreasonable risks when 
used in limited, early-stage clinical studies. Before the investigational biological product may be 
administered to human subjects, however, the sponsor must first submit an investigational new 
drug application (“IND”) to FDA. See 21 C.F.R. § 312.20; see generally 42 U.S.C. § 262(a)(3), 
App'x 002
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21 U.S.C. § 355(i), and 21 C.F.R. Part 312. 
8. 
In general, an IND application contains the results of the laboratory and animal tests 
(referred to as pre-clinical data) that have been performed, gathered, and submitted by the sponsor; 
manufacturing information for the investigational biological product; and proposals, known as 
protocols, describing the sponsor’s plans for testing the investigational biological product in 
human subjects. See generally 21 C.F.R. § 312.23. Tests conducted in human beings are referred 
to as clinical trials. FDA medical and scientific reviewers evaluate the data submitted in the IND, 
including the proposed clinical trial protocols. If the reviewers determine, from the evidence, that 
the biological product does not pose an unreasonable or significant risk of illness or injury to 
human subjects and if there are no other problems with the submission that cause the agency to 
identify the need for a clinical hold, the agency will not bar the clinical trial from proceeding. 
Given that an IND is submitted during the investigational stage of drug development, IND files 
may contain data and information regarding formulations, dosages, or uses that differ from those 
that are ultimately licensed.  
9. 
A subsequent stage of the development process may occur when a sponsor submits 
to FDA a formal application for licensing (i.e., marketing approval), the BLA. See 42 U.S.C. 
§ 262(a)(1)(A). BLAs include various information and data, including nonclinical and clinical 
data; information about manufacturing methods and locations; data establishing stability of the 
product through the dating period; summaries of results from tests performed on the lots of 
representative samples of the product; and, among other things, mockups of the labels, enclosures, 
medication guide if proposed, and containers as applicable. See 21 C.F.R. § 601.2(a); see also, 
e.g., eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy (version 2.1) (Sept. 
2024) (“BLA Table”), https://www.fda.gov/media/179699/download?attachment (laying out 
App'x 003
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organization for BLAs).  
10. 
Under the PHSA, FDA approves a BLA on the basis of a demonstration that: (1) the 
vaccine is “safe, pure, and potent;”1 and (2) the facility in which the vaccine is produced meets 
standards designed to assure that the vaccine continues to be safe, pure, and potent. 42 U.S.C. 
§ 262(a)(2)(C)(i). The applicant must also consent to inspection of the manufacturing facility. Id. 
§ 262(a)(2)(C)(ii). If FDA determines that the application meets statutory and regulatory 
requirements, it will issue a biologics license for the product, thus authorizing the sponsor of that 
particular BLA to market that new product. See 21 C.F.R. § 601.4(a). 
11. 
IND and BLA files continue to be maintained following initial licensure of a 
product, and sponsors may continue to make submissions to the relevant file. For example, clinical 
trial data for formulations, dosages, or uses that differ from the licensed vaccine could be submitted 
to the IND file; and certain post-licensure submissions for the licensed vaccine (such as narrative 
periodic reports) would be submitted to the BLA file. 
CONFIDENTIALITY OF BIOLOGICAL PRODUCT LICENSING FILES 
12. FDA regulations at 21 C.F.R. § 601.50 and 601.51 (along with the FOIA, other 
relevant statutes, and FDA’s other regulations regarding disclosure of records) govern the 
availability of data and information in IND and BLA files. See also 21 C.F.R. § 312.130(b).  
13. 
Under 21 C.F.R. § 601.50, the existence of an IND will not be disclosed by FDA 
unless it has previously been publicly disclosed or acknowledged, and the availability for public 
disclosure of data and information in an IND file for a biological product is handled in accordance 
1 The standard for licensure of a biological product as potent under 42 U.S.C. § 262 has long been 
interpreted by FDA to include effectiveness. See 21 C.F.R. § 600.3(s); Guidance for Industry: 
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 
1998), at 4, https://www.fda.gov/media/71655/download. 
App'x 004
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with 21 C.F.R. § 601.51.   
14. Section 601.51 is titled “Confidentiality of data and information in applications for 
biologics licenses” and defines, for the purposes of that regulation, the term “biological product 
file” (“BPF”) to include, among other things, the BLA and INDs incorporated into the BLA. See 
21 C.F.R. § 601.51(a). Section 601.51 states that, unless a BPF has been previously disclosed or 
acknowledged, FDA cannot disclose its existence or any data or information therein before a BLA 
has been approved. See 21 C.F.R. § 601.51(b)-(c).2   
15. Once a biologics license has been issued, certain data in the BPF is available for 
public disclosure upon receipt of a FOIA request. See, e.g., 21 C.F.R. § 601.51(e); 21 C.F.R. 
§ 20.20; 21 C.F.R. § 20.23. 
16. Section 601.51(e) lists the type of information in a BPF that is available for public 
disclosure following licensure.3 21 C.F.R. § 601.51(e) is not a list of items that must be in a BPF; 
rather, it describes information that, if found in a BPF, may generally be disclosed absent 
2 If the existence of a BPF has been publicly disclosed or acknowledged, FDA generally still cannot 
make information and data in the file available for public disclosure until a license has been issued. 
See 21 C.F.R. § 601.51(d). 
3 21 C.F.R. § 601.51(e) states: “After a license has been issued, the following data and information 
in the biological product file are immediately available for public disclosure unless extraordinary 
circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for 
a test or study, unless it is shown to fall within the exemption established for trade secrets and 
confidential commercial or financial information in § 20.61 of this chapter. (3) Adverse reaction 
reports, product experience reports, consumer complaints, and other similar data and 
information . . . . (4) A list of all active ingredients and any inactive ingredients previously 
disclosed to the public, as defined in § 20.81 of this chapter. (5) An assay method or other 
analytical method, unless it serves no regulatory or compliance purpose and it is shown to fall 
within the exemption established in § 20.61 of this chapter. (6) All correspondence and written 
summaries of oral discussions relating to the biological product file, in accordance with the 
provisions of part 20 of this chapter. (7) All records showing the manufacturer’s testing of a 
particular lot, . . . manufacturing procedures and controls, yield from raw materials, costs, or other 
material falling within § 20.61 of this chapter. [and] (8) All records showing the testing of and 
action on a particular lot by the Food and Drug Administration.” 
App'x 005
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extraordinary circumstances. In kind, 21 C.F.R. § 601.51(f) lists the type of information that, if 
found in a BPF, generally cannot be publicly disclosed even after a biological product is licensed. 
ALFOI’S HANDLING OF PLAINTIFF’S FOIA REQUEST 
17. On August 27, 2021, Plaintiff submitted its FOIA Request to FDA seeking: “[a]ll 
data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the 
exception of publicly available reports on the Vaccine Adverse Events Reporting System.” Pl.’s 
FOIA Request (ECF No. 1-1), at 1; see Declaration of Sarah Kotler (“Kotler Decl.”) (ECF No. 30, 
Ex. D) ¶ 15. Plaintiff’s Request further clarified that (a) “Pfizer Vaccine” meant “the Pfizer-
BioNTech COVID-19 Vaccine, marketed as Comirnaty . . . for individuals 16 years of age and 
older” and (b) its Request “include[ed] but [was] not limited to all data and information in the 
biological product file, as defined in 21 C.F.R. § 601.51(a), for the Pfizer Vaccine enumerated in 
21 C.F.R. § 601.51(e).” Pl.’s FOIA Request (ECF No. 1-1) at 1 & n.2.  
18. 
FDA assigned Plaintiff’s FOIA Request the control number 2021-5683. 
19. 
On September 9, 2021, FDA denied Plaintiff’s request for expedited processing, 
see Ltr. From FDA to PHMPT (ECF No. 1-4); Kotler Decl. ¶¶ 17-21, and the FOIA Request 
entered ALFOI’s complex queue for processing.   
20. 
Before Plaintiff’s Request came up in the queue, Plaintiff filed the present action. 
See Compl. for Declaratory & Inj. Relief (ECF No. 1) (Sept. 16, 2021). 
21. 
In the ensuing few months, given the breadth of Plaintiff’s FOIA Request, the 
limited resources of ALFOI, and the large amount of information that had already been made 
publicly available about Comirnaty, FDA attempted to engage with Plaintiff for Plaintiff to more 
narrowly identify the records of greatest interest and agree to a reasonable processing schedule. 
22. 
Between November 17, 2021, and January 31, 2022, ALFOI produced 13,727 
App'x 006
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pages of responsive records to Plaintiff that Plaintiff had identified as “priority” records.  
23. 
On January 6, 2022, this Court ordered a processing schedule of 55,000 pages every 
thirty days. On February 2, 2022, upon consideration of the agency’s motion to partially modify 
the January Order to “stand up” unprecedented and extraordinary operations to comply with the 
Order, the Court allowed for a graduated processing schedule, which required CBER to process 
10,000 pages per month in March and April 2022; 80,000 pages per month in May, June, and July 
2022; 70,000 pages in August 2022; and 55,000 pages per month thereafter. ECF No. 56 
(“February 2, 2022 Order”). To the extent CBER processed more than the required page count in 
any month, the Court permitted CBER to “bank” the extra pages and apply them to a later month 
toward its quota for that month. Id.  
24. 
Pursuant to the Court’s February 2, 2022 Order, ALFOI processed 1,187,147 pages 
of responsive records over the course of twenty-one months and spent more than $3.5 million 
through October 2023 to do so.4   
25. 
Combined with the 13,727 pages of records produced prior to the Court’s February 
2, 2022 Order, FDA processed a grand total of 1,200,874 pages of responsive records in response 
to Plaintiff’s FOIA Request.   
ALFOI’S SEARCH FOR THE COMIRNATY BIOLOGICAL PRODUCT FILE 
26. 
Initially, ALFOI interpreted Plaintiff’s FOIA Request as a “request for all publicly 
releasable information in the original biologics license application submitted by BioNTech-Pfizer 
4 Following the Court’s February 2022 Order, and the Court’s June 12, 2023 production order in 
PHMPT v. FDA, 22-cv-915 (N.D. Tex.) (“PHMPT 2”) (requiring FDA to process across the two 
cases at least 90,000 to 110,000 pages per month from July 2023 through November 2023 and, 
starting in December 2023, in PHMPT 2, at least 180,000 pages per month until June 2025), FDA 
has sought stays in other FOIA litigations citing the voluminous production requirements in both 
PHMPT cases. To date, 7 stays have been granted, and 3 stay requests are awaiting decisions. 
App'x 007
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for the Comirnaty vaccine” with internal file number STN 125742/0/0 and STN 125742/0/1. See 
Burk Dec. 2021 Decl. ¶ 25.5 In other words, ALFOI initially interpreted Plaintiff’s FOIA Request 
as seeking publicly releasable portions of Pfizer’s initial BLA submissions (through May 18, 
2021). However, in the spirit of the Court’s comments during its 2021 and 2022 hearings with the 
parties and in an attempt to provide Plaintiff with the greatest scope of data and information that 
the literal language of its FOIA Request could support, ALFOI searched for and processed the 
entirety of the BPF for the Pfizer-BioNTech Comirnaty vaccine approved for individuals 16 years 
of age and older (“original Comirnaty vaccine licensure”) through October 27, 2021, the date 
ALFOI began its search. 
27. 
The BPF, defined by 21 C.F.R. § 601.51(a), is composed of, not only the BLA, but 
also “all data and information submitted with or incorporated by reference in [the BLA], INDs 
incorporated into any such application, master files, and other related submissions.” Discussed in 
detail below, ALFOI conducted an expansive search across multiple, independent filing systems 
for the following records related to the original Comirnaty vaccine licensure through the search 
cut-off date of October 27, 2021: (i) records submitted by Pfizer to the BLA prior to licensure; 
(ii) records submitted by Pfizer to the BLA following licensure; (iii) FDA-generated records 
routinely prepared and filed during review of BLA submissions; (iv) IND records incorporated 
into the BLA; (v) master file records referenced in the BLA; (vi) other records incorporated by 
5 For BLAs, an applicant may submit rolling submissions so long as they have identified the 
submission accordingly (e.g., part 1 of 2). STN 125742/0/0 was part of a rolling submission by 
Pfizer, which included two separate submissions: part 1 of 2 (STN 125742/0/0, submitted on May 
6, 2021) and part 2 of 2 (STN 125742/0/1, submitted on May 18 2021). My December 2021 
declaration mistakenly omitted a reference to STN 125742/0/1, which ALFOI also considered 
responsive to Plaintiff’s FOIA Request at the time. See Burk December 2021 Decl. ¶ 25.  
App'x 008
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reference into the BLA; and (vii) other related submissions for the original licensure (Biological 
Product Deviation Reports, certain lot release materials, and lot distribution reports).  
Biologics License Application Submissions 
28. 
The bulk of the BPF is the BLA. BLAs are organized by when the information is 
submitted by a sponsor and then by subject matter category: namely, Module 1 Administrative 
Information (e.g., cover letters, general correspondence, and FDA Forms); Module 2 Summaries 
(e.g., pharmacokinetics and quality); Module 3 Quality Information (e.g., chemistry, 
manufacturing, and controls); Module 4 Nonclinical Study Reports; and Module 5 Clinical Study 
Reports. Each module contains specific folders and subfolders, to which sponsors electronically 
submit records. See, e.g., BLA Table. This organization facilitates the agency’s review because 
the BLA is not a single submission; the application process takes a significant period of time, and, 
ordinarily, sponsors submit new and additional data (“amendments”) as the clinical investigations 
continue and as the agency raises questions during its review process that require further 
investigations and submissions.   
29. 
BLA submissions are tracked by an FDA database called Regulatory Management 
System-Biologics Licensing Application (RMS-BLA), which assigns each BLA a unique 
submission tracking number (“STN”). The STN for Pfizer’s BLA for the original Comirnaty 
vaccine licensure is 125742. BLA submissions are downloadable from an FDA database called 
Lorenz docuBridge. Accordingly, ALFOI reviewed Lorenz docuBridge for STN 125742 and 
learned that Pfizer had made 77 submissions to STN 125742/0: 2 containing the original BLA 
application (STN 125742/0/0 and STN 125742/0/1) and 75 subsequent BLA amendment 
submissions up until the date of licensure. ALFOI also discovered that between licensure and 
October 27, 2021, Pfizer made additional submissions to STN 125742, and, upon subsequent 
App'x 009
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review, ALFOI determined that 26 such submissions were responsive (post-marketing 
commitment/requirements (“PMC/Rs”), product correspondence, labeling and promotional 
material, and narrative periodic safety reports submitted to the BLA and related to the original 
Comirnaty vaccine licensure). 
30. 
These BLA submissions consisted of various Module 1-5 records, including but not 
limited to individual Case Report Forms (“CRFs”),6 and clinical data files.  
31. 
ALFOI processed the 77 pre-licensure submissions and the 26 post-licensure 
submissions (approximately 1,079,089 pages)7 in response to Plaintiff’s FOIA Request. 
FDA-Generated Records Related to the BLA 
32. 
 CBERConnect is a centralized database for reviewers to electronically upload/file, 
search, and view, among other things, agency-generated records related to the licensing process. 
Using CBERConnect, ALFOI again searched for STN 125742 and identified 135 records 
generated by FDA in response to, or in conjunction with, Pfizer’s 77 BLA submissions prior to 
licensure and 11 records generated by FDA in response to, or in conjunction with, Pfizer’s 26 BLA 
submissions post-licensure (through October 27, 2021). The FDA-generated records related to 
STN 125742 included, among other things, memoranda of teleconferences between FDA and 
Pfizer, agency review memoranda evaluating the BLA submissions, agency information requests 
to Pfizer, and inspection records.  
6 For BLAs, applicants generally submit case report forms for deaths, other serious adverse events, 
and withdrawals from a study due to adverse events, or as additionally requested by FDA. See 
Guideline for Industry: Structure and Content of Clinical Study Reports (ICH E3) (July 1996), 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-
content-clinical-study-reports. 
7 Forty lines per page for data files. 
App'x 010
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33. 
ALFOI processed the 146 FDA-generated records in response to Plaintiff’s FOIA 
Request. 
Investigational New Drug Application Records Incorporated into the BLA 
34. 
IND submissions are tracked by an FDA database called Biologics Investigational 
and Related Applications Management System (BIRAMS), which assigns each IND a submission 
tracking number (called an “Investigational and Related Applications (IRA) number”). The IRA 
number associated with the original Comirnaty vaccine is 19736.  
35. 
It is standard practice for sponsors and FDA reviewers to refer to IND records by 
IRA number. So, ALFOI searched for “19736” across the 103 BLA submissions and identified 51 
records referenced by tracking number or description/date that were incorporated into the original 
Comirnaty vaccine licensure. 
36. 
ALFOI also searched for “19736” across the 146 FDA-generated records to 
determine whether there were any additional identifiable portions of IND 19736 incorporated into 
the BLA. ALFOI identified 279 additional IND records from that review.  
37. 
ALFOI processed the 330 aforementioned IND records in response to Plaintiff’s 
FOIA Request. 
Drug Master Files 
38. 
ALFOI also searched for master files referenced by Pfizer in the BLA. A drug 
master file (“DMF”) is a submission to FDA that provides confidential, detailed information about, 
among other things, the facilities, processes, or articles used in the manufacturing, processing, 
packaging, and storing of drugs. The submitter is called a DMF holder. DMF holders can be 
makers of container closures used for a vaccine, for example. The purpose of a DMF is so that the 
proprietary information therein is allowed to be incorporated by reference by sponsors of products 
App'x 011
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seeking approval or licensure for FDA’s consideration during review of the sponsor’s application 
without the owner of the master file having to disclose the information in the master file. While 
the sponsors obtain a right of reference to the DMF by the DMF holder’s Letter of Authorization 
(“LOA”), the information in the DMF itself is not disclosed to the sponsor. FDA ordinarily neither 
independently reviews nor approves DMF submissions. Instead, FDA customarily reviews the 
technical contents of DMFs only as is relevant to, and in connection with, the review of 
applications that reference them. See Draft Guidance8 for Industry: Drug Master Files (Oct. 2019), 
https://www.fda.gov/media/131861/download; 21 C.F.R. § 314.420. 
39. 
Subfolder 1.4.2 of the BLA is “Statement of right of reference.” BLA Table, at 1. 
ALFOI looked to that subfolder of STN 125742 to identify the DMFs to which Pfizer had obtained 
a right of reference. The submission for that subfolder identified 8 letters of authorization for 8 
DMFs. All the DMFs were Type III DMFs, meaning that they were related to packaging material. 
See 21 C.F.R. § 314.420(a)(3); 84 Fed. Reg. at 30,970 (FDA’s approach to “the terminology for 
types of master files used for the PHS Act [(i.e., biological products)] has generally tracked its 
approach to the types of DMFs (e.g., Type II, Type III) used for products regulated under the 
[FDCA]”). Type III DMFs include information such as the packaging materials’ intended use, 
components, composition, and controls for release, as well as the names of suppliers or fabricators 
of the components and their acceptance specifications. The 8 DMFs supporting STN 125742 were 
for glass vials and stoppers.  
8 Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public 
that describe the agency’s interpretation of or policy on a regulatory issue. 21 C.F.R. § 10.115(b). 
Guidances that are available as drafts on FDA’s website are available for public comment and later 
consideration by the agency of those comments before issuing an updated draft or a final guidance. 
See 21 C.F.R. § 10.115(g). 
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40. 
The 8 DMFs identified by ALFOI were maintained by FDA’s Center for Drug 
Evaluation and Research (“CDER”). ALFOI contacted CDER’s Division of Information 
Disclosure Policy (“DIDP”) to request DIDP’s assistance in retrieving the DMFs; all but one DMF 
was in paper format and archived at an off-site records storage facility. 
41. 
After all 8 DMFs were retrieved, CDER processed them in response to Plaintiff’s 
FOIA Request. 
Other Records Incorporated by Reference 
42. 
ALFOI also reviewed the BLA records for references to records in the emergency 
use authorization (“EUA”) file for the COVID-19 vaccine for individuals 16 years of age and 
older, which had been authorized prior to Pfizer’s submission of its BLA. EUA records are tracked 
in BIRAMS, and the IRA number associated with Pfizer’s COVID vaccine EUA file is 27034. It 
is standard practice for sponsors and FDA reviewers to refer to EUA records by IRA number. So, 
ALFOI searched for “27034” across the 103 BLA submissions and 146 FDA-generated records. 
That search resulted in 44 references, and ALFOI determined that they did not incorporate by 
reference any EUA-file records. Instead, the references were “mis-hits” (e.g., reflecting a portion 
of a clinical trial participant identification number), were for background or informational purposes 
only (i.e., they did not incorporate by reference a specific EUA record), or were duplicative of 
BLA submissions or IND submissions already processed in response to Plaintiff’s FOIA Request. 
43. 
During the course of its review of BLA records, ALFOI also identified that Pfizer 
had made a submission called a summary monthly safety report (“SMSR”) to the BLA that Pfizer 
called SMSR #10. Accordingly, ALFOI searched for and located SMSRs #1-9 and accompanying 
submission records (which were all in IND 19736), and FDA-generated records reflecting review 
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14 
of these SMSRs (found through CBERConnect) and processed them in response to Plaintiff’s 
FOIA Request. 
Biological Product Deviation Reports
44. 
ALFOI also searched for Biological Product Deviation Reports (“BPDRs”). 
BPDRs are reports by manufacturers of changes or unexpected events that occur during 
manufacturing that have the potential to affect the safety, purity, or potency of the biological 
product. Such reporting typically includes any event in the manufacturer’s facility involving a 
distributed biological product that represents a deviation from current good manufacturing 
practice, applicable regulations, applicable standards, or established specifications; or an 
unexpected or unforeseeable event.     
45. 
BPDRs are accessible through the CBER Error and Accident Reporting System 
(“CEARS”), which is utilized by CBER’s Program Surveillance Branch in its Division of 
Inspections and Surveillance in the Office of Compliance and Biologics Quality (“OCBQ”). 
ALFOI contacted the Program Surveillance Branch asking for “any BPDRs submitted for [the] 
Pfizer Comirnaty covid vaccine” through October 27, 2021. The Branch did not locate any BPDRs 
during that time period for the licensed Comirnaty vaccine.     
Lot Release Materials and Lot Distribution Reports 
46. 
ALFOI also searched for submissions related to lot release. Lot release is a system 
that permits FDA to verify product quality through protocol review and sample testing of 
biological products. FDA regulations provide that “[n]o lot of any licensed product shall be 
released by the manufacturer prior to the completion of tests for conformity with standards 
applicable to such product.” 21 C.F.R. § 610.1. FDA works with sponsors during the BLA review 
process to develop lot release protocols (i.e., specific quality testing, agreed upon by FDA) to be 
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used on each lot of products before distribution. In accordance with 21 C.F.R. § 610.2(a), CBER 
may require manufacturers to submit for CBER review and confirmatory testing samples of any 
lot of a licensed product, together with the protocols showing results of applicable tests when 
deemed necessary for the safety, purity, or potency of the product. Following CBER review, FDA 
will notify the sponsor whether the lot is “released.” See 21 C.F.R. § 610.2(a).  
47. 
Lot release protocols are accessible to agency employees in CBERConnect. ALFOI 
searched CBERConnect for lot release protocols associated with STN 125742 and located 11 lot 
release protocols submitted by Pfizer before the licensure date of August 23, 2021 and 2 lot release 
protocols submitted between licensure and October 27, 2021. 
48. 
ALFOI processed the 13 lot release protocols in response to Plaintiff’s FOIA 
Request. 
49. 
With respect to the lot release letters, ALFOI was aware that 7 responsive lot release 
letters had been publicly posted to FDA’s website as previously released in response to prior FOIA 
requests. 
50. 
ALFOI also contacted CBER’s Product Release Branch in its Division of 
Manufacturing and Product Quality asking for “any associated Lot Release Letters for the product 
Comirnaty” through October 27, 2021. The Product Release Branch provided ALFOI 2 letters 
within the relevant date range (i.e., before October 27, 2021), and ALFOI determined that they, 
along with the 7 aforementioned letters, were already accessible on FDA’s website at 
https://www.fda.gov/media/162868/download?attachment 
(file 
name: 
Pfizer-BioNTech 
Comirnaty STN 125742 COVID-19 Vaccine Lot Notifications (2021).pdf). Accordingly, ALFOI 
did not re-process these records, but ALFOI alerted Plaintiff’s counsel to their availability on 
FDA’s website in the production cover letter dated November 1, 2023, and provided courtesy 
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16 
copies of them in the November 1, 2023 production. A true and correct copy of ALFOI’s 
November 1, 2023 production letter is attached as Exhibit 1. 
51. 
To locate the records reflecting CBER’s testing of lots for the original Comirnaty 
vaccine licensure, ALFOI contacted CBER’s Division of Biological Standards and Quality Control 
asking for “any possible CBER Testing records related to the product Comirnaty (STN 125742)[;] 
. . . these would be records where CBER conducted the tests on the product.” The Division’s 
Quality Assurance Branch responded by providing ALFOI with 5 testing review memos for lots 
within the relevant date range (i.e., before October 27, 2021). ALFOI determined that 2 of the 5 
records were duplicative of records it had identified in its search for FDA-generated records related 
to the BLA, and it processed the other 3 testing review memos in response to Plaintiff’s FOIA 
Request.  
52. 
Finally, ALFOI determined that it did not need to search for lot distribution reports 
submitted by Pfizer related to STN 125742, because an FDA-generated record related to the BLA 
(that ALFOI processed in response to Plaintiff’s FOIA Request) reflected that Pfizer had 
requested, and FDA had approved, a waiver allowing Pfizer’s first report to be filed in January 
2022 (after the October 27, 2021 search cut-off date). Still, to ensure its interpretation of the FDA-
generated record was accurate, ALFOI shared the FDA-generated record with CBER’s Division 
of Pharmacovigilance in its Office of Biostatistics and Pharmacovigilance, who confirmed it “[did] 
not have a lot distribution reports [sic] submitted for STN 125742 prior to 10/27/2021.” Lot 
distribution reports reflect information about the quantity of product distributed under a license in 
the timeframe covered by the report, and waivers are governed by 21 C.F.R. § 600.81. 
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Pursuant to 28 U.S.C. § 1746, I declare under the penalty of perjury that the foregoing is 
true and correct. 
Executed on October 16, 2024. 
 
 
 
 
 
 
_________________________________ 
 
 
 
 
 
Suzann Burk 
 
 
 
 
 
Director 
Division of Disclosure and Oversight Management,  
Office of Communication, Outreach and  
Development  
 
 
 
 
 
 
Center for Biologics Evaluation and Research  
 
 
 
 
 
 
Food and Drug Administration 
 
 
 
 
 
 
U.S. Department of Health and Human Resources 
Suzann H. Burk -
S
Digitally signed by Suzann H. 
Burk -S 
Date: 2024.10.16 16:12:46 -04'00'
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Exhibit 1 
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