Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 1 of 8 PageID 188

IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASFORT WORTH DIVISIONPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCYandCivil Action No. 4:22-cv-915-P

PATRICK AND STEPHANIE DE GARAY,Plaintiffs,v.

U.S. FOOD AND DRUG
ADMINISTRATION,Defendant.
INITIAL JOINT STATUS REPORTPlaintiffs Public Health and Medical Professionals for Transparency (“PHMPT”) andPatrick and Stephanie de Garay, and Defendant United States Food and Drug Administration(“FDA”) submit the following joint status report pursuant to this Court’s Order dated February 7,2023 (the “Order”). See Doc. 21.
1.

This case involves Plaintiffs’ Freedom of Information Act (“FOIA”) requests toFDA which sought expedited processing for: (1) “[a]ll data and information for the Moderna
Vaccine enumerated in 21 C.F.R. § 601.51(e), with the exception of publicly available reports on
the Vaccine Events Reporting System [‘VAERS’]”; and (2) “[a]ll data and information for the 1215-Year-Old Pfizer Vaccine enumerated in 21 C.F.R § 601.51(e), with the exception of [publicVAERS reports.]”2.

Since filing the initial Joint Scheduling Report on January 27, 2023, the parties havecontinued to confer and hereby update the Court as to the status of negotiations:
1Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 2 of 8 PageID 189

a. FDA’s position: This is the parties’ first joint status report. As explained in theJoint Scheduling Report, see Doc. 20, FDA agreed to make efforts to prepare materials forPlaintiffs to assist the parties’ future discussions regarding the scope of Plaintiffs’ FOIA requests
and potential production schedules. On February 6, 2023, Defendant provided Plaintiffs with acomprehensive index of listings and page counts for Moderna’s complete Biologic License
Application (“BLA”) for Spikevax, comprised of Moderna’s original BLA and the subsequent
amendments leading up to licensure for the vaccine. Defendant estimates that the complete BLA
records for Spikevax total over 4 million pages. On February 8, 2023, Defendant provided
Plaintiffs with a similar comprehensive index for Pfizer-BioNTech’s complete supplemental BLA(“sBLA”) for the ages 12-to-15 indication for the Comirnaty vaccine, comprised of the originalsBLA and subsequent amendments leading up to approval for the indication. Defendant estimatesthat the complete sBLA records total nearly 0.5 million pages. On the afternoon of February 17,2023 (the day this filing was due), Plaintiffs emailed Defendant, stating that they propose aproduction rate of 55,000 pages per month.

The parties have not engaged in substantive

negotiations about potential production timelines or the portions of BLA/sBLA records of greatest
priority to Plaintiffs. Given the size and complexity of Plaintiffs’ requests and the BLA and sBLA
records (many of which may be responsive to Plaintiffs’ FOIA requests), and the fact that
Defendant would like to provide a proposal for a production rate to Plaintiffs, Defendant believes
further review and discussion of the provided BLA/sBLA materials is important and that theparties should make a good-faith effort to negotiate a production schedule amongst themselves in
the first instance. Moreover, Plaintiffs’ Complaint requests that production in this case begin after
the completion of production in another FOIA case in this Court. See Doc. 20 at 5 (describing
Pub. Health & Med. Pros. for Transparency v. Food & Drug Admin., No. 4:21-CV-1058-P, 2022

2

Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 3 of 8 PageID 190

WL 90237 (N.D. Tex. Jan. 6, 2022) (“PHMPT 1”)). The next joint status report in PHMPT 1 isdue on March 24, 2023. Defendant respectfully requests time to continue discussions, to include
providing Plaintiffs with a proposal for a production rate, and thus proposes filing a second jointstatus report about the status of negotiations on March 31, 2023, at which time the parties will havethe benefit of the status update in PHMPT 1.
b. Plaintiffs’ position: Plaintiffs’ and Defendant’s counsel have had four meet andconfers and have exchanged numerous emails over the past three months.
Scope of the request: Plaintiffs have informed Defendants, after receipt and review ofthe indices for Moderna’s BLA and Pfizer’s supplemental BLA, that they are not willing to waive
any documents that are responsive to the request. Until all the documents are produced, our clientscannot do a proper analysis, as noted in declarations by independent scientists in PHMPT 1. 1Timing and rate of production: Plaintiffs proposed in its October 11, 2022 complaint that
FDA continue to produce the requested Moderna biologic product file (“BPF”) and the Pfizer 1215 YO BPF at the rate of 55,000 pages a month starting after the production in PHMPT 1 ended.
That proposal, however, was based on two incorrect assumptions. First, based on agency
representations, Plaintiffs thought the production in PHMPT 1 was a month or two away fromcompletion at the time of filing. Second, it assumed there were going to be around 450,000 pages
in the Moderna BPF, similar to what it understood was the page count in the Pfizer BPF (16 yearsand older), and far less than 450,000 pages in the 12 to 15-year-old Pfizer BPF.

As one example, and as published in BMJ, numerous scientists are awaiting a key analysis dataset known as ADSL
(Subject-Level Analysis Data) that has not yet been produced. Pfizer’s own Analysis Data Reviewer Guide states that,“This [ADSL] dataset supported the creation of all other analysis datasets” and that “ADSL.sas must be run first before
any other ADaM datasets; all other programs are depending on ADSL output.” https://www.bmj.com/content/378/bmj.o1731/rr-1. Without this file, the document described above, and all other missing documents,
PHMPT cannot conduct the necessary analyses. As Peter Doshi and Linda Wastila said: “This means that replicatingeven the most basic safety and efficacy analyses that Pfizer presented in its reports is still not directly possible.” Id.
13

Case 4:22-cv-00915-P Document 22 Filed 02/17/23Page 4 of 8 PageID 191

After this action was filed, Plaintiffs began to inquire with FDA’s counsel as to when theproduction in PHMPT 1 would end. However, the agency will not disclose – in either this action
or in PHMPT 1 –when the production in PHMPT 1 will end. Plaintiffs therefore explained thatthey could not wait for some unknown date for the production in this matter to begin. Troublingly,
it is now plain that there are far more pages than we and the Court were led to believe in PHMPT
1. The FDA repeatedly indicated there were approximately 400,000-450,000 pages, 2 and the Court

2The FDA, in PHMPT 1, made numerous representations to PHMPT and to the Court concerning the volume ofresponsive documents. These representations include (and reference the Dkt. numbers from PHMPT 1):

1.
November 5, 2021 (Dkt. 18): “FDA has conducted an initial assessment of the number of records responsive
to Plaintiff’s FOIA request and has determined that more than 329,000 pages of documentary records, plus otherfiles…”
2.
November 15, 2021 (Dkt. 20): “Plaintiff takes issue with the amount of time it will take to process 329,000
pages at a rate of 500 pages per month…”
3.
December 6, 2021 (Dkt. 22): “FDA determined that the original Comirnaty BLA requested by Plaintiff
comprises more than 329,000 pages of records. In addition to those 329,000 pages, the original Comirnaty BLA
includes data files in a format similar to a spreadsheet for which a page count cannot readily be determined. FDA
assessed that Sections 5.2 and 5.3 comprise more than 321,000 pages of records (plus additional data files) …”
4.
December 6, 2021 (Dkt. 23): “ALFOI … determined that the original Comirnaty BLA includes over
329,000 pages of records for which pages could feasibly be counted. In addition to those 329,000 pages, the original
Comirnaty BLA includes additional data files in a format similar to a spreadsheet for which a page count cannot
readily be generated. There are 126 of these data files in Section 5 of the original Comirnaty BLA alone, andthere may be more in other sections. For example, if BLA supplements, amendments and product correspondence
are included, the scope of Plaintiff’s Request could expand by approximately 39,000 pages beyond FDA’s initial
estimate. Similarly, if the investigational new drug applications were included, the scope of Plaintiff’s Request would
likely increase by tens of thousands of additional pages. FDA assessed that Sections 5.2 and 5.3 comprise more than
321,000 pages of records (plus additional data files) …”
5.
December 13, 2021 (Dkt. 29): “The processing schedule demanded by Plaintiff—that FDA process
approximately 329,000 record [sic] in a matter of mere months … Plaintiff’s suggestion that FDA may meet its
extraordinary demand to process in excess of 300,000 pages of responsive documents in a matter of mere months
by “simply” re-assigning its personnel to is likewise misguided.”6.
December 14, 2021 (Scheduling Conference): “The point is that where we’re standing right now, at this very
early juncture in this FOIA case, the FDA simply has not had an adequate opportunity to get its arms aroundthese 400,000 documents at issue here. … At this moment, however, it just has not had sufficient time to get its arms
around the entire corpus of the 400,000 documents at issue, especially to make a firm commitment as to how quickly
it can get through that. … They’re certainly entitled to the full 400,000 documents under the scope -- you know,
under the FOIA statute, the FDA doesn't dispute that. But it is a choice that the plaintiffs are making to ask -- I should
clarify, that’s somewhere in the ballpark of 400,000, once we added in the two additional categories ofdocuments that I think plaintiffs are saying, if I understand them correctly, they want … FDA to expand its
construction of its request to encompass. That will bring in an additional several tens of thousands of documents
and pushes that somewhere close to around 400,000. … It just can’t be the case that you asked for 400,000
documents and get them overnight, which is, essentially, what they are asking for.”In addition, PHMPT echoed this volume estimate multiple times and the agency did not object to or correct those
representations. See, e.g., Dkt. Nos. 26, 31, 44, and the December 14, 2021.

4

Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 5 of 8 PageID 192

said as much at the December 14, 2021 PHMPT 1 conference, 3 but we have received over 751,987
pages to date and there is apparently far more.
Again, Plaintiffs require production of the materials from PHMPT 1 immediately in order
to conduct crucial analysis. Until that material is provided in full, scientists cannot properly
analyze the data therein. For example, the available data reflects there were 20 deaths among thosereceiving the vaccine and 14 among those receiving the placebo, 4 but until all the data is received,
this cannot be confirmed. Similarly, Plaintiffs require the materials from this case immediately
and, thus, Plaintiffs requested that the agency agree to begin producing documents at the rate of
55,000 pages per month beginning in two months.
Immediate need for the documents: There is an acute need for transparency concerningthese products. For one, there are obvious efficacy issues with these products, and after the FDA
has widely and voraciously promoted these products, including on its website 5 and promotional
videos, 6 it is now conflicted from admitting it may have been mistaken. By promoting these shots,
it has hopelessly conflicted itself from later admitting these products have serious issues, including
with efficacy. There are now numerous datasets evidencing negative efficacy of these products. A
recent study of approximately 50,000 workers in the Cleveland Clinic health care system shows,very clearly, that with each dose of COVID-19 vaccine, one’s risk of contracting SARS-CoV-2
increases steadily. 7“…[Y]ou can even see this in tort litigation, 400,000 documents in modern-day litigation is really not a lot …
Certainly in the litigation context, 400,000 documents just isn’t a lot of documents in this day and age.”3

4

See https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf.

5

See https://web.archive.org/web/20230216052947/https://www.fda.gov/.

6

See https://youtu.be/5kL9PIyru1w.

Nabin K. Shrestha, et al., Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine, Medrxiv(Dec. 19, 2022), https://www.medrxiv.org/content/10.1101/2022.12.17.22283625v1.full.pdf?utm_source=substack&utm _medium=email.
75

Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 6 of 8 PageID 193

With regard to the Pfizer documents submitted to license the vaccine for 12- to 15-yearolds, Plaintiffs Stephanie and Patrick de Garay’s daughter is reason alone to demand transparency.
Maddie de Garay was one of only 1,131 children in the Pfizer Covid-19 vaccine clinical trial forthis age group. She was entirely healthy before entering the trial but, after her second shot,
immediately required emergency medical attention and developed a cascade of medical issues thatleft her in a wheelchair and dependent upon a feeding tube to this day. Yet, Pfizer reported her
reaction to FDA as “functional abdominal pain.” Despite providing all of Maddie’s medical
records to the FDA, and numerous follow-ups with them including from undersigned counsel, 8 theFDA’s only response was to tell her parents to file a VAERS report. 9 The de Garay family andPHMPT therefore believe it is a public health imperative that the clinical trial documents submittedby Pfizer to the FDA for this age group be released forthwith.
There are similar acute reasons for transparency regarding Moderna’s data. Over the lastyear and a half, the over 20 studies at the core of CDC’s claims these products are safe relied upon
data collected in the CDC’s v-safe safety system. This is its premier Covid-19 vaccine safetysystem that included 10 million people who completed weekly smartphone-based surveys during
the six weeks after each dose of Covid-19 vaccine and then at 3-, 6-, and 12-months post-vaccine
enabling the agency to “rapidly” study the safety of Covid-19 vaccines. Yet, in those studies, CDC
only released the rate of Americans who reported needing medical care during the first week after
receiving the vaccine even though it was collecting this information beyond the first week. AfterSee https://www.sirillp.com/wp-content/uploads/2022/03/Attachment-1-Oct.-22-2022-Ltr-to-Fed.-Health-Agencies-a4c120ce47dcfe008aa6d9ee38b682e4.pdf; https://www.sirillp.com/wp-content/uploads/2022/03/Attachment-2-1025-2021-VRBPAC-Letter_FINAL-3ba813862ca35aaea42a9c5dcf2480a0.pdf; https://www.sirillp.com/wp-content/uploads/2022/03/Attachment-3-Jan-3-2022-Dr.-Peter-Mark-Letter_2022_01_03-41fe80ff1853909f2e9b5e329a55934e.pdf.
8

https://www.sirillp.com/wp-content/uploads/2022/03/Paul-Richards-email-response_2022_02_26_Redacted33b881e4534f7fc2af8e5872c01984ea.pdf.
96Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 7 of 8 PageID 194

a year-and-a-half legal battle to get this data, it was finally obtained and showed that 7.7% of thosegetting Covid-19 vaccines reported seeking medical care following vaccination, and these people
disproportionately reported receiving the Moderna vaccine.
The fact that this medical product may cause harm is not surprising. What is deeply
concerning is that the reality of harm reported from this product was hidden for over a year and ahalf while the public was provided only the first week of data which gave, at best, a distorted view.
The data needs to be evaluated by neutral scientists who have never promoted these products tothe American people, such that careers and reputation would be shattered by now admitting theopposite. This is the precise reason Plaintiffs now invoke their rights to obtain these documents ina timely manner.
Plaintiffs’ proposal: The rate of 55,000 per month was proposed when it was understoodthat production for PHMPT 1 was close to being completed. It was also proposed with theunderstanding that there would be a similar 450,000-page production for Moderna and a far smaller
production for the 12- to 15-year-old Pfizer trial. Given that the end date for PHMPT 1 is likely
far away, and that FDA is saying there are likely millions of pages in the Moderna trial and 0.5
million pages in the Pfizer 12- to 15-year-old trial, Plaintiffs respectfully request that the Court
order a production rate that is no less than 55,000 pages per month and that production in thismatter begin on April 17, 2023. 10 Alternatively, Plaintiffs’ request that the Court order Plaintiffs
to file their opening brief as to the timing for producing responsive records by March 8, 2023,
FDA to file its opposition by March 22, 2023, and Plaintiffs to file their reply by March 29, 2023.
Respectfully submitted,As FDA has previously explained: “If the parties are unable to agree upon a schedule, courts typically enter aprocessing schedule after considering arguments for each party’s proposed schedule that were presented in a status
report or at a scheduling conference.” (Dkt. 20 in PHMPT 1).
107

Case 4:22-cv-00915-P Document 22 Filed 02/17/23

Page 8 of 8 PageID 195

LEIGHA SIMONTON
UNITED STATES ATTORNEY/s/ Clay R. Mahaffey
CLAY R. MAHAFFEY
Assistant United States Attorney
Wyoming State Bar No. 6-3355
801 Cherry Street, Suite 1700
Fort Worth, Texas 76102
Telephone: (817) 872-9127
Email: clay.mahaffey@usdoj.gov
Attorneys for Defendant/s/ Aaron Siri
Aaron Siri (pro hac vice)
Elizabeth A. Brehm (pro hac vice)
Colin Farnsworth (pro hac vice)
745 Fifth Ave, Suite 500
New York, NY 10151
Tel: (212) 532-1091
aaron@sirillp.com
ebrehm@sirillp.com
cfarnsworth@sirillp.com
Walker D. Moller (Texas Bar No. 24092851)
501 Congress Avenue, Suite 150 – #343
Austin, TX 78701
Tel : (512) 265-5622
wmoller@sirillp.com
Attorneys for Plaintiffs

8