Case 4:22-cv-00915-P Document 1 Filed 10/11/22

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UNITED STATES DISTRICT COURTNORTHERN DISTRICT OF TEXASPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY,
and
Civil Action No.4:22-cv-915________PATRICK AND STEPHANIE DE GARAY,
Plaintiffs,-againstFOOD AND DRUG ADMINISTRATION,
Defendant.

COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
Plaintiffs, as for their Complaint regarding Freedom of Information Act requests against
the above-captioned Defendant, allege as follows:
INTRODUCTION
1.

On January 31, 2022, the Food and Drug Administration (“FDA”) approved theModerna COVID-19 Vaccine, marketed as Spikevax (the “Moderna Vaccine”) for individuals 18
years of age and older. 1
2.

On July 8, 2022, FDA approved the Pfizer-BioNTech COVID-19 Vaccine,

marketed as Comirnaty, for individuals 12 through 15 years of age (the “12-15-Year-Old Pfizer
Vaccine”). 2
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
12

https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

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For the Moderna Vaccine, FDA asserts that “Spikevax meets the FDA’s highstandard for safety, effectiveness, and manufacturing quality required of any vaccine approved foruse in the United States.” 3
4.

Similarly, for the 12-15-Year-Old Pfizer Vaccine, FDA asserts its “approvalfollows a rigorous analysis and evaluation of the safety and effectiveness data conducted by
FDA.” 4
5.

Despite FDA’s assertions, numerous public health officials, media outlets,

journalists, scientists, politicians, public figures, and others with large social or media platforms
have publicly raised questions regarding the sufficiency of the data and information, the adequacyof the review, and the appropriateness of the analyses relied upon by FDA to license the Moderna
Vaccine and the 12-15-Year-Old Pfizer Vaccine (the “COVID-19 Vaccines”).
6.

Plaintiff Public Health and Medical Professionals for Transparency (“PHMPT”) isan organization made up of public health professionals, medical professionals, scientists, andjournalists. PHMPT exists for the sole purpose of disseminating to the public the data andinformation in the biological product files of each of the COVID-19 vaccines.
7.

In furtherance of its mission, and in an effort to ensure that FDA acts in furtheranceof its commitment to transparency, 5 PHMPT previously sought to obtain the data and information
relied upon to license Comirnaty, Pfizer’s COVID-19 vaccine for individuals 16 years of age andolder. As a result of an Order from this Court, FDA is currently producing that data which PHMPT
makes available to the public as it is produced.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
34https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

5

https://www.fda.gov/about-fda/transparency.

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PHMPT now seeks to obtain additional data and information relied upon by FDA

to license the COVID-19 Vaccines. The importance of releasing this information to the public isalso recognized under federal regulation which provides: “After a license has been issued, thefollowing 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 andinformation. (2) A protocol for a test or study . . . .” 21 C.F.R. § 601.51(e).
9.

Upon licensure for each of the COVID-19 Vaccines, PHMPT therefore issued two

requests to FDA pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended)(“FOIA”) for “[a]ll data and information for [the COVID-19 Vaccines] enumerated in 21 C.F.R.
§ 601.51(e)[6] with the exception of publicly available reports on the Vaccine Adverse Events
Reporting System.” 7
10.

A near identical request for the 12-15-Year-Old Pfizer Vaccine was later submitted

to FDA by Patrick and Stephanie de Garay (the “de Garays”), parents of minor M.D., who suffered
substantial injuries from a serious and ongoing adverse reaction to the 12-15-Year-Old Pfizer
Vaccine during her participation in Pfizer’s clinical trial for 12- to 15-year-olds. 8
11.

The public and the medical and scientific community have a substantial interest inreviewing the data and information underlying FDA’s approval of the COVID-19 Vaccines.

21 C.F.R. § 601.51(e) provides that, after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”6

For the avoidance of doubt, the FOIA Request includes, but is not limited to, all of the data and information in the
biological product file, as defined in 21 C.F.R. § 601.51(a), for [the COVID-19 Vaccines], enumerated in 21 C.F.R. §601.51(e), with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.

7

https://www.foxnews.com/media/ohio-woman-daughter-covid-vaccine-reaction-wheelchair; see also
https://thehighwire.com/videos/rigged-maddies-story/.
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Releasing this data should also confirm FDA’s conclusion that the COVID-19

Vaccines are safe and effective and, thus, further the FDA’s mission to increase confidence in the
COVID-19 Vaccines and their uptake.
13.

The public’s need for this information is urgent given the fact that the COVID-19

Vaccines have been, or continue to be, mandated for large segments of the American public.
Moreover, both public and private policy makers continue to adjust their vaccine policies basedon the information that is publicly available and publicized by influential participants on both sidesof the ongoing public debate regarding the COVID-19 Vaccines’ safety and effectiveness.
14.

With legislators, policy makers, and parents deciding how best to protect

Americans of all ages during the upcoming winter season and academic school year, there is no
more urgent or appropriate time for the immediate disclosure of the COVID-19 Vaccines’
biological product files (“BLA files”). The public’s value in the release of the BLA files would
be significantly diminished if the disclosure were delayed because millions of Americans, and theirpolicy makers, will be making these medical and policy decisions in the coming months. If thedisclosure of the BLA files is delayed, many of these Americans, and many on behalf of theirchildren, will be forced to make irreversible medical decisions before the independent scientificcommunity and journalists have had time to review and report upon the basis for FDA’s licensureof the COVID-19 Vaccines.
15.

In an effort to disseminate the requested information to the public as expeditiously

as possible, given the time sensitive nature of the issue, both PHMPT and the de Garays(collectively, the “Plaintiffs”) requested expedited processing of the FOIA requests pursuant to 5
U.S.C. § 552(a)(6)(E)(v)(II).

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On March 7, 2022, FDA denied PHMPT’s request for expedited processing of its

FOIA request regarding the Moderna Vaccine. PHMPT appealed the decision on June 1, 2022
and FDA still has not resolved that appeal.
17.

On August 15, 2022, FDA denied PHMPT’s request for expedited processing for

its FOIA request regarding the 12-15-Year-Old Pfizer Vaccine.
18.

Similarly, on August 29, 2022, FDA denied the de Garays’ request for expedited

processing of their FOIA request regarding the 12-15-Year-Old Pfizer Vaccine.
19.

The Plaintiffs bring this action to challenge FDA’s determinations and to seek anorder compelling FDA to produce responsive records on an expedited basis.
PARTIES
20.

Public Health and Medical Professionals for Transparency is a not-for-profit

organization with an office located at 1090 Texan Trail, Suite 534, Grapevine, Texas, 76051 in
Tarrant County, Texas.
21.

To date, PHMPT has approximately 5,865 members, including medical and publichealth professionals, such as professors and researchers in medical-related disciplines from Yale
School of Public Health, UCLA David Geffen School of Medicine, University of Maryland Schoolof Pharmacy, The Warren Alpert Medical School of Brown University, Oregon Health & Science
University, University of California San Francisco, David Geffen School of Medicine at UCLA,
University of Leicester, University of Southern Denmark, The University of Sydney, Universityof Oxford, Institute for Scientific Freedom, University of Toronto, University of Auckland,
University of Muenster, and Deutenomics Science Institute, as well as other universities andjournalists.

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Patrick and Stephanie de Garay reside in Clermont County, Ohio and are the parentsof 14-year-old M.D., who has suffered and continues to suffer severe adverse events following
vaccination in Pfizer’s clinical trial for 12- to 15-year-olds.
23.

FDA is an agency within the Executive Branch of the United States Government,

organized within the Department of Health and Human Services. FDA is an agency within themeaning of 5 U.S.C. § 552(f).
JURISDICTION AND VENUE
24.

This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B)and 28 U.S.C. § 1331. Venue is proper within this District pursuant to 5 U.S.C. § 552(a)(4)(B)and 28 U.S.C. § 1391.
FACTS
I.

FDA Licensure of COVID-19 Vaccines
25.

FDA may only license vaccines that have been proven to be “safe and effective,”see, e.g., 21 U.S.C. § 393, and FDA makes this determination based on, inter alia, clinical trial
reports provided by the sponsor which must be sufficient to demonstrate the product is both “safe”
and “effective.” 9 21 C.F.R. 601.2(a).
26.

In order to demonstrate that they are safe and effective, Pfizer and Moderna

conducted clinical trials for each of their COVID-19 vaccines and reported results of those trials,
as well as other studies, to the FDA as part of their products’ BLA files.

FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download; see also
https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved; https://www.fda.gov/about-fda/what-wedo.
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A. FDA Licensure of Pfizer’s Comirnaty Vaccine and PHMPT’s Related Case27.

Upon licensure of Pfizer’s first COVID-19 vaccine, Comirnaty, for use inindividuals 18 years and older, PHMPT submitted a FOIA request to obtain the data within the
product’s BLA file. Like in the instant action, PHMPT’s expedited processing request was denied
and PHMPT commenced a litigation, Public Health and Medical Professionals for Transparency
v. Food and Drug Administration, 4:21-cv-01058-P, in this Court to obtain the documents from
FDA.
28.

On January 6, 2022, this Court ordered FDA to produce the responsive documentsfrom Comirnaty’s BLA file at a rate of 55,000 pages every 30 days until production is complete.
The parties subsequently agreed to, and the Court ordered, slight modifications of the production
schedule; however, the parties maintained the rate of 55,000 pages every 30 days for a majority ofthe production.

That BLA file is currently being produced and, to date, has resulted inapproximately 470,614 pages of documents being made public.
29.

The public has shown great interest in these documents. To date, and as explained

further below, there have been approximately three-quarters of a million downloads of the
documents and data released and PHMPT’s website itself has drawn over 2.7 million visitors and4.5 million views in the last 12 months.
30.

Once the entirety of the BLA file has been produced, independent experts andresearchers will be able to conduct their own analyses about the efficacy of the vaccine.
B. FDA’s Licensure of Pfizer’s 12-15-Year-Old Vaccine and Moderna’s Vaccine
31.

Following the start of the clinical trials for Pfizer’s vaccine for persons 16 years ofage and older, Pfizer conducted clinical trials in children ages 12 to 15 years old.

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The Plaintiffs’ daughter, M.D., was one of the participants in Pfizer’s clinical trials

for the 12-15-Year-Old Pfizer Vaccine. 10 In fact, she was one of only approximately 1,000
children in this age range who were injected with the investigational vaccine. Within 24-hours ofreceiving the second dose of the vaccine during the clinical trial, M.D. experienced a serious
adverse reaction to the vaccine, including severe pain throughout her body and the feeling that her“heart was being ripped out through her neck,” and she presented to the emergency room. 11 M.D.
was subsequently admitted to the hospital and later discharged with the diagnosis that her
symptoms were the result of adverse reaction to the vaccine. 12 M.D.’s health continued to rapidly
decline and, despite the de Garays’ thorough documentation, reporting, and outreach regarding
their daughter’s sudden onset symptoms – which ultimately necessitated her continued use of afeeding tube and wheelchair – the de Garays received no attention from Pfizer or the FDA. 13 In
Pfizer’s data presented to the FDA in its application for an EUA, M.D.’s severe, systemic, andongoing adverse reaction to the 12-15-Year-Old Pfizer Vaccine was categorized as “functional
abdominal pain.” 1433.

Notwithstanding the de Garays’ reporting of their daughter’s wide range of severe

symptoms, Pfizer’s inaccurate and misleading characterization thereof, and the safety alarms that
this should have been ringing, FDA granted the vaccine EUA and subsequently licensed the useof the 12-15-Year-Old Pfizer Vaccine on July 8, 2022. 15

10

See Patrick de Garay’s Declaration (Exhibit 7 at pages 9-10.)11https://thehighwire.com/videos/rigged-maddies-story/ (see video at 6:44-8:20)

12

Id.

13

See generally id.

14

Id. at 1:04:40

15

See https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

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34.

The Moderna Vaccine was likewise licensed by the FDA on January 31, 2022. 16

35.

The Code of Federal Regulations expressly provides that “[a]fter 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 andeffectiveness data and information . . .” 21 C.F.R. § 601.51(e) (emphasis added).
36.

There is an ongoing, national public debate regarding the adequacy of the data andinformation, and analyses of same, relied upon by FDA to license the COVID-19 Vaccines.
37.

On the one hand, there are numerous public health officials, media outlets,

journalists, scientists, politicians, public figures, and others with large social or media platforms
that have declared that the data and information underlying the licensure of the Moderna Vaccine
is more than sufficient for licensure.
38.

For example, in a press release issued on January 31, 2022, then-acting FDA

Commissioner Janet Woodcock stated,
The public can be assured that Spikevax [the Moderna Vaccine]meets the FDA’s high standards for safety, effectiveness, andmanufacturing quality required of any vaccine approved for use in
the United States. While hundreds of millions of doses of Moderna
COVID-19 Vaccine have been administered to individuals underemergency use authorization, we understand that for someindividuals, FDA approval of this vaccine may instill additional
confidence in making the decision to get vaccinated. 17Peter Marks, MD, PhD, the Director of FDA’s Center for Biologics Evaluation and Research,made similar remarks:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
16

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
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The FDA’s medical and scientific experts conducted a thoroughevaluation of the scientific data and information included in theapplication pertaining to the safety, effectiveness, andmanufacturing quality of Spikevax [the Moderna Vaccine]. This
includes the agency’s independent verification of analyses
submitted by the company, our own analyses of the data, along witha detailed assessment of the manufacturing processes, test methods
and manufacturing facilities. Safe and effective vaccines are ourbest defense against the COVID-19 pandemic, including currently
circulating variants. The public can be assured that this vaccine wasapproved in keeping with the FDA’s rigorous scientific standards. 18
39.

Even prior to FDA’s approval of the Moderna Vaccine, government officials,

public health authorities, and medical professionals repeatedly claimed that COVID-19 vaccines
were “safe and effective.” 1940.

For the 12-15-Year-Old Pfizer Vaccine, FDA asserts that its approval followed “arigorous analysis and evaluation of the safety and effectiveness data conducted by FDA” 20 and theCenter for Disease Control and Prevention (“CDC”) currently “recommends COVID-19 vaccines
for everyone 6 months and older and boosters for everyone 5 years and older.” Furthermore, CDC
states generally 21 that
COVID-19 vaccines have undergone – and will continue to undergo– the most intensive safety monitoring in the U.S. history. Evidence
from hundreds of millions of COVID-19 vaccines alreadyadministered in the United States, and billions of vaccines
administered globally, demonstrate that they are safe and effective.

18

Id.

See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html; see also
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccineshave
proventobesafe,
effective
andlife-saving.”);https://www.
doh.wa.gov/Emergencies/COVID19/Vaccine-Information/Safety-and-Effectiveness (“COVID-19 vaccines aresafe.”).
1920

https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

21

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html.

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On the other hand, numerous public health officials, media outlets, journalists,scientists, politicians, public figures, and others with large social or media platforms have publicly
raised questions regarding the sufficiency of the data and information, the adequacy of the review,and the appropriateness of the analyses relied upon to the license the COVID-19 Vaccines,
including a number of scientists and journalists who are members of PHMPT.
42.

For example, on June 1, 2021, a group of 27 clinicians, scientists, and patientadvocates, including PHMPT members Peter Doshi, PhD, Senior Editor for The BMJ and
Associate Professor of Pharmaceutical Health Services Research at the University of Maryland
School of Pharmacy, 22 and Peter A. McCullough, MD, former Professor of Medicine at Texas
A&M College of Medicine, filed a Citizen Petition 23 with FDA, stating that the available evidence
for licensure of the COVID-19 Vaccines “is simply not mature enough at this point to adequately
judge whether clinical benefits outweigh the risks in all populations.” 24 Separately, Dr. Doshi has
publicly questioned the lack of transparency regarding the vaccine approval process 25 which Peter
Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research, publicly
disputed. 26
43.

More recently, a paper published on June 23, 2022 and updated on September 9,2022 titled, Serious Adverse Events of Special Interest Following mRNA Vaccination in
Randomized Trials, states: “These study limitations all stem from the fact that the raw data from22

https://www.bmj.com/about-bmj/editorial-staff/peter-doshi.

23

https://www.regulations.gov/document/FDA-2021-P-0521-0001.

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/.
24

See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/;
https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-weneed-more-details-and-the-raw-data/; https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95effective-vaccines-lets-be-cautious-and-first-see-the-full-data/.
25

26

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/.

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COVID-19 vaccine clinical trials are not publicly available. Given the global public health
implications, there is an urgency to make all COVID-19 trial data public, particularly
regarding serious adverse events, without any further delay.” 27
44.

Numerous other recent papers have presented data that have called into serious

question the efficacy of these vaccines, including data that reflect issues which should have been
seen during the clinical trial if it had been conducted properly and the results fully reported to the
FDA:
a. An article in the New England Journal of Medicine discusses a study that included
887,193 children (273,157 vaccinated children) and showed that children who had
COVID-19 and were subsequently vaccinated were much more likely to get
reinfected than their peers who also had COVID-19 and were not vaccinated. 28
b. Data from the Dutch government evaluating mRNA vaccines found that “in the
period from March 15 to June 28, 2022, there was hardly any visible protective
effect of the COVID-19 basic vaccination series against hospital and ICU-intake.”
In fact, when researchers stratified the risks of hospitalization and intensive care bytime from the date of vaccination and by age, it was demonstrated that the risks
increase over time. 29
c. A study among adolescents in Brazil and Scotland analyzed vaccine effectivenessof two doses of Pfizer’s vaccine against symptomatic and severe COVID-19. The
27

Fraiman, J., et al., Serious adverse events of special interest following mRNA vaccination in randomized trials,
SSRN (June 23, 2022) https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239 (emphasis added).
28

See Lin, Dan-yu, et al., Letter to the Editor: Effects of Vaccination and Previous Infection on Omicron Infections inChildren, NEJM (Sept. 22, 2022) https://www.nejm.org/doi/full/10.1056/NEJMc2209371?query=featured_home.

See
https://www.rivm.nl/covid-19-vaccinatie/bescherming-coronavaccins-tegen-ziekenhuisopname/booster-enherhaalprik-bij-ouderen-nodig-om-bescherming-op-peil-te-brengen (Dutch version). https://www.rivm.nl/en/covid19-vaccination/vaccine-effectiveness-in-preventing-hospital-admissions/covid-19-booster-jab-and-repeatvaccination-needed-for-older-people-to-restore-protection (English version).
29

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study found waning vaccine protection against symptomatic COVID-19 from 27
days after the second dose. 30
d. A study published in the Lancet looking at effectiveness of Pfizer’s vaccine inchildren in Italy states: “Our estimates of the effectiveness of full vaccination
against SARS-CoV-2 infection are significantly lower than those reported in theclinical trial that led to the approval of BNT162b2 in children (90.7% in theapproval trial vs 29.4% in our study).” The study also states, “our estimates ofvaccine effectiveness against infection coincide with the estimate reported in the
USA in a previous study” and that “this decline could be due to immunity waning,as described in the adult population vaccinated with mRNA vaccines.” 31
e. A study printed in JAMA, which was conducted from December 2021 to February
2022 during Omicron variant predominance and included 121,952 tests from sites
across the United States, estimated vaccine effectiveness against symptomatic
infection among adolescents 12 to 15 years of age at 16.6% at two months after two
doses. The study concluded: “Among children and adolescents, estimated VE for
2 doses of [Pfizer’s vaccine] was modest and decreased rapidly.” 32
45.

Likewise, numerous recent papers have presented data of serious safety issues withthese vaccines, including data that reflect issues which should have been seen during the clinical30
See Florentino, P.T. et al., Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID19 among adolescents in Brazil and Scotland over time: a test-negative case-control study, Lancet Infect Dis. (Aug.
8, 2022) https://pubmed.ncbi.nlm.nih.gov/35952702/.
31
See Sacco, C., et al., Effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection and severe COVID-19 inchildren aged 5-11 years in Italy; a retrospective analysis of January-April, 2022, The Lancet (July 9, 2022)
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01185-0/fulltext.

See Fleming-Dutra, K., et al., Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARSC0V-2 Infection in Children and Adolescents During Omicron Predominance, AMA JAMA (June 14, 2022)
https://pubmed.ncbi.nlm.nih.gov/35560036/.
32

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trial if it had been conducted properly and the results fully reported to the FDA, including immune,
neurological and circulatory system disorders. For example, the following is a list of studies on
the adverse effects on the heart and circulatory system in children from the COVID-19 vaccine:a. A recent study in the American Heart Association journal, conducted between
December 2020 and December 2021, acknowledged that deaths had resulted frommyocarditis post-vaccination, identifying 345 people in England who had died ofmyocarditis after receiving a COVID-19 vaccine. 33
b. Another study in Tropical Medicine and Infectious Disease of 301 adolescents
found that 54 patients, or 17.94%, had abnormal electrocardiograms after
vaccination with Pfizer’s COVID-19 vaccine, resulting in one case of
myopericarditis, four cases of subclinical myocarditis, and two cases of
pericarditis. 34
c. A Kaiser Permanente study determined that the rate of myocarditis used by federal
health authorities was incorrect and that the actual rate was nearly double, at 1 in
4,800 children vaccinated, observing, “The true incidence of myopericarditis ismarkedly higher than the incidence reported to US advisory committees,” as thestudy had identified “approximately twice as many cases of myopericarditis
following COVID-19 mRNA vaccination.” 35

Patone, M., et al., Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by
Age and Sex, Circulation (Aug. 22, 2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9439633/.
33

34
Mansanguan, S., et al., Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents,
Tropical Med. & Infec. Dis. (Aug. 19, 2022), https://www.mdpi.com/2414-6366/7/8/196/htm.

Shariff, K.., et al., Risk of Myopericarditis following COVID-19 mRNA vaccination in a Large Integrated Health
System: A Comparison of Completeness and Timeliness of Two Methods, MedRxiv (Dec. 27, 2021),
https://www.medrxiv.org/content/10.1101/2021.12.21.21268209v1.full.pdf.
35

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d. A study from the Norwegian Institute of Public Health involving 23.1 million
Scandinavians ages 12 and up found that the risk of myocarditis after mRNA
vaccines was highest in males aged 16 to 24 after the second dose. 36
e. An analysis of 42 million people ages 13 and older by Oxford researchers foundhigher rates of vaccine-induced myocarditis than COVID-19-induced myocarditis
in males ages 16 to 39 after second and third doses of Pfizer’s COVID-19 vaccine
and after first and second doses of Moderna’s COVID-19 vaccine. 37
II.

Vaccine Mandates
46.

The public debate over the safety and effectiveness of the COVID-19 Vaccinesconcerns matters of current exigency to the American public because it has also led to invasive
policy decisions that affect the livelihoods of the American public. Over the objections of many,
Americans are still being mandated or otherwise pressured to take this product by the federal

Karlstad, O., et al., SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents,
JAMA Cardiology (Apr. 20, 2022), https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253.
36

37
Patone, M., et al., Risk of Myocarditis Following Sequential COVID-19 Vaccinations by Age and Sex, MedRxiv(Dec; 25, 2021), https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf+html.

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government, 38 local governments, 39 public and private employers, 40 universities, 41 schools,42 andvarious other institutions.43
47.

Furthermore, now that FDA has approved the 12-15-Year-Old Pfizer Vaccine, there

are many indications that states and school districts will begin mandating these vaccines forSee, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1; https://apnews.com/article/business-health-coronavirus-pandemic-coronavirus-vaccine-4cf7451267
919302de4a7b591508e80c; https://media.defense.gov/2021/Aug/25/2002838826/-1/-1/0/MEMORANDUM-FORMANDATORY-CORONAVIRUS-DISEASE-2019-VACCINATION-OF-DEPARTMENT-OF-DEFENSESERVICE-MEMBERS.PDF.
38

See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html; https://www1.nyc.
gov/site/doh/covid/covid-19-vaccines-keytonyc.page; https://news.yahoo.com/orleans-now-requires-proof-vaccina
tion-230433492.html?guccounter=1.
39

See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html; https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatory-for-all-employees/;
https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccines-workers-headquarters-79177220;
https://www.kpbs.org/news/2021/aug/17/encinitas-covid-19-vaccine-negative-test-employees/; https://www.cnbc.
com/2021/08/09/covid-vaccine-mandates-sweep-across-corporate-america-as-delta-surges.html;
https://www.
reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/; https://thehill.com/
policy/healthcare/569051-pfizers-full-approval-triggers-new-vaccine-mandates/; https://www.cvshealth.com/newsand-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-and-corporate-employees.
40

See e.g., https://blockclubchicago.org/2022/07/18/will-your-college-still-require-covid-vaccinations-now-that-thestate-dropped-its-mandate/; https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccinationmandates-facing-pushback-n1273916; https://www.colorado.edu/covid-19-updates/covid-19-vaccination; https://
uhs.berkeley.edu/requirements/covid19.
41

See, e.g., https://abcnews.go.com/US/dc-require-students-12-older-vaccinated-covid-19/story?id=87130087;
https://www.4j.lane.edu/coronavirus/healthsafety/ (school staff and volunteers must get COVID-19 vaccine);
https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-school-districtmandates-vaccines-for-eligible-students; https://patch.com/massachusetts/salem/salem-school-committee-approvesvaccine-mandate-sports-band;https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-forhigh-risk-school-sports/3232745/;
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-toissue-mandate-for-students-12-and-up-get-vaccine-or-face-weekly-testing.html;
https://www.mercurynews.com/
2021/08/19/la-county-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/.
42

See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachersstaff-mayor-2021-08-23/;https://www.cbsnews.com/news/california-covid-vaccine-teachers-mandate/; https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccine-mandate.html; https://www.governor.ny.gov/
news/governor-cuomo-announces-covid-19-vaccination-mandate-healthcare-workers;
https://www.cdph.ca.gov/
Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx;
https://www.
nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html; https://www.denvergov.org/Govern
ment/COVID-19-Information/Public-Health-Orders-Response/News-Updates/2021/Mayor-Hancock-AnnouncesCOVID-19-Vaccine-Requirement-for-Employees; https://www.bostonherald.com/2021/08/19/baker-issues-vaccinemandate-for-42000-state-employees/.
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children to attend public school. 44 Washington, D.C. has already announced a mandate forstudents ages 12 and older. 45
III.

PHMPT’s FOIA Request for the Moderna Vaccine’s BLA File48.

In furtherance of PHMPT’s mission to disseminate information to the public, andin an effort to ensure that FDA acts consistent with its commitment to transparency, 46 PHMPT
submitted a FOIA request on February 23, 2022, seeking the following documents to be producedon an expedited basis pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II):All data and information for the Moderna Vaccine enumerated in 21
C.F.R. § 601.51(e) 47 with the exception of publicly available reportson the Vaccine Adverse Events Reporting System. 48(Exhibit 1.)
49.

On March 7, 2022, FDA denied PHMPT’s request for expedited processing(“PHMPT’s Denial Letter” or “Denial Letters”) and assigned the request FOIA Control # 20221614. In PHMPT’s Denial Letter, FDA stated, in relevant part:I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling need that involves an imminent threat to the life or
https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-covid-19-vaccinerequirements-for-schools/; see also https://www.latimes.com/california/story/2022-01-24/new-vaccine-legislationcalifornia-schoolchildren-mandate.
44

45

See https://abcnews.go.com/US/dc-require-students-12-older-vaccinated-covid-19/story?id=87130087.

46

https://www.fda.gov/about-fda/transparency.

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”47

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e), withthe exception of publicly available reports on the Vaccine Adverse Events Reporting System.

48

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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 yourrequest for expedited processing.
(Exhibit 2.)50.

On June 1, 2022, PHMPT submitted an appeal challenging FDA’s decision to deny

PHMPT’s requests for Expedited Processing. (Exhibit 3.)
51.

FDA acknowledged PHMPT’s appeal on June 1, 2022, assigned it appeal file 20-

0076AA, and declared that the appeal fell under “unusual circumstances” pursuant to 5 U.S.C. §552(a)(6)(B)(i) and 5 U.S.C. § 552(a)(6)(B)(iii) of the FOIA. (Exhibit 4.)
52.

Given the “unusual circumstances” claimed by FDA, it was required to make adetermination with respect to PHMPT’s appeal for expedited processing by July 15, 2022. As ofthe date of this filing, FDA has not made a determination.
IV.

PHMPT’s FOIA Request for the 12-15-Year-Old Pfizer Vaccine’s BLA File
53.

In furtherance of PHMPT’s mission to disseminate information to the public, andin an effort to ensure that FDA acts consistent with its commitment to transparency, 49 PHMPT
submitted the following FOIA request to FDA on August 8, 2022 and sought expedited processing
pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II):All data and information for the 12-15-Year-Old Pfizer Vaccine
enumerated in 21 C.F.R. § 601.51(e) 50 with the exception of49

https://www.fda.gov/about-fda/transparency.

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
50

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publicly available reports on the Vaccine Adverse Events Reporting
System. 51
This request excludes any data and information responsive to andbeing produced in FOIA Control # 2021-5683 (previously made on
behalf of PHMPT) and is meant to capture all data and information
within the biological product file that concerns the authorization andapproval of Comirnaty for use in 12-15-year-olds.
(Exhibit 5.)
54.

On August 15, 2022, FDA denied PHMPT’s request for expedited processing(“PHMPT’s Denial Letter” or “Denial Letters”). In PHMPT’s Denial Letter, FDA stated, in
relevant part:I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling 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 yourrequest for expedited processing.
(Exhibit 6.)V.

The de Garays’ FOIA Request
55.

In furtherance of the de Garays’ advocacy for their vaccine-injured daughter, as

well as their public advocacy in educating the public of the serious adverse events children may
experience after receiving the 12-15-Year-Old Pfizer Vaccine, and in an effort to ensure that FDA
acts consistent with its commitment to transparency, 52 the de Garays submitted the following
request to FDA on August 22, 2022 and sought expedited processing pursuant to 5 U.S.C. §552(a)(6)(E)(v)(II)::

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the 12-15-Year-Old 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.
51

52

https://www.fda.gov/about-fda/transparency.

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All data and information for the 12-15-Year-Old Pfizer Vaccine
enumerated in 21 C.F.R. § 601.51(e) 53 with the exception of
publicly available reports on the Vaccine Adverse Events Reporting
System. 54
This request excludes any data and information responsive to andbeing produced in FOIA Control # 2021-5683 (as that will be
publicly available) and is meant to capture all data and information
within the biological product file that concerns the authorization andapproval of Comirnaty for use in 12-15-year-olds.
(Exhibit 7.)
56.

On August 29, 2022, FDA denied the de Garays’ request for expedited processing(“de Garays’ Denial Letter” or “Denial Letters”) and assigned the request FOIA Control # 20226129. In the de Garays’ Denial Letter, FDA stated in relevant part:I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling 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 yourrequest for expedited processing.
(Exhibit 8.)
ARGUMENT
57.

FOIA provides for “expedited processing of request for records” upon a showingof “compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(I). As defined by FOIA, a “compelling need”

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”53

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the 12-15-Year-Old 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.
54

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is justified when the person requesting information is (A) “primarily engaged in disseminating
information” and (B) there is an “urgency to inform the public concerning actual or alleged Federal
Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
58.

When an agency denies a request for expedited processing, the decision is subject

to immediate judicial review. 5 U.S.C. § 522(a)(6)(E)(iii). A requester is not required to pursue
an administrative appeal before seeking judicial review of its request for expedited processing of
a FOIA request. Elec. Privacy Info. Ctr. v. Dep’t of Defense, 355 F. Supp. 2d 98, 100 (D.D.C.
2004).
59.

Therefore, as demonstrated above, 55 Plaintiffs are authorized to bring this action

because their requests for expedited processing have been denied by FDA.
60.

Furthermore, as explained below, both Plaintiffs can demonstrate a “compellingneed” for the expedited processing of their FOIA requests. 5 U.S.C. § 552(a)(6)(E)(i)(I); 5 U.S.C.
§ 552(a)(6)(E)(v)(II).
I.

Plaintiffs Are Primarily Engaged in Disseminating Information
61.

In this instance, FDA’s Denial Letters do not challenge the Plaintiffs’ claims thatthey are primarily engaged in disseminating information.
62.

PHMPT is an organization made up of public health professionals, medical

professionals, scientists, and journalists. PHMPT exists for the sole purpose of disseminating to
the public the data and information in the biological product files for each of the COVID-19
Vaccines. PHMPT intends to make any records produced in response to this FOIA request
immediately available to the public through both its website and its individual members’ platforms,
as it has with the Comirnaty data. Many of PHMPT’s individual members, including all of its

55

See, e.g., supra ¶¶ 48-52

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members that are journalists, are primarily engaged in disseminating information to the public anddo so across various platforms, including through interviews, 56 articles, 57 blogs, 58 essays, 59 andpodcasts. 60 PHMPT and its members fully intend to analyze and disseminate the data andinformation underlying the licensure (or FDA “approval”) of the COVID-19 Vaccines, that it
hopes to receive from its FOIA requests.
63.

The de Garays have become influential public advocates in educating the public

on the serious adverse events children may experience after receiving the 12-15-Year-Old Pfizer
Vaccine. Their advocacy began shortly after their daughter, M.D., who was a participant in theclinical trials for the 12-15-Year-Old Pfizer Vaccine, 61 suffered the extreme adverse reaction that
ultimately necessitated her continued use of a feeding tube and wheelchair. 62 As part of the deGarays’ public advocacy, they have worked with a number of media organizations including Fox
See, e.g., https://www.foxnews.com/transcript/ingraham-angle-on-mask-mandates-bidens-failure-in-his-role(Harvey Risch).
56

See, e.g., https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi); https://www.bmj.com/content/371/
bmj.m4058 (Peter Doshi); https://www.bmj.com/content/371/bmj.m4037 (Peter Doshi); https://www.wsj.
com/articles/are-covid-vaccines-riskier-than-advertised-11624381749;
https://www.wsj.com/articles/universityvaccine-mandates-violate-medical-ethics-11623689220(Aaron Kheriaty and Gerard V. Bradley); https://
thefederalist.com/2021/07/05/how-college-covid-vaccine-mandates-put-students-in-danger/ (Andrew Bostom, Aaron
Kheriaty, Peter A. McCullough, Harvey A. Rish, Michelle Cretella, and Gerard V. Bradley);
https://thefederalist.com/2021/08/18/why-forcing-unvaccinated-students-to-wear-cloth-masks-is-anti-science/(Andrew Bostom, Gerard Bradley, Aaron Kheriaty, and Harvey Risch); https://www.bmj.com/content/bmj/374/bmj.
n1737.full.pdf (Serena Tinari and Catherine Riva); https://www.bmj.com/content/372/bmj.n627 (Serena Tinari);
https://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735 (Sarah Tanveer, Anisa Rowhani-Farid,
Kyungwan Hong, Tom Jefferson, Peter Doshi); https://www.arcdigital.media/p/medical-ethicist-sues-the-university(Justin Lee).
57

See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-acovid-19-vaccine/ (Peter Doshi); https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95effective-vaccines-lets-be-cautious-and-first-see-the-full-data/ (Peter Doshi); see also https://www.recheck.ch/wordpress/en/covid-certificate/ (Catherine Riva and Serena Tinari).
58

See https://www.andrewbostom.org/2021/06/why-collegiate-covid-19-vaccine-mandates-are-lysenkoist-antiscience/ (Andrew Bostom).
59

See, e.g., https://www.andrewbostom.org/2021/05/dr-andrew-bostom-discusses-the-unfavorable-risk-benefit-ratioof-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorizationonly-mrna-vaccine/(Andrew Bostom).
60

61

See Patrick de Garay’s Declaration (Exhibit 7 at pages 9-10.)62https://www.foxnews.com/media/ohio-woman-daughter-covid-vaccine-reaction-wheelchair.

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News and the Highwire, as well as advocacy groups, that have and will continue to disseminate
their story. These include:a. June 28, 2021: Appearance on Senator Ron Johnson’s press conference withindividuals who suffered adverse reactions to COVID-19 vaccines. 63
b. June 29, 2021: Federalist Article: “Twitter Censors Video of Mother Describing
Daughter’s COVID-19 Vaccine Side Effects.” 64
c. July 1, 2021: Coverage of testimony at Senator Ron Johnson press conference byTucker Carlson Tonight. 65
d. July 2, 2021: Appearance on Tucker Carlson Tonight. 66
e. November 2, 2021: Appearance on Senator Ron Johnson’s Expert Panel on Federal
Vaccine Mandates. 67
f. December 12, 2021: Australian Senator Gerard Rennick Facebook post on de Garay
testimony. 68
g. January 12, 2022: Discussion of de Garays by podcast host Joe Rogan on the Joe
Rogan Experience. 69
h. January 27, 2022: Interview by Epoch Times. 70

63

https://youtu.be/lAeVLdMnerQ?t=1885.

https://thefederalist.com/2021/06/29/twitter-censors-video-of-mother-describing-daughters-covid-19-vaccine-sideeffects/.
64

65

https://www.foxnews.com/transcript/tucker-people-in-charge-create-disaster-after-disaster at 12:00.

66

https://video.foxnews.com/v/6262045756001#sp=show-clips.

67

https://rumble.com/vokrf7-sen.-johnson-expert-panel-on-federal-vaccine-mandates.html at 22:25.

68

https://www.facebook.com/watch/?v=637650331001531.

69

https://rumble.com/vsgwe2-joe-rogan-on-maddie-de-garay-and-suppression-of-vaccine-adverse-events..html.

https://www.theepochtimes.com/the-vaccine-injured-and-their-fight-for-treatment-transparency-trial-participantsstephanie-and-maddie-de-garay-and-brianne-dressen_4241609.html?welcomeuser=1.
70

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i. April 7, 2022: Interview on Operation Mama Bears. 71
j. April 10, 2022: Appearance at Defeat the Mandates Rally at Grand Park, Los
Angeles, CA. 72
k. May 5, 2022: Interview on Broken Truth. 73
l. June 28, 2022: Interview on Blaze Media’s Conservative Review. 74
m. August 13, 2022: Appearance on The HighWire, “Rigged: Maddie’s Story.” 75
64.

Therefore, both Plaintiffs are “primarily engaged in disseminating information to

the general public.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
II.

There Is an Urgency to Inform the Public Concerning Actual or Alleged Federal
Government Activity
65.

First, the urgency to inform the public concerning the data and information

underlying a licensed vaccine is reflected in the Code of Federal Regulations which expressly
provides that “[a]fter a license has been issued, the following data and information in the biologicalproduct file are immediately available for public disclosure unless extraordinary circumstances areshown: (1) All safety and effectiveness data and information . . . .” 21 C.F.R. § 601.51(e)(emphasis added). Therefore, FDA’s own regulations expressly recognize the importance of
having the data and information relied upon to license a vaccine “immediately available for public
disclosure.” Id. FDA’s regulation not only supports the need for expedited treatment under FOIA
but is also an independent legal basis that requires expedited treatment of this request.

71

https://www.youtube.com/watch?v=25kYj80Wn-g.

72

https://rumble.com/v10yrh1-vaccine-injured-speak-out-at-defeat-the-mandates-los-angeles-ca.html at 7:00.

73

https://brokentruth.com/108-clinical-trials-harm-kids/.

74

https://www.iheart.com/podcast/263-the-conservative-co-28419175/episode/the-full-story-of-maddie-de-9882654

6/.
75

https://thehighwire.com/videos/rigged-maddies-story/.

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66.

Page 25 of 30 PageID 25

Moreover, FDA may only license vaccines that have been proven to be “safe andeffective,” see, e.g., 21 U.S.C. § 393, and FDA makes this determination based on, inter alia,
clinical trial reports provided by the sponsor which must be sufficient to demonstrate the productis both “safe” and “effective.” 76 21 C.F.R. § 601.2(a). To assure FDA’s commitment totransparency, 77 and to promote the public’s and the medical and scientific communities’
confidence in the conclusions reached by FDA, it is not surprising that 21 C.F.R. § 601.51(e)requires FDA to immediately disclose all safety and effectiveness data and information after a
product is licensed, absent any extraordinary circumstances. This is the same information thatwould be responsive to the Plaintiffs’ requests.
67.

Beyond FDA’s own regulations which admit the urgent need for transparency anddisclosure for the requested information, there are two additional reasons that warrant expedited
treatment of this request.
68.

First, as explained above, 78 there is an ongoing, national public debate regarding

the adequacy of the data and information, and analyses of same, relied upon by FDA to license the
COVID-19 Vaccines.
69.

Although public health officials, media outlets, journalists, scientists, politicians,

public figures, and others with large social or media platforms that have declared that the data andinformation underlying the licensure of the COVID-19 Vaccines are more than sufficient forlicensure, numerous public health officials, media outlets, journalists, scientists, politicians, public

FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download; see also
https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved; https://www.fda.gov/about-fda/what-wedo.
76

77

https://www.fda.gov/about-fda/transparency.

78

See, e.g., supra ¶¶ 36-45.

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figures, and others with large social or media platforms have publicly raised questions regarding
the sufficiency of the data and information, the adequacy of the review, and appropriateness of theanalyses relied upon to license the COVID-19 Vaccines, including a number of the scientists andjournalists that are members of PHMPT.
70.

The public debate is unlikely to be settled without full disclosure of the data andinformation underlying FDA’s conclusion that the COVID-19 Vaccines are “safe and effective.”
71.

Secondly, there is also an urgent need for the public to have immediate access tothe data and information underlying the licensure of the COVID-19 Vaccine because, over theobjections of many, this product has been, and continues to be mandated to individuals across thecountry by the federal government, local governments, public and private employers, universities,
schools, and various other institutions.79
72.

While the presence of these mandates continues to fluctuate over the course of thevarious stages of the COVID-19 pandemic, at the federal level, the Pentagon has continued to
mandate COVID-19 vaccines for all military personnel. 80
73.

The urgency regarding the safety and effectiveness information is especiallyrelevant for United States Military. Despite the passage of deadlines for active-duty members toreceive the COVID-19 vaccines, tens-of-thousands of active-duty service members refuse to getthem. 8179 See, e.g., supra ¶¶46-47.

https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military/;see
also
https://www.nbcnews.com/news/military/deadline-passes-one-10-army-national-guard-soldiers-still-unvaccinatedrcna36269.
80

https://www.forbes.com/sites/teakvetenadze/2021/12/15/military-starts-ejecting-unvaccinated-service-members/?sh=7981d3146ed0.
81

26

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74.

Page 27 of 30 PageID 27

Most recently, the Army announced roughly 40,000 National Guardsmen and22,000 reservists will be barred from service for refusing to get vaccinated against COVID-19.
This decision effectively cuts off the pay and benefits for more than 60,000 service members andprohibits them from participating in training. 82
75.

These separations of service members ironically come at a time when the military

faces serious recruiting challenges. 83 For example, after the first five months of 2022, the Armyreached only 23% of its active-duty goal for new recruits, and the Air Force obtained 2,300 fewer
recruits in the first fiscal quarter than it did in 2021. 84 Army Gen. Joseph Martin, Vice Chief ofStaff for the Army, has stated that, if these short falls continue, they may have an impact on the
military’s readiness. 85
76.

With regards to the 12-15-Year-Old Pfizer Vaccine, after its FDA approval, policy

makers are reviewing the available information to determine if COVID-19 vaccine requirements
are appropriate for students for the 2022-2023 school year, and beyond. 86
77.

Having multiple trusted independent authorities review the safety and effectivenessdata sought in these FOIA requests will only assist the public, as well as private institutions, inevaluating vaccine decisions and policies.
78.

During a time when COVID-19 vaccine mandates are being implemented over theobjection of those who have questions about the data and information supporting the safety andefficacy of the COVID-19 Vaccines, and individuals with these questions are being expelled from82

https://nypost.com/2022/07/08/army-cuts-pay-from-over-60k-unvaccinated-national-guard-reserves/.

https://thehill.com/opinion/national-security/3527921-the-military-has-a-serious-recruiting-problem-congressmust-fix-it/; see also https://www.military.com/daily-news/2022/07/06/army-cuts-off-more-60k-unvaccinated-guardand-reserve-soldiers-pay-and-benefits.html.
83

84

Id.

85

https://www.pbs.org/newshour/politics/army-cuts-expected-force-size-amid-unprecedented-shortfall-of-recruits.

868686 See, e.g., supra ¶¶ 46-47.

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employment, school, transportation, restaurants, entertainment facilities, and the military, thepublic has an urgent and immediate need to have access to this data.
79.

Finally, the information Plaintiffs seek concerns actual or alleged federal

government activity – namely, whether FDA properly approved the COVID-19 Vaccines basedon adequate data and information. Additionally, Plaintiffs’ requests concern FDA’s regulatory
obligation to make parts of the COVID-19 Vaccines BLA file “immediately available for public
disclosure” once a license has been issued. 87 Such parts include all safety and effectiveness dataand information, 88 which is precisely the information Plaintiffs’ FOIA requests seek on an
expedited basis. (Exhibit 1, 5 & 8.)80.

The general public’s interest in the data sought by the Plaintiffs’ requests has

already been demonstrated by the public’s engagement with the ongoing release of similar datafrom PHMPT’s litigation to disclose the BLA file for Pfizer’s COVID-19 vaccine, Comirnaty.89
The data produced by FDA has been made public on PHMPT’s website. Despite the fact that only
a portion of the data has been released, and hence is not yet ready for proper analysis by the public,
there have been approximately three-quarters of a million downloads of the documents and data
released to date by members of the public. The website itself has drawn over 2.7 million visitorsand 4.5 million views in the last 12 months which makes clear that the public, and especiallyindividuals involved in healthcare, have a sincere interest in viewing the documents considered by
the FDA in approving Pfizer’s COVID-19 vaccine and the legal process which led to their release.
81.

Therefore, Plaintiffs have demonstrated that they are primarily engaged indisseminating information and that there is an urgency to inform the public concerning actual or87

21 C.F.R. § 601.51(e).

88

Id.

89 See, e.g., supra ¶¶ 27-30.

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alleged Federal Government activity and, thus, FDA should provide expedited processing for therequested records because Plaintiffs have a “compelling need”. 5 U.S.C. § 552(a)(6)(E)(i)(I).
REQUESTED RELIEF
WHEREFORE, Plaintiffs pray that this Court:a.

Provide for expeditious proceedings in this action;b.

Enter an order directing FDA to produce all responsive documents at the rate of

55,000 pages per month after the FDA completes its production in the related case, Public
Health and Medical Professionals for Transparency v. Food and Drug Administration,
Index No. 4:21-cv-01058-P;
c.

Award Plaintiffs their costs and reasonable attorneys’ fees incurred in this action asprovided by 5 U.S.C. § 552(a)(4)(E); andd.

Grant such other and further relief as the Court may deem just and proper.

29

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Dated: October 11, 2022

Page 30 of 30 PageID 30

SIRI & GLIMSTAD LLP
Aaron Siri (pro hac vice to be filed)
Elizabeth A. Brehm (pro hac vice to be filed)
Colin Farnsworth (pro hac vice to be filed)745 Fifth Ave, Suite 500
New York, NY 10151
Tel: (212) 532-1091
aaron@sirillp.com
ebrehm@sirillp.com
cfarnsworth@sirillp.com/s/ Walker D. Moller
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

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Exhibit 1

Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22

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FREEDOM OF INFORMATION ACT REQUESTEXPEDITED PROCESSING REQUESTEDVIA ONLINE PORTAL

February 23, 2022

Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Re: Moderna COVID-19 Vaccine Biological Product File (IR#0710)
Dear Sir or Madam:This firm represents Public Health and Medical Professionals for Transparency(“PHMPT”).
On January 31, 2022, the Food and Drug Administration (“FDA”) approved the Moderna 1
COVID-19 Vaccine, marketed as Spikevax (the “Moderna Vaccine”) for individuals 18 years ofage and older. On behalf of PHMPT and its individual members, please provide the following
records to foia@sirillp.com in electronic form:
All data and information for the Moderna Vaccine enumerated
in 21 C.F.R. § 601.51(e) 2 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System. 3

1

For purposes of this request, Moderna shall be interpreted to include Moderna, Inc. and any of its parents, subsidiaries
and affiliates.
2
21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”3
For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e) withthe exception of publicly available reports on the Vaccine Adverse Events Reporting System.

Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22

I.

Page 3 of 9 PageID 33

EXPEDITED PROCESSING REQUESTEDPHMPT requests expedited processing for this request as it meets the requirements forexpedited processing under both FDA’s FOIA Regulations as well as FOIA itself.
A. PHMPT Qualifies for Expedited Processing Under FOIA
FOIA provides for “expedited processing of requests for records” upon a showing of“compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(I). The requestor shows a “compelling need” when
it is “primarily engaged in disseminating information,” and there is an “urgency to inform thepublic concerning actual or alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
Here, PHMPT is an organization made up of public health professionals, medical
professionals, scientists, and journalists. PHMPT exists for the sole purpose of disseminating to
the public the data and information in the biological product files for each of the COVID-19
vaccines. PHMPT intends to make any records produced in response to this FOIA request
immediately available to the public through both its website and its individual members’ platforms.
Many of PHMPT’s individual members, including all its members that are journalists, areprimarily engaged in disseminating information to the public and do so across various platforms,
including through interviews, articles, blogs, essays, and podcasts. Therefore, PHMPT and manyof its members are “primarily engaged in disseminating information [] to inform the public,” and,as explained below, there is a clear “urgency to inform the public concerning actual or alleged
Federal Government activity,” which in this case is the data and information underlying thelicensure of the Moderna Vaccine. Accordingly, expedited processing of this request under FOIA
is warranted.
B. PHMPT Qualifies for Expedited Processing Under the FDA’s FOIA
Regulations
Notably, separate and apart from the FDA’s obligation to comply with FOIA, it has anindependent duty to inform the public concerning the data and information underlying a licensed
vaccine. The FDA’s Regulations expressly provide that “[a]fter a license has been issued, thefollowing 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 andinformation . . .” 21 C.F.R. § 601.51(e)(1) (emphasis added). Thus, the FDA’s own regulations
expressly recognize the importance of having the data and information relied upon to license a
vaccine “immediately available for public disclosure.” Id. This policy supports the FDA’s
claimed commitment to, 4 and assurances of, transparency 5 as a lack of transparency erodes theconfidence the medical and scientific communities and the public have in the conclusions reachedby the FDA. However, the fact that the FDA did not release the documents following licensure
necessitated this FOIA request.

4

https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparencycovid-19-euas (last visited 2/19/2022).
5
https://www.fda.gov/about-fda/transparency/transparency-initiative (last visited 2/19/2022); https://www.fda.gov/n
ews-events/speeches-fda-officials/fostering-transparency-improve-public-health (last visited 2/19/2022).

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But aside from the FDA’s duty to make immediately available the safety and effectivenessdata of a licensed vaccine, the FDA’s FOIA regulations anticipate scenarios where FOIA requests
must be expedited. Specifically, a requestor is entitled to expedited processing where:(1) The requester is primarily engaged in disseminating information
to the general public and not merely to a narrow interest group;(2) There is an urgent need for the requested information and that it
has a particular value that will be lost if not obtained anddisseminated quickly; however, a news media publication or
broadcast deadline alone does not qualify as an urgent need, nordoes a request for historical information; and(3) The request for records specifically concerns identifiable
operations or activities of the Federal Government.
21 C.F.R. § 20.44(c)(1)-(3).
PHMPT easily meets all three requirements. As noted above, PHMPT is an organization
made up of public health professionals, medical professionals, scientists, and journalists that was
created and exists for the sole purpose of disseminating to the public the data and information in
the biological product files for each of the COVID-19 vaccines. Therefore, PHMPT is certainly“primarily engaged in disseminating information to the general public.” 21 C.F.R. § 20.44(c)(1).
Next, there is plainly an urgent public need for transparency with regard to the data relied
upon in licensing the Moderna Vaccine for at least two distinct reasons beyond the FDA’s own
regulations which admit the urgent need for transparency and disclosure of this information. As
required by Congress, the FDA may only license vaccines that have been proven to be “safe andeffective,” see, e.g., 21 U.S.C. § 393, and the FDA makes this determination based on, inter alia,
clinical trial reports provided by the sponsor which must be sufficient to demonstrate the productis both “safe” and “effective.” 6 21 C.F.R. 601.2(a). There is, however, an ongoing, public national
debate regarding the adequacy of the data and information, and analyses of same, relied upon by
the FDA to license the COVID-19 vaccines, including the Moderna Vaccine. On the one hand,
there are numerous public health officials, media outlets, journalists, scientists, politicians, public
figures, and others with large social or media platforms that have declared that the data andinformation underlying the licensure of the Moderna Vaccine is more than sufficient for licensure.
For example, in a statement released on January 31, 2022, acting FDA Commissioner Janet
Woodcock, M.D., stated:
The public can be assured that Spikevax meets the FDA’s highstandards for safety, effectiveness and manufacturing quality
6

The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download (last visited
02/19/2022). See also https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (last visited
02/19/2022); https://www.fda.gov/about-fda/what-we-do (last visited 02/19/2022).

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required of any vaccine approved for use in the United States. Whilehundreds of millions of doses of Moderna COVID-19 Vaccine havebeen administered to individuals under emergency use
authorization, we understand that for some individuals, FDA
approval of this vaccine may instill additional confidence in making
the decision to get vaccinated. 7
Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation andResearch, made similar remarks:
The FDA’s medical and scientific experts conducted a thoroughevaluation of the scientific data and information included in theapplication pertaining to the safety, effectiveness, andmanufacturing quality of Spikevax. This includes the agency’s
independent verification of analyses submitted by the company, ourown analyses of the data, along with a detailed assessment of the
manufacturing processes, test methods and manufacturing facilities. . . Safe and effective vaccines are our best defense against the
COVID-19 pandemic, including currently circulating variants. The
public can be assured that this vaccine was approved in keeping with
the FDA’s rigorous scientific standards. 8
Even prior to FDA approval of the Moderna Vaccine, government officials, public healthauthorities, and medical professionals repeatedly claimed that COVID-19 vaccines were “safe andeffective.” 9
On the other hand, numerous public health officials, media outlets, journalists, scientists,
politicians, public figures, and others with large social or media platforms have publicly raisedquestions regarding the sufficiency of the data and information, the adequacy of the review, andappropriateness of the analyses relied upon to license the Moderna Vaccine, including a numberof the scientists and journalists that are members of PHMPT. For example, in July 2021, a groupof 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi, Ph.D.,
Senior Editor for The BMJ and Associate Professor of Pharmaceutical Health Services Researchat the University of Maryland School of Pharmacy, 10 and Peter A. McCullough, M.D. filed anamended Citizen Petition 11 with the FDA, claiming that the available evidence for licensure of the7

https://www.cnn.com/2022/01/31/health/moderna-covid-vaccine-fda-approval/index.html.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
9See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 02/19/2022). See also
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccines have proven to be safe, effective and life-saving.”) (last visited 02/19/2022); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID-19 vaccines are safe”)(last visited 02/19/2022).
10
https://www.bmj.com/about-bmj/editorial-staff/peter-doshi (last visited 02/19/2022).
11
https://www.regulations.gov/document/FDA-2021-P-0521-0001 (last visited 02/19/2022).
8

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Moderna Vaccine “is simply not mature enough at this point to adequately judge whether clinicalbenefits outweigh the risks in all populations.” 12 Separately, Dr. Doshi has publicly questioned
the lack of transparency regarding the vaccine approval process 13 which Dr. Peter Marks publicly
disputed. 14 Aaron Kheriaty, M.D., former-Professor of Psychiatry at UCI School of Medicine,former-Director of the Medical Ethics Program at UCI Health, 15 and a member of PHMPT, hasalso questioned the FDA’s approval process. For example, in an article published in the WallStreet Journal, Dr. Kheriaty questioned the need for student vaccination requirements based on,among other things, a review 16 by the FDA’s Vaccines and Related Biological Products Advisory
Committee that indicates a risk of heart inflammation after vaccination. 17 Government officials
have raised similar concerns about the lack of transparency in the review process, arguing that it
is “essential” for the FDA to, among other things, “make the data generated by clinical trials andsupporting documents submitted to the FDA by developers available to the public.” 18 PHMPT
incorporates by reference, as if cited and fully set forth herein, any and all articles, media, andpublications regarding or reflecting the public discussion, discourse, and debate regarding theModerna Vaccine, including all matters related to the licensure of this product.
Given this widespread and ongoing public debate, the medical and scientific communities
and the public have an immediate need to review the data and information underlying the licensureof the Moderna Vaccine. Public disclosure of this information will inform this ongoing publicdebate. Releasing this data should also confirm the FDA’s conclusion and thus increase
confidence in the safety and efficacy of the Moderna Vaccine.
Secondly, and perhaps even more significantly, there is an urgent need for the public tohave immediate access to the data and information underlying the licensure of the Moderna
Vaccine because, over the objections of many, this product is being mandated to individuals across12

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/ (last visited 02/19/2022).
13
See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-Pfizer-and-modernas-95effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2020/
11/26/peter-doshi-Pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/(lastvisited 02/19/2022).
14
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-Pfizer-biontech-vaccine/ (lastvisited 02/19/2022).
15
https://www.aaronkheriaty.com/bio (last visited 02/19/2022).
16
https://www.fda.gov/media/150054/download (last visited 02/19/2022)17
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220 (last visited
02/19/2022).
18
https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 02/19/2022).

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the country by the federal government, 19 local governments, 20 public and private employers,21
universities, 22 schools, 23 and various other institutions, 24 and many are expected to follow suit.
At the federal level, legislation was introduced that would require COVID-19 vaccines for air
travel into or out of the United States, 25 and the Pentagon has mandated the COVID-19 vaccines

19

See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 02/19/2022); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-vaccine-4cf7451267919302de4a7b591508e80c (last visited 02/19/2022); https://media.defense.gov/
2021/Aug/25/2002838826/-1/-1/0/MEMORANDUM-FOR-MANDATORY-CORONAVIRUS-DISEASE-2019VACCINATION-OF-DEPARTMENT-OF-DEFENSE-SERVICE-MEMBERS.PDF(last visited 2/19/2022);
https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-biden-to-announcenew-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (last visited 02/19/2022).
20
See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited
02/19/2022); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 2/19/2022); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 02/19/2022).
21
See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited
02/19/2022); https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 2/19/2022); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 02/19/2022); https://www.kpbs.org/news/2021/aug/17/encinitas-covid19-vaccine-negative-test-employees/ (last visited 02/19/2022); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-sweep-across-corporate-america-as-delta-surges.html (last visited 2/19/2022); https://www.reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 02/19/2022); https://thehill.com/policy/healthcare/569051-Pfizers-full-approval-triggers-new-vaccine-mandates (last visited 02/19/2022);
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-andcorporate-employees (last visited 02/19/2022).
22
See (last visited 02/19/2022). See also, e.g., https://www.nbcnews.com/health/health-news/colleges-universitiescovid-vaccination-mandates-facing-pushback-n1273916 (last visited 02/19/2022); https://www.colorado.edu/covid19-updates/covid-19-vaccination (last visited 02/19/2022); https://uhs.berkeley.edu/requirements/covid19 (last visited
02/19/2022);
https://huhs.harvard.edu/covid-19-vaccine-requirement-faqs(lastvisited02/19/2022);
https://www2.gmu.edu/safe-return-campus/vaccination-requirements (last visited 2/07/2022).
23
See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-schooldistrict-mandates-vaccines-for-eligible-students (last visited 2/19/2022); https://patch.com/massachusetts/salem/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 2/19/2022); https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 02/19/2022);
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-upget-vaccine-or-face-weekly-testing.html (last visited 02/19/2022); https://www.mercurynews.com/2021/08/19/lacounty-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 02/19/2022).
24
See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachersstaff-mayor-2021-08-23/ (last visited 02/19/2022); https://www.cbsnews.com/news/california-covid-vaccineteachers-mandate/ (last visited 02/19/2022); https://www.nytimes.com/2021/08/18/us/washington-state-teachervaccine-mandate.html (last visited 02/19/2022); https://www.governor.ny.gov/news/governor-cuomo-announcescovid-19-vaccination-mandate-healthcare-workers(lastvisited02/19/2022);
https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx(lastvisited02/19/2022); https://www.nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited
02/19/2022);
https://www.denvergov.org/Government/COVID-19-Information/Public-Health-OrdersResponse/News-Updates/2021/Mayor-Hancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (lastvisited 2/19/2022); See https://www.bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-stateemployees/ (last visited 02/19/2022).
25
https://www.congress.gov/bill/117th-congress/house-bill/4980?q=%7B%22search%22:%5b%224980%252 (lastvisited 02/19/2022).

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for all military personnel. 26 At the state level, legislation has been introduced to require COVID19 vaccines for all post-secondary students, 27 all state employees, 28 and even for all citizens ofvarious states. 29 As explained by Dr. Anthony Fauci, “a flood” of vaccine mandates follow FDA
approval of a COVID-19 vaccine, 30 and President Biden has actively encouraged “companies in
the private sector to step up the vaccine requirements[.]” 31 During a time when COVID-19 vaccine
mandates are being implemented over the objection of those that have questions about the data andinformation supporting the safety and efficacy of the Moderna Vaccine, and individuals with thesequestions are being expelled from employment, school, transportation, and the military, the public
has an urgent and immediate need to have access to this data. The value of this information willbe all but useless to these individuals if they are forced to receive a vaccine prior to seeing the data
relied upon by the FDA and various institutions mandating approved vaccines. Without immediate
access to the data, many of these individuals will forever lose the chance to evaluate the data forthemselves and see whether this vaccine is indeed “safe and effective” prior to being mandated toreceive it. Having multiple trusted independent authorities, including PHMPT, review the safety
and effectiveness data sought in this FOIA request will almost certainly assist these individuals in
evaluating their vaccine decisions. Therefore, for all of these reasons, PHMPT has shown there is“an urgent need for the requested information and that it has a particular value that will be lost if
not obtained and disseminated quickly.” 21 C.F.R. § 20.44(c)(2).
Finally, PHMPT’s request meets the third requirement for expedited processing – that“[t]he request for records specifically concerns identifiable operations or activities of the Federal
Government.” 21 C.F.R. § 20.44(c)(3). Here, PHMPT’s records request specifically concerns
identifiable activities—i.e., approval of the Moderna Vaccine—by the Federal Government—to
wit, the FDA.
In light of the above, PHMPT has demonstrated that its request qualifies for expedited
processing under both the FDA’s FOIA regulations, as well as FOIA itself. PHMPT incorporates
by reference, as if cited and fully set forth herein, any and all articles, media, and publications
26

https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military (last visited
02/19/2022).
27
See New York bill S6495, available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
02/19/2022).
28
See, e.g., https://www.nj.com/coronavirus/2021/08/murphy-orders-vaccination-requirement-for-all-nj-stateworkers-including-at-public-colleges.html (last visited 02/19/2022).
29
See New York bill A11179, available at https://www.nysenate.gov/legislation/bills/2019/A11179. See generally
https://eastcountytoday.net/buffy-wicks-transportation-bill-could-become-california-vaccine-passport-bill/(lastvisited 02/19/2022).
30
https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-fullapproval/5513121001/ (last visited 2/19/22).
31
https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-following-Pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 02/19/2022). See also
https://www.nytimes.com/2021/08/23/us/Pfizer-vaccine-mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts toannounce vaccine mandates for their employees”) (last visited 02/19/2022); https://www.msn.com/enus/news/us/now-that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccinationrates-in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeongeneral-vivek-murthy-says-205530053.html (quoting the Surgeon General referring to vaccine mandates as“reasonable”) (last visited 02/19/2022).

Page 7 of 8

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Page 9 of 9 PageID 39

regarding or reflecting the public discussion, discourse, and debate regarding the mandating or
potential mandating of the Moderna Vaccine. PHMPT certifies that the information in this request
is true and correct to the best of its knowledge and belief.
II.

FEE WAIVER REQUESTPHMPT is a nonprofit and asks that you waive any and all fees or charges pursuant to 5
U.S.C. § 552(a)(4)(A)(iii) on the basis that “disclosure of the [requested] information is in the
public interest because it is likely to contribute significantly to public understanding of theoperations or activities of the government[.]” Specifically, disclosure of the requested information
will immediately address the ongoing public debate about the safety and efficacy of the Moderna
Vaccine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
requests will not contribute to any commercial activities.
Note that in the event only a portion or portions of a requested file are exempted fromrelease, the remainder must still be released. We therefore request that we be provided with all
non-exempt portions which are reasonably segregable or can be deidentified. We further requestthat you describe any redacted, deleted, or withheld material in detail and specify the statutory
basis for the denial as well as your reasons for believing that the alleged statutory justification
applies. Please also separately state your reasons for not invoking your discretionary powers torelease the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. PHMPT reserves all rights to appeal the withholding or deletionof any information.
A determination regarding expedited processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the dateof your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial ofthis request and PHMPT may immediately file an administrative appeal or an action.
If you would like to discuss our requests or any issues raised in this letter, please feel free
to contact Aaron Siri at (212) 532-1091 or foia@sirillp.com during normal business hours. Thankyou for your time and attention to this matter.
Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.

Page 8 of 8

Case 4:22-cv-00915-P Document 1-2 Filed 10/11/22

Page 1 of 2 PageID 40

Exhibit 2

Case 4:22-cv-00915-P Document 1-2 Filed 10/11/22

Page 2 of 2 PageID 41

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Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Page 1 of 25 PageID 42

Exhibit 3

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Page 2 of 25 PageID 43

FDA FREEDOM OF INFORMATION ACT APPEAL
EXPEDITED PROCESSING
VIA EMAIL

June 1, 2022

Director, Office of the Executive Secretariat
US Food & Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
FDAFOIA@fda.hhs.gov
Re: Expedited Processing Appeal of FOIA Control #2022-1614 (IR#0710)
Dear Sir or Madam:This firm represents Public Health and Medical Professionals for Transparency(“PHMPT”). On behalf of PHMPT, on February 23, 2022, we requested records on an expedited
basis from the files of the Food and Drug Administration (“FDA”) pursuant to the Freedom ofInformation Act (5 U.S.C. § 552, as amended) (“FOIA”). The FDA designated the request as
FOIA Control #2022-1614 (the “FOIA Request”). In a letter dated March 7, 2022, the FDA
denied PHMPT’s request for expedited processing (the “Denial Letter”). PHMPT writes now toappeal that determination.
A.

The FOIA Request

On February 23, 2022, PHMPT submitted the FOIA Request to the FDA for the following
documents:
All data and information for the Moderna Vaccine enumerated in 21
C.F.R. § 601.51(e) 1 with the exception of publicly available reportson the Vaccine Adverse Events Reporting System.

1

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”

Page 1 of 11

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Page 3 of 25 PageID 44(Exhibit 1.) 2
In the FOIA Request, PHMPT requested that the FDA expedite processing for this request
pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II) and provided detailed reasons for requesting expedited
processing. (Exhibit 1.)
On March 1, 2022, FDA acknowledged the FOIA Request and assigned it Request Number#2022-1614. On March 7, 2022, FDA and denied PHMPT’s request for expedited processing.
(Exhibit 2.) The denial letter stated in relevant part:
The Electronic Freedom of Information Act (EFOIA) Amendments of1996 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 shownand in other cases as determined by the agency. The term “compellingneed” 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 madeby “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 notmeet the criteria under the FOIA. You have not demonstrated acompelling 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 yourrequest for expedited processing. The responding agency office willprocess your request in the order in which it was received.
(Exhibit 3).
B.

Argument

FOIA provides for “expedited processing of requests for records” upon a showing of“compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(I). A requestor shows a “compelling need” when
it is “primarily engaged in disseminating information,” and there is an “urgency to inform thepublic concerning actual or alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
PHMPT requested expedited processing of the FOIA Request on the basis that it is“primarily engaged in disseminating information” and that there is an “urgency to inform thepublic concerning actual or alleged Federal Government activity.” PHMPT demonstrated in its
FOIA Request that it exists for the sole purpose of disseminating to the public the data andinformation in the biological product files for each of the COVID-19 vaccines. (Exhibit 1.) That
2

All “Exhibits” referenced herein are appended to this letter.

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Page 4 of 25 PageID 45

fact was not challenged by the FDA in its Denial Letter and, therefore, this appeal, focuses solely
on the FDA’s claim that PHMPT failed to demonstrate “there exists an urgency to inform thepublic concerning actual or alleged Federal Government activity.” (Exhibit 3.) For the purposesof this appeal PHMPT fully incorporates all of the arguments, references, and citations
exhaustively detailed in its FOIA Request for expedited processing.
Contrary to FDA’s assertions, as set forth in PHMPT’s FOIA Request, there exists anurgency to inform the public concerning actual or alleged Federal Government activities. In
determining whether there is an “urgency to inform,” and hence a “compelling need,” courts must
consider at least three factors: (i) whether the request concerns a matter of current exigency to theAmerican public; (ii) whether the consequences of delaying a response would compromise asignificant recognized interest; and (iii) whether the request concerns federal government activity.
Al-Fayed v. CIA, 254 F.3d 300, 310 (D.C. Cir. 2001). All three factors are present here and weighin favor of granting expedited processing of PHMPT’s FOIA Request.
(i) PHMPT’s request concerns a matter of current exigency to the American public
As to the first factor, PHMPT’s FOIA Request concerns a matter of current exigency to theAmerican public. PHMPT’s FOIA Request is for the Moderna Vaccine’s biological product file,available under 21 C.F.R. § 601.51(e). The FDA itself acknowledges the exigency in releasing
the biological product file in the Code of Federal Regulations, which expressly provides that“[a]fter a license has been issued . . . data and information in the biological product file are
immediately available for public disclosure unless extraordinary circumstances are shown.” 21
C.F.R. § 601.51(e) (emphasis added). Under this regulation, a critical part of the biological productfile that must be released is “all safety and effectiveness data and information.” 21 C.F.R. §601.51(e)(1). Therefore, the FDA’s own regulations acknowledge the current exigency in making
the Moderna Vaccine’s biological product file, including its safety and effectiveness data andinformation, immediately available for public disclosure. Thus, FDA’s regulation not only
supports the need for expedited treatment under FOIA, but it is also an independent legal basis that
requires expedited treatment of the FOIA Request.
Beyond the FDA’s own regulations recognizing the exigency of records sought in
PHMPT’s FOIA request, there are other reasons why such exigencies exist. As required by
Congress, the FDA may only license vaccines that have been proven to be “safe and effective,”see, e.g., 21 U.S.C. § 393. The FDA makes this determination based on, inter alia, clinical trial
reports provided by the sponsor which must be sufficient to demonstrate the product is both “safe”
and “effective.” 3 21 C.F.R. 601.2(a). There is, however, an ongoing public national debate
regarding the adequacy of the data, information, and analyses relied upon by the FDA to license
the Moderna Vaccine. On the one hand, there are numerous public health officials, media outlets,
journalists, scientists, politicians, public figures, and others with large social or media platforms
that have declared that the data and information underlying the licensure of the Moderna Vaccine

3
The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download (last visited
02/19/2022). See also https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (last visited
02/19/2022); https://www.fda.gov/about-fda/what-we-do (last visited 02/19/2022).

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Page 5 of 25 PageID 46

is more than sufficient for licensure. For example, in a statement released on January 31, 2022,
then-acting FDA Commissioner Janet Woodcock, M.D., stated:
The public can be assured that Spikevax meets the FDA’s high standards for safety,
effectiveness and manufacturing quality required of any vaccine approved for use
in the United States. While hundreds of millions of doses of Moderna COVID-19
Vaccine have been administered to individuals under emergency use authorization,
we understand that for some individuals, FDA approval of this vaccine may instill
additional confidence in making the decision to get vaccinated. 4Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation andResearch, made similar remarks:
The FDA’s medical and scientific experts conducted a thorough evaluation of thescientific data and information included in the application pertaining to the safety,
effectiveness, and manufacturing quality of Spikevax. This includes the agency’s
independent verification of analyses submitted by the company, our own analysesof the data, along with a detailed assessment of the manufacturing processes, test
methods and manufacturing facilities . . . Safe and effective vaccines are our best
defense against the COVID-19 pandemic, including currently circulating variants.
The public can be assured that this vaccine was approved in keeping with the FDA’s
rigorous scientific standards. 5
Even prior to FDA approval of the Moderna Vaccine, government officials, public healthauthorities, and medical professionals repeatedly claimed that COVID-19 vaccines were “safe andeffective.” 6
On the other hand, numerous public health officials, media outlets, journalists, scientists,
politicians, public figures, and others with large social or media platforms have publicly raisedquestions regarding the sufficiency of the data and information, the adequacy of the review, andthe appropriateness of the analyses relied upon to license the Moderna Vaccine, including a
number of scientists and journalists who are members of PHMPT. For example, in July 2021, agroup of 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi,
Ph.D., Senior Editor for The BMJ and Associate Professor of Pharmaceutical Health Services
Research at the University of Maryland School of Pharmacy, 7 and Peter A. McCullough, M.D.
filed an amended Citizen Petition8 with the FDA, claiming that the available evidence for licensure4

https://www.cnn.com/2022/01/31/health/moderna-covid-vaccine-fda-approval/index.html (last visited 03/16/22).

5https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine (last visited 03/16/22).
6

See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 02/19/2022). See also
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccines have proven to be safe, effective and life-saving.”) (last visited 02/19/2022); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID-19 vaccines are safe”)(last visited 02/19/2022).
7

https://www.bmj.com/about-bmj/editorial-staff/peter-doshi (last visited 02/19/2022).

8

https://www.regulations.gov/document/FDA-2021-P-0521-0001 (last visited 02/19/2022).

Page 4 of 11

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Page 6 of 25 PageID 47of the Moderna Vaccine “is simply not mature enough at this point to adequately judge whether
clinical benefits outweigh the risks in all populations.” 9 Separately, Dr. Doshi has publicly
questioned the lack of transparency regarding the vaccine approval process 10 which Dr. Peter
Marks publicly disputed. 11 Aaron Kheriaty, M.D., former-Professor of Psychiatry at UCI Schoolof Medicine, former-Director of the Medical Ethics Program at UCI Health, 12 and a member of
PHMPT, has also questioned the FDA’s approval process. For example, in an article published in
the Wall Street Journal, Dr. Kheriaty questioned the need for student vaccination requirements
based on, among other things, a review 13 by the FDA’s Vaccines and Related Biological Products
Advisory Committee that indicates a risk of heart inflammation after vaccination. 14 Government
officials have raised similar concerns about the lack of transparency in the review process, arguingthat it is “essential” for the FDA to, among other things, “make the data generated by clinical trials
and supporting documents submitted to the FDA by developers available to the public.” 15 PHMPT
incorporates by reference, as if cited and fully set forth herein, any and all articles, media, andpublications regarding or reflecting the public discussion, discourse, and debate regarding theModerna Vaccine, including all matters related to the licensure of this product.
Given this widespread and ongoing public debate, the medical and scientific communities
and the public have an immediate need to review the data and information underlying the licensureof the Moderna Vaccine. The FOIA Request attempts to expedite the disclosure of this criticalinformation. Therefore, PHMPT’s FOIA Request concerns a matter of current exigency to theAmerican public.
Secondly, this public debate over the safety and effectiveness of the Moderna Vaccine
concerns matters of current exigency to the American public because it has led to invasive policy
decisions that affect the livelihoods of the American public. Over the objections of many, thisproduct is being mandated to individuals across the country by the federal government, 16 local

9

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/ (last visited 02/19/2022).
10

See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-Pfizer-and-modernas-95effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2020/
11/26/peter-doshi-Pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/(lastvisited 02/19/2022).
11

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-Pfizer-biontech-vaccine/
visited 02/19/2022).
12

https://www.aaronkheriaty.com/bio (last visited 02/19/2022).

13

https://www.fda.gov/media/150054/download (last visited 02/19/2022).

14

https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220
02/19/2022).

(last

(last

visited15

https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 02/19/2022).
16

See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 02/19/2022); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-vaccine-4cf7451267919302de4a7b591508e80c (last visited 02/19/2022); https://media.defense.gov/
2021/Aug/25/2002838826/-1/-1/0/MEMORANDUM-FOR-MANDATORY-CORONAVIRUS-DISEASE-2019VACCINATION-OF-DEPARTMENT-OF-DEFENSE-SERVICE-MEMBERS.PDF(last visited 2/19/2022);

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governments, 17 public and private employers, 18 universities, 19 schools, 20 and various otherinstitutions, 21 and many others are expected to follow suit. At the federal level, legislation was
introduced that would require COVID-19 vaccines for air travel into or out of the United States, 22
and the Pentagon has mandated COVID-19 vaccines for all military personnel. 23 At the state level,
legislation has been introduced to require COVID-19 vaccines for all post-secondary students, 24

https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-biden-to-announcenew-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (last visited 02/19/2022).
17

See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited
02/19/2022); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 2/19/2022); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 02/19/2022).
18

See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited
02/19/2022); https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 2/19/2022); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 02/19/2022); https://www.kpbs.org/news/2021/aug/17/encinitas-covid19-vaccine-negative-test-employees/ (last visited 02/19/2022); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-sweep-across-corporate-america-as-delta-surges.html (last visited 2/19/2022); https://www.reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 02/19/2022); https://thehill.com/policy/healthcare/569051-Pfizers-full-approval-triggers-new-vaccine-mandates (last visited 02/19/2022);
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-andcorporate-employees (last visited 02/19/2022).
19

See e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facingpushback-n1273916 (last visited 02/19/2022); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (lastvisited 02/19/2022); https://uhs.berkeley.edu/requirements/covid19 (last visited 02/19/2022); https://huhs.harvard.edu/covid-19-vaccine-requirement-faqs (last visited 02/19/2022); https://www2.gmu.edu/safe-return-campus/vaccination-requirements (last visited 2/07/2022).
20

See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-schooldistrict-mandates-vaccines-for-eligible-students (last visited 2/19/2022); https://patch.com/massachusetts/salem/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 2/19/2022); https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 02/19/2022);
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-upget-vaccine-or-face-weekly-testing.html (last visited 02/19/2022); https://www.mercurynews.com/2021/08/19/lacounty-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 02/19/2022).
21

See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachersstaff-mayor-2021-08-23/ (last visited 02/19/2022); https://www.cbsnews.com/news/california-covid-vaccineteachers-mandate/ (last visited 02/19/2022); https://www.nytimes.com/2021/08/18/us/washington-state-teachervaccine-mandate.html (last visited 02/19/2022); https://www.governor.ny.gov/news/governor-cuomo-announcescovid-19-vaccination-mandate-healthcare-workers(lastvisited02/19/2022);
https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx(lastvisited02/19/2022); https://www.nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited
02/19/2022);
https://www.denvergov.org/Government/COVID-19-Information/Public-Health-OrdersResponse/News-Updates/2021/Mayor-Hancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (lastvisited2/19/2022);
https://www.bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-stateemployees/ (last visited 02/19/2022).
22

https://www.congress.gov/bill/117th-congress/house-bill/4980?q=%7B%22search%22:%5b%224980%252 (lastvisited 02/19/2022).
23

https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military
02/19/2022).
24

(last

visitedSee New York bill S6495, available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
02/19/2022).

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all state employees, 25 and even for all citizens of several states. 26 As explained by Dr. Anthony
Fauci, “a flood” of vaccine mandates follow FDA approval of a COVID-19 vaccine, 27 andPresident Biden has actively encouraged “companies in the private sector to step up the vaccine
requirements[.]” 28
During a time when COVID-19 vaccine mandates are being implemented over theobjection of those that have questions about the data and information supporting the safety andefficacy of the Moderna Vaccine, and individuals with these questions are being expelled from
employment, school, transportation, and the military, the public has an urgent and immediate needto have access to this data. The value of this information will be all but useless to these individuals
if they are forced to receive a vaccine prior to seeing the data relied upon by the FDA and thevarious institutions mandating approved vaccines. Without immediate access to the data, many ofthese individuals will forever lose the chance to evaluate the data for themselves and see whether
this vaccine is indeed “safe and effective” prior to being mandated to receive it.
Having multiple trusted independent authorities, including PHMPT, review the safety andeffectiveness data sought in this FOIA request will almost certainly assist these individuals in
evaluating their vaccine decisions. For all of these reasons, PHMPT has demonstrated its request
significantly concerns matters of current exigency to the American public. Therefore, the first
factor in FOIA’s “compelling need” analysis weighs heavily in favor of granting expedited
processing.
(ii)

Consequences in delaying a response would compromise significant recognizedinterests

With respect to the second factor in the “compelling need” analysis, the consequences ofdelaying a response to PHMPT’s FOIA request would compromise significant recognizedinterests. As described above, the FDA’s regulations recognize the public’s interest in having
aspects of the biological product file “immediately available for public disclosure.” 21 C.F.R. §601.51(e). The regulation specifically enables the public to see firsthand the safety andeffectiveness data and information relating to the Moderna Vaccine. Id. This regulation, likemany others that regulate public health and consumer products, is built on significant recognized
25

See, e.g., https://www.nj.com/coronavirus/2021/08/murphy-orders-vaccination-requirement-for-all-nj-stateworkers-including-at-public-colleges.html (last visited 02/19/2022).
26

See New York bill A11179, available at https://www.nysenate.gov/legislation/bills/2019/A11179. See generally
https://eastcountytoday.net/buffy-wicks-transportation-bill-could-become-california-vaccine-passport-bill/(lastvisited 02/19/2022).
27

https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-fullapproval/5513121001/ (last visited 2/19/22).
28

https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-following-Pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 02/19/2022). See also
https://www.nytimes.com/2021/08/23/us/Pfizer-vaccine-mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts toannounce vaccine mandates for their employees”) (last visited 02/19/2022); https://www.msn.com/enus/news/us/now-that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccinationrates-in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeongeneral-vivek-murthy-says-205530053.html (quoting the Surgeon General referring to vaccine mandates as“reasonable”) (last visited 02/19/2022).

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interests, such as “informed consent” and “consumer protection.” This fact is further demonstratedby FDA’s mission statements published on its website: “[T]he mission of FDA is to enforce laws
enacted by the U.S. Congress and regulation established by the agency to protect the consumer’shealth, safety, and pocketbook” 29; “FDA is responsible for advancing the public health by . . .
helping the public get the accurate, science-based information they need to use medical products
and foods to maintain and improve their health.” 30 Moreover, notions of informed consent havebeen codified in jurisdictions all across the United States. For example, in Texas, a “recovery may
be obtained [when there is] negligence in failing to disclose the risks or hazards that could haveinfluenced a reasonable person in making a decision to give or withhold consent.” 31
A sense of trust is created when a product becomes licensed by the FDA, and therefore, as
explained by Dr. Fauci, “a flood” of vaccine mandates follow FDA approval of a COVID-19
vaccine. 32 As anticipated, after the FDA’s approval of Pfizer’s COVID-19 vaccine, Comirnaty,
President Biden actively encouraged “companies in the private sector to step up the vaccine
requirements[.]” 33
Additionally, Moderna has recently requested EUA for its vaccines for children 34 and theserequests are based on data that relate to the clinical trials used for Spikevax. The requested data
underlies the immunobridging that is now occurring in the trials for children 6 months through 17
years of age and would shed light on the efficacy of those vaccines. Parents across the country are
currently being faced with the decision of whether or not to vaccinate their children, whether or
not to administer a booster to their child, and, if so, to choose which vaccine to administer. In
order to make an informed decision and to give informed consent, all of the relevant data should
be disclosed in a timely manner. Otherwise, these parents will be unable to make a truly informed
choice until that happens.
The combination of COVID-19 vaccine mandates, additional EUAs being granted for
different age groups, and the lack of disclosure regarding the determination of the products safety

29

https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-related-laws-regulations-andguidances (last visited 03/16/22).
30

https://www.fda.gov/about-fda/what-we-do (last visited 2/19/22).

31

Tex. Civ. Prac. & Rem. Code § 74.101.

32

https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-fullapproval/5513121001/ (last visited 2/19/22).
33

https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-following-Pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 02/19/2022). See also
https://www.nytimes.com/2021/08/23/us/Pfizer-vaccine-mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts toannounce vaccine mandates for their employees”) (last visited 02/19/2022); https://www.msn.com/enus/news/us/now-that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccinationrates-in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeongeneral-vivek-murthy-says-205530053.html (quoting the Surgeon General referring to vaccine mandates as“reasonable”) (last visited 02/19/2022).
34

See https://www.cnn.com/2022/04/28/health/moderna-vaccine-eua-young-children/index.html and https://www.
healio.com/news/primary-care/20220323/moderna-seeks-covid19-vaccine-authorization-for-kids-younger-than-6.

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and effectiveness, violates the significant recognized interests of informed consent and consumer
protection.
Without disclosure, consumers that are confronted with COVID-19 vaccine mandates areforced to choose between taking a vaccine without the science-based information necessary to
make an informed decision, or losing their job, occupational benefits, access to medical
procedures, 35 and access to educational opportunities. 36 Therefore, no matter a person’s choice
when confronted with a COVID-19 vaccine mandate, a delay in the disclosure of the science-based
information used to determine the Moderna Vaccine’s safety and effectiveness compromises
significant recognized interests: informed consent and consumer protection.
For the reasons set forth above, PHMPT has demonstrated that a delay of its FOIA request
would compromise significant recognized interests. Thus, the second factor in FOIA’s“compelling need” analysis weighs heavily in favor of granting expedited processing.
(iii)

PHMPT’s request concerns federal government activity

Finally, the information PHMPT seeks clearly concerns actual or alleged federal
government activity for at least two reasons. First, the FDA, a federal agency, has a regulatory
obligation to release aspects of the Moderna Vaccine’s biological product file such that it is“immediately available for public disclosure” after a license has been issued. 21 C.F.R. §601.51(e). Such aspects include all safety and effectiveness data and information. Id.
Second, and perhaps most importantly, PHMPT’s request concerns whether the FDA
approved the Moderna Vaccine based on adequate data and information. PHMPT requested
information relating to the federal licensing of the Moderna Vaccine. This particular request
significantly concerns the federal government’s activity since the federal government was not
only involved in the licensure of the Moderna Vaccine but, crucially, the federal government wasalso heavily involved in the vaccine’s research and development. According to the National
Institutes of Health’s (NIH) website:[B]ecause of [the] work that NIH was already doing when the COVID-19 pandemic
began, researchers were able to come up with a vaccine for this new virus much
faster . . .Years before the COVID-19 pandemic began, experts at the NIH Vaccine
Research Center (VRC) were studying coronaviruses to find out how to protect
against them . . . The VRC worked with a company called Moderna to use thisinformation to quickly customize their prototypes approach to the SARS-CoV-2
spike protein. By early February [2020], a COVID-19 vaccine candidate had been
designed and manufactured. This Vaccine is called mRNA 1273 . . . the NIH35

https://www.bbc.com/news/world-us-canada-60132765 (last visited 03/16/22);
https://www.wsoctv.com/news/local/i-will-die-free- unvaccinated-burke-county-man-denied-kidney-transplant-byhospital/OJGAFURR4FGERJB7VT24P5RED4/ (last visited 03/16/22);
https://www.nbc11news.com/2021/10/08/colorado-hospital-denies-unvaccinated-patient-transplant/ (last visited
03/16/22); https://www.foxnews.com/us/uva-hospital-refused-unvaccinated-transplant (last visited 03/16/22);
https://www.businessinsider.com/ohio-woman-liver-disease-denied-transplant-vaccine-cleveland-clinic-2021-10.
36

See New York bill S6495, available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
02/19/2022).

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Moderna vaccine was authorized by the U.S. Food and Drug Administration (FDA)
for emergency use. (emphasis added) 37
The federal government’s activities in designing and manufacturing the “NIH-Moderna
vaccine” is particularly important because federal employees that were a part of its development
and therefore are potential co-owners of the patents involved in the Moderna Vaccine. See U.S.
Application No. 62/972,886 & No. 16/344,774; see also Research Collaboration Agreement 20171179 & “Material Transfer Agreement” executed on 12/16/2019. 38 Moreover, under 15 U.S.C. §3710c, which regulates the “Distribution of royalties received by Federal agencies,” federal
agencies and their employees are authorized to profit from the licensing and assignment of
inventions, such as the Moderna Vaccine. The federal government has already spent $6 billion
helping develop, test, and manufacture the “NIH-Moderna vaccine.” 39 The combination ofpotential conflicts of interest within the federal government itself, and the large sums of taxpayer
money spent to obtain the FDA’s approval of the Moderna Vaccine, requires immediatetransparency into the federal government’s activities. Thus, the third factor in FOIA’s “compellingneed” analysis weighs heavily in favor of granting expedited processing.
PHMPT has demonstrated (i) the request concerns a matter of current exigency to theAmerican public, (ii) the consequences of delaying a response would compromise a significant
recognized interest, and (iii) the request concerns federal government activity. Therefore, PHMPT
has reasonably established under FOIA a “compelling need” for the expedited processing of its
request. 5 U.S.C. § 552(a)(6)(E)(v)(II)C.

Conclusion

Given the foregoing, ICAN hereby appeals and urges the FDA to grant its request forexpedited processing within 20 days of this appeal. Thank you for your time and attention to thismatter. If you require any additional information, please contact us at (212) 532-1091 or throughemail at foia@sirillp.com.

37

https://covid19.nih.gov/news-and-stories/vaccine-development (last visited 03/16/22).

38

https://www.citizen.org/article/the-nih-vaccine/#_ftn2 (last visited 03/16/22).

39

https://www.statnews.com/2021/04/30/u-s-government-has-invested-6-billion-in-modernas-covid-19-vaccine/(last visited 03/16/22).

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Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.
Enclosures

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Exhibit 1

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FREEDOM OF INFORMATION ACT REQUESTEXPEDITED PROCESSING REQUESTEDVIA ONLINE PORTAL

February 23, 2022

Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Re: Moderna COVID-19 Vaccine Biological Product File (IR#0710)
Dear Sir or Madam:This firm represents Public Health and Medical Professionals for Transparency(“PHMPT”).
On January 31, 2022, the Food and Drug Administration (“FDA”) approved the Moderna 1
COVID-19 Vaccine, marketed as Spikevax (the “Moderna Vaccine”) for individuals 18 years ofage and older. On behalf of PHMPT and its individual members, please provide the following
records to foia@sirillp.com in electronic form:
All data and information for the Moderna Vaccine enumerated
in 21 C.F.R. § 601.51(e) 2 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System. 3

1

For purposes of this request, Moderna shall be interpreted to include Moderna, Inc. and any of its parents, subsidiaries
and affiliates.
2
21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”3
For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e) withthe exception of publicly available reports on the Vaccine Adverse Events Reporting System.

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

I.

Page 15 of 25 PageID 56

EXPEDITED PROCESSING REQUESTEDPHMPT requests expedited processing for this request as it meets the requirements forexpedited processing under both FDA’s FOIA Regulations as well as FOIA itself.
A. PHMPT Qualifies for Expedited Processing Under FOIA
FOIA provides for “expedited processing of requests for records” upon a showing of“compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(I). The requestor shows a “compelling need” when
it is “primarily engaged in disseminating information,” and there is an “urgency to inform thepublic concerning actual or alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
Here, PHMPT is an organization made up of public health professionals, medical
professionals, scientists, and journalists. PHMPT exists for the sole purpose of disseminating to
the public the data and information in the biological product files for each of the COVID-19
vaccines. PHMPT intends to make any records produced in response to this FOIA request
immediately available to the public through both its website and its individual members’ platforms.
Many of PHMPT’s individual members, including all its members that are journalists, areprimarily engaged in disseminating information to the public and do so across various platforms,
including through interviews, articles, blogs, essays, and podcasts. Therefore, PHMPT and manyof its members are “primarily engaged in disseminating information [] to inform the public,” and,as explained below, there is a clear “urgency to inform the public concerning actual or alleged
Federal Government activity,” which in this case is the data and information underlying thelicensure of the Moderna Vaccine. Accordingly, expedited processing of this request under FOIA
is warranted.
B. PHMPT Qualifies for Expedited Processing Under the FDA’s FOIA
Regulations
Notably, separate and apart from the FDA’s obligation to comply with FOIA, it has anindependent duty to inform the public concerning the data and information underlying a licensed
vaccine. The FDA’s Regulations expressly provide that “[a]fter a license has been issued, thefollowing 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 andinformation . . .” 21 C.F.R. § 601.51(e)(1) (emphasis added). Thus, the FDA’s own regulations
expressly recognize the importance of having the data and information relied upon to license a
vaccine “immediately available for public disclosure.” Id. This policy supports the FDA’s
claimed commitment to, 4 and assurances of, transparency 5 as a lack of transparency erodes theconfidence the medical and scientific communities and the public have in the conclusions reachedby the FDA. However, the fact that the FDA did not release the documents following licensure
necessitated this FOIA request.

4

https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparencycovid-19-euas (last visited 2/19/2022).
5
https://www.fda.gov/about-fda/transparency/transparency-initiative (last visited 2/19/2022); https://www.fda.gov/n
ews-events/speeches-fda-officials/fostering-transparency-improve-public-health (last visited 2/19/2022).

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But aside from the FDA’s duty to make immediately available the safety and effectivenessdata of a licensed vaccine, the FDA’s FOIA regulations anticipate scenarios where FOIA requests
must be expedited. Specifically, a requestor is entitled to expedited processing where:(1) The requester is primarily engaged in disseminating information
to the general public and not merely to a narrow interest group;(2) There is an urgent need for the requested information and that it
has a particular value that will be lost if not obtained anddisseminated quickly; however, a news media publication or
broadcast deadline alone does not qualify as an urgent need, nordoes a request for historical information; and(3) The request for records specifically concerns identifiable
operations or activities of the Federal Government.
21 C.F.R. § 20.44(c)(1)-(3).
PHMPT easily meets all three requirements. As noted above, PHMPT is an organization
made up of public health professionals, medical professionals, scientists, and journalists that was
created and exists for the sole purpose of disseminating to the public the data and information in
the biological product files for each of the COVID-19 vaccines. Therefore, PHMPT is certainly“primarily engaged in disseminating information to the general public.” 21 C.F.R. § 20.44(c)(1).
Next, there is plainly an urgent public need for transparency with regard to the data relied
upon in licensing the Moderna Vaccine for at least two distinct reasons beyond the FDA’s own
regulations which admit the urgent need for transparency and disclosure of this information. As
required by Congress, the FDA may only license vaccines that have been proven to be “safe andeffective,” see, e.g., 21 U.S.C. § 393, and the FDA makes this determination based on, inter alia,
clinical trial reports provided by the sponsor which must be sufficient to demonstrate the productis both “safe” and “effective.” 6 21 C.F.R. 601.2(a). There is, however, an ongoing, public national
debate regarding the adequacy of the data and information, and analyses of same, relied upon by
the FDA to license the COVID-19 vaccines, including the Moderna Vaccine. On the one hand,
there are numerous public health officials, media outlets, journalists, scientists, politicians, public
figures, and others with large social or media platforms that have declared that the data andinformation underlying the licensure of the Moderna Vaccine is more than sufficient for licensure.
For example, in a statement released on January 31, 2022, acting FDA Commissioner Janet
Woodcock, M.D., stated:
The public can be assured that Spikevax meets the FDA’s highstandards for safety, effectiveness and manufacturing quality
6

The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download (last visited
02/19/2022). See also https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (last visited
02/19/2022); https://www.fda.gov/about-fda/what-we-do (last visited 02/19/2022).

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required of any vaccine approved for use in the United States. Whilehundreds of millions of doses of Moderna COVID-19 Vaccine havebeen administered to individuals under emergency use
authorization, we understand that for some individuals, FDA
approval of this vaccine may instill additional confidence in making
the decision to get vaccinated. 7
Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation andResearch, made similar remarks:
The FDA’s medical and scientific experts conducted a thoroughevaluation of the scientific data and information included in theapplication pertaining to the safety, effectiveness, andmanufacturing quality of Spikevax. This includes the agency’s
independent verification of analyses submitted by the company, ourown analyses of the data, along with a detailed assessment of the
manufacturing processes, test methods and manufacturing facilities. . . Safe and effective vaccines are our best defense against the
COVID-19 pandemic, including currently circulating variants. The
public can be assured that this vaccine was approved in keeping with
the FDA’s rigorous scientific standards. 8
Even prior to FDA approval of the Moderna Vaccine, government officials, public healthauthorities, and medical professionals repeatedly claimed that COVID-19 vaccines were “safe andeffective.” 9
On the other hand, numerous public health officials, media outlets, journalists, scientists,
politicians, public figures, and others with large social or media platforms have publicly raisedquestions regarding the sufficiency of the data and information, the adequacy of the review, andappropriateness of the analyses relied upon to license the Moderna Vaccine, including a numberof the scientists and journalists that are members of PHMPT. For example, in July 2021, a groupof 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi, Ph.D.,
Senior Editor for The BMJ and Associate Professor of Pharmaceutical Health Services Researchat the University of Maryland School of Pharmacy, 10 and Peter A. McCullough, M.D. filed anamended Citizen Petition 11 with the FDA, claiming that the available evidence for licensure of the7

https://www.cnn.com/2022/01/31/health/moderna-covid-vaccine-fda-approval/index.html.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
9See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 02/19/2022). See also
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccines have proven to be safe, effective and life-saving.”) (last visited 02/19/2022); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID-19 vaccines are safe”)(last visited 02/19/2022).
10
https://www.bmj.com/about-bmj/editorial-staff/peter-doshi (last visited 02/19/2022).
11
https://www.regulations.gov/document/FDA-2021-P-0521-0001 (last visited 02/19/2022).
8

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Moderna Vaccine “is simply not mature enough at this point to adequately judge whether clinicalbenefits outweigh the risks in all populations.” 12 Separately, Dr. Doshi has publicly questioned
the lack of transparency regarding the vaccine approval process 13 which Dr. Peter Marks publicly
disputed. 14 Aaron Kheriaty, M.D., former-Professor of Psychiatry at UCI School of Medicine,former-Director of the Medical Ethics Program at UCI Health, 15 and a member of PHMPT, hasalso questioned the FDA’s approval process. For example, in an article published in the WallStreet Journal, Dr. Kheriaty questioned the need for student vaccination requirements based on,among other things, a review 16 by the FDA’s Vaccines and Related Biological Products Advisory
Committee that indicates a risk of heart inflammation after vaccination. 17 Government officials
have raised similar concerns about the lack of transparency in the review process, arguing that it
is “essential” for the FDA to, among other things, “make the data generated by clinical trials andsupporting documents submitted to the FDA by developers available to the public.” 18 PHMPT
incorporates by reference, as if cited and fully set forth herein, any and all articles, media, andpublications regarding or reflecting the public discussion, discourse, and debate regarding theModerna Vaccine, including all matters related to the licensure of this product.
Given this widespread and ongoing public debate, the medical and scientific communities
and the public have an immediate need to review the data and information underlying the licensureof the Moderna Vaccine. Public disclosure of this information will inform this ongoing publicdebate. Releasing this data should also confirm the FDA’s conclusion and thus increase
confidence in the safety and efficacy of the Moderna Vaccine.
Secondly, and perhaps even more significantly, there is an urgent need for the public tohave immediate access to the data and information underlying the licensure of the Moderna
Vaccine because, over the objections of many, this product is being mandated to individuals across12

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/ (last visited 02/19/2022).
13
See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-Pfizer-and-modernas-95effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2020/
11/26/peter-doshi-Pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/(lastvisited 02/19/2022).
14
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-Pfizer-biontech-vaccine/ (lastvisited 02/19/2022).
15
https://www.aaronkheriaty.com/bio (last visited 02/19/2022).
16
https://www.fda.gov/media/150054/download (last visited 02/19/2022)17
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220 (last visited
02/19/2022).
18
https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 02/19/2022).

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the country by the federal government, 19 local governments, 20 public and private employers,21
universities, 22 schools, 23 and various other institutions, 24 and many are expected to follow suit.
At the federal level, legislation was introduced that would require COVID-19 vaccines for air
travel into or out of the United States, 25 and the Pentagon has mandated the COVID-19 vaccines

19

See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 02/19/2022); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-vaccine-4cf7451267919302de4a7b591508e80c (last visited 02/19/2022); https://media.defense.gov/
2021/Aug/25/2002838826/-1/-1/0/MEMORANDUM-FOR-MANDATORY-CORONAVIRUS-DISEASE-2019VACCINATION-OF-DEPARTMENT-OF-DEFENSE-SERVICE-MEMBERS.PDF(last visited 2/19/2022);
https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-biden-to-announcenew-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (last visited 02/19/2022).
20
See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited
02/19/2022); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 2/19/2022); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 02/19/2022).
21
See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited
02/19/2022); https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 2/19/2022); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 02/19/2022); https://www.kpbs.org/news/2021/aug/17/encinitas-covid19-vaccine-negative-test-employees/ (last visited 02/19/2022); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-sweep-across-corporate-america-as-delta-surges.html (last visited 2/19/2022); https://www.reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 02/19/2022); https://thehill.com/policy/healthcare/569051-Pfizers-full-approval-triggers-new-vaccine-mandates (last visited 02/19/2022);
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-andcorporate-employees (last visited 02/19/2022).
22
See (last visited 02/19/2022). See also, e.g., https://www.nbcnews.com/health/health-news/colleges-universitiescovid-vaccination-mandates-facing-pushback-n1273916 (last visited 02/19/2022); https://www.colorado.edu/covid19-updates/covid-19-vaccination (last visited 02/19/2022); https://uhs.berkeley.edu/requirements/covid19 (last visited
02/19/2022);
https://huhs.harvard.edu/covid-19-vaccine-requirement-faqs(lastvisited02/19/2022);
https://www2.gmu.edu/safe-return-campus/vaccination-requirements (last visited 2/07/2022).
23
See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-schooldistrict-mandates-vaccines-for-eligible-students (last visited 2/19/2022); https://patch.com/massachusetts/salem/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 2/19/2022); https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 02/19/2022);
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-upget-vaccine-or-face-weekly-testing.html (last visited 02/19/2022); https://www.mercurynews.com/2021/08/19/lacounty-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 02/19/2022).
24
See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachersstaff-mayor-2021-08-23/ (last visited 02/19/2022); https://www.cbsnews.com/news/california-covid-vaccineteachers-mandate/ (last visited 02/19/2022); https://www.nytimes.com/2021/08/18/us/washington-state-teachervaccine-mandate.html (last visited 02/19/2022); https://www.governor.ny.gov/news/governor-cuomo-announcescovid-19-vaccination-mandate-healthcare-workers(lastvisited02/19/2022);
https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx(lastvisited02/19/2022); https://www.nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited
02/19/2022);
https://www.denvergov.org/Government/COVID-19-Information/Public-Health-OrdersResponse/News-Updates/2021/Mayor-Hancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (lastvisited 2/19/2022); See https://www.bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-stateemployees/ (last visited 02/19/2022).
25
https://www.congress.gov/bill/117th-congress/house-bill/4980?q=%7B%22search%22:%5b%224980%252 (lastvisited 02/19/2022).

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for all military personnel. 26 At the state level, legislation has been introduced to require COVID19 vaccines for all post-secondary students, 27 all state employees, 28 and even for all citizens ofvarious states. 29 As explained by Dr. Anthony Fauci, “a flood” of vaccine mandates follow FDA
approval of a COVID-19 vaccine, 30 and President Biden has actively encouraged “companies in
the private sector to step up the vaccine requirements[.]” 31 During a time when COVID-19 vaccine
mandates are being implemented over the objection of those that have questions about the data andinformation supporting the safety and efficacy of the Moderna Vaccine, and individuals with thesequestions are being expelled from employment, school, transportation, and the military, the public
has an urgent and immediate need to have access to this data. The value of this information willbe all but useless to these individuals if they are forced to receive a vaccine prior to seeing the data
relied upon by the FDA and various institutions mandating approved vaccines. Without immediate
access to the data, many of these individuals will forever lose the chance to evaluate the data forthemselves and see whether this vaccine is indeed “safe and effective” prior to being mandated toreceive it. Having multiple trusted independent authorities, including PHMPT, review the safety
and effectiveness data sought in this FOIA request will almost certainly assist these individuals in
evaluating their vaccine decisions. Therefore, for all of these reasons, PHMPT has shown there is“an urgent need for the requested information and that it has a particular value that will be lost if
not obtained and disseminated quickly.” 21 C.F.R. § 20.44(c)(2).
Finally, PHMPT’s request meets the third requirement for expedited processing – that“[t]he request for records specifically concerns identifiable operations or activities of the Federal
Government.” 21 C.F.R. § 20.44(c)(3). Here, PHMPT’s records request specifically concerns
identifiable activities—i.e., approval of the Moderna Vaccine—by the Federal Government—to
wit, the FDA.
In light of the above, PHMPT has demonstrated that its request qualifies for expedited
processing under both the FDA’s FOIA regulations, as well as FOIA itself. PHMPT incorporates
by reference, as if cited and fully set forth herein, any and all articles, media, and publications
26

https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military (last visited
02/19/2022).
27
See New York bill S6495, available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
02/19/2022).
28
See, e.g., https://www.nj.com/coronavirus/2021/08/murphy-orders-vaccination-requirement-for-all-nj-stateworkers-including-at-public-colleges.html (last visited 02/19/2022).
29
See New York bill A11179, available at https://www.nysenate.gov/legislation/bills/2019/A11179. See generally
https://eastcountytoday.net/buffy-wicks-transportation-bill-could-become-california-vaccine-passport-bill/(lastvisited 02/19/2022).
30
https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-fullapproval/5513121001/ (last visited 2/19/22).
31
https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-following-Pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 02/19/2022). See also
https://www.nytimes.com/2021/08/23/us/Pfizer-vaccine-mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts toannounce vaccine mandates for their employees”) (last visited 02/19/2022); https://www.msn.com/enus/news/us/now-that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccinationrates-in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeongeneral-vivek-murthy-says-205530053.html (quoting the Surgeon General referring to vaccine mandates as“reasonable”) (last visited 02/19/2022).

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regarding or reflecting the public discussion, discourse, and debate regarding the mandating or
potential mandating of the Moderna Vaccine. PHMPT certifies that the information in this request
is true and correct to the best of its knowledge and belief.
II.

FEE WAIVER REQUESTPHMPT is a nonprofit and asks that you waive any and all fees or charges pursuant to 5
U.S.C. § 552(a)(4)(A)(iii) on the basis that “disclosure of the [requested] information is in the
public interest because it is likely to contribute significantly to public understanding of theoperations or activities of the government[.]” Specifically, disclosure of the requested information
will immediately address the ongoing public debate about the safety and efficacy of the Moderna
Vaccine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
requests will not contribute to any commercial activities.
Note that in the event only a portion or portions of a requested file are exempted fromrelease, the remainder must still be released. We therefore request that we be provided with all
non-exempt portions which are reasonably segregable or can be deidentified. We further requestthat you describe any redacted, deleted, or withheld material in detail and specify the statutory
basis for the denial as well as your reasons for believing that the alleged statutory justification
applies. Please also separately state your reasons for not invoking your discretionary powers torelease the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. PHMPT reserves all rights to appeal the withholding or deletionof any information.
A determination regarding expedited processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the dateof your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial ofthis request and PHMPT may immediately file an administrative appeal or an action.
If you would like to discuss our requests or any issues raised in this letter, please feel free
to contact Aaron Siri at (212) 532-1091 or foia@sirillp.com during normal business hours. Thankyou for your time and attention to this matter.
Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.

Page 8 of 8

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Exhibit 2

Page 22 of 25 PageID 63

Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

Page 23 of 25 PageID 64

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Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22

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Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22

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Exhibit 4

Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22

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Annalise Beube
From:
Sent:
To:
Subject:

FDA FOIA <FDAFOIA@fda.hhs.gov>
Wednesday, June 1, 2022 12:04 PM
S&G Information Request Staff; FDA FOIA
RE: [EXTERNAL] Expedited Processing Appeal of FOIA Control #2022-1614 (IR#0710)

Follow Up Flag:
Flag Status:

Follow up
FlaggedAppeal file: 22-0076AA
June 1, 2022
Sending via Email: foia@sirillp.com
This letter acknowledges receipt of your Freedom of Information Act (FOIA) appeal, submitted to the Foodand Drug Administration (FDA). We received your appeal on June 1, 2022. Your appeal challenges the Foodand Drug Administration (FDA’s) response to your original request #2022-1614. Your appeal has been
assigned the above-stated case number based on when it was received in this office. Please reference thisnumber on your correspondence.
Your appeal is summarized below:
Denial of Expedited Processing

Pursuant to 5 U.S.C. § 552(a)(6)(B)(i) and 5 U.S.C. § 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the
HHS FOIA regulations, your appeal falls under “unusual circumstances” in that our office will need to consult
with another office that has substantial interest in the determination of the appeal. The actual processing time
will depend on the complexity of the issues presented in the appeal. For more information about how yourappeal will be processed please refer to the HHS FOIA regulations
https://www.federalregister.gov/documents/2016/10/28/2016-25684/freedom-of-information-regulations).
The FOIA and the HHS FOIA regulations are available at the following web addresses:
https://www.justice.gov/oip/freedom-information-act-5-usc-552 andhttps://www.federalregister.gov/documents/2016/10/28/2016-25684/freedom-of-information-regulations.
If you have any questions, please call (301)796-8975, or email us at fdafoia@fda.hhs.gov.
Sincerely yours,

Sarah Kotler
FDA FOIASarahB.Kotler,J.D.
Director,DivisionofFreedomofInformation
1

Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22

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USFDA
301Ͳ796Ͳ8976

From:S&GInformationRequestStaff<foia@sirillp.com>
Sent:Wednesday,June1,202211:36AM
To:FDAFOIA<FDAFOIA@fda.hhs.gov>
Subject:[EXTERNAL]ExpeditedProcessingAppealofFOIAControl#2022Ͳ1614(IR#0710)

CAUTION:Thisemailoriginatedfromoutsideoftheorganization.Donotclicklinksoropenattachmentsunlessyourecognizethesenderandknowthecontentissafe.

DearSirorMadam,
Attachedpleasefindourclient’sappeal.
Thankyou,
AnnaliseBeube,LawClerkSiri|Glimstad
700SFlowerStreet
Suite1000
LosAngeles,CA90017
Main:212Ͳ532Ͳ1091
Facsimile:646Ͳ417Ͳ5967
www.sirillp.com
Thisemailmaycontainmaterialthatisconfidential,privilegedand/orattorneyworkproductforthesoleuseoftheintendedrecipient.Any
review,relianceordistributionbyothersorforwardingwithoutexpresspermissionisstrictlyprohibited.Ifyouarenottheintendedrecipient,
pleasecontactthesenderanddeleteallcopies.

2

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Exhibit 5

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FDA FREEDOM OF INFORMATION ACT REQUESTVIA ONLINE PORTAL

August 8, 2022

Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Re: Biological Product File for Comirnaty vaccine for 12-15 year-olds (IR#0820)
Dear Sir or Madam:This firm represents Public Health and Medical Professionals for Transparency(“PHMPT”).
On July 8, 2022, the Food and Drug Administration (“FDA”) approved the PfizerBioNTech COVID-19 Vaccine, marketed as Comirnaty for individuals 12 through 15 years of age(the “12-15-Year-Old Pfizer Vaccine”). On behalf of PHMPT and its individual members, pleaseprovide the following records to foia@sirillp.com in electronic form:
All data and information for the 12-15-Year-Old Pfizer Vaccine
enumerated in 21 C.F.R. § 601.51(e) 1 with the exception of
publicly available reports on the Vaccine Adverse Events
Reporting System. 2
This request excludes any data and information responsive toand being produced in FOIA Control # 2021-5683 (previously
1

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”2

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the 12-15-Year-Old 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.

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made on behalf of PHMPT) and is meant to capture all data andinformation within the biological product file that concerns theauthorization and approval of Comirnaty for use in 12-15-yearolds.
Expedited Processing Requested
PHMPT requests expedited processing for this request. FOIA provides for “expedited
processing of requests for records” upon a showing of “compelling need.” 5 U.S.C.
§ 552(a)(6)(E)(i)(I). The requestor shows a “compelling need” when it is “primarily engaged indisseminating information,” and there is an “urgency to inform the public concerning actual or
alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
PHMPT is an organization made up of public health professionals, medical professionals,
scientists, and journalists. PHMPT exists for the sole purpose of disseminating to the public thedata and information in the biological product files for each of the COVID-19 vaccines. PHMPT
intends to make any records produced in response to this FOIA request immediately available tothe public through both its website and its individual members’ platforms. Many of PHMPT’s
individual members, including all its members that are journalists, are primarily engaged indisseminating information to the public and do so across various platforms, including throughinterviews, 3 articles, 4 blogs, 5 essays, 6 and podcasts. 7 Therefore, PHMPT and many of its members
are “primarily engaged in disseminating information to the general public,” and, as explained
below, there is a clear “urgency to inform the public concerning actual or alleged Federal
3

See, e.g., https://www.foxnews.com/transcript/ingraham-angle-on-mask-mandates-bidens-failure-in-his-role(Harvey Risch).
4See, e.g., https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi); https://www.bmj.com/content/371/bmj.m4058(Peter
Doshi);
https://www.bmj.com/content/371/bmj.m4037(Peter
Doshi);
https://
www.wsj.com/articles/are-covid-vaccines-riskier-than-advertised-11624381749;
https://www.wsj.com/articles/
university-vaccine-mandates-violate-medical-ethics-11623689220 (Aaron Kheriaty and Gerard V. Bradley);
https://thefederalist.com/2021/07/05/how-college-covid-vaccine-mandates-put-students-in-danger/ (Andrew Bostom,
Aaron Kheriaty, Peter A. McCullough, Harvey A. Rish, Michelle Cretella, and Gerard V. Bradley);
https://thefederalist.com/2021/08/18/why-forcing-unvaccinated-students-to-wear-cloth-masks-is-anti-science/(Andrew
Bostom,GerardBradley,
Aaron
Kheriaty,
andHarveyRisch);
https://www.bmj.com/content/bmj/374/bmj.n1737.full.pdf(Serena
TinariandCatherineRiva);
https://www.bmj.com/content/372/bmj.n627(Serena
Tinari);https://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735 (Sarah Tanveer, Anisa Rowhani-Farid,
Kyungwan Hong, Tom Jefferson, Peter Doshi); https://www.arcdigital.media/p/medical-ethicist-sues-the-university(Justin Lee).
5

See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-acovid-19-vaccine/ (Peter Doshi); https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95effective-vaccines-lets-be-cautious-and-first-see-the-full-data/ (Peter Doshi). See also https://www.recheck.ch/wordpress/en/covid-certificate/ (Catherine Riva and Serena Tinari).
6See
https://www.andrewbostom.org/2021/06/why-collegiate-covid-19-vaccine-mandates-are-lysenkoist-antiscience/ (Andrew Bostom).
7

See, e.g., https://www.andrewbostom.org/2021/05/dr-andrew-bostom-discusses-the-unfavorable-risk-benefit-ratioof-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorizationonly-mrna-vaccine/ (Andrew Bostom).

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Government activity,” here, the data and information underlying the licensure of the 12-15-YearOld Pfizer Vaccine. Accordingly, expedited processing of this request is warranted.
Recognizing the urgency to inform the public concerning the data and information
underlying a licensed vaccine, the Code of Federal Regulations expressly provides that “[a]fter alicense 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…” 21 C.F.R. § 601.51(e) (emphasis added). The
FDA’s own regulations thus expressly recognize the importance of having the data and information
relied upon to license a vaccine “immediately available for public disclosure.” Id. The FDA’s
regulation not only supports the need for expedited treatment under FOIA but is also an
independent legal basis that requires expedited treatment of this request.
This policy is not surprising given the FDA’s commitment to transparency and its entire
program to assure transparency, because a lack of transparency erodes the confidence the medical
and scientific community and the public have in the conclusions reached by the FDA. 8 There isan urgent public need for such transparency with regard to the 12-15-Year-Old Pfizer Vaccine. As
required by Congress, the FDA may only license vaccines that have been proven to be “safe andeffective,” see, e.g., 21 U.S.C. § 393, and the FDA makes this determination based on, inter alia,
clinical trial reports provided by the sponsor which must be sufficient to demonstrate the productis both “safe” and “effective.” 9 21 C.F.R. 601.2(a). On July 8, 2022, the FDA granted approval to
the 12-15-Year-Old Pfizer Vaccine 10 and, beyond the FDA’s own regulations which admit theurgent need for transparency and disclosure in this situation, there are two additional reasons thatwarrant expedited treatment of this request.
First, there is an ongoing, public national debate regarding the adequacy of the data andinformation, and analyses of same, relied upon by the FDA to license the 12-15-Year-Old Pfizer
Vaccine. For example, on June 1, 2021, a group of 27 clinicians, scientists, and patient advocates,
including PHMPT members Peter Doshi, senior editor for The BMJ and associate professor ofpharmaceutical health services research at the University of Maryland School of Pharmacy, 11 andPeter A. McCullough, professor of medicine at Texas A&M College of Medicine, filed a Citizen
Petition12 with the FDA, claiming that the available evidence for licensure of the Pfizer Vaccine“is simply not mature enough at this point to adequately judge whether clinical benefits outweigh
the risks in all populations.” 13 Separately, Peter Doshi has publicly questioned the lack of
8https://www.fda.gov/about-fda/transparency.

9
The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download; See also
https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved; https://www.fda.gov/about-fda/what-wedo.
10

See https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

11

https://www.bmj.com/about-bmj/editorial-staff/peter-doshi.

12

https://www.regulations.gov/document/FDA-2021-P-0521-0001.

13

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/.

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transparency regarding the vaccine approval process 14 which Peter Marks publicly disputed.15
Andrew Kheriaty, professor of psychiatry at UCI School of Medicine, Director of the Medical
Ethics Program at UCI Health, 16 and a member of PHMPT, has also questioned the FDA’s
approval process. For example, in an article published in the Wall Street Journal, Dr. Kheriaty
questioned the need for student vaccination requirements based on, among other things, a review17
by the FDA’s Vaccines and Related Biological Products Advisory Committee that indicates a riskof heart inflammation after vaccination. 18 Government officials have raised similar concerns about
the lack of transparency in the review process, arguing that it is “essential” for the FDA to, among
other things, “make the data generated by clinical trials and supporting documents submitted to
the FDA by developers available to the public[.]” 19 PHMPT incorporated by reference, as if citedand fully set forth herein, any and all articles, media, and publications regarding or reflecting the
public discussion, discourse and debate regarding the 12-15-Year-Old Pfizer Vaccine, including
all matters related to the licensure of this product.
More recently, a paper published on June 23, 2022 titled Serious Adverse Events of Special
Interest Following mRNA Vaccination in Randomized Trials states: “These study limitations allstem from the fact that the raw data from COVID-19 vaccine clinical trials are not publicly
available. Given the global public health implications, there is an urgency to make all
COVID-19 trial data public, particularly regarding serious adverse events, without any
further delay.” 20
Many of these concerns also stem back to FDA’s May 10, 2021 reissuance of theEmergency Use Authorization (“EUA”) letter of authorization for use of Pfizer-BioNTech’s
COVID-19 in children ages 12 through 15. 21 These public debates have generated substantial
evidence that calls into question the scientific justifications for FDA to issue an EUA for children
12 through 15 when (i) the data does not demonstrate that the known benefits outweigh the known
risks and (ii) there are serious concerns regarding how the trials were conducted. These issues havebeen thoroughly cited and explained in a recent citizen petition filed with the Division of Dockets
Management within the Department of Health and Human Services on May 20, 2022. 22 These
concerns remain unsettled and part of the national debate. However, with the recent FDA approval
14

See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/;
https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-weneed-more-details-and-the-raw-data/; https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95effective-vaccines-lets-be-cautious-and-first-see-the-full-data/.
15

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/.

16

https://www.aaronkheriaty.com/bio.

17

https://www.fda.gov/media/150054/download.

18

https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220.

19

https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf; See also https://www.washingtontimes.com/news/2021/aug/23/editorialthe-coincidental-timing-of-pfizers-vacci/.
20

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239 (emphasis added).

21

https://www.fda.gov/media/144412/download.

22

https://www.regulations.gov/document/FDA-2022-P-0872-0001.

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of the 12-15-Year-Old Pfizer Vaccine, these concerns have generated even more urgency andimportance. Large portions of the public have legitimate fears that FDA never fully demonstrated
whether the known benefits outweigh the known risks 23 for this particular age group for the 1215-Year-Old Pfizer Vaccine, or if the FDA corrected the serious concerns regarding how the 1215-Year-Old Pfizer Vaccine trials were conducted.
Secondly, now that FDA has approved the 12-15-Year-Old Pfizer Vaccine, there are many
indications that states and school districts will begin mandating these vaccines for children toattend public school. 24 Washington, D.C. has already announced a mandate for students ages 12
and older. 25 With legislators, policy makers, and parents deciding how best to protect children as
they return to school this fall, there is no more urgent, or appropriate time for the immediate
disclosure of the 12-15-Year-Old Pfizer Vaccine’s biological product file (“BLA file”). The
public’s value in the release of the BLA file would be significantly diminished if the disclosure isdelayed because millions of children, their parents, and their policy makers will be making medical
decisions and policies in the coming months. If the disclosure of the BLA file is delayed, many ofthese children and parents will be forced to make irreversible medical decisions before theindependent scientific community, and journalist have time to review, and report upon whether
FDA resolved the outstanding concerns regarding its prior EUA when recently approving andlicensing the 12-15-Year-Old Pfizer Vaccine.
In light of the above, PHMPT has demonstrated that its request qualifies for expedited
processing under FOIA. PHMPT incorporates by reference, as if cited and fully set forth herein,
any and all articles, media, and publications regarding or reflecting the public discussion,
discourse, and debate regarding the mandating or potential mandating of the 12-15-Year-Old
Pfizer Vaccine. PHMPT certifies that the information in this request is true and correct to the bestof its knowledge and belief.
Fee Waiver Requested
We ask that you waive any and all fees or charges pursuant to 5 U.S.C. § 552(a)(4)(A)(iii).
PHMPT is a nonprofit and asks that you waive any and all fees or charges pursuant to 5 U.S.C. §552(a)(4)(A)(iii) on the basis that “disclosure of the [requested] information is in the public interest
because it is likely to contribute significantly to public understanding of the operations or activitiesof the government[.]” Specifically, disclosure of the requested information will immediately
address the ongoing public debate about the safety and efficacy of the 12-15-Year-Old Pfizer
Vaccine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
requests will not contribute to any commercial activities.

23

https://www.floridahealth.gov/newsroom/2022/03/20220308-FDOH-covid19-vaccination-recommendationschildren.pr.html.
24https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-covid-19-vaccinerequirements-for-schools/; See also https://www.latimes.com/california/story/2022-01-24/new-vaccine-legislationcalifornia-schoolchildren-mandate.
25

See https://abcnews.go.com/US/dc-require-students-12-older-vaccinated-covid-19/story?id=87130087.

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Note that in the event only a portion or portions of a requested file are exempted fromrelease, the remainder must still be released. We therefore request that we be provided with all
non-exempt portions which are reasonably segregable or can be deidentified. We further requestthat you describe any redacted, deleted, or withheld material in detail and specify the statutory
basis for the denial as well as your reasons for believing that the alleged statutory justification
applies. Please also separately state your reasons for not invoking your discretionary powers torelease the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. PHMPT reserves all rights to appeal the withholding or deletionof any information.
A determination regarding expedited processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the dateof your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial ofthis request and PHMPT may immediately file an administrative appeal or an action. Furthermore,
we specifically request that the agency provide us with an estimated date of completion for thisrequest.
If you would like to discuss our requests or any issues raised in this letter, please feel free
to contact Aaron Siri at (212) 532-1091 or foia@sirillp.com during normal business hours. Thankyou for your time and attention to this matter.
Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.

Page 6 of 6

Case 4:22-cv-00915-P Document 1-6 Filed 10/11/22

Page 1 of 2 PageID 77

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Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

Exhibit 7

Page 1 of 21 PageID 79

Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

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FDA FREEDOM OF INFORMATION ACT REQUESTEXPEDITED PROCESSING REQUESTEDVIA ONLINE PORTAL

August 22, 2022

Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Re: de Garays’ request for Pfizer's BLA file for 12- to 15-year-olds (IR#0832)
Dear Sir or Madam:This firm represents Patrick and Stephanie de Garay, parents of“de Garays”).

de Garay (theOn July 8, 2022, the Food and Drug Administration (“FDA”) approved the PfizerBioNTech COVID-19 Vaccine, marketed as Comirnaty for individuals 12 through 15 years of age(the “12-15-Year-Old Pfizer Vaccine”). On behalf of the de Garays, please provide the following
records to foia@sirillp.com in electronic form:
All data and information for the 12-15-Year-Old Pfizer Vaccine
enumerated in 21 C.F.R. § 601.51(e) 1 with the exception of
publicly available reports on the Vaccine Adverse Events
Reporting System. 2

1

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (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. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”2

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the 12-15-Year-Old 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.

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This request excludes any data and information responsive toand being produced in FOIA Control # 2021-5683 (as that will
be publicly available) and is meant to capture all data andinformation within the biological product file that concerns theauthorization and approval of Comirnaty for use in 12-15-yearolds.
Expedited Processing Requested
The de Garays request expedited processing for this request. FOIA provides for “expedited
processing of requests for records” upon a showing of “compelling need.” 5 U.S.C.
§ 552(a)(6)(E)(i)(I). The requestor shows a “compelling need” when it is “primarily engaged indisseminating information,” and there is an “urgency to inform the public concerning actual or
alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
The de Garays seek this information because their family has been deeply affected by theadverse reactions their daughter has suffered following receipt of the 12-15-Year-Old Pfizer
Vaccine. Mr. and Mrs. de Garay’s daughter,(“”), was a participant in Pfizer’s
clinical trial for the 12-15-Year-Old Pfizer Vaccine. (See de Garay Declaration, Exhibit 1). After
receiving her second shot,
began suffering from an extreme adverse reaction that
ultimately necessitated her use of a feeding tube and wheelchair. 3 Over a year and a half later,
is still suffering. Since this tragedy, the de Garays, who claim to be both “pro-vaccine,
but also pro-informed consent” have become vocal advocates in alerting the public about thepotential serious adverse reactions the 12-15-Year-Old Pfizer Vaccine may cause. 4 Thus, this is
the primary reason they make this FOIA request.
As part of their advocacy, they have worked with a number of media organizations andadvocacy groups. One of these groups is Informed Consent Action Network (“ICAN”). ICAN’s
mission is to disseminate scientific health information to the public. (See Exhibit 2.) In pursuitof its mission, ICAN relies on its own investigative reporting and the help of institutional
whistleblowers and citizen activist, such as de Garays. ICAN is both instrumental in orchestrating
cutting edge investigations into the safety of various medical products, as well as widely
disseminating its findings through various media channels. Most notably, ICAN’s popular website
hosts the organization’s largest education program, The HighWire with Del Bigtree. Utilizing its
media teams’ 40+ years of experience in TV production and investigative journalism, The
HighWire provides hours of new video content to the public each week for free. Most recently,
the de Garays were featured on a nearly two-hour long exposé on the HighWire that detailed thefull story behindparticipation in the 12-15-Year-Old Pfizer Vaccine clinical trial, hersubsequent serious adverse reactions, and the de Garays’ attempt to receive support and answers
from governmental institutions tasked with the oversight of Pfizer’s experimental vaccine. 53https://www.foxnews.com/media/ohio-woman-daughter-covid-vaccine-reaction-wheelchair.

4

Id.

5

See https://thehighwire.com/videos/rigged-maddies-story/.

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The HighWire website has approximately 3.4 million weekly visitors. On Twitter, The
HighWire has approximately 140,000 followers and 1 to 2.5 million impressions in a 28-day
period. Between Rumble and Bitchute, The HighWire has approximately 60,000 followers andgrowing. Additionally, ICAN has 29,000 text subscribers and 194,245 email subscribers. The sizeof ICAN’s audience and subscribers continues to grow and is illustrative of the wide public interestin the subject of health and medical safety. Thus, the de Garays’ story will likely be seen by
millions of people. Moreover, the de Garays’ working relationship with ICAN and the HighWire
provides them with the necessary infrastructure to pursue their goals of public advocacy regarding
12-15-Year-Old Pfizer Vaccine, and to widely disseminated any and all records they receive fromthis FOIA request.
Therefore, between the de Garays’ history of public advocacy regarding the 12-15-YearOld Pfizer Vaccine, and their involvement with media organizations on the issue, regarding the
subject of this FOIA request, they are “primarily engaged in disseminating information to thegeneral public.” Furthermore, as explained below, there is a clear “urgency to inform the publicconcerning actual or alleged Federal Government activity,” here, the data and information
underlying the licensure of the 12-15-Year-Old Pfizer Vaccine. Accordingly, expedited
processing of this request is warranted.
Recognizing the urgency to inform the public concerning the data and information
underlying a licensed vaccine, the Code of Federal Regulations expressly provides that “[a]fter alicense 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…” 21 C.F.R. § 601.51(e) (emphasis added). The
FDA’s own regulations thus expressly recognize the importance of having the data and information
relied upon to license a vaccine “immediately available for public disclosure.” Id. The FDA’s
regulation not only supports the need for expedited treatment under FOIA but is also an
independent legal basis that requires expedited treatment of this request.
This policy is not surprising given the FDA’s commitment to transparency and its entire
program to assure transparency, because a lack of transparency erodes the confidence the medical
and scientific community and the public have in the conclusions reached by the FDA. 6 There isan urgent public need for such transparency with regard to the 12-15-Year-Old Pfizer Vaccine. As
required by Congress, the FDA may only license vaccines that have been proven to be “safe andeffective,” see, e.g., 21 U.S.C. § 393, and the FDA makes this determination based on, inter alia,
clinical trial reports provided by the sponsor which must be sufficient to demonstrate the productis both “safe” and “effective.” 7 21 C.F.R. 601.2(a). On July 8, 2022, the FDA granted approval to
the 12-15-Year-Old Pfizer Vaccine 8 and, beyond the FDA’s own regulations which admit the6

https://www.fda.gov/about-fda/transparency.

7
The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”(https://www fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download; See also
https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved; https://www fda.gov/about-fda/what-wedo.
8

See https://www fda.gov/news-events/press-announcements/fda-roundup-july-8-2022.

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urgent need for transparency and disclosure in this situation, there are two additional reasons thatwarrant expedited treatment of this request.
First, there is an ongoing, public national debate regarding the adequacy of the data andinformation, and analyses of same, relied upon by the FDA to license the 12-15-Year-Old Pfizer
Vaccine. For example, on June 1, 2021, a group of 27 clinicians, scientists, and patient advocates,
including PHMPT members Peter Doshi, senior editor for The BMJ and associate professor ofpharmaceutical health services research at the University of Maryland School of Pharmacy, 9 andPeter A. McCullough, professor of medicine at Texas A&M College of Medicine, filed a Citizen
Petition 10 with the FDA, claiming that the available evidence for licensure of the Pfizer Vaccine“is simply not mature enough at this point to adequately judge whether clinical benefits outweigh
the risks in all populations.” 11 Separately, Peter Doshi has publicly questioned the lack oftransparency regarding the vaccine approval process 12 which Peter Marks publicly disputed.13
Andrew Kheriaty, professor of psychiatry at UCI School of Medicine, Director of the Medical
Ethics Program at UCI Health, 14 and a member of PHMPT, has also questioned the FDA’s
approval process. For example, in an article published in the Wall Street Journal, Dr. Kheriaty
questioned the need for student vaccination requirements based on, among other things, a review15
by the FDA’s Vaccines and Related Biological Products Advisory Committee that indicates a riskof heart inflammation after vaccination. 16 Government officials have raised similar concerns about
the lack of transparency in the review process, arguing that it is “essential” for the FDA to, among
other things, “make the data generated by clinical trials and supporting documents submitted to
the FDA by developers available to the public[.]” 17More recently, a paper published on June 23, 2022 titled Serious Adverse Events of Special
Interest Following mRNA Vaccination in Randomized Trials states: “These study limitations allstem from the fact that the raw data from COVID-19 vaccine clinical trials are not publicly
available. Given the global public health implications, there is an urgency to make all9https://www.bmj.com/about-bmj/editorial-staff/peter-doshi.

10

https://www.regulations.gov/document/FDA-2021-P-0521-0001.

11

See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/.
12

See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/;
https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-weneed-more-details-and-the-raw-data/; https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95effective-vaccines-lets-be-cautious-and-first-see-the-full-data/.
13

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/.

14

https://www.aaronkheriaty.com/bio.

15

https://www.fda.gov/media/150054/download.

16

https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220.

17https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process .pdf; See also https://www.washingtontimes.com/news/2021/aug/23/editorialthe-coincidental-timing-of-pfizers-vacci/.

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COVID-19 trial data public, particularly regarding serious adverse events, without any
further delay.” 18
Many of these concerns also stem back to FDA’s May 10, 2021 reissuance of theEmergency Use Authorization (“EUA”) letter of authorization for use of Pfizer-BioNTech’s
COVID-19 in children ages 12 through 15. 19 These public debates have generated substantial
evidence that calls into question the scientific justifications for FDA to issue an EUA for children
12 through 15 when (i) the data does not demonstrate that the known benefits outweigh the known
risks and (ii) there are serious concerns regarding how the trials were conducted. These issues havebeen thoroughly cited and explained in a recent citizen petition filed with the Division of Dockets
Management within the Department of Health and Human Services on May 20, 2022. 20 These
concerns remain unsettled and part of the national debate. However, with the recent FDA approvalof the 12-15-Year-Old Pfizer Vaccine, these concerns have generated even more urgency andimportance. Large portions of the public have legitimate fears that FDA never fully demonstrated
whether the known benefits outweigh the known risks 21 for this particular age group for the 1215-Year-Old Pfizer Vaccine, or if the FDA corrected the serious concerns regarding how the 1215-Year-Old Pfizer Vaccine trials were conducted.
Secondly, now that FDA has approved the 12-15-Year-Old Pfizer Vaccine, there are many
indications that states and school districts will begin mandating these vaccines for children toattend public school. 22 Washington, D.C. has already announced a mandate for students ages 12
and older. 23 With legislators, policy makers, and parents deciding how best to protect children as
they return to school this fall, there is no more urgent, or appropriate time for the immediate
disclosure of the 12-15-Year-Old Pfizer Vaccine’s biological product file (“BLA file”). The
public’s value in the release of the BLA file would be significantly diminished if the disclosure isdelayed because millions of children, their parents, and their policy makers will be making medical
decisions and policies in the coming months. If the disclosure of the BLA file is delayed, many ofthese children and parents will be forced to make irreversible medical decisions before theindependent scientific community, and journalist have time to review, and report upon whether
FDA resolved the outstanding concerns regarding its prior EUA when recently approving andlicensing the 12-15-Year-Old Pfizer Vaccine.
In light of the above, the de Garays have demonstrated that their request qualifies forexpedited processing under FOIA. The de Garays certify that the information in this request istrue and correct to the best of their knowledge and belief.
18

https://papers.ssrn.com/sol3/papers.cfm?abstract id=4125239 (emphasis added).

19

https://www.fda.gov/media/144412/download.

20

https://www.regulations.gov/document/FDA-2022-P-0872-0001.

21

https://www.floridahealth.gov/newsroom/2022/03/20220308-FDOH-covid19-vaccination-recommendationschildren.pr html.
22

https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-covid-19-vaccinerequirements-for-schools/; See also https://www.latimes.com/california/story/2022-01-24/new-vaccine-legislationcalifornia-schoolchildren-mandate.
23

See https://abcnews.go.com/US/dc-require-students-12-older-vaccinated-covid-19/story?id=87130087.

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Fee Waiver Requested
We ask that you waive any and all fees or charges pursuant to 5 U.S.C. § 552(a)(4)(A)(iii).
The de Garays seek this information to aid in their public advocacy and to assist other organizations
who are interested in promoting the public’s informed consent of the use of the 12-15-Year-Old
Pfizer Vaccine. Thus, we asks that you waive any and all fees or charges pursuant to 5 U.S.C. §552(a)(4)(A)(iii) on the basis that “disclosure of the [requested] information is in the public interest
because it is likely to contribute significantly to public understanding of the operations or activitiesof the government[.]” Specifically, disclosure of the requested information will immediately
address the ongoing public debate about the safety and efficacy of the 12-15-Year-Old Pfizer
Vaccine and the clinical trials underlying the FDA’s approval of same. The information that thede Garays’ request will not contribute to any commercial activities.
Note that in the event only a portion or portions of a requested file are exempted fromrelease, the remainder must still be released. We therefore request that we be provided with all
non-exempt portions which are reasonably segregable or can be deidentified. We further requestthat you describe any redacted, deleted, or withheld material in detail and specify the statutory
basis for the denial as well as your reasons for believing that the alleged statutory justification
applies. Please also separately state your reasons for not invoking your discretionary powers torelease the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. The de Garays reserve all rights to appeal the withholding ordeletion of any information.
A determination regarding expedited processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the dateof your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial ofthis request and the de Garays may immediately file an administrative appeal or an action.
Furthermore, we specifically request that the agency provide us with an estimated date ofcompletion for this request.
If you would like to discuss our requests or any issues raised in this letter, please feel free
to contact Aaron Siri at (212) 532-1091 or foia@sirillp.com during normal business hours. Thankyou for your time and attention to this matter.
Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.

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Exhibit 1

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Exhibit A

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Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

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Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

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Exhibit B

Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

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Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22

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6$5$+.27/(5'LUHFWRUCIVIL COVER SHEETJS 44 (Rev. 10/20) - TXND (10/20)

Case 4:22-cv-00915-P Document 1-9 Filed 10/11/22

Page 1 of 2 PageID 102

The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except asprovided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)

I. (a) PLAINTIFFS
Public Health and Medical Professionals for Transparency, andPatrick and Stephanie de Garay(b) County of Residence of First Listed Plaintiff Tarrant

DEFENDANTS
Food and Drug Administration
County of Residence of First Listed Defendant(EXCEPT IN U.S. PLAINTIFF CASES)NOTE:(c) Attorneys (Firm Name, Address, and Telephone Number)(IN U.S. PLAINTIFF CASES ONLY)IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.

Attorneys (If Known)

Siri and Glimstad LLP 501 Congress Ave. Suite 150 - #343,
Austin TX 78701, 512-265-5622
II. BASIS OF JURISDICTION (Place an “X” in One Box Only)✖

1

U.S. Government
Plaintiff

3

Federal Question(U.S. Government Not a Party)

2

U.S. Government
Defendant

4

Diversity(Indicate Citizenship of Parties in Item III)

III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff(For Diversity Cases Only)
PTF
Citizen of This State
1
2

2

Incorporated and Principal Placeof Business In Another State

5

5

Citizen or Subject of a
Foreign Country33Foreign Nation

6

6

Click here for: Nature of Suit Code Descriptions.

TORTS

110 Insurance
120 Marine
130 Miller Act
140 Negotiable Instrument
150 Recovery of Overpayment& Enforcement of Judgment
151 Medicare Act
152 Recovery of Defaulted
Student Loans(Excludes Veterans)
153 Recovery of Overpayment
of Veteran’s Benefits
160 Stockholders’ Suits
190 Other Contract
195 Contract Product Liability
196 Franchise

REAL PROPERTY
210 Land Condemnation
220 Foreclosure
230 Rent Lease & Ejectment
240 Torts to Land
245 Tort Product Liability
290 All Other Real Property

PERSONAL INJURY
310 Airplane
315 Airplane Product
Liability
320 Assault, Libel &Slander
330 Federal Employers’
Liability
340 Marine
345 Marine Product
Liability
350 Motor Vehicle
355 Motor Vehicle
Product Liability
360 Other Personal
Injury362 Personal Injury Medical Malpractice
CIVIL RIGHTS
440 Other Civil Rights
441 Voting
442 Employment
443 Housing/Accommodations
445 Amer. w/Disabilities Employment
446 Amer. w/Disabilities Other
448 Education

and One Box for Defendant)
PTF
DEF
Incorporated or Principal Place
4
4of Business In This State

Citizen of Another State

IV. NATURE OF SUIT (Place an “X” in One Box Only)
CONTRACTDEF
1

PERSONAL INJURY
365 Personal Injury Product Liability
367 Health Care/
Pharmaceutical
Personal Injury
Product Liability
368 Asbestos Personal
Injury Product
Liability
PERSONAL PROPERTY
370 Other Fraud
371 Truth in Lending
380 Other Personal
Property Damage
385 Property Damage
Product Liability
PRISONER PETITIONS
Habeas Corpus:
463 Alien Detainee
510 Motions to Vacate
Sentence
530 General
535 Death Penalty
Other:
540 Mandamus & Other
550 Civil Rights
555 Prison Condition
560 Civil Detainee Conditions ofConfinement

FORFEITURE/PENALTYBANKRUPTCYOTHER STATUTES

625 Drug Related Seizureof Property 21 USC 881
690 Other

422 Appeal 28 USC 158
423 Withdrawal
28 USC 157

375 False Claims Act
376 Qui Tam (31 USC
3729(a))400 State Reapportionment
410 Antitrust
430 Banks and Banking
450 Commerce
460 Deportation
470 Racketeer Influenced andCorrupt Organizations
480 Consumer Credit(15 USC 1681 or 1692)
485 Telephone Consumer
Protection Act
490 Cable/Sat TV
850 Securities/Commodities/
Exchange
890 Other Statutory Actions
891 Agricultural Acts
893 Environmental Matters
895 Freedom of Information
Act
896 Arbitration
899 Administrative Procedure
Act/Review or Appeal of
Agency Decision
950 Constitutionality ofState Statutes

LABOR
710 Fair Labor Standards
Act
720 Labor/Management
Relations
740 Railway Labor Act
751 Family and Medical
Leave Act
790 Other Labor Litigation
791 Employee Retirement
Income Security Act

IMMIGRATION
462 Naturalization Application
465 Other Immigration
Actions

PROPERTY RIGHTS
820 Copyrights
830 Patent
835 Patent - Abbreviated
New Drug Application
840 Trademark
880 Defend Trade Secrets
Act of 2016
SOCIAL SECURITY
861 HIA (1395ff)
862 Black Lung (923)863 DIWC/DIWW (405(g))
864 SSID Title XVI
865 RSI (405(g))
FEDERAL TAX SUITS
870 Taxes (U.S. Plaintiff
or Defendant)
871 IRS—Third Party
26 USC 7609✖

V. ORIGIN (Place an “X” in One Box Only)
1 Original
Proceeding

2 Removed fromState Court

3

Remanded from
Appellate Court

4 Reinstated or
Reopened

5 Transferred from
Another District(specify)

6 Multidistrict
Litigation Transfer
Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):

5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1331
VI. CAUSE OF ACTION Brief description of cause:
Freedom of Information Act, 5 U.S.C. § 552
DEMAND $VII. REQUESTED INCHECK IF THIS IS A CLASS ACTION
UNDER RULE 23, F.R.Cv.P.
COMPLAINT:VIII. RELATED CASE(S)(See instructions):
IF ANYJUDGEMark T. Pittman
DATE

SIGNATURE OF ATTORNEY OF RECORD

Oct 11, 2022

/s/ Walker D. Moller

CHECK YES only if demanded in complaint:
JURY DEMAND:AMOUNTAPPLYING IFP

Yes✖

DOCKET NUMBER 4:21-cv-01058-P

FOR OFFICE USE ONLYRECEIPT #8 Multidistrict
Litigation Direct File

JUDGEMAG. JUDGENoJS 44 Reverse (Rev. 10/20) - TXND (10/20)

Case 4:22-cv-00915-P Document 1-9 Filed 10/11/22

Page 2 of 2 PageID 103

INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover SheetThe JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, isrequired for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
I.(a)
(b)

(c)

Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and thenthe official, giving both name and title.
County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at thetime of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, notingin this section "(see attachment)".

II.

Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box 1 or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, thecitizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
cases.)

III.

Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark thissection for each principal party.

IV.

Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit codethat is most applicable. Click here for: Nature of Suit Code Descriptions.

V.

Origin. Place an "X" in one of the seven boxes.
Original Proceedings. (1) Cases which originate in the United States district courts.
Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.
Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing
date.
Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.
Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or
multidistrict litigation transfers.
Multidistrict Litigation – Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.
Section 1407.
Multidistrict Litigation – Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket.
PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due tochanges in statue.

VI.

Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service.

VII.

Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.

VIII. Related Cases. This section of the JS 44 is used to reference related cases, if any. If a related case exists, whether pending or closed, insert thedocket numbers and the corresponding judge names for such cases. A case is related to this filing if the case: 1) involves some or all of the same
parties and is based on the same or similar claim; 2) involves the same property, transaction, or event; 3) involves substantially similar issues oflaw and fact; and/or 4) involves the same estate in a bankruptcy appeal.
Date and Attorney Signature. Date and sign the civil cover sheet.

Case 4:22-cv-00915-P Document 1-10 Filed 10/11/22

Page 1 of 2 PageID 104

UNITED STATES DISTRICT COURTNORTHERN DISTRICT OF TEXASPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY,andPATRICK AND STEPHANIE DE GARAY,

Civil Action No. 4:22-cv-915

Plaintiffs,-againstFOOD AND DRUG ADMINISTRATION,
Defendant.

RULE 7.1 STATEMENT
Pursuant to Federal Rule of Civil Procedure 7.1 and to enable District Judges andMagistrate Judges of the Court to evaluate possible disqualification or recusal, the undersigned
counsel for PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY (aprivate non-governmental party) and PATRICK AND STEPHANIE DE GARAY certifies that thefollowing are corporate parents, affiliates and/or subsidiaries of said party, which are publicly held.
None.

Case 4:22-cv-00915-P Document 1-10 Filed 10/11/22

Dated: October 11, 2022

Page 2 of 2 PageID 105

SIRI & GLIMSTAD LLP
Aaron Siri (pro hac vice to be filed)
Elizabeth A. Brehm (pro hac vice to be filed)
Colin Farnsworth (pro hac vice to be filed)745 Fifth Ave, Suite 500
New York, NY 10151
Tel: (212) 532-1091
aaron@sirillp.com
ebrehm@sirillp.com
cfarnsworth@sirillp.com/s/ Walker D. Moller
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