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1 UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
and
PAT
RICK AND STEPHANIE DE GARAY,
P
laintiff s,
-agai
nst-
FOOD AND DRUG ADMINISTRATION,
D
efendant.
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
Plaintiff s, as for their Complaint regarding Freedom of Information Act request s against
the above-captioned Defendant, allege as follows:
INTRODUCTION
1. On January 31, 2022, the Food and Drug Administration (“ FDA ”) approved the
Moderna 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
1https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approving -second -covid -19-vaccine .
2 https://www.fda.gov/news -events/press -announcements/fda -roundup -july-8-2022 . Civil Action No. ________4:22-cv-915Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 1 of 30 PageID 1
2 3. For the Moderna Vaccine, FDA asserts that “Spikevax meets the FDA’s high
standard for safety, effectiveness, and manufacturing quality required of any vaccine approved for
use in the United States.”3
4. Similarly, for the 12 -15-Year -Old Pfizer Vaccine, FDA asserts its “approval
follows a rigorous analysis and evaluation of t he 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 adequacy
of 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 ”) 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 of each of the COVID -19 vaccines.
7. In furtherance of its mission, and in an effort to ensure that FDA acts in furtherance
of 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 and
older. 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.
3https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approving- second -covid -19-vaccine.
4 https://www.fda.gov/news -events/press -announcements/ fda-roundup -july-8-2022 .
5 https://www.fda.gov/about -fda/transparency . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 2 of 30 PageID 2
3 8. 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 is
also recognized under federal regulation which provides: “After a license has been issued, the
following data and information in the biological product file are immediately available for public
disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information. (2) A protoc ol for a test or study . . . .” 21 C.F.R. § 601.51(e).
9. U
pon licensure for each of the COVID- 19 Vaccines , PHMPT therefore issued two
request s to FDA pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended)
(“FOIA ”) for “[a]ll data and infor mation 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 t he medical and scientific community have a substantial interest in
reviewing the data and information underlying FDA’s approval of the COVID -19 Vaccines .
6 21 C.F.R. § 601.51(e) provides that, after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A proto col 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 particula r
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
7 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.
8 https://www.f oxnews.com/media/ohio- woman -daughter -covid -vaccine -reaction -wheelchair ; see also
https://thehighwire.com/videos/rigged -maddies -story/ . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 3 of 30 PageID 3
4 12. 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 polic ies based
on the information that is publicly available and publicized by influential participants on both side s
of 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 file s (“BLA file s”). The public’s value in the release of the BLA file s would
be significantly diminished if the disclosure were delayed because millions of Americans , and their
policy makers , will be mak ing these medical and policy decisions in the coming months. If the
disclosure of the BLA file s is delayed, many of these Americans, and many on behalf of their
children , will be forced to make irreversible medical decisions before the independent scientific
community and journalists have had time to review and report upon the bas is for FDA’s licensure
of 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 r equest s pursuant to 5
U.S.C. § 552(a)(6)(E)(v)(II). Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 4 of 30 PageID 4
5 16. 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, o n 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 an
order 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 public
health 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 School
of 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, University
of Oxford , Institute for Scientific Freedom, University of Toronto, University of A uckland,
University of Muenster, and Deutenomics Science Institute, as well as other universities and
journalists . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 5 of 30 PageID 5
6 22. Patrick and Stephanie de Garay reside in Clermont County, Ohio and are the parents
of 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 Servic es. FDA is an agency within the
meaning 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 .
9 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 -we-
do. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 6 of 30 PageID 6
7 A. FDA Licensure of Pfizer’s Comirnaty Vaccine and PHMPT’s Related Case
27. Upon licensure of Pfizer’s first COVID -19 vaccine, Comirnaty, for use in
individuals 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 documents
from 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 of
the production. That BLA file is currently being produced and, to date, has resulted in approximately 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 and 4.5 million views in the last 12 months .
30. Once the entirety of the BLA file has been produced, independent experts and
researchers 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 of
age and older, Pfizer conducted clinical trials in children ages 12 to 15 years old. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 7 of 30 PageID 7
8 32. The Plaintiffs’ daughter, M.D ., was one of the participant s 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 of
receivi ng 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 resul t 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 a
feeding 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, and
ongoing adverse reaction to the 12-15- Year -Old Pfizer Vaccine was categorized as “functional
abdominal pain .”14
33. Notwithstanding the de Garays ’ reporting of their daughter’s wide range of severe
symptoms, Pfizer’s in accurate and misleading characterization thereof, and the safety alarms that
this should have been ringing, FDA granted the vaccine EUA and subsequently licensed the use
of 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.)
11 https://thehighwire.com/videos/rigged -maddies -story/ (see video at 6:44 -8:20)
12 Id.
13 See generally i d.
14 Id. at 1:04:40
15 See https://www.fda.gov/news -events/press -announcements/fda -roundup- july-8-2022 . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 8 of 30 PageID 8
9 34. The Moderna Vaccine was likewise licens ed 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 and
effectiveness 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 and
information, 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, and
manufacturing quality require d 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 approva l of this vaccine may instill additional
confidence in making the decision to get vaccinated.17
Peter Marks, MD, PhD, the D irector of FDA’s Center for Biologics Evaluation and Research,
made similar remarks:
16 https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approving- second -covid -19-vaccine.
17 https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approving- second -covid -19-vaccine. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 9 of 30 PageID 9
10 The FDA’s medical and scientific experts conducted a thorough
evaluation of the scientific data and information included in the
application pertaining to the safety, effectiveness, and
manufacturing quality of Spikevax [the Moderna Vaccine] . This
includes the agency’s independent verification of analys es
submitted by the company, our own 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.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.”19
40. For the 12-15- Year -Old Pfizer Vaccine, FDA asserts that its approval followed “ a
rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA”20 and the
Center 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 generally21 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 already
administered in the United States, and billions of vaccines
administered globally, demonstrate that they are safe and effective.
18 Id.
19 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
vaccines have proven to be safe, effective and life -saving.”); https://www.
doh.wa.gov/Emergencies/COVID19/Vaccine -Information/Safety -and-Effectiveness ( “COVID- 19 vaccines are
safe.”).
20 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 . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 10 of 30 PageID 10
11 41. 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 V accines,
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 patient
advocates, including PHMPT members Peter Doshi, PhD, Senior E ditor for The BMJ and
Associate Professor of P harmaceutical 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 Petition23 with FDA, stating that the available evidence
for licensure of the COVID -19 V accines “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 process25 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 from
22 https://www.bmj.com/about- bmj/editorial- staff/peter -doshi .
23 https://www.regulations.gov/document/FDA -2021-P- 0521- 0001 .
24 See https://blogs.bmj.com/bmj/2021/06/08/why -we-petitioned -the-fda-to-refrain -from -fully -approving -any-covid -
19-vaccine -this-year/ .
25 See https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval -of-a-covid -
19-vaccine/ ; https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -pfizer -and-modernas -95-effective -vaccines -we-
need -more -details -and-the-raw-data/ ; 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/ .
26 https://www.statnews.com/2020/12/17/did -the-fda-understaff -its-review -of-the-pfizer -biontech -vaccine/ . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 11 of 30 PageID 11
12 COVID- 19 vaccine clinical trials are not publicly available. Given th e 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 refle ct issues which should have been
seen during the clinical trial if it had been conducted properly and the results fully report ed 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 show ed 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 by
time 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 effe ctiveness
of 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 Edito r: Effects of Vaccination and Previous Infection on Omicron Infections in
Children, NEJM (Sept. 22, 2022) https://www.nejm.org/doi/full/10.1056/NEJMc2209371?query=featured_home .
29See https://www.rivm.nl/covid -19-vaccinatie/bescherming -coronava ccins -tegen -ziekenhuisopname/booster -en-
herhaalprik -bij-ouderen- nodig -om-bescherming- op-peil-te-brengen (Dutch version) . https://www.rivm.nl/en/covid -
19-vaccination/vaccine- effectiveness -in-preventing- hospital -admissions/covid- 19-booster -jab-and-repeat -
vaccination -needed -for-older -people -to-restore -protection ( English version). Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 12 of 30 PageID 12
13 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 in
children in Italy states: “ Our estimates of the effectiveness of full vaccination
against SARS -CoV- 2 infection are significantly lower than those reported in the
clinical trial that led to the approval of BNT 162b2 in children (90.7% in the
approval trial vs 29.4% in our study) .” The study also states, “our estimates of
vaccine 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 U nited S tates, 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 with
these vaccines, including data that reflect issues which should have been seen during the clinical
30 See Florentino, P.T. et al., Vaccine effectiveness of two -dose BNT162b2 against symptomatic and severe COVID -
19 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 in
children 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 .
32 See Fleming -Dutra, K., et al., Association of Prior BNT162b2 COVID -19 Vaccination With Symptomatic SARS-
C0V-2 Infection in Children and Adolescents During Omicron Predominance, AMA JAMA (June 14, 2022)
https://pubmed.ncbi.nlm.nih.gov/35560036/ . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 13 of 30 PageID 13
14 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, ack nowledged that deaths had resulted from
myocarditis post -vaccination, identifying 345 people in England who had died of
myocarditis 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, “T he true incidence of myopericarditis is
markedly higher than the incidence reported to US advisory committees,” as the study had identified “approximately twice as many cases of myopericarditis following COVID-19 mRNA vaccination.”
35
33 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/ .
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 .
35 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 , MedR xiv (Dec. 27, 2021),
https://www.medrxiv.org/content/10.1101/2021.12.21.21268209v1.full.pdf . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 14 of 30 PageID 14
15 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 found
higher rates of vaccine -induced myocarditis than COVID -19-induce d 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 Vaccines
concerns matters of current exigency to the American public because it has also led to invasive
policy decisions that affect the livelihoods of the American publi c. Over the objections of many,
Americans are still being mandated or otherwise pressured to take this product by the federal
36 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 .
37 Patone, M., et al. , Risk of Myocarditis Following Sequential COVI D-19 Vaccinations by Age and Sex , MedRxiv
(Dec; 25, 2021), https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf+html . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 15 of 30 PageID 15
16 government,38 local governments,39 public and private employers,40 universities,41 schools,42 and
various 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 for
38 See, e.g., https://www.natlawreview.com/article/covid -19-vaccine- added -to-requirements -green -card-processing-
effective- 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 -FOR -
MANDATORY- CORONAVIRUS -DISEASE -2019- VACCINATION- OF-DEPARTMENT -OF-DEFENSE -
SERVICE -MEMBERS.PDF .
39 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 .
40 See, e.g., https://www.cnbc.com/2021/08/06/united- airlines -vaccine- mandate- employees.html ; https://san
francisco.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/news -
and-insights/statements/cvs -health -will- require -covid -19-vaccinations -for-clinical- and-corporate -employees .
41 See e.g. , https://blockclubchicago.org/2022/07/18/will -your-college -still-require -covid -vaccinations -now-that-the-
state-dropped -its-mandate/ ; https://www.nbcnews.com/health/health -news/colleges -universities -covid- vaccination -
mandates -facing -pushback- n1273916 ; https://www.colorado.edu/covid- 19-updates/covid- 19-vaccination ; https://
uhs.berkeley.edu/requirements/covid19 .
42 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 -district-
mandates -vaccines -for-eligible -students ; https://patch.com/massachusetts/salem/salem -school -committee -approves -
vaccine- mandate- sports -band ; https://www.nbcnewyork.com/news/coronavirus/nyc -will-require -vaccination -for-
high- risk-school -sports/3232745/ ; https://www.nj.com/hudson/2021/08/hoboken- believed -to-be-first-in-state-to-
issue -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/ .
43 See, e.g., https://www.reuters.com/world/us/new -york-city-mandates -covid -19-vaccine -public -school -teachers -
staff-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/gover nor-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 -Announces -
COVID- 19-Vaccine- Requirement -for-Employees ; https://www.bostonherald.com/2021/08/19/baker -issues-vaccine-
mandate- for-42000 -state-employees/ . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 16 of 30 PageID 16
17 children to attend public school.44 Washington, D.C. has already announced a mandate for
students ages 12 and older.45
III. PHMPT’s FOIA Request for the Moderna Vaccine’s BLA File
48. In furtherance of PHMPT’s mission to disseminate information to the public, and
in 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 produced
on 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 reports
on 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 “ Denia l Letters ”) and assigned the request FOIA Control # 2022-
1614. 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 a compelling need that involves an imminent threat to the life or
44https://www.gov.ca.gov/2021/10/01/california -becomes -first-state-in-nation -to-announce -covid- 19-vaccine-
requirem ents-for-schools/ ; see also https://www.latimes.com/california/story/2022 -01-24/new -vaccine- legislation -
california -schoolchildren -mandate.
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 .
47 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (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 ot her 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 particula r
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
48 For the avoidance of doubt, this 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 Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.
Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 17 of 30 PageID 17
18 physical safety of an individual. Neither have you demonst rated that
there exists an urgency to inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying your
request for expedited processing.
(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 F DA, it was required to make a
determination with respect to PHMPT’s appeal for expedited processing by July 15, 2022. As of
the 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, and
in 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 of
49 https://www.fda.gov/about -fda/transparency .
50 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (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 particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].” Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 18 of 30 PageID 18
19 publicly available reports on the Vaccine Adverse Events Reporting
System.51
This request excludes any data and information responsive to and
being 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 and
approval 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 par t:
I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstra ted that
there exists an urgency to inform the public concerning actual or alleged Federal Government activity. Therefore, I am denying your request for expedited processing.
(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): :
51 For the avoidance of doubt, this 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 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.
52 https://www.fda.gov/about -fda/transparency . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 19 of 30 PageID 19
20 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 and
being 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 and
approval 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 # 2022-
6129. In the de Garays ’ Denial L etter, 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 a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity. Therefore, I am denying your request for expedited processing.
(Exhibit 8.)
ARGUMENT
57. FOIA provides for “expedited processing of request for records” upon a showing
of “compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)( I). As defined by FOIA, a “compelling need”
53 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (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 particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
54 For the avoidance of doubt, this 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 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. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 20 of 30 PageID 20
21 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 P laintiffs can demonstrate a “compelling
need ” for the expedited processing of their FOIA request s. 5 U.S.C. § 552(a)(6)(E)(i)(I); 5 U.S.C.
§ 552(a)(6)(E)(v)(II).
I. Plaintiff s Are Primarily Engaged in Disseminating Information
61. In this instance, FDA’s Denial Letters do not challenge the Plaintiffs’ claims that
they 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 Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 21 of 30 PageID 21
22 members that are journalists, are primarily engaged in disseminating information to the public and
do so across various platforms, including through interviews,56 articles,57 blogs,58 essays,59 and
podcasts.60 PHMPT and its member s fully intend to analyze and disseminate the data and
information 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 the
clinical 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 de
Garays ’ public advocacy, they have worked with a number of media organizations including Fox
56 See, e.g., https://www.foxnews.com/transcript/ingraham- angle -on-mask -mandates -bidens -failure -in-his-role
(Harvey Risch).
57 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/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/ (A ndrew 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.c om/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).
58 See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval -of-a-
covid- 19-vaccine/ (Peter Doshi) ; 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/ (Peter Doshi) ; see also https://www.re -
check.ch/wordpress/en/covid -certificate/ ( Catherine Riva and Serena Tinari).
59 See https://www.andrewbostom.org/2021/06/why -collegiate -covid- 19-vaccine- mandates -are-lysenkoist -anti-
science/ ( Andrew Bostom).
60 See, e.g ., https://w ww.andrewbostom.org/2021/05/dr -andrew -bostom -discusses -the-unfavorable -risk-benefit -ratio-
of-covid- 19-vaccination -of-very-low-covid -19-risk-12-to-17-year-olds-with-pfizers -emergency -use-authorization -
only- mrna -vaccine/ (Andrew Bostom).
61 See Patrick de Garay’s Declaration ( Exhibit 7 at pages 9- 10.)
62 https://www.foxnews.com/media/ohio -woman -daughter -covid -vaccine -reaction -wheelchair . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 22 of 30 PageID 22
23 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 with
individuals 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 by
Tucker 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 .
64 https://thefederalist.com/2021/06/29/twitter -censors -video- of-mother -describing -daughters -covid- 19-vaccine- side-
effects/ .
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 .
70 https://www.theepochtimes.com/the -vaccine -injured -and-their-fight -for-treatment -transparency -trial- participants -
stephanie -and-maddie -de-garay -and-brianne -dressen_4241609.html?welcomeuser=1 . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 23 of 30 PageID 23
24 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 P laintiffs are “primarily engaged in disseminating information to
the general public.” 5 U.S.C. § 552(a)(6)(E)(v)(II).
II. There I s 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 l icense 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 refore, 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-98826 54
6/.
75 https://thehighwire.com/videos/rigged -maddies -story/ . Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 24 of 30 PageID 24
25 66. Moreover, 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.”76 21 C.F.R. § 601.2(a). To assure FDA’s commitment to
transparency ,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 that
would be responsive to the Plaintiffs’ requests.
67. Beyond FDA’s own regulations which admit the urgent need for transparency and
disclosure 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 and information underlying the licensure of the COVID -19 Vaccines are mo re than sufficient for
licensure, numerous public health officials, media outlets, journalists, scientists, politicians, public
76 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 conditio n.” 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 -we-
do.
77 https://www.fda.gov/about -fda/transparency .
78 See, e.g., supra ¶¶ 36-45. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 25 of 30 PageID 25
26 figures, and others with large social or media platforms have publicly raised questions regarding
the sufficiency of the data an d information, the adequacy of the review, and appropriateness of the
analyses relied upon to license the COVID -19 Vaccines, including a number of the scientists and
journalists that are members of PHMPT.
70. The public debate is unlikely to be settled withou t full disclosure of the data and
information 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 to
the data and information underlying the licensure of the COVID -19 Vaccine because, over the
objections of many, this product has been, and continues to be mandated to individuals across the country 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 the
various 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 especially
relevant for United States Military. Despite the passage of deadlines for active- duty member s to
receive the COVID -19 vaccines, tens -of-thousands of active -duty service members refuse to get
them.81
79 See, e.g., supra ¶¶46-47.
80 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-unvaccinated -
rcna36269.
81 https://www.forbes.com/sites/teakvetenadze/2021/12/15/military -starts -ejecting -unvaccinated -service- members/
?sh= 7981d3146ed0. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 26 of 30 PageID 26
27 74. Most recently, the Army announced roughly 40,000 National Guardsmen and
22,000 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 and
prohibits 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 Army
reached 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 of
Staff 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 effectivenes s
data sought in these FOIA requests will only assist the public, as well as private institutions, in evaluating vaccine decisions and policies.
78. During a time when COVID-19 vaccine mandates are being implemented over the
objection of those who have questi ons about the data and information supporting the safety and
efficacy of the COVID -19 Vaccines , and individuals with these questions are being expelled from
82 https://nypost.com/2022/07/08/army- cuts-pay-from -over-60k-unvaccinated -national -guard- reserves/ .
83 https://thehill.com/opinion/national- security/3527921 -the-military -has-a-serious -recruiting -problem -congress -
must -fix-it/; see also https://www.military.com/daily -news/2022/07/06/army- cuts-off-more -60k-unvaccinated -guard-
and-reserve -soldiers -pay-and-bene fits.html .
84 Id.
85 https://www.pbs.org/newshour/politics/army -cuts-expected -force -size-amid -unprecedented -shortfall- of-recruits .
868686 See, e.g., supra ¶¶ 46-4 7. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 27 of 30 PageID 27
28 employment, school, transportation, restaurants, entertainment facilities, and the military, the
public 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 based
on adequate data and inf ormation. 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 effectivenes s data
and 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 data
from 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 doc uments and data
released to date by members of the public. The website itself has draw n over 2.7 million visitors
and 4.5 million views in the last 12 months which makes clear that the public, and especially
individuals involved in healthcare, have a sincere interes t 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 in
disseminating information and that there is an urgency to inform the public concerning actual or
87 21 C.F.R. § 601.51(e).
88 Id.
89 See, e.g. , supra ¶¶ 27 -30. Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 28 of 30 PageID 28
29 alleged Federal Government activity and, thus, FDA should provide expedited processing for the
requested records because Plainti ffs have a “compelling need”. 5 U.S.C. § 552(a)(6)(E)(i)(I).
REQUESTED RELIEF
WHEREFORE, Plaintiff s 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 atto rneys’ fees incurred in this action as
provided by 5 U.S.C. § 552(a)(4)(E); and d. Grant such other and further relief as the Court may deem just and proper.
Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 29 of 30 PageID 29
30 Dated: Octo ber 11, 2022 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
[email protected]
ebreh [email protected]
[email protected]
/s/ Walker D. Moller
Walker D. Moller (Texas Bar No. 24092851)
501 Congress Avenue, Suite 150 – #343
Austin, TX 78701
Tel : (512) 265-5622
wmo [email protected]
Attorneys for Plaintiffs Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page 30 of 30 PageID 30
Exhibit 1 Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 1 of 9 PageID 31
FREEDOM OF INFORMATION ACT REQUEST
EXPEDITED PROCESSING REQUESTED
VIA 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
(“PHMP T”).
On January 31 , 202 2, the Food and Drug Administration (“ FDA ”) approved the Moderna1
COVID -19 Vaccine, marketed as Spikevax (the “ Moderna Vaccine ”) for individuals 18 years of
age and older . On behalf of PHMPT and its individual members , please provide the following
records to [email protected] 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 made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol 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 o r 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 particul ar
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 biological
product file , as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e) with
the 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 Page 2 of 9 PageID 32
Page 2 of 8
I. EXPEDITED PROCESSING REQUESTED
PHMPT request s expedited processing for this request as it meets the requirements for
expedited 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 the
public 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, medic al
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 resp onse 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, are
primarily engaged in disseminating inform ation to the public and do so across various platforms,
including through interviews, articles, blogs, essays, and podcasts. Therefore, PHMPT and many
of its members are “primarily engaged in disseminating information [] to inform the public,” and,
as ex plained 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 the
licensure of the Moderna Vaccine. Accordingly, expedited processing of t his 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 an
independent 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, the
following data and information in the biological product file are immediately available for public
disclosure unless extrao rdinary circumstances are shown: (1) All safety and effectiveness data and
information . . .” 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 , transparency5 as a lack of transparency erodes the
confidence the medical and scientific communities and the public have in the conclusions reached
by 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 -transparency -
covid -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/fos tering -transparency -improve -public -health (last visited 2/19/2022). Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 3 of 9 PageID 33
Page 3 of 8
But aside from the FDA’s duty to make immediately available the safety and effectiveness
data of a licensed vaccine, the FDA’s FOIA regulat ions 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) T here 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; however, a news media publication or
broadcast deadline alone does not qualify as an urgent need, nor
does 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 requiremen ts. As noted above, PHMPT is an organization
made up of public health professionals, medical professionals, scientists, and journalists that was
created and e xists for the sole purpose of disseminating to the public the data and information in
the biologi cal 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 b eyond 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 vaccine s that have been proven to be “safe and
effective ,” 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 pr oduct
is 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 and
information underlying the licensure of the Moderna Vaccine is more than sufficient for licensure .
For example, i n a statement release d on January 31 , 202 2, acting FDA Commissioner Janet
Woodcock , M.D., stated :
The public can be assured that Spi kevax meets the FDA ’s high
standards 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 vi sited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 4 of 9 PageID 34
Page 4 of 8
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.7
Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation and
Research, made similar remarks :
The FDA’s medical and scientific experts conducted a thorough
evaluation of the scientific data and information included in the
application pertaining to the safety, effectiveness, and
manufacturing quality of Spikevax. This includes the agency’s
independ ent verification of analyses submitted by the company, our
own 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 t he
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 health
authorities, and medical professionals repeatedly claimed that COVID -19 vaccines were “safe and
effective.”9
On the other hand, numerous public health officials, media outlets, journalists, scientists,
politi cians, 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
appropriateness of the analyses relied upon to license the Moderna Vaccine, including a number
of the scientists and journalists that are members of PHMPT . For example, in July 2021, a group
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,10 and Peter A. McCullough, M.D. filed a n
amended Citizen Petition11 with the FDA, claiming that the available evidence for licensure of the
7 https://www.cnn.com/2022/01/31/health/moderna -covid -vaccine -fda-approval/index.html .
8 https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approv ing-second -covid -19-vaccine .
9 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) .
10 https://www.bmj.com/about -bmj/editorial -staff/peter -doshi (last visited 02/ 19/2022) .
11 https://www.regulations.gov/doc ument/FDA -2021 -P-0521 -0001 (last visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 5 of 9 PageID 35
Page 5 of 8
Moderna Vaccine “is simply not mature enough at this point to adequately judge whether clinical
benefits outweigh the risks in all populations .”12 Separately, Dr. Doshi has publicly questioned
the lack of transparency regarding the vaccine approval process13 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 He alth,15 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 review16 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 and
supporting documents submitted to the FDA by developers available to the public.”18 PHMPT
incorporate s 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
Moderna Vaccine , including all matters related to the licensure of this product .
Given this widespread and ongoing public debate, t he medical and scientific communit ies
and the public have an immediate need to review the data and information underlying the licensure
of the Moderna Vaccine . Public disclosure of this information will inform this ongoing public
debate . 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 significan tly, t here is an urgent need for the public to
have immediate access to the data and information underlying the licensure of the Moderna
Vaccine because , over the objection s of many , this product is being mandated to individuals across
12 See https://blogs.bmj.com/bmj/2021/06/08/why -we-petitioned -the-fda-to-refrain -from -fully -approving -any-covid -
19-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-covid -
19-vaccine/ (last visited 2/19/2022 ); https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -Pfizer -and-modernas -95-
effective -vaccines -we-need -more -detail s-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/ (last
visited 02/ 19/2022) .
14 https://www.statnews.com/ 2020/12/17/did -the-fda-understaff -its-review -of-the-Pfizer -biontech -vaccine/ (last
visited 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/ar ticles/university -vaccine -mandates -violate -medical -ethics -11623689220 (last visited
02/19/2022) .
18https:// 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) . Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 6 of 9 PageID 36
Page 6 of 8
the country by the f ederal 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 in to 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-processing -
effective -oct-1 (last visited 02/19/2022) ; https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine -4cf7451267919302de4a7b5915 08e80c (last visited 02/ 19/2022) ; https://media.defense.gov/
2021/Aug/25/2 002838826/ -1/-1/0/MEMORANDUM -FOR -MANDATORY -CORONA VIRUS -DISEASE -2019 -
VACCINATION -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-announce -
new-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 -mandatory -
for-all-employees/ (last visited 2/19/2022 ); https://abcnews.go.com/Health/wireStory/wal mart-mandates -vaccines -
workers -headquarters -79177220 (last visited 02/ 19/2022) ; https://www.kpbs.org/news/2021/aug/17/encinitas -covid -
19-vaccine -negat ive-test-employees/ (last visited 02/ 19/2022) ; https://www.cnbc.com/2021/08/09/covid -vaccine -
mandates -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 -Pfizer s-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 -and-
corporate -employee s (last visited 02/ 19/2022) .
22 See (last visited 02/ 19/2022) . See also, e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -
covid -vaccination -mandates -facing -pushback -n1273916 (last vi sited 02/ 19/2022) ; https://www.colorado.edu/covid -
19-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 (last visited 02/ 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 -school -
district -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-up-
get-vaccine -or-face-weekly -testing.html (last visited 02/ 19/2022) ; https://www. mercury news .com /2021/08/19/la -
county -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 -teachers -
staff-mayor -2021 -08-23/ (last visited 02/ 19/2022) ; https://www.cbsnews.com/news/california -covid -vaccine -
teachers -mandate/ (last visited 02/ 19/2022) ; https://www.nytimes.com/2021/08/18/us/washington -state-teacher -
vaccine -mandate.html (last visited 02/ 19/2022) ; https://www.governor.ny.gov/news/governor -cuomo -announces -
covid -19-vaccination -mandate -healthcare -workers (last visited 02/ 19/2022) ; https://www.cdph.ca.gov
/Programs/CID/DCDC /Pages/ COVID -19/FAQ -Health -Care-Worker -Vaccine -Requirement.aspx (last visited
02/19/2022) ; 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 -Orders -
Response/News -Updates/2021/Mayor -Hancock -Announces -COVID -19-Vaccine -Requirement -for-Employees (last
visited 2/19/2022 ); See https:// www. bostonherald.com/2021/08/19/baker -issues -vaccine -mandate -for-42000 -state-
employees/ (last visited 02/19/2022) .
25 https://www.congress.gov/bill/117th -congress/house -bill/4980?q=%7B%22search%22:%5b%224980%252 (last
visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 7 of 9 PageID 37
Page 7 of 8
for all military personnel.26 At the state level, legislation has been introduced to require COVID -
19 vaccines for all post -secondary students ,27 all state employees, 28 and even for all citizens of
various 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 encourag ed “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 and
information supporting the safety and efficac y 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 need to 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 FD A and various institutions mandating approved vaccines. Without immediate
access to the data , many of these individuals will forever lo se the chance to evaluate the data for
themselves and see whether th is vaccine is indeed “safe and effective” prior to be ing mandated to
receive 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 opera tions 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-state-
workers -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/ (last
visited 02/ 19/2022) .
30 https://www.usatoday.com/story/news/health/2021/08/06/anthony -fauci -covid -vaccine -mandates -fda-full-
approval/5513121001/ (last visited 2/19/22 ).
31 https://www.msn.com/en -us/ne ws/us/biden -urges -private -companies -to-implement -covid -19-vaccine -require
ments -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, corp orate employers, hospitals and school districts to
announce vaccine mandates for their employees”) (last visited 02/ 19/2022) ; https://www.msn.com/en -
us/news/us/now -that-a-covid -19-shot-is-fully -approved -employer -mandates -are-rolling -in-but-will-vaccination -
rates -in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last v isited 02/ 19/2022) ; https://news.yahoo.com/surgeon -
general -vivek -murthy -says-205530053.html (quoting the Surgeon General referring to vaccine mandates as
“reasonable”) (last visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 8 of 9 PageID 38
Page 8 of 8
regarding or reflecting the public discussion, discourse, and debate regarding the mandating or
potential mandating of the Moderna Vaccine. PHMPT certif ies that the information in this request
is true and correct to the best of its knowledge and belief.
II. FEE WAIVER REQUEST
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 co ntribute significantly to public understanding of the
operations 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
Vacc ine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
request s will not contribute to any commercial activities.
Note that in the event only a portion or portions of a requested file are exempted from
release, 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 request
that 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 to
release the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. PHMPT reserve s all rights to appeal the withholding or deletion
of any information.
A determination regarding expedited processing should be made within ten (1 0) days.
Access to the requested records should be granted within twenty (20) business days from the date
of your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial of
this request and PHMPT may immediately file an admin istrative 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 [email protected] during normal business hours. Thank
you for your time and attention to this matter.
Very truly yours,
/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth , Esq. Case 4:22-cv-00915-P Document 1-1 Filed 10/11/22 Page 9 of 9 PageID 39
Exhibit 2 Case 4:22-cv-00915-P Document 1-2 Filed 10/11/22 Page 1 of 2 PageID 40
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'LUHFWRU6$5$+.27/(56LQFHUHO\Case 4:22-cv-00915-P Document 1-2 Filed 10/11/22 Page 2 of 2 PageID 41
Exhibit 3 Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 1 of 25 PageID 42
Page 1 of 11
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
[email protected]
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 of
Information Act (5 U.S.C. § 552, as amended) ( “FOIA ”). The FDA designated the req uest as
FOIA Control #2022-1614 (the “FOIA Request ”). In a letter dated March 7, 202 2, the FDA
denied PHMPT ’s request for expedited processing (the “Denial Letter ”). PHMPT writes now to
appeal 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 reports
on 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 made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (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 particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].” Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 2 of 25 PageID 43
Page 2 of 11 (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, 202 2, 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 of
1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C.
552(a)(6)(E), to require agencies to consider requests for expedited
processing and grant them whenever a “compelling need ” is shown
and in other cases as determined by the agency. The term “compelling
need ” is defined as (1) involving “an imminent threat to the life or
physical safety of an individual, ” or (2) in the case of a request made
by “a person primarily engaged in disseminating information, urgency
to inform the public concerning actual or alleged Federal Government
activity. ”
I have determined that your request for expedited processing does not
meet the criteria under the FOIA. You have not demonstrated a
compelling need tha t involves an imminent threat to the life or
physical safety of an individual. Neither have you demonstrated that
there exists an urgency to inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying your
request fo r expedited processing. The responding agency office will
process 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 the
public 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 the
public 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 and
information in the biological produc t files for each of the COVID -19 vaccines. (Exhibit 1 .) That
2 All “Exhibits” referenced herein are appended to this letter. Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 3 of 25 PageID 44
Page 3 of 11 fact was not challenged by the FDA in its Denial Letter and, therefore, t his appea l, focuses solely
on the FDA’s claim that PHMPT failed to demonstrate “there exists an urgency to inform the
public concerning actual or alleged Federal Government activity .” (Exhibit 3.) For the purposes
of 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 R equest , there exists an
urgency to inform the public concerning actual or alleged Federal Government activit ies. In
determining whether there is an “urgency to inform,” and hence a “co mpelling need,” court s must
consider at least three factors : (i) whether the request concerns a matter of current exigency to the
American public; ( ii) whether the consequences of delaying a response would compromise a
significant 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 weigh
in favor of granting expedited processing of PHMPT’s FOIA R equest.
(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 the
American 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 product
file 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 and
information , 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 t he 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.go v/about -fda/what -we-do (last visited 02/19/2022). Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 4 of 25 PageID 45
Page 4 of 11 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.4
Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation and
Research, made similar remarks:
The FDA’s medical and scientific experts conducted a thorough evaluation of the
scientific data and information included in the application pertaining to the safety,
effectiveness, and manufacturing quality of Spikevax. This includes the agency’s
indepe ndent verification of analyses submitted by the company, our own 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.5
Even prior to FDA approval of the Moderna Vaccine, government officials, public health
authorities, and medical professionals repeatedly claimed that COVID -19 vaccines were “safe and
effective.”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 raised
questions regarding the sufficiency of the data and information, the adequacy of the review, and
the 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, a
group of 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi,
Ph.D., Senior Editor for The BMJ and Associate Professor of Ph armaceutical 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 licensure
4 https://www.cnn.com/2022/01/31/health/moderna -covid -vaccine -fda-approval/index.html (last visited 03/16/ 22).
5 https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action-
approving -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 v accines 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). Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 5 of 25 PageID 46
Page 5 of 11 of 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 process10 which Dr. Peter
Marks publicly disputed.11 Aaron Kheriaty, M.D., former -Professor of Psychiatry at UCI School
of 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 review13 by the FDA’s Vaccines and Related Biological Products
Advisory Committee that indicates a risk of hea rt inflammation after vaccination.14 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.”15 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
Moderna 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 licensure
of the Moderna Vaccine. The FOIA Request attempts to expedite the disclosure of this critical
information. Therefore, PHMPT’s FOIA Request concerns a matter of current exigency to the
American 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, this
product 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-covid -
19-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-covid -
19-vaccine/ (last visited 2/19/2022); https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -Pfizer -and-modernas -95-
effective -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/ (last
visited 02/19/2022).
11 https://www.statnews.com/2020/12/17/did -the-fda-understaff -its-review -of-the-Pfize r-biontech -vaccine/ (last
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 (last visited
02/19/2022).
15https:/ /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-processing -
effective -oct-1 (last visited 02/19/2022); https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine -4cf7451267919302de4a7b591508e80c (last visited 02/19/2022); https://media.defense.gov/
2021/Aug/25/2002838826/ -1/-1/0/MEMORANDUM -FOR -MANDATORY -CORONA VIRUS -DISEASE -2019 -
VACCINATION -OF-DEPARTMENT -OF-DEFENSE -SERVICE -MEMBERS.PDF (last visited 2/19/2022); Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 6 of 25 PageID 47
Page 6 of 11 governments,17 public and private employers,18 universities,19 schools,20 and various other
institutions,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-announce -
new-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 -mandatory -
for-all-employees/ (last visited 2/19/2022); https://abcnews.go.com/Health/wireStory/walmart -mandates -vaccines -
workers -headquarters -79177220 (last visited 02/19/2022); https://www.kpbs.org/news/2021/aug/17/encinitas -covid -
19-vaccine -negative -test-employees/ (last visited 02/19/2022); https://www.cnbc.com/2021/08/09/covid -vaccine -
mandates -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 -and-
corporate -employees (last visited 02/19/2022).
19 See e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -covid -vaccination -mandates -facing -
pushback -n1273916 (last visited 02/19/2022); https://www.colorado.edu/covid -19-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 (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 -school -
district -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-up-
get-vaccine -or-face-weekly -testing.html (last visited 02/19/2022); https://ww w.mercury news .com /2021/08/19/la -
county -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 -teachers -
staff-mayor -2021 -08-23/ (last visited 02/19/2022); https://www.cbsnews.com/news/california -covid -vaccine -
teachers -mandate/ (last visite d 02/19/2022); https://www.nytimes.com/2021/08/18/us/washington -state-teacher -
vaccine -mandate.html (last visited 02/19/2022); https://www.governor.ny.gov/news/governor -cuomo -announces -
covid -19-vaccination -mandate -healthcare -workers (last visited 02/19/2022); https://www.cd ph.ca.gov
/Programs/CID/DCDC/Pages/ COVID -19/FAQ -Health -Care -Worker -Vaccine -Requirement.aspx (last visited
02/19/2022); 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 -Orders -
Response/News -Updates/2021/Mayor -Hancock -Announces -COVID -19-Vaccine -Requirement -for-Employees (last
visited 2/19/2022); https:// www. bostonherald.com/2021/08/19/baker -issues -vaccine -mandate -for-42000 -state-
employees/ (last visited 02/19/2022).
22 https://www.congress.gov/bill/117th -congress/house -bill/4980?q=%7B%22search%22:%5b%224980%252 (last
visited 02/19/2022).
23 https://thehill.com/policy/defense/568996 -pentagon -to-mandate -covid -19-vaccine -for-military (last visited
02/19/2022).
24 See New York bill S6495, available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
02/19/2022) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 7 of 25 PageID 48
Page 7 of 11 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 and
President Biden has actively encouraged “companies in the private sector to step up the vaccine
requirements[.]”28
During a time when COVI D-19 vaccine mandates are being implemented over the
objection of those that have questions about the data and information supporting the safety and
efficacy 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 need
to 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 r elied upon by the FDA and the
various institutions mandating approved vaccines. Without immediate access to the data, many of
these individuals will forever lose the chance to evaluate the data for themselves and see whether
this vaccine is indeed “safe a nd effective” prior to being mandated to receive 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. 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 recognized
interest s
With respect to the second factor in the “compelling need” analysis, the consequences of
delay ing a response to PHMPT ’s FOIA request would compromise significant recognized
interest s. 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 and
effectiveness data and information relating to the Moderna Vaccine. Id. This regulation, like
many 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-state-
workers -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/ (last
visited 02/19/2022).
27 https://www.usatoday.com/story/news/health/2021/08/06/anthony -fauci -covid -vaccine -mandates -fda-full-
approval/5513121001/ (last visit ed 2/19/22).
28 https://www.msn.com/en -us/news/us/biden -urges -private -companies -to-implement -covid -19-vaccine -require
ments -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 to
announce vaccine mandat es for their employees”) (last visited 02/19/2022); https:/ /www.msn.com/en -
us/news/us/now -that-a-covid -19-shot-is-fully -approved -employer -mandates -are-rolling -in-but-will-vaccination -
rates -in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeon -
general -vivek -murthy -says-205530053.html (quoting the Surgeon General referring to vaccine mandates as
“reasonable”) (last visited 02/19/2022). Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 8 of 25 PageID 49
Page 8 of 11 interests , such as “informed consent” and “consumer protection.” This fact is further demonstrated
by 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’s
health, 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 have
been codified i n 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 have
influenced 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 children34 and these
requests 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 informe d
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 -and-
guidances (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-full-
approval/5513121001/ (last visited 2/19/22).
33 https://www.msn.com/en -us/news/us/biden -urges -private -companies -to-implement -covid -19-vaccine -require
ments -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 to
announce vaccine mandates for their employees”) (last visited 02/19/2022); https://www.msn.com/en -
us/news/us/now -that-a-covid -19-shot-is-fully -approved -employer -mandates -are-rolling -in-but-will-vaccination -
rates -in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last visited 02/19/2022); https://news.yahoo.com/surgeon -
general -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. Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 9 of 25 PageID 50
Page 9 of 11 and effectiveness , violates the significant recognized interest s of informed consent and consumer
protection.
Without disclosure, consumers that are confronted with COVID -19 vaccine mandates are
forced 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 confront ed wi th a COVID -19 v accine mandate, a delay in the disclosure of the science -based
information used to determine the Moderna Vaccine’s safety and effective ness 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, t he information PHMPT seeks clear ly 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 i t 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 f ederal government was
also 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 (V RC) were studying coronaviruses to find out how to protect
against them . . . The VRC worked with a company called Moderna t o use this
information to quickly customize their prototypes approach to the SARS -CoV-2
spike protein. By early February [2020], a C OVID -19 vaccine candidate had been
designed and manufactured. This Vaccine is called mRNA 1273 . . . the NIH -
35 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 -by-
hospital/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://ww w.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) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 10 of 25 PageID 51
Page 10 of 11 Moderna vaccine was authorized by the U.S. Food and Drug Administration (FDA)
for emergency use. (emphasis added)37
The federal government ’s activi ties 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 2017 -
1179 & “Material Transfer Agreement” executed on 12/16/2019 .38 Moreover, under 15 U.S.C . §
3710c, which regulates the “Distribution of royalties received by Federa l 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 of
potential 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 , require s immediate
transparency into the federal government ’s activities. Thus, the third factor in FOIA’s “compelling
need” analysis weighs heavily in favor of granting expedited processing.
PHMPT has demonstrated (i) the request concerns a matter of current exigency to the
American 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 for
expedited processing within 20 days of this appeal. Thank you for your time and attention to this
matter. If you require any additional information, please contact us at (212) 532 -1091 or through
email at [email protected] .
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) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 11 of 25 PageID 52
Page 11 of 11 Very truly yours, /s/ Aaron Siri Aaron Siri, Esq. Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.
Enclosures
Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 12 of 25 PageID 53
Exhibit 1Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 13 of 25 PageID 54
FREEDOM OF INFORMATION ACT REQUEST
EXPEDITED PROCESSING REQUESTED
VIA 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
(“PHMP T”).
On January 31 , 202 2, the Food and Drug Administration (“ FDA ”) approved the Moderna1
COVID -19 Vaccine, marketed as Spikevax (the “ Moderna Vaccine ”) for individuals 18 years of
age and older . On behalf of PHMPT and its individual members , please provide the following
records to [email protected] 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 made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol 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 o r 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 particul ar
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 biological
product file , as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e) with
the 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 Page 14 of 25 PageID 55
Page 2 of 8
I. EXPEDITED PROCESSING REQUESTED
PHMPT request s expedited processing for this request as it meets the requirements for
expedited 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 the
public 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, medic al
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 resp onse 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, are
primarily engaged in disseminating inform ation to the public and do so across various platforms,
including through interviews, articles, blogs, essays, and podcasts. Therefore, PHMPT and many
of its members are “primarily engaged in disseminating information [] to inform the public,” and,
as ex plained 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 the
licensure of the Moderna Vaccine. Accordingly, expedited processing of t his 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 an
independent 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, the
following data and information in the biological product file are immediately available for public
disclosure unless extrao rdinary circumstances are shown: (1) All safety and effectiveness data and
information . . .” 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 , transparency5 as a lack of transparency erodes the
confidence the medical and scientific communities and the public have in the conclusions reached
by 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 -transparency -
covid -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/fos tering -transparency -improve -public -health (last visited 2/19/2022). Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 15 of 25 PageID 56
Page 3 of 8
But aside from the FDA’s duty to make immediately available the safety and effectiveness
data of a licensed vaccine, the FDA’s FOIA regulat ions 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) T here 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; however, a news media publication or
broadcast deadline alone does not qualify as an urgent need, nor
does 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 requiremen ts. As noted above, PHMPT is an organization
made up of public health professionals, medical professionals, scientists, and journalists that was
created and e xists for the sole purpose of disseminating to the public the data and information in
the biologi cal 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 b eyond 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 vaccine s that have been proven to be “safe and
effective ,” 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 pr oduct
is 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 and
information underlying the licensure of the Moderna Vaccine is more than sufficient for licensure .
For example, i n a statement release d on January 31 , 202 2, acting FDA Commissioner Janet
Woodcock , M.D., stated :
The public can be assured that Spi kevax meets the FDA ’s high
standards 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 vi sited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 16 of 25 PageID 57
Page 4 of 8
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.7
Peter Marks, M.D., Ph.D., the director of FDA’s Center for Biologics Evaluation and
Research, made similar remarks :
The FDA’s medical and scientific experts conducted a thorough
evaluation of the scientific data and information included in the
application pertaining to the safety, effectiveness, and
manufacturing quality of Spikevax. This includes the agency’s
independ ent verification of analyses submitted by the company, our
own 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 t he
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 health
authorities, and medical professionals repeatedly claimed that COVID -19 vaccines were “safe and
effective.”9
On the other hand, numerous public health officials, media outlets, journalists, scientists,
politi cians, 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
appropriateness of the analyses relied upon to license the Moderna Vaccine, including a number
of the scientists and journalists that are members of PHMPT . For example, in July 2021, a group
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,10 and Peter A. McCullough, M.D. filed a n
amended Citizen Petition11 with the FDA, claiming that the available evidence for licensure of the
7 https://www.cnn.com/2022/01/31/health/moderna -covid -vaccine -fda-approval/index.html .
8 https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-takes -key-action -
approv ing-second -covid -19-vaccine .
9 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) .
10 https://www.bmj.com/about -bmj/editorial -staff/peter -doshi (last visited 02/ 19/2022) .
11 https://www.regulations.gov/doc ument/FDA -2021 -P-0521 -0001 (last visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 17 of 25 PageID 58
Page 5 of 8
Moderna Vaccine “is simply not mature enough at this point to adequately judge whether clinical
benefits outweigh the risks in all populations .”12 Separately, Dr. Doshi has publicly questioned
the lack of transparency regarding the vaccine approval process13 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 He alth,15 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 review16 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 and
supporting documents submitted to the FDA by developers available to the public.”18 PHMPT
incorporate s 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
Moderna Vaccine , including all matters related to the licensure of this product .
Given this widespread and ongoing public debate, t he medical and scientific communit ies
and the public have an immediate need to review the data and information underlying the licensure
of the Moderna Vaccine . Public disclosure of this information will inform this ongoing public
debate . 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 significan tly, t here is an urgent need for the public to
have immediate access to the data and information underlying the licensure of the Moderna
Vaccine because , over the objection s of many , this product is being mandated to individuals across
12 See https://blogs.bmj.com/bmj/2021/06/08/why -we-petitioned -the-fda-to-refrain -from -fully -approving -any-covid -
19-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-covid -
19-vaccine/ (last visited 2/19/2022 ); https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -Pfizer -and-modernas -95-
effective -vaccines -we-need -more -detail s-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/ (last
visited 02/ 19/2022) .
14 https://www.statnews.com/ 2020/12/17/did -the-fda-understaff -its-review -of-the-Pfizer -biontech -vaccine/ (last
visited 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/ar ticles/university -vaccine -mandates -violate -medical -ethics -11623689220 (last visited
02/19/2022) .
18https:// 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) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 18 of 25 PageID 59
Page 6 of 8
the country by the f ederal 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 in to 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-processing -
effective -oct-1 (last visited 02/19/2022) ; https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine -4cf7451267919302de4a7b5915 08e80c (last visited 02/ 19/2022) ; https://media.defense.gov/
2021/Aug/25/2 002838826/ -1/-1/0/MEMORANDUM -FOR -MANDATORY -CORONA VIRUS -DISEASE -2019 -
VACCINATION -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-announce -
new-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 -mandatory -
for-all-employees/ (last visited 2/19/2022 ); https://abcnews.go.com/Health/wireStory/wal mart-mandates -vaccines -
workers -headquarters -79177220 (last visited 02/ 19/2022) ; https://www.kpbs.org/news/2021/aug/17/encinitas -covid -
19-vaccine -negat ive-test-employees/ (last visited 02/ 19/2022) ; https://www.cnbc.com/2021/08/09/covid -vaccine -
mandates -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 -Pfizer s-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 -and-
corporate -employee s (last visited 02/ 19/2022) .
22 See (last visited 02/ 19/2022) . See also, e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -
covid -vaccination -mandates -facing -pushback -n1273916 (last vi sited 02/ 19/2022) ; https://www.colorado.edu/covid -
19-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 (last visited 02/ 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 -school -
district -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-up-
get-vaccine -or-face-weekly -testing.html (last visited 02/ 19/2022) ; https://www. mercury news .com /2021/08/19/la -
county -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 -teachers -
staff-mayor -2021 -08-23/ (last visited 02/ 19/2022) ; https://www.cbsnews.com/news/california -covid -vaccine -
teachers -mandate/ (last visited 02/ 19/2022) ; https://www.nytimes.com/2021/08/18/us/washington -state-teacher -
vaccine -mandate.html (last visited 02/ 19/2022) ; https://www.governor.ny.gov/news/governor -cuomo -announces -
covid -19-vaccination -mandate -healthcare -workers (last visited 02/ 19/2022) ; https://www.cdph.ca.gov
/Programs/CID/DCDC /Pages/ COVID -19/FAQ -Health -Care-Worker -Vaccine -Requirement.aspx (last visited
02/19/2022) ; 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 -Orders -
Response/News -Updates/2021/Mayor -Hancock -Announces -COVID -19-Vaccine -Requirement -for-Employees (last
visited 2/19/2022 ); See https:// www. bostonherald.com/2021/08/19/baker -issues -vaccine -mandate -for-42000 -state-
employees/ (last visited 02/19/2022) .
25 https://www.congress.gov/bill/117th -congress/house -bill/4980?q=%7B%22search%22:%5b%224980%252 (last
visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 19 of 25 PageID 60
Page 7 of 8
for all military personnel.26 At the state level, legislation has been introduced to require COVID -
19 vaccines for all post -secondary students ,27 all state employees, 28 and even for all citizens of
various 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 encourag ed “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 and
information supporting the safety and efficac y 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 need to 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 FD A and various institutions mandating approved vaccines. Without immediate
access to the data , many of these individuals will forever lo se the chance to evaluate the data for
themselves and see whether th is vaccine is indeed “safe and effective” prior to be ing mandated to
receive 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 opera tions 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-state-
workers -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/ (last
visited 02/ 19/2022) .
30 https://www.usatoday.com/story/news/health/2021/08/06/anthony -fauci -covid -vaccine -mandates -fda-full-
approval/5513121001/ (last visited 2/19/22 ).
31 https://www.msn.com/en -us/ne ws/us/biden -urges -private -companies -to-implement -covid -19-vaccine -require
ments -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, corp orate employers, hospitals and school districts to
announce vaccine mandates for their employees”) (last visited 02/ 19/2022) ; https://www.msn.com/en -
us/news/us/now -that-a-covid -19-shot-is-fully -approved -employer -mandates -are-rolling -in-but-will-vaccination -
rates -in-the-us-go-up/ar-AANGDTy?ocid=uxbndlbing (last v isited 02/ 19/2022) ; https://news.yahoo.com/surgeon -
general -vivek -murthy -says-205530053.html (quoting the Surgeon General referring to vaccine mandates as
“reasonable”) (last visited 02/ 19/2022) . Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 20 of 25 PageID 61
Page 8 of 8
regarding or reflecting the public discussion, discourse, and debate regarding the mandating or
potential mandating of the Moderna Vaccine. PHMPT certif ies that the information in this request
is true and correct to the best of its knowledge and belief.
II. FEE WAIVER REQUEST
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 co ntribute significantly to public understanding of the
operations 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
Vacc ine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
request s will not contribute to any commercial activities.
Note that in the event only a portion or portions of a requested file are exempted from
release, 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 request
that 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 to
release the requested documents in the public interest. Such statements may help to avoid
unnecessary appeal and litigation. PHMPT reserve s all rights to appeal the withholding or deletion
of any information.
A determination regarding expedited processing should be made within ten (1 0) days.
Access to the requested records should be granted within twenty (20) business days from the date
of your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial of
this request and PHMPT may immediately file an admin istrative 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 [email protected] during normal business hours. Thank
you for your time and attention to this matter.
Very truly yours,
/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth , Esq. Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 21 of 25 PageID 62
Exhibit 2Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 22 of 25 PageID 63
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'LUHFWRU6$5$+.27/(56LQFHUHO\Case 4:22-cv-00915-P Document 1-3 Filed 10/11/22 Page 25 of 25 PageID 66
Exhibit 4 Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22 Page 1 of 3 PageID 67
1Annalise Beube
From: FDA FOIA <[email protected]>
Sent: Wednesday, June 1, 2022 12:04 PM
To: S&G Information Request Staff; FDA FOIA
Subject: RE: [EXTERNAL] Expedited Processing Appeal of FOIA Control #2022-1614 (IR#0710)
Follow Up Flag: Follow up
Flag Status: Flagged
Appeal file: 22-0076AA
June 1, 2022
Sending via Email: [email protected]
This letter acknowledges rece ipt of your Freedom of Information Act (FOIA) appeal, submitted to the Food
and Drug Administration (FDA). We rece ived your appeal on June 1, 2022. Your appeal challenges the Food
and Drug Administration (FDA’s) response to your original request #2022-1614 . Your appeal has been
assigned the above-stated case number ba sed on when it was received in this office. Please reference this
number 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 a ppeal falls under “unusual circ umstances” in that our offi ce will need to consult
with another office that has substant ial 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 your
appeal will be processed please re fer 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/freed om-information-act-5-usc-552 and
https://www.federalregister.gov /documents/2016/10/28/2016-25684/freedom -of-information-regulations .
If you have any questions, please ca ll (301)796-8975, or email us at [email protected] .
Sincerely yours,
Sarah Kotler
FDA FOIA
Sarah B.Kotler, J.D.
Director, Division ofFreedom ofInformation Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22 Page 2 of 3 PageID 68
2USFDA
301Ͳ796Ͳ8976
From: S&GInformation Request Staff <[email protected]>
Sent: Wednesday, June 1,2022 11:36 AM
To:FDAFOIA <[email protected]>
Subject: [EXTERNAL] Expedited Processing Appeal ofFOIA Control #2022 Ͳ1614 (IR#0710)
CAUTION: Thisemail originated from outside oftheorganization. Donotclicklinks oropen attachments unless yourecognize the
sender andknow thecontent issafe.
Dear SirorMadam,
Attached please findourclient’s appeal.
Thank you,
Annalise Beube, LawClerk
Siri |Glimstad
700SFlower Street
Suite 1000
LosAngeles, CA90017
Main: 212Ͳ532Ͳ1091
Facsimile: 646Ͳ417Ͳ5967
www.sirillp.com
Thisemail maycontain material thatisconfidential, privileged and/or attorney work product forthesoleuseoftheintended recipient. Any
review, reliance ordistribution byothers orforwarding without express permission isstrictly prohibited. Ifyouarenottheintended recipient,
please contact thesender anddelete allcopies.
Case 4:22-cv-00915-P Document 1-4 Filed 10/11/22 Page 3 of 3 PageID 69
Exhibit 5 Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 1 of 7 PageID 70
Page 1 of 6
FDA FREEDOM OF INFORMATION ACT REQUEST
VIA 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, 202 2, the Food and Drug Administration (“ 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 ”). On behalf of PHMPT and its individual members, please
provide the following records to [email protected] 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 to
and 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 made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol 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 o r 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 particul ar
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 biological
product 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. Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 2 of 7 PageID 71
Page 2 of 6 made on behalf of PHMPT) and is m eant to capture all data and
information within the biological product file that concerns the
authorization and approval of Comirnaty for use in 12 -15-year -
olds.
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 in
disseminating information,” and there is an “ur gency 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 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 th rough both its website and its individual members’ platforms. Many of PHMPT’s
individual members, including all its members that are journalists, are primarily engaged in
disseminating information to the public and do so across various platforms, includin g through
interviews,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) .
4 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-advertise d-11624 381749 ; https://www.wsj.com/articles/
university -vaccine -mandates -violate -medical -ethics -11623689220 (Aaron Kheriaty and Gerard V. Bradle y);
https://thefederalist.com/2021/07/05/how -college -covid -vaccine -mandates -put-students -in-danger/ (Andrew Bostom,
Aaron Kheriaty, Peter A. M cCullough, 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 (Seren a 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) .
5 See, e.g. , https://blogs.bmj.co m/bmj/2021/08/2 3/does -the-fda-think -these -data-justify -the-first-full-approval -of-a-
covid -19-vaccine/ (Peter Doshi) ; https://blogs.bm j.com/bmj/2020/11/26/peter -doshi -pfizer -and-modernas -95-
effective -vaccines -lets-be-cautio us-and-first-see-the-full-data/ (Peter Doshi) . See also https://www.re -
check.ch/wordpress/en/covid -certificate/ (Catherine Riva and Serena Tinari) .
6 See https://www.andrewbostom.org/2021/06/why -collegiate -covid -19-vaccine -mandates -are-lysenkoist -anti-
science/ (Andrew Bostom) .
7 See, e.g. , https://www.a ndrewbostom.org/2021/05/dr -andrew -bostom -discusses -the-unfavorable -risk-benefit -ratio-
of-covid -19-vaccination -of-very-low-covid -19-risk-12-to-17-year-olds-with-pfizers -emergency -use-authorization -
only-mrna -vaccine/ (Andrew Bostom) . Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 3 of 7 PageID 72
Page 3 of 6 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 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 s hown: (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 availa ble 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 c ommitment 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 is
an 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 and
effective,” 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 product
is both “safe” and “effective.”9 21 C.F.R. 601.2(a). On July 8 , 202 2, the FDA granted approval to
the 12-15-Year -Old Pfizer Vaccine10 and, beyond the FDA’s own regulations which admit the
urgent need for transparency and disclosure in this situation, there are two additional reasons that
warrant expedited treatment of this request.
First, there is 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 12-15-Year -Old Pfizer
Vaccine. For example, on June 1, 2021, a group of 27 clinicians, scient ists, and patient advocates,
including PHMPT members Peter Doshi, senior editor for The BMJ and associate professor of
pharmaceutical health services research at the University of Maryland School of Pharmacy,11 and
Peter A. McCullough, professor of medicin e 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 risk s in all populations.”13 Separately, Peter Doshi has publicly questioned the lack of
8 https://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 -we-
do.
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-covid -
19-vaccine -this-year/ . Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 4 of 7 PageID 73
Page 4 of 6 transparency regarding the vaccine approval process14 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 ba sed on, among other things, a review17
by the FDA’s Vaccines and Related Biological Products Advisory Committee that indicates a risk
of heart inflammation after vaccination.18 Government officials have raised similar concerns about
the lack of transparenc y 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 referen ce, 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 12-15-Year -Old Pfizer Vaccine, including
all matters related to the licensure of thi s 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 all
stem 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, particula rly regarding serious adverse events, without any
further delay .”20
Many of these concerns also stem back to FDA’s May 10, 2021 reissuance of the
Emergency Use Authorization (“EUA”) letter of authorization fo r 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 outweig h the known
risks and (ii) there are serious concerns regarding how the trials were conducted. These issues have
been thoroughly cited and explained in a recent citizen petition fil ed 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-covid -
19-vaccine/ ; https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -pfizer -and-moder nas-95-effective -vaccines -we-
need -more -details -and-the-raw-data/ ; 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/ .
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 .
19https ://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/editorial -
the-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 . Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 5 of 7 PageID 74
Page 5 of 6 of the 12-15-Year -Old Pfizer Vaccine, these concerns have generated even more urgency and
importance . Large portions of the public have legitimate fears that FDA never fully demonstrated
whether the known benefits outweigh the known risks23 for this particular age group for the 12-
15-Year -Old Pfizer Vaccine , or if the FDA corrected the serious concerns regarding how the 12-
15-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 vac cines for children to
attend 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 is
delayed 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 of
these children and parents will be forced to make irreversible medical decisions before the
independent scientific community, and journalist have time to review, and report upon whether
FDA resolved the outst anding concerns regarding its prior EUA when recently approving and
licensing 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 th e 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 best
of its knowledge and belief.
Fee Waiver R equested
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 pub lic understanding of the operations 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 12-15-Year -Old Pfizer
Vaccine and the cli nical 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 -recommendations -
children.pr.html .
24https://www.gov.ca.gov/2021/10/01/california -becomes -first-state-in-nation -to-announce -covid -19-vaccine -
requirements -for-schools/ ; See also https://www.latimes.com/california/story/2022 -01-24/new -vaccine -legislation -
california -schoolchildren -mandate .
25 See https://abcnews.go.com/US/dc -require -students -12-older -vaccinated -covid -19/story?id=87130087 . Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 6 of 7 PageID 75
Page 6 of 6 Note that in the event only a portion or portions of a requested file are exempted from
release, the remainder must stil l be released. We therefore request that we be provided with all
non-exempt portions which are reasonably segregable or can be deidentified. We further request
that you describe any redacted, deleted, or withheld material in detail and specify the statut ory
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 to
release 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 deletion
of any information.
A determination regarding expedited processing should be made within ten (10) days.
Access to th e requested records should be granted within twenty (20) business days from the date
of your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial of
this 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 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 (2 12) 532 -1091 or [email protected] during normal business hours. Thank
you for your time and attention to this matter.
Very truly yours,
/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Colin Farnsworth, Esq.
Case 4:22-cv-00915-P Document 1-5 Filed 10/11/22 Page 7 of 7 PageID 76
Exhibit 6Case 4:22-cv-00915-P Document 1-6 Filed 10/11/22 Page 1 of 2 PageID 77
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'LUHFWRU6$5$+.27/(56LQFHUHO\Case 4:22-cv-00915-P Document 1-6 Filed 10/11/22 Page 2 of 2 PageID 78
Exhibit 7Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22 Page 1 of 21 PageID 79
Page 1 of 6
FDA FREEDOM OF INFORMATION ACT REQUEST
EXPEDITED PROCESSING REQUESTED
VIA 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 Garay ( the
“de Garays ”).
On July 8, 2022, the Food and Drug Administration (“ 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 ”). On behalf of the de Garays, please provide the following
records to [email protected] 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 made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (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 ingredien ts
. . . . (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 particul ar
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 biological
product 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.
Case 4:22-cv-00915-P Document 1-7 Filed 10/11/22 Page 2 of 21 PageID 80
Page 2 of 6 This request excludes any data and information responsive to
and being 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 and approval of Comirnaty for use in 12-15-year-
olds.
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 in disseminating 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 the
adverse reactions their daughter has suffered following receipt of the 12-15- Year -Old Pfizer
Vaccine. Mr. and Mrs. d e 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 the
potential 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 work ed with a number of media organizations and
advocacy 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 pursuit
of 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 the
full story behind participation in the 12-15- Year -Old Pfizer Vaccine clinical trial, her
subsequent 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.5
3 https://www.foxnews.
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