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

Civil Action No. 4:22-cv-915-P

Plaintiffs,-againstFOOD AND DRUG ADMINISTRATION,
Defendant.

BRIEF IN SUPPORT OF TIMELY PRODUCTION SCHEDULE

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TABLE OF CONTENTSINTRODUCTION .......................................................................................................................... 1
FACTS ............................................................................................................................................ 5
I. PLAINTIFFS PHMPT AND THE DE GARAYS .............................................................. 5
II. FDA LICENSURE OF MODERNA AND PFIZER 12-15 COVID-19 VACCINE .......... 8III. SERIOUS PUBLIC CONCERNS RAISED REGARDING THE FDA’S DECISION ..... 9
IV. THE FOIA REQUESTS ................................................................................................... 17
ARGUMENT ................................................................................................................................ 20
CONCLUSION ............................................................................................................................. 23ii

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TABLE OF AUTHORITIESStatutes
21 C.F.R. § 601.2 .......................................................................................................................... 21
21 C.F.R. § 601.51 ................................................................................................................. passim
21 U.S.C. § 393 ............................................................................................................................. 20
5 U.S.C. § 552 ............................................................................................................... 8, 17, 18, 19iii

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INTRODUCTION
Plaintiffs, PHMPT and Patrick and Stephanie de Garay, respectfully come before this Court
to seek a production schedule for the documents submitted by Pfizer to the FDA to license its
Covid-19 vaccine for 12- to 15-year-old children (“Pfizer 12-15 data”) and for the documents
submitted by Moderna to the Food and Drug Administration (“FDA”) to license its Covid-19
vaccine for adults (“Moderna data”).
PHMPT 1 Related Proceeding
The Court dealt with a similar request seeking the documents the FDA relied upon tolicense Pfizer’s Covid-19 vaccine for those 16 and older (“Pfizer 16+ data”) in a related action,
PHMPT v. FDA (4:21-cv-01058-P) (“PHMPT 1”). After extensive briefing and oral argument,
and patiently listening to both sides, the Court reasoned that the FDA must produce the expected
450,000 pages at the rate of 55,000 pages per month starting on or before March 1, 2022. (PHMPT
1, ECF 35.) The FDA desired to move out the start date, and the parties agreed, in relevant part,on the following schedule, again expecting that production of the approximately 450,000 pages
would be completed in 2022: “The FDA will produce 80,000 pages on or before May 2, June 1,
and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before
the first business day of each month thereafter.” (PHMPT 1, ECF 56.)
Current Requests and Exigent Need for SameAs with the Pfizer 16+ data, PHMPT also wants to make public the Moderna data and the
Pfizer 12-15 data. There is an acute need for the Pfizer 12-15 data to be made public because theother Plaintiffs in this action, the de Garays, have a daughter who was just one of 1,131 children
who received the vaccine in the clinical trial for Pfizer’s Covid-19 vaccine for this age group.
Directly after her second shot, she was rushed to the emergency room and eventually ended up in1

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a wheelchair with a feeding tube, which remains her current condition. Despite her serious andongoing adverse reaction, Pfizer reported her serious harm to the FDA as mere “functional
abdominal pain.” The undersigned sent the FDA the child’s medical records and repeatedly tried
to notify it about this misrepresentation, including in three additional letters. When the FDA finallyresponded 128 days later, on February 26, 2022, it merely suggested that the de Garays file a
VAERS report (which, of course, they had already done). In addition to this very specific andserious safety issue, there are also clear efficacy issues with this product that independent scientists
need to review.
The Moderna trial has similar issues concerning the safety and efficacy of the product thatindependent scientists need to be able to review. As detailed below, these include serious efficacy
issues such that recent studies, including a 50,000 person Cleveland Clinic study, have found thatthose receiving this vaccine are, in fact, more likely to have Covid-19 than those that do not receive
this vaccine; and that the more doses received, the more likely one is to have Covid-19.
In PHMPT 1, Plaintiff’s members have been chomping at the bit to get the full production
because, as repeatedly explained in that action, until they have all the documents, they cannot
conduct a proper analysis. For example, there appear to be 20 deaths among those getting theCovid-19 vaccine and 14 among those getting the placebo, but an analysis of this data cannot beproperly performed until all the documents in PHMPT 1 are produced. There were also 3,410 total
cases of “suspected but unconfirmed Covid-19” in Pfizer’s trial which were not counted as part ofthe efficacy results because Pfizer decided to exclude them. Knowing the exact number of suchindividuals, and how many were in the placebo and how many in the vaccine group, is critical foran accurate calculation of the actual efficacy of Pfizer’s Covid-19 vaccine in its clinical trial for2

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those 16 and older. None of this, like many other analyses, can be performed until all the data is
produced.
Given these exigencies and seeing firsthand just how critical having all the data is,Plaintiffs sought expedited processing for the Pfizer 12-15 data and the Moderna data. The FDA
denied this request and denied their appeal of the denial. This action therefore ensued.
In an effort to comport with the guidance from the Court in PHMPT 1, Plaintiffs’
complaint, filed on October 11, 2022, requested that the FDA be required to continue producing,at the rate of 55,000 pages per month, the documents requested herein upon completion of the
production in PHMPT 1, which at that time PHMPT expected to occur in 2022. What Plaintiffs
did not realize is that PHMPT was misled into believing there were only around 450,000 pages to
produce in PHMPT 1. It is now clear that was not the case because the FDA has already produced
765,479 pages, and there is, apparently, no end in sight.
Reflecting the likely volume of the responsive documents to be produced in PHMPT 1, the
FDA has now advised Plaintiffs that there are around 4 million pages submitted by Moderna tolicense its product (in addition to other responsive documents in the product file). PHMPT has
written a letter to the FDA in PHMPT 1 advising that it believes the FDA was not candid with theplaintiff or the Court in that matter. The FDA’s only substantive response to date has been that the“FDA is working diligently to make those estimates [estimated remaining page count] as precisely
as possible” and will not provide even a ballpark estimate on when completion of production in
PHMPT 1 will occur, despite numerous requests.
Requested Production Schedule
Given the foregoing, Plaintiffs respectfully seek a production schedule in this matter
independent of the production schedule in PHMPT 1. In that matter, the FDA claimed its resources,3

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despite billions of dollars in taxpayer funds, limited it to producing at the rate of 500 pages permonth. The Court, however, explained that “excessive delay by the agency in its response is often
tantamount to denial” and that a “production rate [of 55,000 pages per month] … appropriatelybalances the need for unprecedented urgency in processing this request with the FDA’s concerns
regarding the burdens of production.”
This appropriate balancing presumably assumed there were approximately 450,000 pages
which would have resulted in the completion of the production in 2022. This careful balancing
was, however, based on the misleading understanding there were around 450,000 pages. It istherefore respectfully submitted that the FDA should not be permitted to now seek to delay
production of the Pfizer 12-15 data and the Moderna data in order to complete production of the
Pfizer 16+ data.
It is also clear the FDA can produce far more than 55,000 per month, having produced in
PHMPT 1:•••••90,702 pages in May 2022,
90,640 pages in June 2022,
90,877 pages in July 2022,
88,656 pages in August 2022, and88,142 pages in September 2022.

Until this month, the FDA had continued to produce a minimum of 55,000 pages per month, andthe same types of documents have been produced during the months when approximately 90,000
pages were produced and months when 55,000 pages have been produced. This reflects that the
FDA can produce at least 35,000 additional pages per month and, respectfully, likely hundreds ofthousands of more pages per month if the FDA applied just .001% of the taxpayer dollars it
receives.

4

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FDA has advised that the Pfizer 12-15 data is 497,289 pages in the Biologic License
Application (not counting other responsive documents within the product file). Assuming thisnumber is accurate, it would take approximately 9 months to produce at the rate of 55,000 pages
per month. Plaintiffs respectfully request that the FDA be ordered to produce all of the Pfizer 1215 data at the rate of at least 55,000 pages per month, with the final production of any remaining
documents to occur on October 15, 2023.
Again seeking to remain within the range of the Court’s prior guidance, Plaintiffs also
request that, at minimum, the FDA be required to produce all of the Moderna data within 18
months of completion of the Pfizer 12-15 data at the rate of at least 55,000 pages per month withthe final production of any remaining documents to occur on April 15, 2025. The Plaintiffs,
however, respectfully submit that a shorter production schedule would be more appropriate,especially considering that the Moderna Covid-19 vaccine was designed, developed,
manufactured, and purchased using taxpayer funds, but make the foregoing production schedule
proposal in an attempt to remain in accord with the Court’s prior guidance.
FACTS
I.

PLAINTIFFS PHMPT AND THE DE GARAYSPHMPT has approximately 5,865 members, mostly comprised of medical and public healthprofessionals, including professors and researchers in medical-related disciplines from Yale
School of Public Health, UCLA David Geffen School of Medicine, University of Maryland Schoolof Pharmacy, Warren Alpert Medical School of Brown University, Oregon Health & Science
University, UC San Francisco, David Geffen School of Medicine at UCLA, University of5

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Leicester, University of Southern Denmark, University of Sydney, University of Oxford,
University of Toronto, and University of Auckland, as well as other universities and journalists. 1
Patrick and Stephanie de Garay are the parents of now 14-year-old M.D., who has sufferedand continues to suffer severe adverse events following vaccination in Pfizer’s clinical trial for 12to 15-year-olds. M.D. was one of only 1,131 participants in Pfizer’s clinical trials for the 12 to 15year-olds who received a Covid-19 vaccine. 2 Within 24 hours of receiving the second dose of thevaccine during the clinical trial on January 20, 2021, M.D., at 12 years old, 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. 3 M.D.
was subsequently admitted to the hospital and later discharged with the diagnosis that her
symptoms resulted from an adverse reaction to the vaccine. 4 M.D.’s health continued to rapidly
decline and, despite the de Garays’ thorough documentation, reporting, and outreach regarding
their daughter’s sudden onset symptoms – which ultimately necessitated her continued use of afeeding tube and wheelchair – the de Garays received no attention from Pfizer or the FDA. 5 In
Pfizer’s data presented to the FDA in its application for an EUA, M.D.’s severe, systemic, andongoing adverse reaction to the Pfizer 12-15 vaccine was categorized as “functional abdominal
pain.” 6 FDA granted emergency use authorization of Pfizer’s vaccine for 12 to 15-year-olds on
May 10, 2021.

1

See https://phmpt.org/.

See https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizerbiontech-covid-19-vaccine-emergency-use; see also Patrick de Garay’s Declaration (Exhibit 7 at pages 9-10.)23https://thehighwire.com/videos/rigged-maddies-story/ (see video at 6:44-8:20).

Id. See also https://www.sirillp.com/wp-content/uploads/2021/10/1-21-2021-My-Health-Summary-pgs-1027-to1034_Redacted-b3f4451617070003bed8aaff8a47d98a.pdf.
4

5

See generally id.

6

Id. at 1:04:40. See also https://www.fda.gov/media/148542/download at 30.

6

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Notwithstanding the de Garays’ reporting of their daughter’s wide range of severe
symptoms, Pfizer’s inaccurate and misleading characterization thereof, the inadequate assessmentof potential causality of M.D.’s injuries from the vaccine, and the safety alarms that this shouldhave been ringing, FDA granted the vaccine EUA on May 10, 2021 and – after the undersigned
wrote to FDA about M.D. on October 22, 2021, October 25, 2021, January 3, 2022, February 7,
2022, and March 8, 2022 7 – the agency subsequently licensed the use of the Pfizer 12-15 Vaccine
on July 8, 2022. 8
The FDA also was invited to the November 2021 round table held by Senator Ron Johnsonwith regard to those injured by Covid-19 vaccines – at which Stephanie de Garay spoke, and M.D.
was present – but did not attend. 9 There has also been widespread media coverage of M.D.’s case,but, nonetheless the FDA has failed to reach to the de Garays. 10

See https://www.sirillp.com/wp-content/uploads/2023/03/3-08-2022-Ltr-to-Dr.-Paul-Richards-FDA-re-Maddie-deGaray-608d98239f37f6f035190541103e5dc5.pdf.
78

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

See https://rumble.com/vokrf7-sen.-johnson-expert-panel-on-federal-vaccine-mandates.html at 22:25 (November 2,
2021: Appearance on Senator Ron Johnson’s Expert Panel on Federal Vaccine Mandates.); Senator Johnson also helda second roundtable concerning the Covid-19 vaccines to which FDA was also invited and did not attend. See
https://www.ronjohnson.senate.gov/2022/12/sen-ron-johnson-hears-from-experts-and-medical-professionals-oncovid-19-vaccine-efficacy-and-safety.
9

See https://youtu.be/lAeVLdMnerQ?t=1885. (June 28, 2021: Appearance on Senator Ron Johnson’s press
conference with individuals who suffered adverse reactions to COVID-19 vaccines); see also
https://thefederalist.com/2021/06/29/twitter-censors-video-of-mother-describing-daughters-covid-19-vaccine-sideeffects/ (June 29, 2021: Federalist Article: “Twitter Censors Video of Mother Describing Daughter’s COVID-19
Vaccine Side Effects”); https://www.foxnews.com/transcript/tucker-people-in-charge-create-disaster-after-disaster at
12:00 (July 1, 2021: Coverage of testimony at Senator Ron Johnson press conference by Tucker Carlson Tonight.);
https://video.foxnews.com/v/6262045756001#sp=show-clips (July 2, 2021: Appearance on Tucker Carlson Tonight);
https://rumble.com/vsgwe2-joe-rogan-on-maddie-de-garay-and-suppression-of-vaccine-adverse-events..html(January 12, 2022: Discussion of de Garays by podcast host Joe Rogan on the Joe Rogan Experience.);https://thehighwire.com/videos/rigged-maddies-story/ (August 13, 2022: Appearance on The HighWire, “Rigged:
Maddie’s Story.”).
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FDA LICENSURE OF MODERNA AND PFIZER 12-15 COVID-19 VACCINEOn January 31, 2022, the FDA approved the Moderna Covid-19 Vaccine, marketed as

Spikevax (the “Moderna Vaccine”) for individuals 18 years of age and older. 11 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.” 12
On July 8, 2022, FDA approved the Pfizer-BioNTech Covid-19 Vaccine, marketed as
Comirnaty, for individuals 12 through 15 years of age (the “Pfizer 12-15 Vaccine”). 13 FDA asserts
its “approval follows a rigorous analysis and evaluation of the safety and effectiveness data
conducted by FDA.” 14
Plaintiffs seek the release of the records relied upon by the FDA to license these products.
The importance of releasing this information to the public is explicitly recognized under federal
regulation, which provides: “After a license has been issued, the following data and informationin the biological product file are immediately available for public disclosure unless extraordinary
circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol fora test or study . . . .” 15
Hence, upon licensure for the Pfizer 12-15 Vaccine and Moderna Vaccine (the “Covid-19
Vaccines”), PHMPT issued two requests to FDA pursuant to the Freedom of Information Act (5U.S.C. § 552, as amended) (“FOIA”) for “[a]ll data and information for [the COVID-19 Vaccines]

See
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
11

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-actionapproving-second-covid-19-vaccine.
1213

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

14

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

15

21 C.F.R. § 601.51(e).

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enumerated in 21 C.F.R. § 601.51(e)[16] with the exception of publicly available reports on the
Vaccine Adverse Events Reporting System.” 17 A near identical request for the Pfizer 12-15
Vaccine was later submitted to FDA by Patrick and Stephanie de Garay. 18
III.

SERIOUS PUBLIC CONCERNS RAISED REGARDING THE FDA’S DECISION
Despite FDA’s assertions, numerous public health officials, media outlets, journalists,scientists, politicians, public figures, and others with large media platforms have publicly raisedquestions regarding the sufficiency of the data, the adequacy of the review, and the appropriatenessof the analyses relied upon by FDA to license the Covid-19 Vaccines. The de Garays, based on
their personal experience with the Pfizer product, similarly question how their daughter’s case washandled and the evidence regarding the thoroughness and reliability of the larger clinical trial.
Independent review is critically needed because the FDA was already promoting theseproducts prior to their licensure, potentially biasing their decision-making process. For example,
Dr. Peter Marks, the head of the FDA’s division that decides on licensure of these products, put
out promotional videos encouraging the uptake for unlicensed uses of these products:

21 C.F.R. § 601.51(e) provides that, after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
16

17
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.

https://www.foxnews.com/media/ohio-woman-daughter-covid-vaccine-reaction-wheelchair; see also
https://thehighwire.com/videos/rigged-maddies-story/.
18

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While Dr. Marks was making promotional videos, 19 he also received letters about the serious
injuries M.D. sustained in the Pfizer 12-15 clinical trial that he ignored.
There were also numerous prestigious journals that published articles calling into question
many aspects of the decision to authorize these products, which apparently were not consideredwhen the FDA licensed them. A petition about these issues was recently filed with the FDA by 9highly credentialed and world-renown scientists, two of whom are PHMPT members, which
requested the following actions by the FDA:
1.
Add language clarifying that phase III trials were notdesigned to determine and failed to provide substantial evidence ofvaccine efficacy against SARS-CoV-2 transmission or death.

See, e.g., https://www.youtube.com/watch?v=IJNc_DJ1DyE (Do the current COVID-19 vaccines work?, January
27, 2022); https://www.youtube.com/watch?v=k9ekkC3fhqo (Risks of not getting my child vaccinated against
COVID-19, February 10, 2022); https://www.youtube.com/watch?v=YgPj5MoD3hY (When might we have vaccines
for our youngest children?, February 25, 2022); https://www.youtube.com/watch?v=EGIhEcGZaQg (Is it stillnecessary to get vaccinated or get a booster shot?, April 4, 2022); https://www.youtube.com/watch?v=bf7zBKszkJo(Should 12-through 17-year-olds receive a COVID-19 booster?, March 24, 2022). Each of these videos predates FDA
approval of Pfizer’s 12-15 vaccine and features Dr. Marks promoting the Covid-19 vaccines.
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2.
Add language clarifying that the immunobridging surrogate
endpoint used in multiple authorized indications has not beenvalidated to predict clinical efficacy.
3.
Add safety and efficacy results data from manufacturer
randomized trials of current bivalent boosters that reported results
after EUA was granted.
4.
Add a clear statement that FDA authorized a new Pfizer
vaccine formulation containing Tris buffer without requiring
clinical studies to evaluate efficacy, safety or bioequivalence to theformulation containing phosphate buffer.
5.
Add a clear statement disclosing that a Pfizer phase III
randomized trial in pregnant women (NCT04754594) wascompleted as of July 2022 but there have been no results reported.
6.
Add a clear statement that Pfizer vaccine efficacy wanes
after 2 months following dose 2 according to the Pfizer phase III
randomized trial.
7.
The following adverse event types should be added to theAdverse Reactions section of labeling:a. multisystem inflammatory syndrome (MIS) in children;b. pulmonary embolism;c. sudden cardiac death;d. neuropathic and autonomic disorders.
8.
The following reproductive health and lactation related
adverse event types should be added to the Adverse Reactions
section of labeling:a. decreased sperm concentration;b. heavy menstrual bleeding;c. detection of vaccine mRNA in breastmilk.
9.
Add frequency data for clinical and subclinical myocarditis.
10.
Labeling should present trial results on serious adverse
events in tables with statistics, as is done for non-serious adverse
events.
11.
Petitioner also requests the FDA create a Medication Guide
and communicate these labeling changes via a Dear Health Care
Provider (DHCP) letter. 20
There are far more issues and questions that can likely be answered if the data requested in PHMPT
1 and herein were made public. For example, a paper published on June 23, 2022 and updated on
September 9, 2022 titled Serious Adverse Events of Special Interest Following mRNA Vaccinationin Randomized Trials, states: “These study limitations all stem from the fact that the raw data from20

https://www.regulations.gov/document/FDA-2023-P-0360-0001.

11

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COVID-19 vaccine clinical trials are not publicly available. Given the global public health
implications, there is an urgency to make all COVID-19 trial data public, particularly
regarding serious adverse events, without any further delay.” 21
The urgency to publicize all this data is becoming more acute with each passing day. For
example, a recent Cleveland Clinic study of over 50,000 individuals found that the more doses of
Covid-19 vaccine received, the greater the chances of getting Covid-19: 22

Numerous other recent papers have presented data that have called into serious question
the efficacy of these vaccines, including data that reflect issues that should have been seen during

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).
21

See Nabin K. Shrestha, et al., Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine,
https://www.medrxiv.org/content/10.1101/2022.12.17.22283625v1.
Medrxiv(Dec.
19,2022),
full.pdf?utm_source=substack&utm _medium=email.
22

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the clinical trial if it had been conducted properly and had the results been fully reported to the
FDA:
a. An article in the New England Journal of Medicine discusses a study that included
887,193 children (273,157 vaccinated children) and showed that children who had
Covid-19 and were subsequently vaccinated were much more likely to get
reinfected than their peers who also had Covid-19 and were not vaccinated. 23
b. Data from the Dutch government evaluating mRNA vaccines found that “in the
period from March 15 to June 28, 2022, there was hardly any visible protective
effect of the COVID-19 basic vaccination series against hospital and ICU-intake.”
In fact, when researchers stratified the risks of hospitalization and intensive care bytime from the date of vaccination and by age, it was demonstrated that the risks
increase over time. 24
c. A study among adolescents in Brazil and Scotland analyzed vaccine effectivenessof two doses of Pfizer’s vaccine against symptomatic and severe Covid-19. The
study found waning vaccine protection against symptomatic Covid-19 from 27 days
after the second dose. 25
d. A study published in the Lancet looking at effectiveness of Pfizer’s vaccine inchildren in Italy states: “Our estimates of the effectiveness of full vaccination

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

23

See
https://www.rivm.nl/covid-19-vaccinatie/bescherming-coronavaccins-tegen-ziekenhuisopname/booster-enherhaalprik-bij-ouderen-nodig-om-bescherming-op-peil-te-brengen (Dutch version). https://www.rivm.nl/en/covid19-vaccination/vaccine-effectiveness-in-preventing-hospital-admissions/covid-19-booster-jab-and-repeatvaccination-needed-for-older-people-to-restore-protection (English version).
24

See Florentino, P.T. et al., Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID19 among adolescents in Brazil and Scotland over time: a test-negative case-control study, Lancet Infect Dis. (Aug.
8, 2022) https://pubmed.ncbi.nlm.nih.gov/35952702/.
25

13

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against SARS-CoV-2 infection are significantly lower than those reported in theclinical trial that led to the approval of BNT162b2 in children (90.7% in theapproval trial vs 29.4% in our study).” The study also states, “our estimates ofvaccine effectiveness against infection coincide with the estimate reported in the
USA in a previous study” and that “this decline could be due to immunity waning,as described in the adult population vaccinated with mRNA vaccines.” 26
e. A study printed in JAMA, conducted from December 2021 to February 2022 during
Omicron variant predominance and included 121,952 tests from sites across theUnited States, estimated vaccine effectiveness against symptomatic infection
among adolescents 12 to 15 years of age at 16.6% at two months after two doses.
The study concluded: “Among children and adolescents, estimated VE for 2 dosesof [Pfizer’s vaccine] was modest and decreased rapidly.” 27
Likewise, numerous recent papers have presented data of serious safety issues with thesevaccines, including data that reflects issues that should have been seen during the clinical trial if it
had been conducted properly and the results fully reported to the FDA, including immune,
neurological, and circulatory system disorders. For example, a recent peer-reviewed study looking
at close to 300,000 people in California finds that Covid-19 vaccines are linked to a 20% rise in
new diagnoses for at least three months post-vaccination. More specifically, adults have sharply
higher risks of being diagnosed with heart, skin, and psychiatric conditions for at least 90 days

26
See Sacco, C., et al., Effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection and severe COVID-19 inchildren aged 5-11 years in Italy; a retrospective analysis of January-April, 2022, The Lancet (July 9, 2022)
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01185-0/fulltext.

See Fleming-Dutra, K., et al., Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARSC0V-2 Infection in Children and Adolescents During Omicron Predominance, AMA JAMA (June 14, 2022)
https://pubmed.ncbi.nlm.nih.gov/35560036/.
27

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after they receive Covid-19 shots. 28 Additionally, the following is a list of studies on the adverse
effects on the heart and circulatory system in children from the Covid-19 vaccine:a. A recent study in the American Heart Association journal, conducted between
December 2020 and December 2021, acknowledged that deaths had resulted frommyocarditis post-vaccination, identifying 345 people in England who had died ofmyocarditis after receiving a Covid-19 vaccine. 29
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. 30
c. A Kaiser Permanente study determined that the rate of myocarditis used by federal
health authorities was incorrect and that the actual rate was nearly double, at 1 in
4,800 children vaccinated, observing, “The true incidence of myopericarditis ismarkedly higher than the incidence reported to US advisory committees,” as thestudy had identified “approximately twice as many cases of myopericarditis
following COVID-19 mRNA vaccination.” 31

Kwan, A. et al., Apparent risks of postural orthostatic tachycardia syndrome diagnoses after COVID-19 vaccination
https://www.nature.com/articles/s44161-022-00177and
SARS-Cov-2
infection,
(Dec.
12,
2022),
8?utm_source=substack&utm_medium=email#author-information.
28

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/.
29

30
Mansanguan, S., et al., Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents,
Tropical Med. & Infec. Dis. (Aug. 19, 2022), https://www.mdpi.com/2414-6366/7/8/196/htm.

Shariff, K.., et al., Risk of Myopericarditis following COVID-19 mRNA vaccination in a Large Integrated Health
System: A Comparison of Completeness and Timeliness of Two Methods, MedRxiv (Dec. 27, 2021),
https://www.medrxiv.org/content/10.1101/2021.12.21.21268209v1.full.pdf.
31

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d. A study from the Norwegian Institute of Public Health involving 23.1 million
Scandinavians ages 12 and up found that the risk of myocarditis after mRNA
vaccines was highest in males aged 16 to 24 after the second dose. 32
e. An analysis of 42 million people ages 13 and older by Oxford researchers foundhigher rates of vaccine-induced myocarditis than Covid-19-induced myocarditis inmales ages 16 to 39 after second and third doses of Pfizer’s Covid-19 vaccine andafter first and second doses of Moderna’s Covid-19 vaccine. 33
There is also an urgent need for full transparency regarding these products because
Americans are still being mandated or otherwise pressured to take this product by the federal
government, 34 local governments, 35 public and private employers, 36 universities, 37 schools, 38 andKarlstad, 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.
32

33
Patone, M., et al., Risk of Myocarditis Following Sequential COVID-19 Vaccinations by Age and Sex, MedRxiv(Dec; 25, 2021), https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf+html.

See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1; https://apnews.com/article/business-health-coronavirus-pandemic-coronavirus-vaccine-4cf7451267
919302de4a7b591508e80c; https://media.defense.gov/2021/Aug/25/2002838826/-1/-1/0/MEMORANDUM-FORMANDATORY-CORONAVIRUS-DISEASE-2019-VACCINATION-OF-DEPARTMENT-OF-DEFENSESERVICE-MEMBERS.PDF.
34

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.
35

See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html; https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatory-for-all-employees/;
https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccines-workers-headquarters-79177220;
https://
www.kpbs.org/news/2021/aug/17/encinitas-covid-19-vaccine-negative-test-employees/;
https://www.cnbc.com/
2021/08/09/covid-vaccine-mandates-sweep-across-corporate-america-as-delta-surges.html;
https://www.
reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/; https://thehill.com/
policy/healthcare/569051-pfizers-full-approval-triggers-new-vaccine-mandates/; https://www.cvshealth.com/newsand-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-and-corporate-employees.
36

See e.g., https://blockclubchicago.org/2022/07/18/will-your-college-still-require-covid-vaccinations-now-that-thestate-dropped-its-mandate/; https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccinationmandates-facing-pushback-n1273916; https://www.colorado.edu/covid-19-updates/covid-19-vaccination; https://
uhs.berkeley.edu/requirements/covid19.
37

See, e.g., https://abcnews.go.com/US/dc-require-students-12-older-vaccinated-covid-19/story?id=87130087;
https://www.4j.lane.edu/coronavirus/healthsafety/ (school staff and volunteers must get Covid-19 vaccine);
https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-school-districtmandates-vaccines-for-eligible-students; https://patch.com/massachusetts/salem/salem-school-committee-approves38

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various other institutions, all at the direct or indirect recommendation or encouragement of theFederal Government, all of which is premised on the FDA’s conclusion these products are safeand effective. 39
Furthermore, now that FDA has approved the Pfizer 12-15 Vaccine, there are indications
that states and school districts will begin mandating these vaccines for children to attend publicschool. 40 Washington, D.C., has already announced a mandate for students ages 12 and older. 41
IV.

THE FOIA REQUESTSPHMPT 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) 42 with the exception of publicly available reports
vaccine-mandate-sports-band;https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-forhigh-risk-school-sports/3232745/;
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-toissue-mandate-for-students-12-and-up-get-vaccine-or-face-weekly-testing.html;
https://www.mercurynews.com/
2021/08/19/la-county-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/.
See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachersstaff-mayor-2021-08-23/;https://www.cbsnews.com/news/california-covid-vaccine-teachers-mandate/; https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccine-mandate.html; https://www.governor.ny.gov/
news/governor-cuomo-announces-covid-19-vaccination-mandate-healthcare-workers;
https://www.cdph.ca.gov/
Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx;
https://www.
nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html; https://www.denvergov.org/Govern
ment/COVID-19-Information/Public-Health-Orders-Response/News-Updates/2021/Mayor-Hancock-AnnouncesCOVID-19-Vaccine-Requirement-for-Employees; https://www.bostonherald.com/2021/08/19/baker-issues-vaccinemandate-for-42000-state-employees/.
39

https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-covid-19-vaccinerequirements-for-schools/; see also https://www.latimes.com/california/story/2022-01-24/new-vaccine-legislationcalifornia-schoolchildren-mandate.
40

See https://osse.dc.gov/page/district-columbia-immunization-attendance-policy (“Beginning in the 2023-24 school
year, the COVID-19 vaccine is required for school enrollment and attendance in the District of Columbia for all
students who are of an age for which there is a COVID-19 vaccination fully approved by the US Food and Drug
Administration (FDA)”).
41

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
42

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on the Vaccine Adverse Events Reporting System. 43(Dkt. No. 1 at 17) On March 7, 2022, FDA denied PHMPT’s request for expedited processing(“PHMPT’s Denial Letter” or “Denial Letters”) and assigned the request FOIA Control # 20221614. In PHMPT’s Denial Letter, FDA stated, in relevant part:I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling need that involves an imminent threat to the life or
physical safety of an individual. Neither have you demonstrated that
there exists an urgency to inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying yourrequest for expedited processing.
(Id. at 17-18.) On June 1, 2022, PHMPT submitted an appeal challenging FDA’s decision to deny
PHMPT’s requests for expedited processing. (Id. at 18) 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. (Dkt. No. 1 at 18.) Given the “unusual circumstances” claimed by FDA, it was required tomake 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.
PHMPT also 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):For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e), withthe exception of publicly available reports on the Vaccine Adverse Events Reporting System.

43

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All data and information for the Pfizer 12-15 Vaccine enumerated
in 21 C.F.R. § 601.51(e) 44 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System. 45
This request excludes any data and information responsive to andbeing produced in FOIA Control # 2021-5683 (previously made on
behalf of PHMPT) and is meant to capture all data and information
within the biological product file that concerns the authorization andapproval of Comirnaty for use in 12-15-year-olds.
(Dkt. No. 1 at 18.) On August 15, 2022, FDA denied PHMPT’s request for expedited processing(“PHMPT’s Denial Letter” or “Denial Letters”). In PHMPT’s Denial Letter, FDA stated, in
relevant part:I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling need that involves an imminent threat to the life or
physical safety of an individual. Neither have you demonstrated that
there exists an urgency to inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying yourrequest for expedited processing.
(Id. at 19)
The de Garays also submitted a request to FDA on August 22, 2022 for the data relied upon
to license the Pfizer 12-15 Vaccine and sought expedited processing pursuant to 5 U.S.C. §552(a)(6)(E)(v)(II). (Dkt. No. 1 at 19-20) On August 29, 2022, FDA denied the de Garays’ request
for expedited processing (“de Garays’ Denial Letter” or “Denial Letters”) and assigned therequest FOIA Control # 2022-6129. In the de Garays’ Denial Letter, FDA stated in relevant part:

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients. . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”44

For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biologicalproduct file, as defined in 21 C.F.R. § 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. §601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.
45

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I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling need that involves an imminent threat to the life or
physical safety of an individual. Neither have you demonstrated that
there exists an urgency to inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying yourrequest for expedited processing.
(Id. at 20.)
ARGUMENTThe 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 alicense has been issued, the following data and information in the biological product file are
immediately available for public disclosure unless extraordinary circumstances are shown: (1) All
safety and effectiveness data and information . . . .” 46 Therefore, FDA’s own regulations expressly
recognize the importance of having the data and information relied upon to license a vaccine“immediately available for public disclosure.” 47 FDA’s regulation not only supports the need forexpedited treatment under FOIA but is also an independent legal basis that requires expedited
treatment of this request.
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”

46

21 C.F.R. § 601.51(e) (emphasis added).

47

Id.

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and “effective.” 48 To assure FDA’s commitment to transparency 49 and to promote the public’s andthe 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 andeffectiveness data after a product is licensed, absent any extraordinary circumstances. This is thesame information that would be responsive to Plaintiffs’ requests.
Beyond the FDA’s own regulations, which admit the urgent need for transparency anddisclosure of the requested information, there are two additional reasons that warrant a reasonable
and timely production of responsive documents.
First, as explained above, 50 there is an ongoing, national public debate regarding theadequacy of the data and information, and analyses of same, relied upon by the FDA to license theCovid-19 Vaccines.
Although public health officials, media outlets, journalists, scientists, politicians, public
figures, and others with large media platforms have declared that the data and information
underlying the licensure of the Covid-19 Vaccines are more than sufficient for licensure, numerous
public health officials, media outlets, journalists, scientists, politicians, public figures, and otherswith large media platforms have publicly raised questions regarding the sufficiency of the data andinformation, 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.

21 C.F.R. § 601.2 (a). 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 theduration 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.
48

49

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

50

See, e.g., supra ¶¶ 36-45.

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The public debate is unlikely to be settled without full disclosure of the data andinformation underlying the FDA’s conclusion that the Covid-19 Vaccines are “safe and effective.”
Secondly, there is also an urgent need for the public to have immediate access to the dataand information underlying the licensure of the Covid-19 Vaccines because, over the objectionsof 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. 51
Regarding the Pfizer 12-15 Vaccine, after its FDA approval, policymakers are reviewing
the available information to determine if Covid-19 vaccine requirements are appropriate forstudents for the 2023-2024 school year and beyond. 52
Having multiple trusted independent authorities review the safety and effectiveness datasought in these FOIA requests will only assist the public and private institutions in evaluating
vaccine decisions and policies.
During a time when Covid-19 vaccine mandates are being implemented over the objectionof those who have questions about the data and information supporting the safety and efficacy of
the Covid-19 Vaccines, and individuals with these questions are being expelled from employment,
school, and other critical parts of civil society, the public has an urgent and immediate need tohave access to this data.
It is crucial that the American public be granted the transparency necessary – and on thetimeline necessary – to review and assess the government’s justifications for its actions. The
declared emergency of Covid-19 led to numerous government actions that greatly affected the51

See, e.g., supra ¶¶46-47.

52See, e.g., supra ¶¶ 46-47.

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American people, and without having full access to the data to which they are entitled, Americans
cannot judge whether all of those actions were justified. This presents a grave risk if this country
is ever confronted with a similar declared emergency in the future. Hindsight is 20/20 only if allof the data is out in the open.
CONCLUSION
For the foregoing reasons, Plaintiffs respectfully request that the Court order the FDA toproduce all documents responsive to the Pfizer 12-15 request on or before October 15, 2023 andall documents responsive to the Moderna request on or before April 15, 2025.
Dated: March 8, 2023
SIRI & GLIMSTAD LLP/s/ Aaron Siri
Aaron Siri, NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353
Colin M. Farnsworth, OR Bar No. 213351
745 Fifth Avenue, Suite 500
New York, New York 10151
Tel: (212) 532-1091
Fax: (646) 417-5967
aaron@sirillp.com
ebrehm@sirillp.com
Walker D. Moller, TX Bar No. 24092851
1005 Congress Ave., Suite 925-C36
Austin, TX 78701
Tel : (512) 265-5622
wmoller@sirillp.com
John C. Sullivan, TX Bar No. 24083920
SL LAW PLLC
610 Uptown Boulevard, Suite 2000
Cedar Hill, TX 75104
john.sullivan@the-sl-lawfirm.com
Tel: (469) 523-1351
Fax: (469) 613-0891
Attorneys for Plaintiffs

23