Court filing

Motion to Stay — CHD v. FDA

Filed April 15, 2022 in Children's Health Defense v. Food & Drug Administration; one of 7 filings from this case.

Record facts

Court	U.S. District Court for the Western District of Texas, Waco Division
Filed	2022-04-15

U.S. District Court for the Western District of Texas, Waco Division · No. 6:22-cv-00093-ADA-DTG · Doc. 14 · 2022-04-15 · Docket on CourtListener

Full text

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TEXAS

CHILDREN’S HEALTH DEFENSE,

)
Case No. 6:22-cv-93
DEBORAH L. ELSE, an individual, and
)
SACHA DIETRICH, an individual,

) Date: ___________________

)

Plaintiffs,

) Time: ___________________

)

) Dept: ___________________

)
FOOD and DRUG ADMINISTRATION, and
)
JANET WOODCOCK, Acting Commissioner
)
of Food and Drug Administration,

)

Defendants.

)
________________________________________ )

PLAINTIFFS’ MOTION TO STAY THE FOOD and DRUG ADMINISTRATION’S
EMERGENCY USE AUTHORIZATION OF THE PFIZER-BIONTECH COVID-19
VACCINE FOR CHILDREN AGES FIVE THROUGH ELEVEN

TO THE HONORABLE JUDGE OF THE COURT:
COME NOW Plaintiffs Children’s Health Defense (“CHD”), Deborah L. Else, and Sacha
Dietrich ask this Court to issue an administrative stay of the Food and Drug Administration's
(“FDA”) Emergency Use Authorization (“EUA”) of the Pfizer-BioNTech COVID-19 vaccine for
minor children ages five through eleven pending judicial review of Plaintiffs’ complaint.
Children who receive the Pfizer-BioNTech COVID-19 biologic face substantial risk of death and
serious injury, while receiving little or no health benefit. The FDA’s misuse of emergency
powers triggers mandates by municipalities, schools, public accommodations, and medical
facilities nationwide, violating the informed consent requirement of both EUA statutory authority
and the Nuremberg Code, the latter of which prohibits such experimentation on un-consenting
children. There are tangible injuries to Plaintiffs since FDA’s actions simultaneously pose
imminent injury to minors through ongoing, un-consented medical experimentation and threat of
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 1 of 26

forfeiture of fundamental freedoms. CHD is forced to divert critical resources to this issue within
its mission. Plaintiffs ask this Court to urgently right this wrong.

Dated: April 15, 2022
Respectfully submitted,
__/s/ Robert E. Barnes__________

Robert E. Barnes, Esq.
Member of the Western District of Texas
235919/CA
Email: robertbarnes@barneslawllp.com
BARNES LAW
700 South Flower Street, Suite 1000
Los Angeles, California 90017
Telephone: (310) 510-6211

Robert F. Kennedy, Jr., Esq.
Mary S. Holland, Esq.
Subject to admission Pro Hac Vice
Email: mary.holland@childrenshealthdefense.org
Children’s Health Defense
1227 N. Peachtree Pkwy, Suite 202
Peachtree City, GA 30269

Counsel for Plaintiffs CHILDREN’S HEALTH
DEFENSE, DEBORAH L. ELSE, and SACHA
DIETRICH

Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 2 of 26

iii

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TEXAS

CHILDREN’S HEALTH DEFENSE,

)
DEBORAH L. ELSE, an individual, and

)
SACHA DIETRICH, an individual,

)

Plaintiffs,

)

)
FOOD and DRUG ADMINISTRATION, and
)
JANET WOODCOCK, Acting Commissioner
)
of Food and Drug Administration,

)

Defendants.

)
________________________________________ )

PLAINTIFFS’ MEMORANDUM IN SUPPORT OF MOTION TO STAY THE FOOD &
DRUG ADMINISTRATION’S EMERGENCY USE AUTHORIZATION OF THE
PFIZER-BIONTECH COVID-19 BIOLOGIC FOR CHILDREN AGES FIVE THROUGH
ELEVEN

Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 3 of 26

TABLE OF CONTENTS

INTRODUCTION…………………………………………………………..……..…………… 1

FACTS…………………………………………………………………………………………... 2

I.
COVID-19 poses no emergency for children ages five through eleven…………. 2
II.
The Pfizer-BioNTech COVID-19 “vaccine” confers no benefit to children……. 3
III.
Pfizer-BioNTech’s experimental “vaccine” often has severe adverse effects..…. 4
IV.
Clinical trials for children ages five through eleven were insufficient………...... 8
V.
The Pfizer-BioNTech COVID-19 biologic fails to meet the traditional definition
of “vaccine”………………………………………………………………………… 10

VI.
Defendants’ EUA absent a stay will result in discriminatory treatment towards
unvaccinated children……………………………………………………………... 11

LEGAL STANDARD…………………………………………………………………………. 13

ARGUMENT AND AUTHORITIES………………………………………………………… 15

I.
Petition to review EUA is likely to succeed on its merits ……..………………… 15

A. The FDA’s 5-11 EUA violates APA 5 U.S.C. § 706(2)(A)....................................... 15

II.
Plaintiffs will suffer irreparable harm absent a stay …………………………… 17

III.
A stay will not substantially injure others and furthers the public interest …... 19

CONCLUSION………………………………………………………………………………... 20

Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 4 of 26

TABLE OF AUTHORITIES
Cases:
Burlington Truck Lines v. United States,
371 U.S. 156 (1962) …………………………...….......................................................... 15

Michigan v. EPA,
576 U.S. 743 (2015) ……………………….…………………........................................ 15

Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto Ins. Co.,
463 U.S. 29 (1983) ……………………….………………….…………………………. 15

Nken v. Holder,
556 U.S. 410 (2009)………..………………….……………………......................... 14, 15

Sampson v. Murray,
415 U.S. 61 (1974) ………..………………….………………………………………… 14

Winter v. Nat. Res. Def. Council, Inc.,
555 U.S. 7 (2008) ……….……………………………………………………………… 14

Statutes:
5 U.S.C. § 551.……………………….………………….………………….…….…………….. 14
5 U.S.C. § 705.……………………….………………….……………………...................... 14, 15
21 U.S.C. § 360bbb-3……………….………………….……………............................... 2, 16, 17

Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 5 of 26

INTRODUCTION
The FDA authorizes pharmaceutical companies to experiment on children without their
consent. FDA’s EUA greenlights mandates of this experimental biologic on children to the
enormous profit of the pharmaceutical companies, while simultaneously immunizing these same
drug companies against any liability for any injuries their products cause.
With the granting of EUA status of the Pfizer-BioNTech COVID-19 vaccine for children
as young as five years old, the FDA is conducting a dangerous and unprecedented
experiment. Using its emergency powers, FDA authorized an experimental biologic for children,
even though no COVID-19 health emergency exists for five year old children. This drug is
neither safe nor effective and does not fit the traditional definition of “vaccine,” as was
represented via this authorization. Despite knowledge that authorization would result in
mandatory use without informed consent, Defendants engaged in neither the requisite scientific
or citizen discourse, ignored citizen and scientific petitions alike, and skipped any notice-and-
comment process altogether. The FDA misused its emergency powers to authorize an
experimental mRNA vaccine for minor children despite serious safety concerns, inadequate
testing, and outright misrepresentation of the biologic.
The FDA’s action poses irreparable and immediate injury to plaintiffs and places
plaintiffs' minor children at imminent risk of harm. The FDA unlawfully and injuriously
mischaracterizes any purported legal source of their power, falsely represents this body-altering
experimental mRNA gene therapy to be injected into children, and impermissibly redefines the
word “vaccine” itself. CHD as an institution suffers and its essential resources are diverted to
address this danger. The FDA claims to be above the law, the citizenry, and even this court. This
suit follows, and, due to the urgent threat posed, this motion made necessary thereby.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 6 of 26

FACTS

I.
COVID-19 poses no emergency for children ages five through eleven
Defendants abused their authority under the emergency use authorization statute when it
granted the EUA at issue because no “actual or potential emergency” exists for children ages five
through eleven from COVID-19. 21 U.S.C. § 360bbb–3(a)(1).
Data on the risks posed from COVID-19 show that it is entirely unnecessary for children
in this age group to be vaccinated. Death from COVID-19 in healthy children is statistically zero.
A German study concluded that “children without comorbidities were found to be significantly
less likely to suffer from a severe or fatal disease course,” with the lowest risk observed in
healthy children aged five through eleven.1 Within this group, the “ICU admission rate was 0.2
per 10,000 and case fatality could not be calculated, due to an absence of cases.”2 Similarly, a
Johns Hopkins study monitoring 48,000 children diagnosed with COVID “found a mortality rate
of zero among children without a pre-existing medical condition,”3 while a study published in
Nature Medicine showed that children under 18 with no comorbidities have virtually no risk of
death from COVID-19.4 Children also have low risk of severe symptoms and hospitalization,
with COVID-19 “hospitalizations occurred at a rate of 10.8 per 100,000 children,” 5 and infected

1 Sorg, AL, Hufnagel, M., Diffloth, N. Risk of Hospitalization, severe disease, and mortality due
to COVID-19 and PIMS-TS in children with SARS-CoV-2 infection in Germany, medRxiv,
November 30, 2021, doi: https://doi.org/10.1101/2021.11.30.21267048.
2 Id.
3 Marty Makari, The Flimsy Evidence Behind the CDC’s Push to Vaccinate Children, Wall St. J.,
Jul. 19, 2021, http://www.wsj.com/articles/cdc-covid-19-coronavirus-vaccine-side-effects-
hospitalization-kids-11626706868.
4 Smith, C. et al. Deaths in children and young people in England after SARS-CoV-2 Infection
during the first pandemic year, Nat Med 28 (2022): 185-192, https://doi.org/10.1038/s41591-
021-01578-1.
5 Ward, J.L., Harwood, R., Smith, C. et al. Risk factors for PICU admission and death among
children and young people hospitalized with COVID-19 and PIMS-TS in England during the
first pandemic year. Nat Med 28, 193–200 (2022). https://doi.org/10.1038/s41591-021-01627-9
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 7 of 26

children often experience mild or asymptomatic disease.6 Furthermore, epidemiological studies
suggest that children do not significantly contribute to the spread of SARS-CoV-2 and that
younger children may be less likely to transmit the virus.7
The calculated risk from COVID-19 is realistically even lower, as this “emergency” was
based on inaccurate death statistics. The CDC recently corrected its COVID-19 mortality data for
children, which was “inflated” in a “coding logic error” in which non-COVID-19 related deaths
were counted in the statistics reduced the total pediatric deaths from COVID-19 by nearly 24%
(1,755 individuals to 1,356). 8 315 of those occurred in children ages five through eleven; this is
equivalent to under 200 children per year in a population of approximately 28 million children
aged five through eleven, which is under a 0.00000714 risk of death. Acknowledging this data,
Florida became the first U.S. state to recommend against healthy children receiving this
biologic, publishing guidance on March 8, 2022 that “healthy children from ages 5 to 17 may not
benefit from receiving the currently available COVID-19 vaccine.”9
II.
The Pfizer-BioNTech COVID-19 “vaccine” confers no benefit to children
This biologic has proven to be monumentally less successful than the originally promised
90% effectiveness claimed by Pfizer-BioNTech. A comprehensive study of over 365,000

6 Encinosa, W. et al., Severity of Hospitalizations from SARS-CoV-2 vs Influenza and
Respiratory Syncytial Virus Infection in Children Aged 5 to 11 Years in 11 US States, Feb. 21,
2022, JAMA Pediatrics, https://jamanetwork.com/journals/jamapediatrics/fullarticle/2789353.
7 European Centrse for Disease Prevention and Control (ECDC). COVID-19 in children and the
role of school settings in COVID-19 transmission. Stockholm, 2020. Available:
https://www.ecdc.europa.eu/en/publications-data/children-and-school-settings-covid-19-
transmission.
8 CDC Says It Accidentally Inflated Children’s COVID Death Numbers In “Coding Logic
Error,” Daily Caller, March 18, 2022, available at https://dailycaller.com/2022/03/18/cdc-data-
kids-pediatric-covid-coronavirus-deaths/?s=09; COVID Data Tracker, CDC, updated March 21,
2022, available at https://covid.cdc.gov/covid-data-tracker/#demographics.
9 Florida Department of Health Issues New Guidance Regarding COVID-19 Vaccination
Recommendations for Children, Florida Health, March 8, 2022.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 8 of 26

children ages five through eleven revealed that that biologic has an effectiveness of a mere
12%.10 A study of hundreds of thousands of children in New York revealed that the COVID-19
vaccines offered “virtually no protection against infection, even within a month after full
immunization.”11 What’s more, a Danish study found no statistically significant positive effect
against Omicron infection was seen 30 days after vaccination, and after 90 days, it conferred a
negative effectiveness, i.e. greater susceptibility to infection.12 This trend is seen worldwide, with
highly vaccinated populations demonstrating a higher COVID-19 infection rate.
The CDC excludes COVID-19 on their published list of “vaccine-preventable diseases”
for a clear reason: this COVID-19 biologic fails to prevent COVID-19. At best, it reduces the
incidence of hospitalization and death, of which children are at an incredibly low risk. As
COVID-19 poses an infinitesimal risk to children ages five through eleven, and none to healthy
children, and vaccination is ineffective at preventing infection or transmission, there is no
medical necessity, or even justification, for pediatric COVID-19 vaccination.
III.
Pfizer-BioNTech’s experimental “vaccine” often has severe adverse effects
While the medical benefits of pediatric COVID-19 vaccination are negligible, the known
risks of a short-term adverse reaction are incredibly serious, and the full medical risks are
unknown due to the speed with which this biologic was created and administered to the public.

10 Dorabawila, V. et al., Effectiveness of the BNT162b2 vaccine among children 5-11 and 12-17
years in New York after the Emergency of the Omicron Variant, Feb. 28, 2022,
https://www.medrxiv.org/content/10.1101/2022.02.25.22271454v1.
11 New York Times, Pfizer Shot Is Far Less Effective in 5- to 11-Year-Olds Than in Older Kids,
New Data Show, Feb. 28, 2022, https://www.nytimes.com/2022/02/28/health/pfizer-vaccine-
kids.html.
12 C.H. Hanson et al., Vaccine effectiveness against SARS-CoV-2 infection with the Omicron or
Delta variants following a two-dose or booster BNT162B2 or mRNA-1273 vaccination series: A
Danish cohort study (Dec. 23, 2021), https://www.medrxiv.org/content/10.1101/2021.12.20.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 9 of 26

Evidence available prior to the EUA showed that this experimental vaccine threatens
significant health risks. The Vaccine Adverse Event Reporting System (VAERS) quickly had
more adverse events attributed to COVID-19 vaccines than any vaccine in history. Between
November 3 and December 19, 2021, VAERS received an overwhelming 4,249 reports for
children aged five through eleven years who received the Pfizer-BioNTech COVID-19
vaccine.13 100 of these reports were for serious events, such as fever, vomiting, increased
troponin, seizure, myocarditis, and death. However, the FDA failed to adequately heed any of
these warning signals prior to this authorization. Indeed, the licensure of Pfizer’s COMIRNATY
on August 23, 2021 required that Pfizer conduct post-marketing studies on safety, 14
demonstrating that the FDA was aware of the dangers this biologic could pose. 15 The results of
these studies will not be reported to the FDA until 2023, 2024, and 2025—long after scores of
children might be injured by this experimental vaccine.
Furthermore, released post-vaccination monitoring data from the FDA, who opposed the
release and contended that it should occur more than 50 years from now, due to FOIA litigation
demonstrate that the FDA was aware of severe health risks posed by this biologic. The FDA’s
report shows that within the first three months following the initial authorization of the biologic
for individuals ages 16 and up, 42,086 case reports were filed containing 158,893 adverse
events.16 Of these 42,086 reports, 1,223 resulted in death. The report summarizes that:

13 COVID-19 Vaccine Safety in Children Aged 5-11 Years – United States, November 3-
December 19, 2021, CDC,
https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a1.htm#T1_down.
14 COMIRNATY BLA Approval, FDA, August 23, 2021.
15 These required studies included investigating “the occurrence of myocarditis and pericarditis,”
and deferred pediatric studies to evaluate the safety and effectiveness of COMIRNATY in
children 12-15, children 6 months to <12 years of age, and infants <6 months of age.
16 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048
(BNT162B2) Received Through 28-FEB-2021, FDA, April 30, 2021.
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6
The System Organ Classes (SOCs) that contained the greatest number
(>2%) of events, in the overall dataset, were General disorders and administration
site conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal
and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin
and subcutaneous tissue disorders (8,476), Respiratory, thoracic and mediastinal
disorders (8,848), Infections and infestations (4,610), Injury, poisoning and
procedural complications (5,590), and Investigations (3,693).”
An alarming number—more than 1,300—of adverse events of special interest (AESI), were also
identified as potentially relevant during that time and listed in the report.17 Many key documents
containing essential clinical trial and post-vaccination data have yet to be released.
Testing specific to children yielded similar concerns. Pfizer's 12-to-15-year-old clinical
trial, which included a mere 2,264 randomized adolescents, yielded side effects such as high
fever, anaphylaxis, possible myocarditis and pericarditis that resulted in hospitalization,
“exacerbation” of depression, neuralgia, severe abdominal pain, and lymphadenopathy.18 There
were no cases of severe COVID-19 observed in either the test or placebo group. The risk of
myocarditis, a potentially fatal heart condition, for adolescents has been alarmingly high,
specifically for males. The FDA itself acknowledged that the data shows “known serious risks of
myocarditis” caused by this vaccine.19 There is a higher reported rate of myocarditis in children
ages 12 through 15 than in children ages 16 through 17 vaccinated against COVID-19.20 Within
8 weeks after this biologic was offered to children 12-15 years, there were 19 times the expected
17 Id.
18 Frenk, R., Klein, N., Kitchin, N. Safety, Immunogenicity, and Efficacy of the BNT162B2
Covid-19 Vaccine in Adolescents. N Engl J Med. 2021; 385:239-250. doi:
10.1056/NEJMoa2107456
19 FDA, Letter to Pfizer Inc., Aug. 23, 2021, p. 6.
20 Krug, A, Stevenson, J, Høeg, TB. BNT162b2 Vaccine-Associated Myo/Pericarditis in
Adolescents: A Stratified Risk-Benefit Analysis. Eur J Clin Invest. 2022; 00:e13759.
doi:10.1111/eci.13759
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7
number of myocarditis cases compared to typical rates.21 If this trend continues, then children
ages five through eleven may be at an even greater risk of myocarditis than it initially appeared.
Following the clinical trials for the cohort at issue, the CDC also conducted health check-
in surveys for 42,504 children for the week following vaccination. Observed adverse event
occurrence and frequency published by the CDC can be observed in the following chart. 22
Research suggests that data on vaccine injuries are underestimates. In Germany, public
health insurers report substantially larger numbers of adverse effects from COVID-19 injections
that may be 8 to 10 times higher than those reported by Germany’s vaccine regulatory body.23
The potential risks of immediate adverse effects and long-term vaccine-induced health
risks outweigh any negligible benefit, and the true extent of the health risks posed by COVID-19
vaccination will not be known for years. Despite contrary evidence, the Director of the FDA’s
21 Rose, J., McCullough, P., A Report on Myocarditis Adverse Events in the U.S. Vaccine
Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable
Biological Products, available at
https://web.archive.org/web/20211007022704/https://doi.org/10.1016/j.cpcardiol.2021.101011.
22 Id.
23 German Public Health Insurer; Vaccine Side Effects Maybe 8 to 10 Times More Frequent than
Officially Reported, eugyppius: a plague chronicle, February 23, 2022.
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8
Center for Biologics Evaluation and Research stated publicly that the FDA is “confident in the
safety, effectiveness and manufacturing data behind this authorization” and hopes to “build
confidence of parents who are deciding whether to have their children vaccinated.”24 Every child
between the ages of five and eleven who sustained an injury from this vaccine has done so as a
direct result of FDA’s actions and false representations.
The FDA, by arbitrarily and capriciously ignoring the abundance of alarming data
warning of the dangers of this biologic, has instead forged ahead on its quest of mass
vaccination, no matter how heavy the costs to children and their families.
IV.
Clinical trials for children ages five through eleven were insufficient
Even if the overwhelming warning signs above were absent, the clinical trial research
into the Pfizer-BioNTech biologic for children five through eleven was inadequate to properly
determine the safety and efficacy of the vaccine. The Phase 1 clinical trial included only 48
children.25 To account for side effects seen with higher doses in the phase 1 clinical trial for
children under 12, the FDA was forced to lower the mRNA dose to 10 µm (10 millionths of a
gram) for children ages 5 through 11 in the phase 2/3 clinical trials. Yet, even at this reduced
dosage, serious injury has been reported.
The Phase 2/3 clinical trial included 2,268 participants; 1,518 received the vaccine and
750 received the placebo. Side effects seen during the narrow observational period included
injection-site pain, fatigue and headache, chills, muscle pain, and rashes. “Systemic events were
reported more often after the second dose of BNT162b2 than after the first dose,” implying that
24 FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5
through 11 Years of Age, FDA, October 29, 2021.
25 Walter, E.B., Talaat, K.R., Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11
Years of Age, The New England Journal of Medicine, Nov. 9, 2021, doi:
10.1056/NEJMoa2116298.
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the more injections individuals receive, the more likely an adverse event.26 The small trial lasted
less than six months—far too short to ever know the long-term risks.
The phase 2/3 clinical trial data was published by September 6, 2021; less than two
months before the EUA was granted. Normally, participants are monitored for 2 years after
receiving the first dose. Defendants only had a few months of data prior to authorizing this
biologic, so it was impossible to know long-term effects of the trial. The trial acknowledges that
the “[l]imitations of the study include the lack of longer-term follow-up to assess the duration of
immune responses, efficacy, and safety,”27 and promises that “longer-term follow-up from this
study, which will continue for 2 years, should provide clarification.”28 The study also clearly
states that it was not “powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-
olds” and emphasizes the necessity of studies with expanded cohorts and additional safety
assessments.29 These studies were very short-term, had samples that were not representative of
the total population, and had poor predictive power because of their limited size.30 There has
been virtually no investigation into these severe side effects that threaten pediatric recipients of
this biologic. And yet, Defendants have nonetheless opted to authorize their use for children.
Furthermore, as FDA freely admits, the formula authorized for children five through
eleven varies from the one that has been previously administered. During the Vaccine and
Related Biological Products Advisory Committee (VRBPAC) meeting held to discuss the EUA
at issue, the FDA stated: “the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11

26 Id.
27 Id.
28 Id.
29 Id.
30 Kostoff, R., Calina, D., Why are we vaccinating children against COVID-19?, Toxicology
Report, doi: https://doi.org/10.1016/j.toxrep.2021.08.010.
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years of age uses tromethamine (Tris) buffer instead of the phosphate buffered saline (PBS) as
used in the previous formulation and excludes sodium chloride and potassium chloride.31 The
use of the different inactive ingredients for this cohort alone allegedly is to help stabilize the
vaccine under refrigerated temperatures, but the formulation also contains medicines used for
heart attacks, i.e. tromethamine and tromethamine hydrochloride, potentially to counteract the
known risks of myocarditis and pericarditis in children and young adults. The biologic that is
authorized for use in children five through eleven years of age includes different inactive
ingredients compared to the vaccine that has been studied in clinical trials. As such, the biologic
as it is being administered to young children currently is by definition untested.
V.
The Pfizer-BioNTech COVID-19 biologic drug fails to meet the traditional
definition of “vaccine”

The Pfizer-BioNTech COVID-19 biologic does not fall under the traditional definition of
“vaccine” and has thus been continuously misrepresented by Defendants, and ultimately the
pharmaceutical companies, media, and American government. Pfizer-BioNTech’s experimental
mRNA biologic is among the first of its kind, utilizing a brand-new delivery system and gene
therapy technology. Unlike vaccines that have come before it, this biologic does not actually
contain the virus, SARS-CoV-2, that causes the COVID-19 disease, but rather delivers mRNA
sequences that infiltrate the body’s cells and yield the production of a spike protein that mimics
the SARS-CoV-2 coronavirus. The mRNA component injected into the body utilizes the host
cell’s own machinery to produce the spike protein. This is a different mechanism than that of

31 Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting October
26, 2021 FDA Briefing Document EUA amendment request for Pfizer-BioNTech COVID-19
Vaccine for use in children 5 through 11 years of age.
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traditional vaccines, such as inactivated, attenuated, subunit, or protein-based vaccines that do
not penetrate human cells but utilize the actual virus to activate the body’s immune response.
While not a “vaccine” under the traditional definition, this experimental injection does
fall under the FDA Office of Cellular, Tissue, and Gene Therapies’ definition of “gene therapy
products,” although the FDA failed to study and test it as such. Gene therapies have never been
widely used in a general population and using them in this manner is still experimental.
VI.
Defendants’ EUA absent a stay will result in discriminatory treatment towards
unvaccinated children

The history of the FDA and its role in regulating medical products has led the public to trust
the FDA’s actions without question. The very fact that the FDA authorized this product, instilled
faith in its use and misled confidence in an experimental vaccine. Cultural and societal shifts that
directly affect children have and will continue to occur as a result.
Defendants’ unlawful EUA has already triggered mandates and policies that segregate
and endanger vaccinated and unvaccinated children. New Orleans became the first major school
district in the United States to mandate that all children ages five and up receive a COVID-19
experimental injection.32 Furthermore, a bill proposed in California, SB 871, would require all
children to receive a COVID-19 injection to attend childcare For school.33
Before the 5-11 EUA was even granted, there were calls from a Texas State Board of
Education member to immediately add the COVID-19 vaccine to the list of public-school
mandatory immunizations.34 In his request letter to the Department of State Health Services, he

32 Mandate to Vaccinate New Orleans Schoolchildren Kicking In, U.S. News, January 31, 2022.
33 SB-871, California Legislature, 2021-2022 Legislative Session (California 2022).
34 Texas education official calls for mandatory COVID vaccines, KHOU 11, September 4, 2021,
available at https://www.khou.com/article/news/health/coronavirus/vaccine/texas-mandatory-
immunizations-covid-students-school/285-bd8f997f-0cf2-49ce-a950-65014acf1e82.
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argued that this step should be taken “[n]ow that the Pfizer-BioNTech vaccine has received full
FDA approval.”35 The vaccine available under the 5-11 EUA is not the same as Pfizer’s licensed
Comirnaty, which, according to the CDC, is not yet available to the public.36 This is an example
of how school officials have been misled by FDA’s bait-and-switch as well as the eagerness to
mandate this biologic for young children.
Even more alarming are reports of hospitals refusing to perform organ transplants for
patients who have not received a COVID-19 vaccine.37 The Cleveland Clinic, the University of
Colorado Hospital, and Brigham and Women’s Hospital have all engaged in this type of
abhorrent discrimination. Just recently, a North Texas teenager was denied a kidney transplant
due to his vaccination status.38 This discriminatory treatment has shockingly even applied to
young children. In December 2021, a five-year-old girl in Texas who needed a kidney transplant
was removed from the transplant list because she had not received the COVID-19 vaccine.
Despite being medically fragile, this child and her family are being forced to choose between
risking her life with an EUA experimental vaccine and being barred from receiving a life-saving
transplant. This violates Defendants’ assurance in its published fact sheet for this vaccine that if
parents choose not to vaccinate their child, “it will not change your child’s standard medical

35 Id.
36 CDC, Covid-19 Vaccine Codes, available at
https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html.
37 Hospitals are denying transplants for patients who aren’t vaccinated against Covid, with
backing from ethicists, Stat News, January 26, 2022, available at
https://www.statnews.com/2022/01/26/hospitals-are-denying-transplants-for-patients-who-arent-
vaccinated-against-covid-with-backing-from-ethicists/.
38 Henry, S., Cook Children’s Health Care System Denying Transplant to Unvaxxed Child,
Scorecard, February 18, 2022, available at https://texasscorecard.com/state/cook-childrens-
health-care-system-denying-transplant-to-unvaxxed-child/.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 17 of 26

care.”39 This is the kind of horrific discrimination that Texas children currently face if this illicit
EUA is not stayed. And such discrimination will likely only grow worse without judicial action.
Plaintiffs fear their children will experience pressure and coercion to receive the vaccine
to participate in society, attend school, or have access to basic medical needs. Plaintiffs are
concerned that Texas schools and municipalities may follow other states and implement
discriminatory vaccine mandates as a prerequisite for school attendance or activity participation.
Although Gov. Abbot has signed an executive order prohibiting COVID-19 vaccine mandates,
current policies such as those at Texas hospitals exist which could certainly lead to serious
physical harm or death of unvaccinated individuals, and raises concern that such an executive
order is insufficient to prevent legitimate harm from befalling Plaintiffs’ children.
Should this trend continue, this EUA is likely to cause mental and physical harm not only
to the children who receive the biologic and suffer an adverse effect, but also to those who
refrain and are subject to egregious discrimination based on the completion of an ineffectual,
unnecessary, and potentially dangerous medical procedure. Legal limits on the FDA’s power
continue to be eviscerated using the “emergency” exceptions intended for actual emergencies,
and their misappropriation and misuse by the FDA, along with the mislabeling and mis-
advertising of this drug disguised as a “vaccine,” pose real risks to Plaintiffs’ minor children.
LEGAL STANDARD
When deciding whether to grant a stay, courts typically consider four factors: whether
Plaintiffs have shown: (1) the likelihood of success on the merits, (2) the likelihood of
irreparable harm to them in the absence of a stay, (3) that the balance of equities weighs in

39 Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-BioNTech
Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19 For Use in Individuals 5
Through 11 Years Of Age, FDA.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 18 of 26

plaintiffs’ favor, and (4) that a stay is in the public interest.40 While authority is split regarding
how to weigh certain factors or whether to use a sliding scale, in either case the “third and fourth
factors, harm to the opposing party and the public interest, merge when the Government is the
opposing party.”41 As the FDA and Janet Woodcock, acting in her official capacity, are an
institution and employee, respectively, of the Department of Health and Human Services, the
third and fourth factors merge.

The Administrative Procedures Act’s (APA) stay provision allows courts to grant a stay
on the proceedings in cases properly arising out of the APA. 5 U.S.C. § 705 provides that:
When an agency finds that justice so requires, it may postpone the effective date
of action taken by it, pending judicial review. On such conditions as may be
required and to the extent necessary to prevent irreparable injury, the reviewing
court, including the court to which a case may be taken on appeal from or on
application for certiorari or other writ to a reviewing court, may issue all
necessary and appropriate process to postpone the effective date of an agency
action or to preserve status or rights pending conclusion of the review
proceedings.

The APA defines agency action as a “rule, order, license, sanction, relief, or the equivalent or
denial thereof, or failure to act.”42

In Sampson v. Murray, 415 U.S. 61 (1974), the Supreme Court relied on the APA’s
legislative history to observe that § 705 was intended to codify the existing power of federal
courts to issue a stay.43 While both stays and preliminary injunctions are temporary remedies,
stays are different from preliminary injunctions in one important way: preliminary injunctions

40 Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 25 (2008); See also, Fed. R. Civ. P. 65.
41 Nken v. Holder, 556 U.S. 410, 420 (2009); See, e.g., Winter v. Nat. Res. Def. Council, Inc.,
555 U.S. 7, 51 (2008) (Ginsburg, J., dissenting); Eric J. Murdock & Andrew J. Turner, How
“Extraordinary” Is Injunctive Relief in Environmental Litigation? A Practitioner’s Perspective,
42 ENVTL. L. REP. NEWS & ANALYSIS 10464 (2012).
42 5 U.S.C. § 551(13).
43 Id. at 68 n.15 (citing S. REP. NO. 752, at 230 (1945)) (citing S. REP. NO. 752, at 230 (1945)).
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 19 of 26

act on the person while stays act on the proceeding.44

Under APA § 705, the Court is obliged, in the interest of justice and to prevent
irreparable injury, to stay the EUA that Defendants unlawfully granted to Pfizer-BioNTech’s
biologic for children ages five through eleven.
ARGUMENT AND AUTHORITIES
I.
Petition to review EUA is likely to succeed on its merits

“The first factor, a strong showing of a likelihood of success on the merits, requires more
than a mere possibility that relief will be granted.”45 In this case, there is a strong likelihood that
the Court will find that FDA’s EUA for Pfizer-BioNTech'sCOVID-19 vaccine for children ages
five through eleven is arbitrary and capricious agency action that abuses the FDA’s emergency
use powers and should be invalidated.
A. The FDA’s 5-11 EUA violates APA 5 U.S.C. § 706(2)(A)

The Administrative Procedures Act (APA) protects the public from arbitrary and
capricious executive branch action by imposing the rule of reason and the rule of law through
judicial oversight. An agency is “required to engage in reasoned decision making”46 that requires
the agency to “articulate a satisfactory explanation for its action.”47 This process requires
Defendants to articulate clear rationales for decisions, especially when their actions are bound to
lead to medical mandates with severe consequences for millions of people.48 The Plaintiffs have
a strong likelihood of demonstrating that Defendants have violated this requirement.

44 Nken v. Holder, 556 U.S. 418, 420 432–33. (2009).
45 Id. at 420.
46 Michigan v. EPA, 576 U.S. 743, 750 (2015).
47 Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43
(1983).
48 Burlington Truck Lines v. United States, 371 U.S. 156, 158 (1962).
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 20 of 26

16
Defendants abused their power in granting this EUA in three ways: (1) by disguising their
authorization of this untested medical experimentation on children as “emergency” authorized
power, when no such emergency authorized power so permits; (2) by misrepresenting this
biologic as safe and effective “vaccine” for young children, thus denying the informed consent
rights of children and their parents under both statute and the Nuremberg Code; and (3) by
changing the definition of vaccine to include this biologic, reversing more than a century of
medical terminology and thereby exceeding authority provided by Congress or the Constitution.
Defendants abused their emergency use power by authorizing a biologic for children
where no emergency exists, there is no net benefit to children receiving the biologic, and the
biologic poses significant known and unknown dangers that have yet to be properly investigated.
Defendants refused to acknowledge the mild, if not nonexistent, threat that COVID-19 poses to
children ages five through eleven. The EUA statute requires that to issue an authorization under
§ 360bbb-3, it must be reasonable to believe that “the known and potential benefits of the
product . . . outweigh the known and potential risks of the product,” “based on the totality of
scientific evidence available.”49 However, Defendants cannot satisfy this minimum threshold in
this case nor reasonably believe in this circumstance that such a determination would accurately
reflect the available science and data. The FDA abused its power and shirked its obligation to, as
the agency boasts, “protect[] the public health by assuring the safety, effectiveness, and security
of . . . drugs, vaccines, and other biological products for human use.”50
Defendants failed to consider relevant data regarding the adverse effects observed in
the clinical trials, witnessed from the administration of this biologic, and provided to them in
49 21 U.S.C. § 360bbb-3(c)(2)(B).
50 FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5
through 11 Years of Age, FDA, October 29, 2021.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 21 of 26

CHD’s citizen petition. Exh. 1. Defendants authorized a biologic that has undergone insufficient
clinical trials and have failed to satisfy any safety protocol regarding this biologic, ultimately
encouraging a culture of false marketing and mass medical experimentation on young children.
Through this EUA, the FDA has failed to provide accurate representations of the dangers and
risks associated with the Pfizer-BioNTech experimental vaccine, blatantly ignoring individuals’
rights of informed consent, medical freedom, and personal autonomy, as the emergency use
statute so requires. As a condition of authorization under EUA, it must be ensured that
“individuals to whom the product is administered are informed . . . of the significant known and
potential benefits and risks of such use, and the extent to which such benefits and risks are
unknown.”51 Defendants did not adequately adhere to this requirement, knowing that such an
authorization would inevitably result in instances of mandatory vaccination.
Furthermore, a vaccine should confer inoculation, meaning the introduction of an
infectious agent to the body to produce immunity. This biologic provides no guarantee of such a
benefit. Defendants have marketed this biologic as a “vaccine” although it fails to meet the
traditional definition and is in fact an experimental gene therapy.
II.
Plaintiffs will suffer irreparable harm absent a stay
The FDA’s EUA for the Pfizer-BioNTech vaccine will result in harm to the young
children of Plaintiffs Deborah L. Else and Sacha Dietrich, the children for whom CHD
advocates, and CHD as it continues to advocate against Defendants’ illicit actions.
Monetary recovery is unavailable against the Defendants due to sovereign immunity,
leaving declaratory and injunctive relief as the sole remedies. CHD continues to experience
substantial costs incurred from the diversion of essential resources at a critical juncture due to the

51 Id. at §360bbb-3(e)(1)(A)(ii).
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 22 of 26

Defendants' actions at issue here. Exh. 2. Defendants' misuse of emergency powers,
misrepresentation of a dangerous biologic as a safe vaccine for children, and misappropriation
power to effectively use its emergency authorization to trigger mandates of an untested product
without meaningful informed consent and with no accountability due to the immunity afforded
“emergency” biologics “treating” pandemics, caused and causes real economic injury to Plaintiff
CHD, and this is the least dangerous injury Defendants inflict.
Plaintiffs’ children are threatened by continued COVID-19 vaccine mandates and
coercion from schools and pediatricians, and an inundation of pro-vaccine messaging in the
media and on television, stemming directly from Defendants’ inaccurate and illicit representation
of safety and effectiveness, of which the Pfizer-BioNTech experimental vaccine is neither. Exh.
3 & 4. The longer this EUA remains unchecked, the more guaranteed that Plaintiffs’ children,
and the children on behalf of whom CHD advocates, are imminently subjected to discrimination
based on their vaccination status. This EUA has already resulted in mandates of experimental
mRNA gene therapy to participate in society, attend school, and even receive medical treatment.
The FDA’s authorization has allowed Pfizer and federal agencies to mislead the public about
vaccine safety, spreading harmful misinformation to parents and children who may opt to receive
it, at the behest of unconstitutional mandates, based on the FDA’s authorization.
Plaintiffs’ children, and indeed all Texas children, are at serious risk from these
encroaching mandates. In just two short months following the 5-11 EUA, Texas hospitals began
denying life-saving treatment to unvaccinated children. Any child can be involved in an accident
or experience a serious illness that may put them in a situation where they require emergency
treatment from a hospital or health care facility. Plaintiffs’ children could die or face life-long
health consequences because of the discrimination that is occurring in Texas healthcare facilities.
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 23 of 26

This deadly second-class treatment of unvaccinated children is likely to become more prevalent
entirely due to Defendants’ reckless action to authorize the product for this age cohort.
The FDA’s nationwide authorization of Pfizer-BioNTech’s experimental injection poses
a severe threat to approximately 28 million young children. Aside from the known severe side
effects, many of which are irreversible of the Pfizer injection, the long-term adverse effects are
virtually unknown. As such, young children who are forced to receive this vaccine may become
victims of the FDA’s reckless actions and be subject to untold adverse effects as a direct result if
this authorization. There is significant potential for harm if individuals are forced to receive a
vaccine when they mistakenly believe that they are receiving a safe, effective, and licensed
product for which there is some legal recourse, when in fact there is virtually no liability.
Furthermore, without a stay, Children’s Health Defense will suffer harm through a
substantial diversion of resources to counteract Defendants’ ill-advised authorization and to
correct this critical error. Exh. 2. Injury results from the marketing and expense of this action,
which is imminent and ongoing, and the continued advocacy on behalf of children who have and
will be injured by this EUA, without monetary remedy due to sovereign immunity.
III.
A stay will not substantially injure others and furthers the public interest

Generally, when looking at the effect an action may have on the public interest, courts
consider not only the law but also ethics. According to the American Medical Association, under
the Code of Medical Ethics, it is a patient's right to be able to give informed consent to her
physician when considering medical care or treatment.52 Informed consent fosters trust and
support in the doctor-patient relationship. It is in the public interest that those seeking vaccines

52 Code of Medical Ethics Opinion 2.1.1, ama-assn.org (September 5, 2021)
https://www.amaassn.org/delivering-care/ethics/informed-consent
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 24 of 26

receive accurate, truthful, complete information, and that they give informed consent or informed
refusal. To be able to give informed consent, the patient must be able to understand: (1) the
relevant medical information and the implications of treatment alternatives for an independent,
voluntary decision; (2) the burdens, risks, and expected benefits of all options, including
alternative treatments; and (3) the documentation the healthcare workers provide.
The public is served by protecting the sacred right of informed consent, especially as it
pertains to EUA products. Furthermore, the American public, and especially parents and
children, have an interest in ensuring that FDA is fulfilling the duty with which it was entrusted:
ensuring that pharmaceutical products are reasonably safe and effective prior to release to the
public. Beyond failing spectacularly in this duty with this most recent abuse of power, the FDA
has taken the opposite approach: prematurely authorizing an experimental vaccine in the name of
a nonexistent emergency, to the detriment of the children Defendants are tasked with protecting,
and to the ultimate benefit of pharmaceutical revenue.
By granting a stay on the FDA’s EUA for children ages five through eleven, this Court
will end the Defendants’ dangerous gamble with the lives of American children and require that
they follow the law and uphold their duty to protect the American public. Parents, children, and
the American people deserve no less from their government and its agents.
CONCLUSION

For the aforementioned reasons, this Court should grant Plaintiffs’ Motion for Stay and
direct the FDA to comply with federal law and suspend its 5-11 EUA for Pfizer-BioNTech
vaccine pending judicial review of Plaintiffs’ complaint.
Dated: April 15, 2022

Respectfully submitted,
Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 25 of 26

/s/ Robert E. Barnes
Robert E. Barnes, Esq.
Member of the Western District of Texas
235919/CA
Member, Western District of Texas
Email: robertbarnes@barneslawllp.com
BARNES LAW
700 South Flower Street, Suite 1000
Los Angeles, California 90017
Telephone: (310) 510-6211

Counsel for Plaintiffs CHILDREN’S HEALTH
DEFENSE, DEBORAH L. ELSE, and SACHA
DIETRICH

Case 6:22-cv-00093-ADA-DTG Document 14 Filed 04/15/22 Page 26 of 26

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