Amicus Curiae Brief — Anthony Marciano, Applicant v. Eric Adams, Mayor of the City of New York, et al.

NO. 22A178

In the

Supreme Court of the United States

ANTHONY MARCIANO, individually and on behalf

of all other individuals similarly situated,

Applicant/Petitioner,

v.

ERIC ADAMS, Mayor of the City of New York, in his official capacity;

ASHWIN VASAN, Commissioner of Health and Mental Hygiene, in

his official capacity; KEECHANT SEWELL, Police Commissioner, in

her official capacity; THE NEW YORK CITY BOARD OF HEALTH;

and THE CITY OF NEW YORK,

Respondents.

On Emergency Application for Writ of Injunction

to the Honorable Clarence Thomas

BRIEF OF AMICUS CURIAE

PHYSICIANS FOR INFORMED CONSENT

IN SUPPORT OF APPLICANT/PETITIONER

GREGORY J. GLASER

COUNSEL OF RECORD

4399 BUCKBOARD DRIVE #423

COPPEROPOLIS, CA 95228

(925) 642-6651

GREG@PICPHYSICIANS.ORG

COUNSEL FOR AMICUS CURIAE

SEPTEMBER 24, 2022

SUPREME COURT PRESS

♦

(888) 958-5705

♦

BOSTON, MASSACHUSETTS

i

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES .......................................................................................... ii

IDENTITY AND INTEREST OF AMICUS CURIAE .................................................. 1

SUMMARY OF ARGUMENT ....................................................................................... 1

ARGUMENT .................................................................................................................. 2

A. INFORMED CONSENT/REFUSAL IN VACCINATION IS A FUNDAMENTAL RIGHT

TRIGGERING STRICT SCRUTINY. ........................................................................... 2

B. THERE IS NO EVIDENCE THAT COVID-19 VACCINES PREVENT THE INFECTION

OR TRANSMISSION OF SARS-COV-2 OR COVID-19, AND IN FACT THERE IS

EVIDENCE TO THE CONTRARY (THAT IT HAS A NEGATIVE EFFECT ON

IMMUNITY) .......................................................................................................... 9

C. THOSE PREVIOUSLY INFECTED WITH COVID-19 SHOULD NOT HAVE LESS

RIGHTS THAN THOSE VACCINATED FOR COVID-19 ............................................ 12

D. COVID-19 VACCINES HAVE HAD NO MEASURABLE IMPACT ON THE COVID19 MORTALITY RATE .......................................................................................... 13

CONCLUSION............................................................................................................. 15

ii

TABLE OF AUTHORITIES

Page

TABLE OF AUTHORITIES

CASES

Addington v. Texas,

441 U.S. 418 (1979) ................................................................................................ 4

Carey v. Population Services Intl,

431 U.S. 678 (1977) ................................................................................................ 4

City of Newark v. JS,

279 N.J. Super. 178 (1993) ..................................................................................... 4

Foucha v. Louisiana,

504 U.S. 71 (1992) .................................................................................................. 4

Green v. Edwards,

164 W.Va. 326 (1980) ............................................................................................. 4

Jacobson v. Massachusetts,

197 U.S. 11 (1905) .................................................................................................. 3

John Doe #1 #14 & Jane Doe #1 #2 v. Austin,

No. 3:21-cv-1211-AW-HTC, 2021 U.S. Dist. LEXIS 236327

(N.D. Fla. Nov. 12, 2021)........................................................................................ 9

O’Connor v. Donaldson,

422 U.S. 563 (1975) ................................................................................................ 4

Panhandle Eastern Pipeline Co. v. State Highway Commission,

294 U.S. 613 (1935) ................................................................................................ 5

Union Pac. Ry. Co. v. Botsford,

141 U.S. 250 (1891) ................................................................................................ 3

Vitek v. Jones,

445 U.S. 480 (1980) ................................................................................................ 4

Washington v. Harper,

494 U.S. 210 (1990) ................................................................................................ 3

STATUTES

21 U.S.C. § 360bbb-3...................................................................................................... 9

iii

TABLE OF AUTHORITIES—Continued

Page

OTHER AUTHORITIES

American College of Obstetricians and Gynecologists,

Ethical issues with vaccination in obstetrics and gynecology. Committee

Opinion No. 829. OBSTET GYNECOL 2021;138:e16-23. https://www.acog.org/

clinical/clinical-guidance/committee-opinion/articles/2021/07/ethical-issueswith-vaccination-in-obstetrics-and-gynecology ..................................................... 3

American Medical Association,

AMA Principles of Medical Ethics: I, II, V, VIII. Informed Consent. (2022)

https://www.ama-assn.org/delivering-care/ethics/informed-consent ................... 2

Brown CM, et al,

Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine

Breakthrough Infections, Associated with Large Public Gatherings —

Barnstable County, Massachusetts, July 2021. MMWR MORB MORTAL WKLY

REP 2021;70:1059-1062. https://www.cdc.gov/mmwr/volumes/70/wr/

mm7031e2.htm ..................................................................................................... 11

Bryant A, et al,

Ivermectin for prevention and treatment of COVID-19 infection: a systematic

review, meta-analysis, and trial sequential analysis to inform clinical

guidelines. AM J THER. 2021 Jun 21;28(4):e434-60. https://www.ncbi.nlm.nih.

gov/pmc/articles/PMC8248252/ .............................................................................. 7

C19early.com,

COVID-19 early treatment: real-time analysis of 2,118 studies [cited 2022

Sept 18]. https://c19early.com/ ............................................................................... 7

C19early.com,

COVID-19 studies: ivermectin; [cited 2022 Sept 18]. https://c19ivermectin.

com .......................................................................................................................... 7

C19early.com,

COVID-19 studies: vitamin D; [cited 2022 Sept 18]. https://c19vitamind.com ... 8

C19early.com,

HCQ for COVID-19: real-time meta analysis of 362 studies; [cited 2022 Sept

18]. https://hcqmeta.com ........................................................................................ 8

CDC (September 8, 2022),

Immunization Information Systems, COVID-19 Vaccine Related Codes. https:

//www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html ................... 8

CDC,

Interim Public Health Recommendations for Fully Vaccinated People. Covid-

iv

TABLE OF AUTHORITIES—Continued

Page

19, Vaccines. Updated July 28, 2021. https://www.cdc.gov/coronavirus/2019-

ncov/vaccines/fully-vaccinated-guidance.html .................................................... 11

Centers for Disease Control and Prevention,

Washington, D.C.: U.S. Department of Health and Human Services. COVID

data tracker: trends in number of COVID-19 cases and deaths in the US

reported to CDC, by state/territory; [cited 2022 Apr 2]. https://covid.cdc.gov/

covid-data-tracker/#trends_totaldeaths .............................................................. 14

CNN Situation Room,

The Situation Room, interview with CDC Director Walensky. (August 5,

2021) https://twitter.com/CNNSitRoom/status/1423422301882748929 ............ 11

Colson, T.,

Top WHO scientist says vaccinated travelers should still quarantine, citing

lack of evidence that COVID-19 vaccines prevent transmission. BUSINESS

INSIDER. https://www.businessinsider.com/who-says-no-evidence-coronavirusvaccine-prevent-transmissions-2020-12?op=1 .................................................... 11

Dennis JM, et al,

Improving survival of critical care patients with coronavirus disease 2019 in

England: a national cohort study, March to June 2020. CRIT CARE MED. 2021

Feb 1;49(2):209-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803441/ .. 7

FDA Vaccines and Related Biological Products Advisory Committee,

FDA briefing document: Application for licensure of a booster dose for

Comirnaty (COVID-19 Vaccine, mRNA). FDA Vaccines and Related

Biological Products Advisory Committee Meeting: September 17, 2021. https:/

/www.fda.gov/media/152176/download .................................................................. 7

FDA Vaccines and Related Biological Products Advisory Committee,

FDA briefing document: EUA amendment request for a booster dose for the

Janssen COVID-19 vaccine. Vaccines and Related Biological Products

Advisory Committee Meeting: October 15, 2021. https://www.fda.gov/media/

153037/download. ................................................................................................... 6

Fraiman J, et al,

Serious adverse events of special interest following mRNA COVID-19

vaccination in randomized trials in adults. VACCINE. 2022 Sep

22;40(40):5798-5805. https://pubmed.ncbi.nlm.nih.gov/36055877/ ...................... 6

Horwitz LI, et al,

Trends in COVID-19 risk-adjusted mortality rates. J HOSP MED. 2021

Feb;16(2):90-2. https://www.journalofhospitalmedicine.com/jhospmed/article/

230561/hospital-medicine/trends-covid-19-risk-adjusted-mortality-rates. .......... 7

v

TABLE OF AUTHORITIES—Continued

Page

Ilie PC, et al,

The role of vitamin D in the prevention of coronavirus disease 2019 infection

and mortality. AGING CLIN EXP RES. 2020 Jul;32(7):1195-8. https://www.ncbi.

nlm.nih.gov/pmc/articles/PMC7202265/ ................................................................ 8

Ioannidis, JPA,

Reconciling estimates of global spread and infection fatality rates of COVID19: an overview of systematic evaluations. EUR J CLIN INVEST.

2021;51:e13554. https://onlinelibrary.wiley.com/doi/epdf/10.1111/eci.13554 ...... 7

Lin, DY, et al,

Letter to the Editor: Effects of Vaccination and Previous Infection on

Omicron Infections in Children. NEW ENGLAND JOURNAL OF MEDICINE.

(September 2022) https://www.nejm.org/doi/full/10.1056/NEJMc2209371 ......... 6

Manskar, N,

Moderna boss says COVID-19 vaccine not proven to stop spread of virus. NEW

YORK POST. (November 24, 2020) https://nypost.com/2020/11/24/modernaboss-says-covid-shot-not-proven-to-stop-virus-spread/ ....................................... 11

Mariner, W et al.,

Jacobson v. Massachusetts: It’s Not Your Great-Great-Grandfather’s Public

Health Law, 95 AM. J. PUB. HEALTH 581 (2005). https://www.ncbi.nlm.nih.

gov/pmc/articles/PMC1449224/ .............................................................................. 4

Massetti, PhD, et al.,

Summary of Guidance for Minimizing the Impact of COVID-19 on Individual

Persons, Communities, and Health Care Systems — United States, August

2022. Weekly/August 19, 2022/71(33);1057-1064. https://www.cdc.gov/mmwr/

volumes/71/wr/mm7133e1.htm ............................................................................ 12

Physicians for Informed Consent,

COVID-19 — Disease Information Statement (DIS). Aug 2021. https://

physiciansforinformedconsent.org/covid-19/ ......................................................... 7

Physicians for Informed Consent,

Janssen (Johnson & Johnson) COVID-19 Vaccine: Short-Term Efficacy &

Safety Data. May 2021. https://www.physiciansforinformedconsent.org/

COVID-19-vaccines ........................................................................................ 10, 13

Physicians for Informed Consent,

Moderna COVID-19 vaccine: short-term efficacy and safety data. Apr 2021.

https://www.physiciansforinformedconsent.org/COVID-19-vaccines................. 10

vi

TABLE OF AUTHORITIES—Continued

Page

Physicians for Informed Consent,

Pfizer-BioNTech COVID-19 vaccine: short-term efficacy and safety data. Jun

2021. https://www.physiciansforinformedconsent.org/COVID-19-vaccines ....... 10

Shitrit P, et al,

Nosocomial outbreak caused by the SARS-CoV-2 Delta variant in a highly

vaccinated population, Israel, July 2021. Euro Surveill. 2021 Sep;26(39).

https://pubmed.ncbi.nlm.nih.gov/34596015/ ....................................................... 12

Stieg, C,

Dr. Fauci on CDC mask guidelines: ‘We are dealing with a different virus now.

CNBC (July 28, 2021) https://www.cnbc.com/2021/07/28/dr-fauci-on-why-cdcchanged-guidelines-delta-is-a-different-virus.html ............................................... 11

Subramanian SV, et al,

Increases in COVID-19 are unrelated to levels of vaccination across 68

countries and 2947 counties in the United States. EUR J EPIDEMIOL. 2021 Sep

30:1-4. https://pubmed.ncbi.nlm.nih.gov/34591202/ ........................................... 12

Thomas SJ, et al,

C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA

covid-19 vaccine through 6 months. N ENGL J MED. 2021 Nov 4;385(19):1761-

73. https://pubmed.ncbi.nlm.nih.gov/34525277 .................................................... 6

U.S. Food and Drug Administration,

Vaccines and Related Biological Products Advisory Committee. FDA briefing

document: Janssen Ad26.COV2.S vaccine for the prevention of COVID-19.

Vaccines and Related Biological Products Advisory Committee Meeting:

February 26, 2021. https://www.fda.gov/media/146217/download ............... 10, 13

U.S. Food and Drug Administration,

Vaccines and Related Biological Products Advisory Committee. FDA briefing

document: Moderna COVID-19 vaccine. Vaccines and Related Biological

Products Advisory Committee Meeting: December 17, 2020. https://www.fda.

gov/media/144434/download ................................................................................ 10

U.S. Food and Drug Administration,

Vaccines and Related Biological Products Advisory Committee. FDA briefing

document: Pfizer-BioNTech COVID-19 vaccine. Vaccines and Related

Biological Products Advisory Committee Meeting: December 10, 2020. https:/

/www.fda.gov/media/144245/download ............................................................... 10

1

IDENTITY AND INTEREST OF AMICUS CURIAE1

Amicus Curiae is PHYSICIANS FOR INFORMED CONSENT (“PIC”), a 501(c)(3)

educational nonprofit organization focused on science and statistics. PIC delivers

data on infectious diseases and vaccines, and unites doctors, scientists, healthcare

professionals, attorneys, and families who support voluntary vaccination. In

addition, its COALITION FOR INFORMED CONSENT consists of about 300 U.S. and

international organizations.

This brief is submitted pursuant to leave requested by the unopposed

accompanying motion.

SUMMARY OF ARGUMENT

Respondents’ vaccine mandate would not pass strict scrutiny for scientific

reasons, because there is no legal or scientific justification for Respondents to

discriminate against unvaccinated people.

There is no evidence that any of the currently available COVID-19 vaccines

prevent the infection or transmission of SARS-CoV-2 or COVID-19, and in fact there

is evidence that the spread of SARS-CoV-2 occurs in spite of vaccination. CDC data

show mass vaccination with the COVID-19 vaccine has had no measurable impact

on the COVID-19 mortality rate in the U.S.

1 Amicis curiae states that no counsel for a party authored any part of this brief, and no person or

entity other than amicus and their counsel made a monetary contribution to the preparation or

submission of this brief.

2

Yet there is evidence that the vaccines have a rapidly declining effect on

immunity within just a few months, to the point of zero immunity within six

months. Previous SARS-CoV-2 or COVID-19 infection is more effective at

preventing SARS-CoV-2 or COVID-19 infection than COVID-19 vaccines, thereby

removing any purported justification for depriving unvaccinated people of their

Constitutionally protected rights. Those previously infected with COVID-19 should

not have less rights than those vaccinated for COVID-19.

ARGUMENT

A. INFORMED

CONSENT/REFUSAL

IN

VACCINATION

IS

A

FUNDAMENTAL

RIGHT

TRIGGERING STRICT SCRUTINY.

Universally recognized by physicians, informed consent/refusal in vaccination is

a fundamental right, as it is essential to the patient’s bodily integrity. See e.g.,

Informed consent to medical treatment is fundamental in both ethics and

law. Patients have the right to receive information and ask questions

about recommended treatments so that they can make well-considered

decisions about care. Successful communication in the patient-physician

relationship fosters trust and supports shared decision making.” Citation:

American Medical Association (2022), AMA Principles of Medical Ethics: I,

II, V, VIII. Informed Consent. https://www.ama-assn.org/delivering-care/

ethics/informed-consent.

Informed consent is a core component of the ethical clinical relationship.

As with all forms of medical therapy, informed consent should precede

vaccination administration . . . If the patient declines, this informed

refusal of recommended vaccination should be respected . . . .Patients who

decline vaccination should continue to be supported with appropriate care

options that honor their autonomous choices.”

Ethical issues with vaccination in obstetrics and gynecology. (2021) Committee

Opinion No. 829. American College of Obstetricians and Gynecologists.

3

OBSTET GYNECOL 2021;138:e16-23. https://www.acog.org/clinical/clinical-guidance/

committee-opinion/articles/2021/07/ethical-issues-with-vaccination-in-obstetricsand-gynecology.

Safeguarding informed consent/refusal is indeed essential to a successful doctorpatient relationship. Vaccination carries risk of harm and is an invasive medical

procedure. For a state or federally funded institution to engage in coercing this

medical procedure upon patients (by threating to strip their livelihood) is a direct

infringement upon the right of bodily integrity.

The fundamental right of bodily integrity has been well recognized in the

United States. As this Supreme Court found in Union Pac. Ry. Co. v. Botsford, 141

U.S. 250, 251 (1891), “No right is held more sacred, or is more carefully guarded by

the common law, than the right of every individual to the possession and control of

his own person, free from all restraint or interference of others, unless by clear and

unquestionable authority of law.” See also Washington v. Harper, 494 U.S. 210, 229

(1990) (“The forcible injection of medication into a nonconsenting person’s body

represents a substantial interference with that person’s liberty.”)

Petitioner’s brief discusses a method advocated by legal scholars to bring

Jacobson v. Massachusetts, 197 U.S. 11 (1905) in line with intermediate scrutiny if

not strict scrutiny.

For example, applying Jacobson to the modern day, leading scholars at Boston

University published wisely:

Public health programs that are based on force are a relic of the 19th

century; 21st century public health depends on good science, good

communication, and trust in public health officials to tell the truth. In each

of these spheres, constitutional rights are the ally rather than the enemy

4

of public health. Preserving the public’s health in the 21st century requires

preserving respect for personal liberty.

Even in an emergency, when there is a rapidly spreading contagious

disease and an effective vaccine, the state is not permitted to forcibly

vaccinate or medicate anyone. The constitutional alternative is to

segregate infected and exposed people separately [allowing selfquarantine] to prevent them from transmitting the disease to others.

While [the Supreme Court] has not decided a case that involved isolation

or quarantine for disease, it has held that civil commitment for mental

illness is unconstitutional unless a judge determines the person is

dangerous by reason of a mental illness [citations omitted]. Assuming, as

most scholars do, that the law governing commitment to a mental

institution also applies to involuntary confinement for contagious diseases,

the government would have the burden of proving, by “clear and

convincing evidence,” that the individual actually has, or has been exposed

to, a contagious disease and is likely to transmit the disease to others if not

confined [citations omitted].

In cases that involve civil commitment or involuntary hospitalization for

mental illness, the Court has required the state to prove—by clear and

convincing evidence—that a person is mentally ill and that the illness

renders the person dangerous to others. Foucha v. Louisiana, 504 U.S. 71

(1992), Carey v. Population Services Intl, 431 U.S. 678 (1977), O’Connor v.

Donaldson, 422 U.S. 563, 580 (1975), Addington v. Texas, 441 U.S. 418,

425 (1979), Vitek v. Jones, 445 U.S. 480, 494 (1980).

When the HIV epidemic began in 1981, these principles from the 1970s

reminded legislators at both the state and federal levels that people could

not be involuntarily detained simply because they had HIV infection. Only

a few individuals who imminently threatened to infect other people by

deliberate or uncontrollable behavior would meet the constitutional test.

More recently, the same approach has been used by lower courts in some

cases that involved people who had active, contagious tuberculosis. City of

Newark v. JS, 279 N.J. Super. 178 (1993). Green v. Edwards, 164 W.Va.

326 (1980).

Jacobson v. Massachusetts: It’s Not Your Great-Great-Grandfather’s Public Health

Law, 95 AM. J. PUB. HEALTH 581, 588 (2005). https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC1449224/.

5

Petitioner Marciano’s brief (at page 32) references the quarantine rights and

procedures meant to govern New York City. If such procedures had been actually

implemented faithfully as individualized due process, there would have been little

room for executive rule by fiat. The vaccine mandates that have transpired in New

York City since 2021, and indeed throughout the Nation, have circumvented

individualized due process, to the extent due process should require the government

to meet a meaningful burden of proof before tribunals making evidentiary findings

at individualized hearings. Such due process would have provided, as the New York

legislature appears to have intended, checks and balances against executive rule by

fiat.

In Panhandle Eastern Pipeline Co. v. State Highway Commission, 294 U.S. 613,

622 (1935), this Court stated famously,

The police power of a state, while not susceptible of definition with

circumstantial precision, must be exercised within a limited ambit and is

subordinate to constitutional limitations. It springs from the obligation of

the state to protect its citizens and provide for the safety and good order of

society. Under it there is no unrestricted authority to accomplish whatever

the public may presently desire. It is the governmental power of selfprotection and permits reasonable regulation of rights and property in

particulars essential to the preservation of the community from injury.

Public health authority is not unlimited, but rather is limited by courts

assessing whether injury is being done to individuals and the community. The

scientific authorities presented in this amicus brief are intended to so aid the Court,

especially to the extent the burden should be upon the government to meet strict

scrutiny.

6

Here are some of the key data points highlighting the importance of informed

consent, which further emphasize that Respondents’ vaccine mandate should not

survive any level of scrutiny:

Because all subjects in the COVID-19 clinical trials were observed for only two

to six months, the long-term safety of COVID-19 vaccines for any age group is not

known. Meanwhile, substantial risks of the vaccine are increasingly calculable, such

as myocarditis and pericarditis.2

The clinical trials detected that vaccine immunity wanes significantly over a

short period of time. For example, the Pfizer vaccine efficacy decreased by 8% to

18% within only six months, and the Johnson & Johnson vaccine efficacy decreased

by 25% to 29% within only six months.3 Additionally, the efficacy measured in the

clinical trials was against the original Wuhan strain, not the new variants.

In clinical trials, a third dose of Pfizer or Moderna vaccine or a second dose of

Johnson & Johnson vaccine has not been evaluated for efficacy against disease, but

2 Fraiman J, et al (September 2022). Serious adverse events of special interest following mRNA

COVID-19 vaccination in randomized trials in adults. VACCINE. 2022 Sep 22;40(40):5798-5805. https:

//pubmed.ncbi.nlm.nih.gov/36055877/

3 Thomas SJ, et al (November 2021), C4591001 Clinical Trial Group. Safety and efficacy of the

BNT162b2 mRNA covid-19 vaccine through 6 months. N ENGL J MED. 2021 Nov 4;385(19):1761-73.

https://pubmed.ncbi.nlm.nih.gov/34525277.

FDA (October 2021). Vaccines and Related Biological Products Advisory Committee. FDA briefing

document: EUA amendment request for a booster dose for the Janssen COVID-19 vaccine. Vaccines

and Related Biological Products Advisory Committee Meeting: October 15, 2021. https://www.fda.

gov/media/153037/download.

See also, Lin, DY, et al (September 2022), Letter to the Editor: Effects of Vaccination and Previous

Infection on Omicron Infections in Children. NEW ENGLAND JOURNAL OF MEDICINE. https://www.

nejm.org/doi/full/10.1056/NEJMc2209371 (“rapid decline in protection”)

7

rather antibody counts were observed in a small number of vaccinated subjects for

only one month.4

Treatments for COVID-19 have improved significantly since the pandemic

began in early 2020, resulting in improved survival rates in hospitalized cases.5

Indeed, for people not living in a nursing home, the overall survival rate of COVID19 is 99.8% in the U.S., and 99.999% for children specifically.6

Hundreds of studies have observed the effectiveness of various treatments,

the most studied being ivermectin, vitamin D, hydroxychloroquine (HCQ), and

monoclonal antibodies.7 These treatments may also be beneficial for prophylaxis

(i.e., pre-exposure or post-exposure prevention of symptomatic COVID-19

infections).8

4 See footnote 2, and FDA (September 2021). Vaccines and Related Biological Products Advisory

Committee. FDA briefing document: Application for licensure of a booster dose for Comirnaty

(COVID-19 Vaccine, mRNA). Vaccines and Related Biological Products Advisory Committee

Meeting: September 17, 2021. https://www.fda.gov/media/152176/download.

5 Horwitz LI, et al (2021) Trends in COVID-19 risk-adjusted mortality rates. J HOSP MED. 2021

Feb;16(2):90-2.

https://www.journalofhospitalmedicine.com/jhospmed/article/230561/hospital-medicine/

trends-covid-19-risk-adjusted-mortality-rates.

Dennis JM, et al (2021). Improving survival of critical care patients with coronavirus disease 2019 in

England: a national cohort study, March to June 2020. CRIT CARE MED. 2021 Feb 1;49(2):209-14.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803441/.

6 Ioannidis, JPA. Reconciling estimates of global spread and infection fatality rates of COVID- 19: an

overview of systematic evaluations. EUR J CLIN INVEST. 2021;51:e13554. https://onlinelibrary.wiley.

com/doi/epdf/10.1111/eci.13554.

Physicians for Informed Consent (2021). COVID-19 — Disease Information Statement (DIS). Aug

2021. https://physiciansforinformedconsent.org/covid-19/.

7 C19early.com. COVID-19 early treatment: real-time analysis of 2,118 studies [cited 2022 Sept 18].

https://c19early.com/.

8 C19early.com. COVID-19 studies: ivermectin; [cited 2022 Sept 18]. https://c19ivermectin.com.

Bryant A, et al (2021). Ivermectin for prevention and treatment of COVID-19 infection: a systematic

review, meta-analysis, and trial sequential analysis to inform clinical guidelines. AM J THER. 2021

Jun 21;28(4):e434-60. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248252/.

8

Ultimately, history favors those who uphold civil rights, such as Petitioner.

As a housecleaning matter, Petitioner Marciano’s brief states at pages 25 and

31,

A majority of this Court would likely agree, as it did in NFIB, the City

Respondents’ have no inherent legislative authority to engage in

fundamental, medical policy decisions reserved for the legislature . . . A

majority of this Court would likely agree this case is not about police power

to mandate a legislatively authorized vaccination as erroneously

determined below.

Amicus Curiae concurs this case does not concern a legislative vaccine mandate.

However, had the New York legislature explicitly granted authority to the mayor to

mandate a COVID-19 vaccine on city employees, amicus submits a mandate would

still violate strict scrutiny for the scientific and ethical reasons stated herein, which

are in addition to the reasons stated in Petitioner’s brief.

Amicus was unable to locate any evidence in this case that an FDA-approved

COVID-19 vaccine (Comirnaty or Spikevax) was available to Petitioner Anthony

Marciano. This absence of evidence appears consistent with healthcare observations

in real-time that EUA label vaccines are widely available, but not FDA-approved

vaccines. See CDC (September 8, 2022). Immunization Information Systems,

COVID-19 Vaccine Related Codes. https://www.cdc.gov/vaccines/programs/iis/COVID19-related-codes.html (“These vaccines are listed separately because they represent

C19early.com. COVID-19 studies: vitamin D; [cited 2022 Sept 18]. https://c19vitamind.com.

Ilie PC, et al (2020). The role of vitamin D in the prevention of coronavirus disease 2019 infection

and mortality. AGING CLIN EXP RES. 2020 Jul;32(7):1195-8. https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC7202265/.

C19early.com. HCQ for COVID-19: real-time meta analysis of 362 studies; [cited 2022 Sept 18].

https://hcqmeta.com.

9

NDCs that will not be manufactured or made available in the near term even if

authorized.”)

This supports Petitioner’s statutory argument for informed consent pursuant to

21 U.S.C. § 360bbb-3; John Doe #1 #14 & Jane Doe #1 #2 v. Austin, No. 3:21-cv1211-AW-HTC, 2021 U.S. Dist. LEXIS 236327, at *17 (N.D. Fla. Nov. 12, 2021)

(finding that EUA vaccines cannot be mandated, “Because the plaintiffs have not

shown they are (or will be) required to receive an EUA-labeled, non-BLA-compliant

vaccine, the plaintiffs have not shown a likelihood of success”).

B. THERE IS NO EVIDENCE THAT COVID-19 VACCINES PREVENT THE INFECTION OR

TRANSMISSION OF SARS-COV-2 OR COVID-19, AND IN FACT THERE IS EVIDENCE TO

THE CONTRARY (THAT IT HAS A NEGATIVE EFFECT ON IMMUNITY)

Government statements confirm there is no evidence that COVID-19 vaccines

prevent the spread of SARS-CoV-2 or COVID-19.

Therefore,

there

is

no

scientific

justification

to

discriminate

against

unvaccinated people. Clinical trials for the Pfizer-BioNTech, Moderna, and Janssen

(Johnson & Johnson) COVID-19 vaccines were not designed to observe

asymptomatic infection with SARS-CoV-2 or the effect of the vaccine on the spread

(transmission) of COVID-19. Consequently, in its briefing document for each

vaccine, the U.S. Food and Drug Administration (FDA) states that “it is possible

that asymptomatic infections may not be prevented as effectively as symptomatic

infections” and “data are limited to assess the effect of the vaccine against

transmission of SARS-CoV-2 from individuals who are infected despite vaccination.”

Furthermore, “additional evaluations including data from clinical trials and from

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vaccine use post-authorization will be needed to assess the effect of the vaccine in

preventing virus shedding and transmission, in particular in individuals with

asymptomatic infection.” Citations:

1. U.S. Food and Drug Administration, Vaccines and Related Biological

Products Advisory Committee. FDA briefing document: Pfizer-BioNTech

COVID-19 vaccine. Vaccines and Related Biological Products Advisory

Committee Meeting: December 10, 2020. https://www.fda.gov/media/

144245/download.

2. Physicians for Informed Consent. Pfizer-BioNTech COVID-19 vaccine:

short-term efficacy and safety data. Jun 2021. https://www.physicians

forinformedconsent.org/COVID-19-vaccines.

3. U.S. Food and Drug Administration, Vaccines and Related Biological

Products Advisory Committee. FDA briefing document: Moderna COVID-19

vaccine. Vaccines and Related Biological Products Advisory Committee

Meeting: December 17, 2020. https://www.fda.gov/media/144434/download.

4. Physicians for Informed Consent. Moderna COVID-19 vaccine: short-term

efficacy and safety data. Apr 2021. https://www.physiciansforinformed

consent.org/COVID-19-vaccines.

5. U.S. Food and Drug Administration, Vaccines and Related Biological

Products Advisory Committee. FDA briefing document: Janssen

Ad26.COV2.S vaccine for the prevention of COVID-19. Vaccines and Related

Biological Products Advisory Committee Meeting: February 26, 2021. https:/

/www.fda.gov/media/146217/download.

6. Physicians for Informed Consent. Janssen (Johnson & Johnson) COVID-19

Vaccine: Short-Term Efficacy & Safety Data. May 2021. https://www.

physiciansforinformedconsent.org/COVID-19-vaccines.

For over one year now, government statements have repeatedly confirmed that

COVID-19 vaccines do not prevent the spread of SARS-CoV-2 or COVID-19, and

that both vaccinated and unvaccinated persons equally transmit the virus. For

example:

11

●

NIAID Director Dr. Anthony Fauci: “We know now as a fact that [vaccinated

people with Covid-19] are capable of transmitting the infection to someone

else.”9

●

CDC Director Dr. Rochelle Walensky: “[W]hat the [vaccines] can’t do

anymore is prevent transmission.”10

●

WHO Chief Scientist Dr. Soumya Swaminathan: “At the moment I don’t

believe we have the evidence of any of the vaccines to be confident that it’s

going to prevent people from actually getting the infection and therefore

being able to pass it on.”11

●

Chief Medical Officer of Moderna Dr. Tal Zaks: “There’s no hard evidence

that [the vaccine] stops them from carrying the virus transiently and

potentially infecting others who haven’t been vaccinated.”12

And these admissions from government officials have been supported by realtime data, such as the CDC study of one COVID-19 outbreak in July 2021 where

74% of cases were fully vaccinated. 13

9 Stieg, C (July 28, 2021), Dr. Fauci on CDC mask guidelines: ‘We are dealing with a different virus

now. https://www.cnbc.com/2021/07/28/dr-fauci-on-why-cdc-changed-guidelines-delta-is-a-different-virus.

html.

10 CNN (August 5, 2021), The Situation Room, interview with CDC Director Walensky. https://

twitter.com/CNNSitRoom/status/1423422301882748929.

11 Colson, T. (December 29, 2020), Top WHO scientist says vaccinated travelers should still

quarantine, citing lack of evidence that COVID-19 vaccines prevent transmission. BUSINESS INSIDER.

https://www.businessinsider.com/who-says-no-evidence-coronavirus-vaccine-prevent-transmissions2020-12?op=1.

12 Manskar, N (November 24, 2020). Moderna boss says COVID-19 vaccine not proven to stop

spread of virus. NEW YORK POST. https://nypost.com/2020/11/24/moderna-boss-says-covid-shot-notproven-to-stop-virus-spread/.

13 Brown CM, et al (2021). Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine

Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County,

Massachusetts, July 2021. MMWR MORB MORTAL WKLY REP 2021;70:1059-1062. https://www.cdc.

gov/mmwr/volumes/70/wr/mm7031e2.htm.

Another CDC statement highlighting this, “ . . .preliminary evidence suggests that fully vaccinated

people who do become infected with the Delta variant can spread the virus to others.” CDC. Interim

Public Health Recommendations for Fully Vaccinated People. Covid-19, Vaccines. Updated July 28,

2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.

12

Another study of a COVID-19 outbreak in July 2021 published in

Eurosurveillance found that “all transmissions between patients and staff occurred

between masked and vaccinated individuals, as experienced in an outbreak from

Finland.” The authors state that the study “challenges the assumption that high

universal vaccination rates will lead to herd immunity and prevent COVID-19

outbreaks.”14

A Harvard study investigating COVID-19 cases across 68 countries and across

2,947 counties in the U.S. found “no significant signaling of COVID-19 cases

decreasing with higher percentages of population fully vaccinated.”15

C. THOSE PREVIOUSLY INFECTED WITH COVID-19 SHOULD NOT HAVE LESS RIGHTS

THAN THOSE VACCINATED FOR COVID-19

There is evidence that previous SARS-CoV-2 or COVID-19 infection is more

effective at preventing SARS-CoV-2 or COVID-19 infection than COVID-19

vaccines. Therefore, it follows that those previously infected with COVID-19 should

not have less rights than those vaccinated for COVID-19.

Recent CDC guidance recognizes vaccinated and unvaccinated people should be

treated alike for COVID-19 testing purposes.16

14 Shitrit P, et al (2021). Nosocomial outbreak caused by the SARS-CoV-2 Delta variant in a highly

vaccinated population, Israel, July 2021. Euro Surveill. 2021 Sep;26(39). https://pubmed.ncbi.nlm.

nih.gov/34596015/.

15 Subramanian SV, et al (2021). Increases in COVID-19 are unrelated to levels of vaccination

across 68 countries and 2947 counties in the United States. EUR J EPIDEMIOL. 2021 Sep 30:1-4. https:

//pubmed.ncbi.nlm.nih.gov/34591202/.

16 Massetti, PhD, et al. (August 2022), Summary of Guidance for Minimizing the Impact of COVID19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022.

Weekly/August 19, 2022/71(33);1057-1064. https://www.cdc.gov/mmwr/volumes/71/wr/mm7133e1.

htm (“When implemented, screening testing strategies should include all persons, irrespective of

vaccination status.”)

13

The Janssen (Johnson & Johnson) COVID-19 vaccine clinical trial included over

2,000 subjects that had contracted SARS-CoV-2 before the study. The trial recorded

the incidence of COVID-19 in that unvaccinated group at least 28 days after the

vaccination of the other subjects in the study. The COVID-19 incidence of the

unvaccinated group with prior SARS-CoV-2 infection was 0.1% (2/2,021), whereas

the COVID-19 incidence of vaccinated subjects was 0.59% (113/19,306). These data

suggest that there are six times more cases of COVID-19 in vaccinated subjects

than in unvaccinated subjects previously infected with SARS-CoV-2. This also

means that an unvaccinated person previously infected with SARS-CoV-2 has 99.9%

chance of being protected from a repeat infection. 17

D. COVID-19 VACCINES HAVE HAD NO MEASURABLE IMPACT ON THE COVID-19

MORTALITY RATE

CDC data show mass vaccination with COVID-19 vaccines has had no

measurable impact on the COVID-19 mortality rate in the U.S. In the nine months

before the introduction of mass vaccination (April 2020 through December 2020),

there were about 356,000 COVID-19 deaths or 39,500 deaths per month — a

mortality rate of 0.120 per 1,000 people. In the nine months after the introduction of

mass vaccination (January 2021 through September 2021), there were 342,000

17 Physicians for Informed Consent. Janssen (Johnson & Johnson) COVID-19 Vaccine: Short-Term

Efficacy & Safety Data. May 2021. https://www.physiciansforinformedconsent.org/COVID-19vaccines.

FDA (2021). Vaccines and Related Biological Products Advisory Committee. FDA briefing document:

Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. Vaccines and Related Biological

Products Advisory Committee Meeting: February 26, 2021. Table 14: vaccine efficacy of first

occurrence of moderate to severe/critical COVID-19, including non-centrally confirmed cases, with

onset at least 14 or at least 28 days after vaccination, by baseline SARS-CoV-2 status, per protocol

set; 30. https://www.fda.gov/media/146217/download.

14

COVID-19 deaths or 38,000 deaths per month — a mortality rate of 0.115 per 1,000

people. And in the five months that followed (October 2021 through February 2022),

there were an additional 249,000 COVID-19 deaths or 49,800 deaths per month — a

mortality rate of 0.151 per 1,000 people.18

18 Centers for Disease Control and Prevention. Washington, D.C.: U.S. Department of Health and

Human Services. COVID data tracker: trends in number of COVID-19 cases and deaths in the US

reported to CDC, by state/territory; [cited 2022 Apr 2]. https://covid.cdc.gov/covid-data-tracker/

#trends_totaldeaths.

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CONCLUSION

Petitioner should retain the right and dignity of informed consent/refusal

without penalty. The scientific data demonstrate that vaccine mandates have not

been proven to create a safer environment. Applying strict scrutiny, Respondents’

vaccine mandate fails to advance a compelling government interest that is narrowly

tailored to protect public health. If there is any doubt here, it helps to remember

that history favors upholding civil rights.

Respectfully submitted,

/s/ Gregory J. Glaser

GREGORY J. GLASER

COUNSEL OF RECORD

4399 BUCKBOARD DRIVE #423

COPPEROPOLIS, CA 95228

(925) 642-6651

GREG@PICPHYSICIANS.ORG

COUNSEL FOR AMICUS CURIAE

PHYSICIANS FOR INFORMED CONSENT

SEPTEMBER 24, 2022