Court filing

Amicus Brief of AMA, ACP, AAP, and Medical Society Amici — Biden v. Missouri

Record facts

Court	Supreme Court of the United States
Filed	2021-12-21

Summary

A motion for leave to file and brief of the American Medical Association, the American College of Physicians and other medical organizations as amici curiae, dated December 21, 2021, in Joseph R. Biden, Jr., President of the United States, et al. v. Missouri, et al., No. 21A240, in the Supreme Court of the United States. The filing supports the applicants’ application for a stay of the injunction issued by the U.S. District Court for the Eastern District of Missouri pending appeal to the Eighth Circuit. The motion states that amici include fifteen national medical societies and an organization representing patients and the public health, and asks leave to file without ten days’ notice under this Court’s Rule 37.2(a). The brief argues that the vaccination rule promulgated by the Centers for Medicare & Medicaid Services is neither arbitrary nor capricious.

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No. 21A240
In the Supreme Court of the United States
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
Applicants,
v.
MISSOURI, ET AL.,
Respondents.

ON APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED STATES
DISTRICT COURT FOR THE EASTERN DISTRICT OF MISSOURI PENDING APPEAL TO THE
UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT AND FURTHER
PROCEEDINGS IN THIS COURT

MOTION FOR LEAVE TO FILE AND BRIEF OF AMERICAN MEDICAL
ASSOCIATION, AMERICAN COLLEGE OF PHYSICIANS, AMERICAN
ACADEMY OF FAMILY PHYSICIANS, AMERICAN ACADEMY OF
PEDIATRICS, COUNCIL OF MEDICAL SPECIALTY SOCIETIES,
AMERICAN ACADEMY OF ALLERGY, ASTHMA & IMMUNOLOGY,
AMERICAN COLLEGE OF CHEST PHYSICIANS, AMERICAN COLLEGE
OF MEDICAL GENETICS AND GENOMICS, AMERICAN GERIATRICS
SOCIETY, AMERICAN PSYCHIATRIC ASSOCIATION, AMERICAN
SOCIETY FOR CLINICAL PATHOLOGY, AMERICAN SOCIETY OF
HEMATOLOGY, AMERICAN THORACIC SOCIETY, SOCIETY OF
GENERAL INTERNAL MEDICINE, SOCIETY OF INTERVENTIONAL
RADIOLOGY, AND AMERICAN LUNG ASSOCIATION AS AMICI CURIAE
IN SUPPORT OF APPLICANTS’ APPLICATION FOR A STAY OF THE
INJUNCTION PENDING APPEAL

JESSICA ANNE MORTON
Counsel of Record
JEFFREY B. DUBNER
RACHEL L. FRIED
JOANN KINTZ
SEAN A. LEV
DEMOCRACY FORWARD FOUNDATION
P.O. Box 34553
Washington, DC 20043
(202) 448-9090
jmorton@democracyforward.org

Counsel for Amici Curiae

1
The American Medical Association, American College of Physicians, American
Academy of Family Physicians, American Academy of Pediatrics, Council of Specialty
Medical Societies, American Academy of Allergy, Asthma & Immunology, American
College of Chest Physicians, American College of Medical Genetics and Genomics,
American Geriatrics Society, American Psychiatric Association, American Society for
Clinical Pathology, American Society of Hematology, American Thoracic Society,
Society of General Internal Medicine, Society of Interventional Radiology, and
American Lung Association respectfully move for leave to file the enclosed brief as
amici curiae in support of Applicants’ application for a stay of the injunction issued
by the United States District Court for the Eastern District of Missouri pending
appeal, including leave to file without ten days’ notice to the parties, as ordinarily
required by this Court’s Rule 37.2(a), and leave to file in 8½- by 11-inch format.
Amici include fifteen national medical societies and an organization representing
patients and the public health. Amici have a strong interest in promoting public
health and reducing the spread of COVID-19, particularly within their own
workplaces. The attached brief reflects Amici’s extensive review of medical literature
supporting the efficacy and safety of COVID-19 vaccines authorized or approved by
the U.S. Food and Drug Administration. Accordingly, the proposed brief will assist
the Court because it sets forth medical and scientific information demonstrating that
the vaccination rule promulgated by the Centers for Medicare & Medicaid Services is
neither arbitrary nor capricious and that maintaining the stay of that standard would
cause severe and irreparable harm to the public interest.

2
Courts have repeatedly granted leave for one or more of Amici to file briefs as
amici curiae in cases related to federal vaccination policies. This includes the Court
of Appeals below, which accepted an amicus curiae brief on behalf of a number of
Amici in this matter. See App. 1a; see also, e.g., Order, In re MCP No. 165, OSHA
Rule on COVID-19 Vaccination and Testing, 86 Fed. Reg. 61402, No. 21-7000 (6th
Cir. Dec. 3, 2021), Dkt. No. 299 (granting motion of American Medical Association to
file amicus curiae brief); Instanter Order, Indiana v. OSHA, No. 21-3066 (7th Cir.
Nov. 18, 2021), Dkt. No. 22, (same); Court Order, BST Holdings v. OSHA, No. 21-
60845 (5th Cir. Nov. 11, 2021) (same).
Counsel for Amici have consulted with the parties’ counsel. In light of the briefing
schedule, it was not feasible to give the parties ten days’ notice of filing of this brief,
but counsel for Amici informed counsel for all parties of their intent to file within
hours of the filing of the application at issue. Applicants take no position on this
motion. Counsel for Respondents have consented to the timely filing of an amicus
brief.
To the extent that leave is required, Amici respectfully move for leave to file the
attached brief on 8½- by 11-inch paper rather than in booklet form, given the
expedited nature of the briefing. Should the Clerk’s Office, the Circuit Justice, or the
Court so require, Amici commit to re-filing expeditiously in booklet format. See S. Ct.
Rule 21.2(c).

3
For the foregoing reasons, Amici respectfully move for leave to file the attached
amicus curiae brief in support of Applicants’ application for a stay of the injunction
pending appeal.
Dated: December 21, 2021
Respectfully submitted,
Jessica Anne Morton
Counsel of Record
Jeffrey B. Dubner
Rachel L. Fried
JoAnn Kintz*
DEMOCRACY FORWARD FOUNDATION
P.O. Box 34553
Washington, DC 20043
(202) 448-9090
jmorton@democracyforward.org

Counsel for Amici Curiae

* Not admitted in the District of Columbia;
practicing
under
the
supervision
of
Democracy Forward lawyers.

No. 21A240
In the Supreme Court of the United States

JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
Applicants,
v.
MISSOURI, ET AL.,
Respondents.

BRIEF OF AMERICAN MEDICAL ASSOCIATION, AMERICAN COLLEGE
OF PHYSICIANS, AMERICAN ACADEMY OF FAMILY PHYSICIANS,
AMERICAN ACADEMY OF PEDIATRICS, COUNCIL OF MEDICAL
SPECIALTY SOCIETIES, AMERICAN ACADEMY OF ALLERGY, ASTHMA
& IMMUNOLOGY, AMERICAN COLLEGE OF CHEST PHYSICIANS,
AMERICAN COLLEGE OF MEDICAL GENETICS AND GENOMICS,
AMERICAN GERIATRICS SOCIETY, AMERICAN PSYCHIATRIC
ASSOCIATION, AMERICAN SOCIETY FOR CLINICAL PATHOLOGY,
AMERICAN SOCIETY OF HEMATOLOGY, AMERICAN THORACIC
SOCIETY, SOCIETY OF GENERAL INTERNAL MEDICINE, SOCIETY OF
INTERVENTIONAL RADIOLOGY, AND AMERICAN LUNG ASSOCIATION
AS AMICI CURIAE IN SUPPORT OF APPLICANTS’ APPLICATION FOR A
STAY OF THE INJUNCTION PENDING APPEAL

i
TABLE OF CONTENTS
Table of Authorities ...................................................................................................... ii
Interest of Amici Curiae ............................................................................................... 1
Introduction and Summary of Argument .................................................................... 7
Argument ...................................................................................................................... 8
I. COVID-19 Poses A Grave Danger To The Health Of Healthcare Facility Staff
And Patients. ........................................................................................................... 8
II. Vaccines Provide A Safe And Effective Way To Help Reduce Transmission Of
COVID-19 In Healthcare Facilities. ..................................................................... 10
III.The More Healthcare Facility Staff Who Get Vaccinated, The Safer Healthcare
Facilities Become. ................................................................................................. 12
IV. Widespread Vaccination Is The Most Effective Way To Protect Healthcare
Facility Staff And Patients From COVID-19. ...................................................... 15
Conclusion .................................................................................................................. 17

ii
TABLE OF AUTHORITIES
Other Authorities
Page(s)
American Medical Ass’n, AMA, AHA, ANA urge vaccinations as U.S.
reaches 750,000 COVID-19 deaths, https://bit.ly/3C07CIS .................................. 13
Mike Baker & Giulia Heyward, Idaho allows overwhelmed hospitals
across the state to ration care if necessary, N.Y. Times (Sept. 16,
2021), https://nyti.ms/30Ee0ZP ............................................................................. 14
Mike Baker, ‘Their Crisis’ Is ‘Our Problem’: Washington Grapples With
Idaho Covid Cases, N.Y. Times (Sept. 13, 2021),
https://nyti.ms/3e3vxxi .......................................................................................... 14
Yinon M. Bar-On et al., Protection of BNT162b2 Vaccine Booster
against Covid-19 in Israel, 385 New Eng. J. Med. 1393 (Oct. 7,
2021), https://bit.ly/327ijh2 ................................................................................... 11
Jack J. Barry et al., Unvaccinated Workers Say They’d Rather Quit
Than Get a Shot, but Data Suggest Otherwise, Scientific American
(Sept. 24, 2021), https://bit.ly/3kUYKOT ............................................................. 17
Alex Bhattacharya et al., Healthcare-associated COVID-19 in England:
a national data linkage study, 83 J. Infection 565 (Aug. 30, 2021),
https://bit.ly/31xXHO9 ............................................................................................ 9
Catherine H. Bozio et al., Laboratory-Confirmed COVID-19 Among
Adults Hospitalized with COVID-19-Like Illness with Infection-
Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity — Nine
States, January–September 2021, 70 Morbidity & Mortality Weekly
Rep. 1539 (Nov. 5, 2021), https://bit.ly/3kvoBwR ................................................. 15
Alyson M. Cavanaugh et al., Reduced Risk of Reinfection with SARS-
CoV-2 After COVID-19 Vaccination — Kentucky, May–June 2021,
70 Morbidity & Mortality Weekly Rep. 1081 (Aug. 13, 2021),
https://bit.ly/306e4Bg ............................................................................................ 15
CDC, Appendices (Nov. 12, 2021), https://bit.ly/3nbxAos .......................................... 16
CDC, Benefits of Getting a COVID-19 Vaccine (last updated Nov. 29,
2021), https://bit.ly/3H6BsiF ................................................................................. 10
CDC, CDC Endorses ACIP’s Updated COVID-19 Vaccine
Recommendations (Dec. 16, 2021), https://bit.ly/3yzUTfJ .................................... 10

iii
CDC, COVID Data Tracker, https://bit.ly/3Du7Glz (last visited Dec. 21,
2021) ........................................................................................................................ 8
CDC, COVID Data Tracker: Variant Proportions (last visited Dec. 20,
2021), https://bit.ly/3snnhk7 ................................................................................... 9
CDC, COVID Data Tracker Weekly Review, Centers for Disease Control
and Prevention (Dec. 17, 2021), https://bit.ly/3EYAdAb ........................................ 8
CDC, Delta Variant: What We Know About the Science (Aug. 26, 2021),
https://bit.ly/3plAmcy .............................................................................................. 9
CDC, Disease Burden of Flu (Oct. 4, 2021), https://bit.ly/3ocAuZA ............................ 8
CDC, Omicron Variant: What You Need to Know (updated Dec. 19,
2021), https://bit.ly/327xwyr ................................................................................... 9
CDC, Rates of laboratory-confirmed COVID-19 hospitalizations by
vaccination status, (last updated Dec. 2, 2021),
https://bit.ly/3oIwsZ4 ............................................................................................ 12
CDC, Science Brief: Community Use of Masks to Control the Spread of
SARS-CoV-2 (updated Dec. 6, 2021), https://bit.ly/30inWYx ................................. 9
CDC, Vaccination to Prevent COVID-19 Outbreaks with Current and
Emergent Variants — United States, 2021 (July 27, 2021),
https://bit.ly/3GhocGC ........................................................................................... 14
CDC, Vaccine Effectiveness: How Well Do Flu Vaccines Work? (last
visited Dec. 16, 2021), https://bit.ly/3HifLMP ...................................................... 11
COVID-19 Vaccination and Testing; Emergency Temporary Standard,
86 Fed. Reg. 61,402 (Nov. 5, 2021) ....................................................................... 12
Mark E. Czeisler et al., Delay or Avoidance of Medical Care Because of
COVID-19-Related Concerns — United States, June 2020, 69
Morbidity & Mortality Weekly Rep. 1250 (Sept. 11, 2020),
https://bit.ly/3oYjdVx ............................................................................................ 13
Carlos del Rio et al., Confronting the Delta Variant of SARS-CoV-2,
Summer 2021, 326 JAMA 1001 (Aug. 18, 2021),
https://bit.ly/3bVL5Cj ............................................................................................ 13
FDA, COVID-19 vaccine safety surveillance (Dec. 7, 2021),
https://bit.ly/3y1dDET ........................................................................................... 10

iv
Ashley Fowlkes et al., Effectiveness of COVID-19 Vaccines in
Preventing SARS-CoV-2 Infection Among Frontline Workers Before
and During B.1.617.2 (Delta) Variant Predominance — Eight U.S.
Locations, December 2020–August 2021, 70 Morbidity & Mortality
Weekly Rep. 1167 (Aug. 24, 2021), https://bit.ly/3px2OGB ................................. 11
Jessica Ibiebele et al., Occupational COVID-19 exposures and
secondary cases among healthcare personnel, 49 Am. J. Infection
Control 1334 (Oct. 2021), https://bit.ly/3lI0lIo ..................................................... 16
Kathy Katella, Comparing the COVID-19 Vaccines: How Are They
Different?, Yale Med. (Dec. 16, 2021), https://bit.ly/307jEU5 .............................. 11
Clark Kauffman, Iowa’s nursing home infections and outbreaks are up
20% over last week, Iowa Cap. Dispatch (Oct. 29, 2021),
https://bit.ly/3oIpMu0 ........................................................................................... 10
Nicola P. Klein et al., Surveillance for Adverse Events After COVID-19
mRNA Vaccination, 326 JAMA 1390 (Sept. 3, 2021),
https://bit.ly/3F1XQYM ......................................................................................... 10
Katherine Lontok, How Effective Are COVID-19 Vaccines in
Immunocompromised People, Am. Society for Microbiology (Aug. 12,
2021), https://bit.ly/3F24HBh ............................................................................... 13
Apoorva Mandavilli, C.D.C. Internal Report Calls Delta Variant as
Contagious as Chickenpox, N.Y. Times (July 30, 2021),
https://nyti.ms/3EtJXTb .......................................................................................... 9
Brian E. McGarry et al., Nursing Home Staff Vaccination and Covid-
19 Outcomes, New Eng. J. Med., Correspondence (Dec. 8, 2021),
https://bit.ly/3pQ7O9H .......................................................................................... 13
Medicare and Medicaid Programs; Omnibus COVID-19 Health Care
Staff Vaccination, 86 Fed. Reg. 61,555 (Nov. 5, 2021) ........................................... 7
Temet M. Michael et al., Epidemiology of Covid-19 in a Long-Term
Care Facility in King County, Washington, 382 New Eng. J. Med.
2005 (May 21, 2020), https://bit.ly/3pBvoXy........................................................... 9
Tahmina Nasserie et al., Assessment of the Frequency and Variety of
Persistent Symptoms Among Patients With COVID-19: A Systematic
Review, JAMA Network Open (May 26, 2021), https://bit.ly/3qocFkk .................. 8

v
Long H. Nguyen et al., Risk of COVID-19 among front-line health-care
workers and the general community: a prospective cohort study, 5
Lancet e475 (July 31, 2020), https://bit.ly/31ABwY2 ............................................. 9
OSHA, Protecting Workers: Guidance on Mitigating and Preventing the
Spread of COVID-19 in the Workplace (updated June 10, 2021),
https://bit.ly/3s8qm7L ........................................................................................... 16
Pfizer, Pfizer and BioNTech Announce Phase 3 Trial Data Showing
High Efficacy of a Booster Dose of Their COVID-19 Vaccine (Oct. 21,
2021), https://bit.ly/3EXQa9K ............................................................................... 11
Aaron Richterman et al., Hospital-Acquired SARS-CoV-2 Infection:
Lessons for Public Health, 324 JAMA 2155 (Nov. 13, 2020),
https://bit.ly/3Irc8Va ..........................................................................................9, 16
Amber K. Sabbatini et al., Excess Mortality Among Patients
Hospitalized During the COVID-19 Pandemic, 16 J. Hosp. Med. 596
(July 21, 2021), https://bit.ly/3Hs5EEU................................................................ 14
Karen Shen et al., Estimates of COVID-19 Cases and Deaths Among
Nursing Home Residents Not Reported in Federal Data, JAMA
Network Open (Sept. 9, 2021), https://bit.ly/3lG02h2 ............................................ 9
Tim Stelloh, Alabama heart patient dies after hospital contacts 43 ICUs
in 3 states, family says, NBC News (Sept. 12, 2021),
https://nbcnews.to/3nyOz4t ................................................................................... 14
Maxime Taquet et al., 6-month neurological and psychiatric outcomes
in 236379 survivors of COVID-19: a retrospective cohort study using
electronic health records, The Lancet Psychiatry (Apr. 6, 2021),
https://bit.ly/3DXTbGo ............................................................................................ 8
Sara Y. Tartof et al., Effectiveness of mRNA BNT162b2 COVID-19
Vaccine Up to 6 Months, 398 Lancet 1407 (Oct. 4, 2021),
https://bit.ly/3ouPvqS ............................................................................................ 11
Mark W. Tenforde, Association Between mRNA Vaccination and
COVID-19 Hospitalization and Disease Severity, 326 JAMA 2043
(Nov. 4, 2021), https://bit.ly/3bZBHhb .................................................................. 12
Jessica Trufant, South Shore Health set to fire 9 staffers over COVID
vaccine; 99.6% of employees vaccinated, The Patriot Ledger (Dec. 10,
2021), https://bit.ly/30en1ID ................................................................................. 17

vi
WHO, Preventing and mitigating COVID-19 at work, World Health
Organization (May 19, 2021), https://bit.ly/3wMJ451.......................................... 16
Stanley Xu et al., COVID-19 Vaccination and Non–COVID-19
Mortality Risk — Seven Integrated Health Care Organizations,
United States, December 14, 2020–July 31, 2021, 70 Morbidity &
Mortality Weekly Rep. 1520 (Oct. 29, 2021), https://bit.ly/3D1ZRn4.................10
Carl Zimmer & Sheryl Stolberg, New Studies Raise Hopes That
Vaccines Prevent Severe Disease From Omicron, N.Y. Times (Dec.
15, 2021), https://nyti.ms/3H3uCd4 ...............................................................12

INTEREST OF AMICI CURIAE
Amici are associations representing medical professionals and patients and the
public health across disciplines. They accordingly have a strong interest in both
patient care and the applicability of the Centers for Medicare & Medicaid Services’
rule to their members’ workplaces.1
The American Medical Association is the largest professional association of
physicians, residents, and medical students in the United States. Additionally,
through state and specialty medical societies and other physician groups seated in its
House of Delegates, substantially all physicians, residents, and medical students in
the United States are represented in the AMA’s policy-making process. The AMA was
founded in 1847 to promote the art and science of medicine and the betterment of
public health, and these remain its core purposes. AMA members practice in every
medical specialty and in every state.
The American College of Physicians is the largest medical specialty organization
in the U.S. Its membership includes 161,000 internal medicine physicians, related
subspecialists, and medical students. Internists apply scientific knowledge and
clinical expertise to the diagnosis, treatment, and compassionate care of adults across
the spectrum from health to complex illness. ACP and its physician members lead the
profession in education, standard-setting, and the sharing of knowledge to advance
the science and practice of internal medicine.

1 This brief is filed with the written consent of Respondents; Applicants took no position on
this filing of this brief. Pursuant to Sup. Ct. R. 37.6, counsel for Amici authored this brief in whole; no
party’s counsel authored, in whole or in part, this brief; and no person or entity other than Amici and
their counsel contributed monetarily to preparing or submitting this brief.

2
Founded in 1947, the American Academy of Family Physicians is one of the
largest national medical organizations, representing 133,500 family physicians and
medical students nationwide. AAFP seeks to improve the health of patients, families,
and communities by advocating for the health of the public and by supporting its
members in providing continuous comprehensive health care to all.
The American Academy of Pediatrics was founded in 1930 and is a national, not-
for-profit professional organization dedicated to furthering the interests of child and
adolescent health. The AAP’s membership includes over 67,000 primary care
pediatricians, pediatric medical subspecialists, and pediatric surgical specialists.
Over the past year-and-a-half, the AAP has devoted substantial resources to
researching the scientific literature regarding how to treat COVID-19 and reduce its
spread so that the AAP can provide up-to-date, evidence-based guidance for
pediatricians and public health officials.
The Council of Medical Specialty Societies is a coalition of forty-seven specialty
societies representing more than 800,000 physicians across the house of medicine.
CMSS provides a proactive platform to address emerging issues across specialty
societies that influence the future of healthcare and the patients it serves. CMSS
supports and strengthens member specialty societies to address future challenges
through convening, collective voice, and action across specialties.
The American Academy of Allergy, Asthma & Immunology is the leading
membership organization of more than 7,000 allergists/immunologists (in the United
States, Canada, and seventy-two other countries) and patients’ trusted resource for

3
allergies, asthma, and immune deficiency disorders. This membership includes
allergist/immunologists and allied health and related healthcare professionals—all
with a special interest in the research and treatment of allergic and immunologic
diseases.
The American College of Chest Physicians, known as CHEST, is comprised of
more than 19,000 physicians, advance practice providers, respiratory therapists, and
other front line health care professionals who provide patient care in pulmonary,
critical care, and sleep medicine. CHEST serves as an important connection to clinical
knowledge, research, and resources, including through its highly respected peer-
reviewed journal, clinical practice guidelines, and consensus statements. CHEST is
interested
in
providing
evidence-based
guidance
on
respiratory
disease-
related public health issues and advocating for best practices in patient care.
The American College of Medical Genetics and Genomics is the only nationally
recognized medical professional organization solely dedicated to improving health
through the practice of medical genetics and genomics, and the only medical specialty
society in the U.S. that represents the full spectrum of medical genetics disciplines in
a single organization. The ACMG is dedicated to improving health through the
clinical and laboratory practice of medical genetics and to guiding the safe and
effective integration of genetics and genomics into all of medicine and healthcare,
resulting in improved personal and public health.
The American Geriatrics Society is a nationwide, not-for-profit society of
geriatrics healthcare professionals founded in 1942 and dedicated to improving the

4
health, independence, and quality of life of older people. AGS’s more than 6,000
members include geriatricians, geriatrics nurse practitioners, social workers, family
practitioners, physician assistants, pharmacists, and internists who are pioneers in
advanced-illness care for older individuals, with a focus on championing
interprofessional teams, eliciting personal care goals, and treating older people as
whole persons. AGS advocates for policies and programs that support the health,
independence, and quality of life of all of us as we age. AGS has a strong interest in
policies to prevent and mitigate COVID-19 infection as an important public health
intervention for the health and safety of our nation—but most critically for our
vulnerable populations.
The American Psychiatric Association, with more than 37,400 members, is the
nation’s leading organization of physicians who specialize in psychiatry. APA
members engage in research into and education about diagnosis and treatment of
mental health and substance use disorders, and are front-line physicians treating
patients who experience mental health and/or substance use disorders. APA has
participated in numerous cases in this Court and in the United States Courts of
Appeals.
The American Society for Clinical Pathology is a 501(c)(3) non-profit medical
specialty society representing more than 100,000 members. ASCP is one of the
nation’s largest medical specialty societies and the world’s largest organization
representing the field of laboratory medicine and pathology. ASCP membership is
uniquely diverse, consisting broadly of board-certified pathologists, other physicians,

5
clinical scientists, certified medical technologists and technicians, and educators.
Together, ASCP’s mission is to provide excellence in education, certification, and
advocacy on behalf of patients, pathologists, and laboratory professionals to advance
medicine and improve patient care. ASCP has on several occasions this year outlined
its unwavering support for vaccine uptake and related mandates. See, e.g., Statement
Supporting
OSHA’s
COVID
Vaccine
Requirement
(Nov.
17,
2021),
https://bit.ly/3dun6uS; To End the Pandemic, ASCP Urges that All Americans Be
Vaccinated (Aug. 11, 2021), https://bit.ly/3IvV6VS; Joint Statement in Support of
COVID-19 Vaccine Mandates for All Workers in Health and Long-Term Care (July
29, 2021), https://bit.ly/3IvV6VS.
The American Society of Hematology is the world’s largest professional society of
hematologists, including approximately 18,000 clinicians and researchers, who are
dedicated to furthering the understanding, diagnosis, treatment, and prevention of
disorders affecting the blood. ASH believes that vaccinations offer the best protection
against contracting COVID-19, prevent severe illness and hospitalization, and will
help save lives.
The American Thoracic Society is an international, nonprofit, nonpartisan
organization with more than 15,000 physicians, scientists, nurses, and respiratory
therapists dedicated to improving the health and wellbeing of patients suffering from
critical care illness, pulmonary disease and sleep disordered breathing. ATS’s
members are on the front lines of the COVID-19 response, treating patients with
COVID-19 in hospital intensive care units and inpatient hospital wards, and caring

6
for patients with long-COVID-19. Given ATS’s close and daily interaction with
COVID-19 patients, ATS’s members are also at significant risk for occupational
exposures to COVID-19. As such ATS has a compelling interest in seeing the federal
government establish and enforce science-based vaccination and testing policy to
protect the American public from further spread of COVID-19.
The Society of General Internal Medicine represents more than 3,000 of the
nation’s leading academic general internists, who are dedicated to the mission of
cultivating innovative educators, researchers, and clinicians in general internal
medicine, leading the way to better health for everyone. The Society’s members
advance the practice of medicine through their commitment to providing
comprehensive, coordinated, and cost-effective care to adults, educating the next
generation of outstanding physicians, and conducting cutting-edge research to
improve quality of care and clinical outcomes of all patients.
The Society of Interventional Radiology is a nonprofit, professional medical
society representing more than 8,000 practicing interventional radiology physicians,
trainees, students, scientists, and clinical associates, dedicated to improving patient
care through the limitless potential of image-guided therapies. SIR’s members work
in a variety of settings and at different professional levels—from medical students
and residents to university faculty and private practice physicians.
The American Lung Association is the nation’s oldest voluntary health
organization committed to a world free of lung disease. SARS-CoV-2 (COVID-19) is a
respiratory disease that has a dramatic impact on people with lung diseases including

7
lung cancer and chronic obstructive pulmonary disease. The American Lung
Association strongly supports vaccinations and has created public education and
information to increase access and overcome vaccine hesitancy. The Lung Association
has also invested significant resources in research, education and public policy
advocacy regarding the adverse health effects caused by COVID-19.
INTRODUCTION AND SUMMARY OF ARGUMENT
The United States is in an unprecedented and ongoing public health crisis as it
battles COVID-19—a battle that can be won only with widespread vaccination. While
vaccination of all workers is critical to protecting public health and safety, it is even
more urgent that healthcare workers be vaccinated: the potential for transmission of
the SARS-CoV-2 virus in healthcare settings puts not only frontline workers, but also
patients, at risk. Amici’s extensive review of the medical literature demonstrates that
COVID-19 vaccines authorized or approved by the U.S. Food and Drug
Administration are safe and effective, and the widespread use of those vaccines is the
best way to keep COVID-19 from spreading within healthcare facilities. Maintaining
the injunction against the Centers for Medicare & Medicaid Services’ interim final
rule requiring vaccination of covered healthcare facility staff2 would therefore
severely and irreparably harm patients and undermine the public interest.

2 Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination, 86
Fed. Reg. 61,555 (Nov. 5, 2021).

8
ARGUMENT
I.
COVID-19 Poses A Grave Danger To The Health Of Healthcare Facility
Staff And Patients.
COVID-19 presents a severe risk to public health. Although most people infected
with the virus will experience mild to moderate symptoms, individuals with COVID-
19 can become seriously ill or die at any age. As of December 21, 2021, there have
been more than fifty million confirmed cases of COVID-19 in the United States,3
leading to more than 3,529,000 hospitalizations4 and more than 803,000 deaths—
more than twenty-two times the number of people in the United States who die from
influenza in the average year.5 Even those who recover from COVID-19 may
experience debilitating symptoms lasting for several months or more after the acute
phase of infection. A systematic review of forty-five studies found that 73% of infected
individuals experienced at least one long-term symptom.6 Studies also indicate that
COVID-19 is associated with increased risk of adverse neurological and psychiatric
outcomes.7
SARS-CoV-2 is highly transmissible. The original strain was more contagious
than the flu, and the Delta variant of SARS-CoV-2, the leading strain until recent

3 COVID Data Tracker, CDC, https://bit.ly/3Du7Glz (last visited Dec. 21, 2021).
4 COVID Data Tracker Weekly Review, CDC (Dec. 17, 2021), https://bit.ly/3EYAdAb.
5 Disease Burden of Flu, CDC (Oct. 4, 2021), https://bit.ly/3ocAuZA.
6 Tahmina Nasserie et al., Assessment of the Frequency and Variety of Persistent Symptoms
Among Patients With COVID-19: A Systematic Review, JAMA Network Open (May 26, 2021),
https://bit.ly/3qocFkk.
7 Maxime Taquet et al., 6-month neurological and psychiatric outcomes in 236379 survivors of
COVID-19: a retrospective cohort study using electronic health records, The Lancet Psychiatry (Apr. 6,
2021), https://bit.ly/3DXTbGo.

9
days, is more than twice as contagious as previous variants.8 The surging Omicron
variant—which now accounts for 73% of new cases in the United States—appears to
be more contagious still.9 Crucially, more than 50% of the spread of the virus may be
from individuals who have no symptoms at the time of transmission.10
Transmission in healthcare facilities has been a major factor in the spread of
COVID-19. Since the beginning of the COVID-19 outbreak in February 2020, COVID-
19 has ravaged nursing homes, long-term care facilities, and hospitals.11 A study
found that “[u]p to 1 in 6 SARS-CoV-2 infections among hospitalised patients with
COVID-19 in England during the first 6 months of the pandemic could be attributed
to [healthcare-associated] transmission.”12 Another study found that frontline
healthcare workers had a threefold risk of contracting SARS-CoV-2 compared to the
general population.13 And healthcare facilities are still loci of outbreaks of the Delta
variant. Outbreaks in Iowa nursing homes during October 2021, for example, caused

8 Delta Variant: What We Know About the Science, CDC (Aug. 26, 2021), https://bit.ly/3plAmcy;
Apoorva Mandavilli, C.D.C. Internal Report Calls Delta Variant as Contagious as Chickenpox, N.Y.
Times (July 30, 2021), https://nyti.ms/3EtJXTb.
9 Omicron Variant: What You Need to Know, CDC (updated Dec. 19, 2021),
https://bit.ly/327xwyr; COVID Data Tracker: Variant Proportions, CDC (last visited Dec. 20, 2021),
https://bit.ly/3snnhk7.
10 Science Brief: Community Use of Masks to Control the Spread of SARS-CoV-2, CDC (updated
Dec. 6, 2021), https://bit.ly/30inWYx.
11 See, e.g., Karen Shen et al., Estimates of COVID-19 Cases and Deaths Among Nursing Home
Residents Not Reported in Federal Data, at 2, JAMA Network Open (Sept. 9, 2021),
https://bit.ly/3lG02h2 (“[N]ursing homes have been centers for outbreaks and excess mortality from
the COVID-19 pandemic . . . .”); Aaron Richterman et al., Hospital-Acquired SARS-CoV-2 Infection:
Lessons for Public Health, 324 JAMA 2155 (Nov. 13, 2020), https://bit.ly/3Irc8Va; see also, e.g., Temet
M. Michael et al., Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington,
382 New Eng. J. Med. 2005 (May 21, 2020), https://bit.ly/3pBvoXy.
12 Alex Bhattacharya et al., Healthcare-associated COVID-19 in England: a national data
linkage study, 83 J. Infection 565, 565 (Aug. 30, 2021), https://bit.ly/31xXHO9.
13 Long H. Nguyen et al., Risk of COVID-19 among front-line health-care workers and the
general community: a prospective cohort study, 5 Lancet e475, e476 (July 31, 2020),
https://bit.ly/31ABwY2.

10
at least 370 residents and staff to become infected.14 Requiring healthcare facility
staff to be vaccinated is therefore a crucial step toward protecting healthcare staff
and patients from COVID-19.
II. Vaccines Provide A Safe And Effective Way To Help Reduce
Transmission Of COVID-19 In Healthcare Facilities.
COVID-19 vaccines are safe. Before FDA authorized/approved and the Centers
for Disease Control and Prevention recommended use of the COVID-19 vaccines in
the population, scientists conducted extensive clinical trials. FDA, CDC, and their
advisory committees conducted rigorous reviews of the data, and continue to monitor
the vaccines’ safety.15 A study of more than six million people who received the Pfizer
or Moderna vaccines found that serious side effects are very rare.16 Another study
concluded that there is no increased risk for mortality among recipients of any of the
COVID-19 vaccines, and that vaccine recipients in fact had lower non-COVID-19
mortality risks than did unvaccinated people.17
COVID-19 vaccines are also effective. First, each of the three vaccines greatly
reduces the likelihood of contracting SARS-CoV-2. The Pfizer, Moderna, and

14 Clark Kauffman, Iowa’s nursing home infections and outbreaks are up 20% over last week,
Iowa Cap. Dispatch (Oct. 29, 2021), https://bit.ly/3oIpMu0.
15 Benefits of Getting a COVID-19 Vaccine, CDC (last updated Nov. 29, 2021),
https://bit.ly/3H6BsiF; Nicola P. Klein et al., Surveillance for Adverse Events After COVID-19 mRNA
Vaccination, 326 JAMA 1390 (Sept. 3, 2021), https://bit.ly/3F1XQYM; COVID-19 vaccine safety
surveillance, FDA (Dec. 7, 2021), https://bit.ly/3y1dDET.
16 Klein et al., supra note 15.
17 Stanley Xu et al., COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven
Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021, 70 Morbidity
& Mortality Weekly Rep. 1520 (Oct. 29, 2021), https://bit.ly/3D1ZRn4. Although the CDC recently
recommended the Pfizer or Moderna vaccines over the J&J/Janssen vaccine, the CDC’s advisory
committee made clear that “receiving any vaccine is better than being unvaccinated.” Press Release,
CDC, CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations (Dec. 16, 2021),
https://bit.ly/3yzUTfJ.

11
J&J/Janssen vaccines are 91.3%, 90%, and 72% effective against infection,
respectively.18 A study of vaccine effectiveness between December 14, 2020 and
August 14, 2021 found that vaccines were 80% effective at preventing SARS-CoV-2
infection among frontline workers.19 Although the vaccines’ efficacy wanes over time,
initial data on Pfizer booster shots, during a time when Delta was the prevalent
variant, show that they may boost the vaccine efficacy to more than 95%.20 For
comparison, the flu vaccination reduces the risk of flu illness by between 40% and
60%.21
Second, each of the three vaccines is even more effective against serious illness
and death. Studies have estimated the Pfizer, Moderna, and J&J/Janssen vaccines
as 95.3%–97%, 95%, and 86% effective against severe disease, respectively.22 The
vaccines are likewise highly effective against hospital admissions, “even in the face
of widespread dissemination of the delta variant.”23 According to one analysis,
between March 11 and August 15, 2021, unvaccinated people accounted for 84.2% of

18 Kathy Katella, Comparing the COVID-19 Vaccines: How Are They Different?, Yale Med. (Dec.
16, 2021), https://bit.ly/307jEU5.
19 Ashley Fowlkes et al., Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2
Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance —
Eight U.S. Locations, December 2020–August 2021, 70 Morbidity & Mortality Weekly Rep. 1167 (Aug.
24, 2021), https://bit.ly/3px2OGB.
20 Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose
of Their COVID-19 Vaccine, Pfizer (Oct. 21, 2021), https://bit.ly/3EXQa9K. A study comparing people
in Israel 60 years old and older who have and have not received third-dose boosters also provides
support for the increased efficacy of booster shots. See Yinon M. Bar-On et al., Protection of BNT162b2
Vaccine Booster against Covid-19 in Israel, 385 New Eng. J. Med. 1393 (Oct. 7, 2021),
https://bit.ly/327ijh2.
21 Vaccine Effectiveness: How Well Do Flu Vaccines Work?, CDC (last visited Dec. 16, 2021),
https://bit.ly/3HifLMP.
22 Katella, supra note 18.
23 Sara Y. Tartof et al., Effectiveness of mRNA BNT162b2 COVID-19 Vaccine Up to 6 Months,
398 Lancet 1407, 1407 (Oct. 4, 2021), https://bit.ly/3ouPvqS.

12
patients hospitalized for COVID-19, including those infected with the Delta variant.24
As of October 30, 2021, the age-adjusted rate of COVID-19-associated
hospitalizations in unvaccinated adults was more than 12 times that of fully
vaccinated adults.25 Although research regarding vaccine efficacy against the
Omicron variant is still developing, initial reports suggest that vaccination, including
a booster, remains efficacious against severe disease.26
Third, evidence suggests that those who are fully vaccinated are contagious for
shorter periods than unvaccinated people.27 Most importantly, “[r]egardless of viral
loads in vaccinated and unvaccinated individuals, the fact remains clear that
unvaccinated people pose a higher risk of transmission to others than vaccinated
people, simply because they are much more likely to get COVID-19 in the first
place.”28
III. The More Healthcare Facility Staff Who Get Vaccinated, The Safer
Healthcare Facilities Become.
The more healthcare facility staff who get vaccinated, the closer we are to slowing
the spread of the virus, creating a safer environment, and preventing staff and
patient illness due to COVID-19. As the American Medical Association has explained,

24 Mark W. Tenforde, Association Between mRNA Vaccination and COVID-19 Hospitalization
and Disease Severity, 326 JAMA 2043 (Nov. 4, 2021), https://bit.ly/3bZBHhb.
25 See Rates of laboratory-confirmed COVID-19 hospitalizations by vaccination status, CDC
(last updated Dec. 2, 2021), https://bit.ly/3oIwsZ4.
26 See Carl Zimmer & Sheryl Stolberg, New Studies Raise Hopes That Vaccines Prevent Severe
Disease From Omicron, N.Y. Times (Dec. 15, 2021), https://nyti.ms/3H3uCd4.
27 See COVID-19 Vaccination and Testing; Emergency Temporary Standard, 86 Fed. Reg.
61,402, 61,419 (Nov. 5, 2021).
28 Id.

13
“[t]he only way to truly end this pandemic is to ensure widespread vaccination.”29
Widespread vaccination is the only practical way to push the effective reproduction
rate of the SARS-CoV-2 virus below one, the rate at which endemic transmission
begins to die out.
Widespread vaccination reduces the likelihood of infections among both
vaccinated and unvaccinated people. During the wave of Delta infections, “states with
high vaccination rates (>70% of the population) are reporting lower numbers of
vaccine breakthrough cases as well as hospitalizations and deaths from COVID-19.”30
An analysis found that “[i]n the presence of high community prevalence of Covid-19,
nursing homes with low staff vaccination coverage had higher numbers of cases and
deaths than those with high staff vaccination coverage.”31 Widespread vaccination is
particularly important for people who cannot get vaccinated due to age or medical
condition, as well as immunocompromised people, who remain particularly
susceptible to infection even after vaccination32—and who may be particularly likely
to encounter workers in healthcare facilities, where social distancing is not an option.
Widespread vaccination is likewise critical to ensuring that patients feel sufficiently
safe in healthcare settings to seek treatment in the first place.33

29 Press Release, American Medical Ass’n, AMA, AHA, ANA urge vaccinations as U.S. reaches
750,000 COVID-19 deaths (Nov. 4, 2021) (emphasis added), https://bit.ly/3C07CIS.
30 Carlos del Rio et al., Confronting the Delta Variant of SARS-CoV-2, Summer 2021, 326 JAMA
1001, 1002 (Aug. 18, 2021), https://bit.ly/3bVL5Cj.
31 Brian E. McGarry et al., Nursing Home Staff Vaccination and Covid-19 Outcomes, New Eng.
J. Med., Correspondence (Dec. 8, 2021), https://bit.ly/3pQ7O9H.
32 Katherine Lontok, How Effective Are COVID-19 Vaccines in Immunocompromised People?,
Am. Soc’y for Microbiology (Aug. 12, 2021), https://bit.ly/3F24HBh.
33 See Mark E. Czeisler et al., Delay or Avoidance of Medical Care Because of COVID-19-Related
Concerns — United States, June 2020, 69 Morbidity & Mortality Weekly Rep. 1250 (Sept. 11, 2020),

14
Widespread vaccination also protects against overwhelming healthcare systems
with COVID-19 patients. “COVID-19 surges [a]re associated with higher rates of in-
hospital mortality among patients without COVID-19, suggesting disruptions in care
patterns for patients with many common acute and chronic illnesses.”34 For example,
during the pandemic, an antiques dealer in Alabama died from a cardiac event after
dozens of intensive care units in three states turned him down for lack of space.35 In
Idaho, where hospitals across the state were authorized to ration care, one hospital
canceled elective procedures and postponed necessary procedures, including excising
brain tumors.36 Widespread vaccination will result in fewer severe cases requiring
medical intervention and fewer infections among healthcare workers, freeing up
crucial resources to provide quality care to patients facing non-COVID-19-related
illnesses. Low vaccination rates, not vaccination requirements, pose the real threat
of overwhelming the healthcare system.37

https://bit.ly/3oYjdVx (“By June 30, 2020, because of concerns about COVID-19, an estimated 41% of
U.S. adults had delayed or avoided medical care . . . .”).
34 See Amber K. Sabbatini et al., Excess Mortality Among Patients Hospitalized During the
COVID-19 Pandemic, 16 J. Hosp. Med. 596, 596 (July 21, 2021), https://bit.ly/3Hs5EEU (emphasis
added).
35 Tim Stelloh, Alabama heart patient dies after hospital contacts 43 ICUs in 3 states, family
says, NBC News (Sept. 12, 2021), https://nbcnews.to/3nyOz4t.
36 Mike Baker & Giulia Heyward, Idaho allows overwhelmed hospitals across the state to ration
care if necessary, N.Y. Times (Sept. 16, 2021), https://nyti.ms/30Ee0ZP; Mike Baker, ‘Their Crisis’ Is
‘Our Problem’: Washington Grapples With Idaho Covid Cases, N.Y. Times (Sept. 13, 2021),
https://nyti.ms/3e3vxxi.
37 Vaccination to Prevent COVID-19 Outbreaks with Current and Emergent Variants — United
States, 2021, CDC (July 27, 2021), https://bit.ly/3GhocGC (indicating that residents of nursing homes
in which 75% or less of staff are vaccinated experience higher rates of SARS-CoV-2 infection).

15
IV. Widespread Vaccination Is The Most Effective Way To Protect
Healthcare Facility Staff And Patients From COVID-19.
The statistics on COVID-19 vaccine efficacy speak for themselves. No other
measure has been shown to reduce the risk of infection, hospitalization, and death to
the degree that vaccination does. The science is clear: no arguments against the need
for vaccination are medically valid, other than to accommodate a medical
contraindication.
Natural immunity—the immunity against SARS-CoV-2 that develops following
recovery from infection—is not an adequate substitute for vaccination.38 Studies have
shown that unvaccinated people are at least twice as likely to become reinfected as
are vaccinated people.39
Other mitigation measures, such as mask wearing and social distancing, remain
important. They do not, however, provide the same level of protection against COVID-
19 as does vaccination. Although masks can be highly effective at limiting the
transmission of SARS-CoV-2, many people choose not to wear masks, even when
encouraged or legally required to do so. Noncontinuous mask-wearing and other
inadequate personal protective equipment use has been linked to transmission of the

38 See Catherine H. Bozio et al., Laboratory-Confirmed COVID-19 Among Adults Hospitalized
with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity
— Nine States, January–September 2021, 70 Morbidity & Mortality Weekly Rep. 1539 (Nov. 5, 2021),
https://bit.ly/3kvoBwR (finding 5.49 times higher odds of laboratory-confirmed COVID-19 among
previously infected, unvaccinated patients than among fully vaccinated patients).
39 Alyson M. Cavanaugh et al., Reduced Risk of Reinfection with SARS-CoV-2 After COVID-19
Vaccination — Kentucky, May–June 2021, 70 Morbidity & Mortality Weekly Rep. 1081 (Aug. 13, 2021),
https://bit.ly/306e4Bg.

16
virus in healthcare facilities.40 Vaccination is even more essential for healthcare
facility staff, who may not be able to completely physically distance from others
during the performance of their duties.41
Even for those who work remotely at times, vaccination provides the best
protection against COVID-19. The virus spreads through respiratory droplets or
aerosols when an infected individual talks, breathes heavily, sings, coughs, or
sneezes. Particles containing the virus can spread more than six feet, and infection
can occur in a matter of minutes.42 Infection can thus occur even in environments
where staff use of shared spaces is staggered or reduced, or where staff are in physical
proximity to each other only rarely.43 And because staff who do not interact with
patients can transmit the virus to those who do, a rule that applies only to staff
members with patient contact would be insufficiently protective.
Although the district court concluded that the CMS rule “will have a crippling
effect” on healthcare facilities by creating a shortage of services, App. 33a, that
concern has not been borne out in hospital systems that have already imposed
vaccination requirements. For example, when Houston Methodist Hospital first
required its workers to be vaccinated, 15% were unvaccinated; that number dropped

40 Richterman, supra note 11; Jessica Ibiebele et al., Occupational COVID-19 exposures and
secondary cases among healthcare personnel, 49 Am. J. of Infection Control 1334 (Oct. 2021),
https://bit.ly/3lI0lIo.
41 Richterman, supra note 11.
42 Appendices, CDC (Nov. 12, 2021), https://bit.ly/3nbxAos (“close contact” definition);
Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace,
OSHA (updated June 10, 2021), https://bit.ly/3s8qm7L.
43 Indeed, the World Health Organization considers remote workers at “lower risk[],” not no
risk, of infection. Preventing and mitigating COVID-19 at work, at 2, World Health Organization (May
19, 2021), https://bit.ly/3wMJ451.

17
to 2% after the mandate, and only 153 workers resigned or were fired.44 Similarly, at
Indiana University Health, only 0.3% of employees resigned in the face of a
vaccination requirement.45 All but nine of South Shore Health’s 5,649 staff complied
with its COVID-19 vaccine requirement.46
Immediate, widespread vaccination against COVID-19 is the surest way to
protect healthcare facility staff, patients, and the public, and to end this costly
pandemic.
CONCLUSION
For the reasons stated above and in Applicants’ filings, Amici urge this Court to
grant Applicants’ application for a stay of the injunction pending appeal.

Respectfully submitted,

JESSICA ANNE MORTON
Counsel of Record
JEFFREY B. DUBNER
RACHEL L. FRIED
JOANN KINTZ*
SEAN A. LEV
DEMOCRACY FORWARD FOUNDATION
P.O. Box 34553
Washington, DC 20043
(202) 448-9090
jmorton@democracyforward.org

* Not admitted in the District of Columbia;
practicing under the supervision of
Democracy Forward lawyers.

Counsel for Amici Curiae
DECEMBER 2021

44 Jack J. Barry et al., Unvaccinated Workers Say They’d Rather Quit Than Get a Shot, but
Data Suggest Otherwise, Scientific American (Sept. 24, 2021), https://bit.ly/3kUYKOT.
45 Id.
46 Jessica Trufant, South Shore Health set to fire 9 staffers over COVID vaccine; 99.6% of
employees vaccinated, The Patriot Ledger (Dec. 10, 2021), https://bit.ly/30en1ID.

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Amicus Brief of AMA, ACP, AAP, and Medical Society Amici — Biden v. Missouri

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