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Brief - Scotus

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No. 21A241

In the Supreme Court of the United States
XAVIER BECERRA, SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL.,
Applicants,
v.
LOUISIANA, ET AL.,
Respondents.

ON APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED STATES
DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA PENDING APPEAL TO THE
UNITED STATES COURT OF APPEALS FOR THE FIFTH 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
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 Western District of Louisiana 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.

1
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 United

States Court of Appeals for the Eighth Circuit when it considered the CMS rule at

issue here. See Clerk Order, Missouri v. Biden, No. 21-3725 (8th Cir. Dec. 13, 2021);

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).

2
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.

3
No. 21A241

In the Supreme Court of the United States
XAVIER BECERRA, SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL.,
Applicants,
v.
LOUISIANA, 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

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

i
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

ii
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

iii
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

iv
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

v
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

vi
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.
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

2
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

3
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,

4
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

5
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

6
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 staff 2 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).

7
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 hospitalizations 4 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.

8
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.

9
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.

10
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.

11
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.

12
“[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 vaccination 32—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),

13
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).

14
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.

15
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 expressed concern that the CMS rule will cause

staffing shortages that will negatively affect patients, App. 32a, 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 to 2% after

40 Richterman, supra note 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.
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.

16
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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