Amended Motion For Leave To File Amicus Curiae

Summary

An amended motion for leave to file an amicus curiae brief of American Commitment Foundation, Inc., supporting applicants, a stay of agency standard, and certiorari before judgment, in the Supreme Court of the United States, 21A244 in consolidation with 21A247, National Federation of Independent Business, et al. v. Occupational Safety and Health Administration, et al., and State of Ohio, et al. v. Department of Labor. The motion asks leave to file the brief without 10 days' advance notice to the parties and states that notice was provided to all parties on January 4, 2022. The Questions Presented ask whether to stay the emergency temporary standard issued by OSHA and whether to grant certiorari before judgment. Leonard E. Ireland, Jr. is Counsel of Record, with Seldon J. Childers, dated January 2022.

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Full text

21A244 in consolidation with 21A247

In the Supreme Court of the Anited States

NATIONAL FEDERATION OF INDEPENDENT BUSINESS, ET AL.,
Applicants,

Uv.

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, ET AL.,
Respondents.

STATE OF OHIO, ET AL.,
Applicants,

Vv.

DEPT. OF LABOR, OCCUPATIONAL SAFETY AND HEALTH ADMIN., ET AL.,
Respondents.

On Applications for Stay of Administrative Action and Petition for a Writ
of Certiorari to the United States Court of Appeals for the Sixth Circuit

AMENDED MOTION FOR LEAVE TO FILE AMICUS CURIAE
BRIEF OF AMERICAN COMMITMENT FOUNDATION, INC. AS
AMICUS CURIAE SUPPORTING APPLICANTS, A STAY OF
AGENCY STANDARD, AND CERTIORARI BEFORE JUDGMENT

LEONARD E. IRELAND, JR. SELDON J. CHILDERS

18 N.W. 33"? COURT CHILDERSLAW, LLC
Gainesville, FL 32607 2135-B NW 40* Terrace
(352) 376-4694 Gainesville, FL 32605
lireland@clayton-john- (352) 335-0400

ston.com jchilders@smartbizlaw.com

Counsel of Record

Counsel for Movants-Amicus
———
MOTION FOR LEAVE
TO FILE AMICUS CURIAE BRIEF

Amicus American Commitment Foundation, Inc.
respectfully moves for leave (1) to file the attached
amicus curiae brief in opposition to the eleven Emer-
gency Applications, filed on December 17— 20, 2021,
seeking a stay or injunction pending certiorari review
of the Sixth Circuit’s decision granting a motion to dis-
solve a stay of the Occupational Safety and Health Ad-
ministration (OSHA) Emergency Temporary Stand-
ard on COVID-19 vaccination and testing (ETS),
which was issued by the Fifth Circuit before being
transferred to the Sixth Circuit, and (2) to file the en-
closed brief without 10 days’ advance notice to the par-
ties of amicus’ intent to file.

Amicus provided notice to all parties of their intent
to file an amicus brief in opposition to the emergency
applications by email on January 4, 2022. Counsel for
the petitioners-applicants in 7 of the 15 applications—
Nos. 21A242, 21A243, 21A244, 21A246, 21A247,
21A248, 21A249, 21A250, 21A251, 21A252, 21A258,
21A259, 21A260 and 21A267—stated that they con-
sent or do not object to the filing.

American Commitment Foundation is a 501(c)(8)
charitable foundation organized to educate the gen-
eral public about concepts that advance economic free-
dom and constitutionally limited government, led by
its president Phil Kerpen. The Foundation was ad-
ii
vised in the preparation of this brief by epidemiolo-

gists Jay Bhattacharya of Stanford University and
Andrew Bostom of Brown University.

Specifically, the scientific and technical landscape
related to the Covid-19 pandemic is, like the virus it-
self, ever evolving. Amicus seek to file this brief to in-
form the Court of the latest developing scientific and
technical information related to the dominant viral
variant, referred to as “Omicron.” Amicus are confi-
dent that this information will inform and assist the
Court as it considers the weighty legal matters related
to this dispute.

Given the expedited consideration of this matter of
significant national interest, amicus respectfully re-
quest leave to file the enclosed brief without 10 days’
advance notice to the parties of intent to file. The
Sixth Circuit granted the government’s motion to dis-
solve the stay imposed by the Fifth Circuit on the
evening of December 17, 2021, and the applications
for a stay were filed in this Court on December 17, 18,
and 20. The Court set a deadline of December 30 for
respondent's brief. Counsel for amicus provided notice
to all parties on January 4, 2022. Because of the rapid
schedule and because no party has opposed the filing,
amicus request that the Court grant leave to file the
attached amicus brief without 10 days’ advance notice
to the parties.

To the extent that leave is required, the proposed
amicus respectfully moves for leave to file the at-
tached brief on 81/2- by 11-inch paper rather than in
ii
booklet form, given the expedited briefing. Should the
Clerk’s Office or the Court so require, the proposed

amicus commit to re-filing expeditiously in booklet
format. See S. Ct. Rule 21.2(c).

CONCLUSION

For the foregoing reasons, amicus American Com-
mitment Foundation respectfully requests that the
Court grant this motion to file the attached proposed
amicus brief and accept it in the format and at the
time submitted.

Respectfully submitted,
LEONARD E. IRELAND, JR. SELDON J. CHILDERS

18 N.W. 3322 COURT 2135 40TH TERRACE,
Gainesville, FL 32607 Suite B

(852) 376-4694 Gainesville, FL 32605
lireland@clayton-john- (852) 335-0400

ston.com Counsel for Movants-Amt-
Counsel of Record cus

January 2022.
lv
QUESTIONS PRESENTED

1. Whether the Court should stay the emer-
gency temporary standard that the Occupational
Safety and Health Administration issued, which ex-
ceeded its statutory authority and violates the United
States Constitution.

2. Whether the Court should grant certiorari
before judgment so that it can review the ETS before
the cases become moot.
Vv
TABLE OF CONTENTS

Motion for Leave to File Amicus Curiae Brief.......... 1
Questions Presented .............:ssssseeeeeeeceeceesseeeeeeeeresseees 1V
Table of Contents ........cccccccccceceeeeeeeeeeeseeeeeeeeeeeeennaeaeeeens Vv
Table of Authorities............cccccccccceeeeeeeeeeeeeeeennneneeererees vi
Interest of AMICUS CULIAE ..ceeeccececsetceeeeeteeeeeneneeeenaes 1
Introduction & Summary of Argument.........eeee 3
ATE UM CN bissusscasasssvsssvsassseasvanvansanvensasen castdenascsvauvecvaneeneN 4

I. Omicron Is Now the Dominant Variant.......... 4

II. Omicron Does Not Present a Grave

III.Vaccines Are Ineffective At Preventing
Omicron Infections ..................::ceseeeeseeneeeaneees 18

Conclusion ...........ccccsecceeecenceccnseccceecencecatcceeeeeeeccenveranes 26
vi
TABLE OF AUTHORITIES

Other Authorities

Aziz Sheikh, Steven Kerr, Mark Woolhouse,
Jim McMenamin, and Chris Robertson,
Severity of Omicron variant of concern and
vaccine effectiveness against symptomatic
disease: national cohort with nested test
negative design study in Scotland, The

University of Ediburgh (Dec. 22, 2021). .............

CBC News, Ontario pushes back school
reopening to Jan. 5, restricts PCR testing to

high-risk individuals (Dec. 30, 2021)...........000

CDC, Case Surveillance/United States COVID-
19 Cases and Deaths by State,
https://data.cdc.gov/Case-
Surveillance/United-States-COVID-19-Cases-
and-Deaths-by-State-o/9mfq-cb36 (visited

San. 4, 2022)... ceesesseesesececcecceeeseeseeseusessreeeeesees

CDC, COVID Data Tracker,
https://covid.cdc.gov/covid-data-
tracker/#variant-proportions (visited Jan. 4,

CDC, Estimated flu-related illnesses, medical
visits, hospitalizations, and deaths in the
United States - 2017-2018 flu season (Sept.

BO, 2021) ee eeeeceecesseeeeeesseeecerssseeereesaeeeeteneeesenes

CDC, https://data.cde.gov/resource/9bhg-

heku.esv?sex=All Sexes ....cceccecccecsseeeccseeeceveceueceee

25
vii

Christian Holm Hansen PhD, Astrid Blicher
Schelde PhD, Ida Rask Moustsen-Helm PhD,
Hanne-Dorthe Emborg PhD, Tyra Grove
Krause PhD, Kare Molbak DMSc, Palle
Valentiner Branth, Vaccine effectiveness
against SARS-CoV-2 infection with the
Omicron or Delta variants following a two-
dose or booster BNT162b2 or mRNA-1278
vaccination series: a Danish cohort study,
medRxiv (Dec. 22, 2021) ......ccccccccccesessseeseeeeessseees 20

Dep't: Health Republic of South Africa, Media
Release: Cabinet Approves Changes to
COVID-19 Regulations (Dec.30, 2021)............. 11

Genomic Epidemiology of novel coronavirus —
Global subsampling,
https://nextstrain.org/ncov/gisaid/global?f_cou
ntry=South®%20Africa
https://nextstrain.org/ncov/gisaid/global?f_cou
ntry=South%20Africa (visited Jan. 4, 2022) .......... 6

Harry Moultrie @hivepi), Twitter (Dec. 27,
2021, 3:29 AM),
https://twitter.com/hivepi/status/14753834294
08SEC peeemmvarenmenneacieRr nen MINE nENCEENER TERED AEELSE INSEE 10

LKS Faculty of Medicine, The University of
Hong Kong, HKUMed finds Omicron SARS-
CoV-2 can infect faster and better than Delta
in human bronchus but with less severe
infection in the lung (Dec. 15, 2021).............ccceseeeees 9
vill
Moderna, Moderna Announces Preliminary
Booster Data and Updates Strategy to

Address Omicron Variant (Dec. 20, 2021) ..........

National Institute for Communicable Diseases,
Frequently Asked Questions for the B.1.1.529
mutated SARS-COV-2 lineage in South
Africa,
https://www.nicd.ac.za/frequently-asked-
questions-for-the-b-1-1-529-mutated-sars-cov-
2-lineage-in-south-africa/ (visited Jan.4,

Nicole A. Doria-Rose, Xiaoying Shen, Stephen
D. Schmidt, Sijyy O'Dell, , Charlene McDanal,
Wenhong Feng, Jin Tong, Booster of mRNA-
1278 vaccine reduces SARS-CoV-2 Omicron
Escape from Neutralizing Antibodies,

medRxiv (Dec. 15, 2021)... ecccecccecceeeeeeeeaeeeeeees

Nicole Wolter, Waasila Jassat , Sibongile
Walazal, Richard Welch, Harry Moultrie,
Michelle Groome, Daniel Gyamfi
Amoako,Early assessment of the clinical
severity of the SARS-CoV-2 Omicron variant

in South Africa, medRxiv (Dec. 21, 2021)...........

Oliver Barnes, John Burn-Murdoch, and
Richard Milne, Omicron cases less likely to
require hospital treatment, studies show, Ars

Technica (Dec. 22, 2021)... eceeesseeteeeeereeeeeeeeees
1X
Ontario, All Ontario: Case numbers and

spread, https://covid-19.ontario.ca/data/case-
numbers-and-spread (visited Jan. 5, 2022).......... 24

Our World in Data, Coronavirus (COVID-19)
Vaccinations,

https://ourworldindata.org/covid-vaccinations
(visited Jan. 4, 2022)

Our World in Data, Moving-average case
fatality rate of COVID-19,
https://ourworldindata.org/explorers/coronavi
rus-data-
explorer?zoomToSelection=true&time=2020-
03-
01..latest&facet=none&pickerSort=asc&picke
rMetric=location& Metric=Casetfatalityt+rate
&Interval=7-
day+rolling+taverage&Relative+to+Populatio
n=true&Color+by+test+positivity=false&coun
try=~ZAF (visited Jan. 4, 2022)

Pfizer, Pfizer and BioNTech provide update on
monicron variant (Dec. 8, 2021)

Pieter Streicher (@pieterstreicher), Twitter
(Dec. 27, 2021, 12:56 PM),
https://twitter.com/pieterstreicher/status/147
5525908475830278. ......ccccccesesseecceeesseseereeeeseneeenanees 16

Robert Koch Institut, Wochentlicher Lagebericht
des RKI zur Coronavirus-Krankheit-2019
(COVID-19) (Dec. 30, 2021) ......cccceccccceessteeeeeeseeeeees Ba)
x

Shabir A. Madhi, Gaurav Kwatra, Jonathan E.
Myers, Waasila Jassat, Nisha Dhar,
Christian K. Mukendi, Amit J. Nana, South
African Population Immunity and Severe
Covid-19 with Omicron variant, medRxiv

(Dec. 21, 2021)... eesccsccccceessesccceeseceseccecenseeees

Sivan Gazit, Roei Shlezinger, Galit Perez, Roni
Lotan, Asaf Peretz, Amir Ben-Tov, Dani
Cohen, Khitam Muhsen, Gabriel Chodick, Tal
Patalon (2021) Comparing SARS-CoV-2
natural immunity to vaccine-induced
immunity: reinfections versus breakthrough

infections, medRxiv (Aug. 25, 2021)...

The White House, Press Briefing by White
House COVID-19 Response Team and Public

Health Officials (Dec. 29, 2021), ....cccccccccccceceeeeeee

UK Health Security Agency, SARS-CoV-2
variants of conern and variants under

investigation in England (Dec. 23, 2021)............
INTEREST OF AMICUS CURIAE!

The American Commitment Foundation is a
501(c)(8) charitable foundation organized to educate
the general public about concepts that advance eco-
nomic freedom and constitutionally limited govern-
ment, led by its president Phil Kerpen. The Founda-
tion was advised in the preparation of this brief by ep-
idemiologists Jay Bhattacharya of Stanford Univer-
sity and Andrew Bostom of Brown University.

Jay Bhattacharya is a Professor of Health Policy at
Stanford University School of Medicine, a research as-
sociate at the National Bureau of Economic Research,
and the Director of Stanford’s Center for Demography
and Economics of MHealth and Aging. Dr.
Bhattacharya holds an M.D. and Ph.D. from Stanford
University. He has published 155 scholarly articles in
peer-reviewed journals in the fields of medicine, eco-
nomics, health policy, epidemiology, statistics, law,
and public health, among others. His research has
been cited in the peer-reviewed scientific literature
more than 12,500 times.

Dr. Bhattacharya has testified as an expert in nu-
merous lawsuits related to the Covid-19 pandemic
generally and vaccine mandates in particular, and has
devoted substantial time in research and writing on
the subject.

1 Amicus have moved for leave to file this brief. No party’s
counsel authored the brief in whole or in part, and no party or
party’s counsel, nor anyone other than amicus or their counsel,
contributed money intended to fund its preparation or submis-
sion.
2

Andrew Bostom is currently affiliated with the
Brown University Center For Primary Care and Pre-
vention, and was an Associate Professor of Medicine
and Family Medicine at The Warren Alpert Medical
School of Brown University from 1997 until June,
2021. A clinical trialist and epidemiologist, Dr. Bos-
tom designed and completed the largest randomized,
controlled trial ever conducted in chronic kidney
transplant recipients.

Dr. Bostom has 114 scholarly, peer-reviewed pub-
lications focused on epidemiology and clinical trials.
He has testified as an expert witness in lawsuits per-
taining to the Covid-19 pandemic—specifically on vac-
cine and mask mandates—while researching and
writing extensively on those subjects.
3

INTRODUCTION &
SUMMARY OF ARGUMENT

Substantial new factual developments related to
the Omicron variant, arising after the filing, briefing,
and arguing of the original cases, substantially under-
mine the government’s justification for the ETS
standard. The Omicron variant is — or will shortly be
— the dominant viral strain in the United States, ac-
counting for nearly all new SARS-CoV2 infections.

This significant change in circumstances negates
the factual basis for the OSHA order in two ways: it
dramatically reduces the risk of severe illness or
death, and it renders the existing vaccines ineffective
at reducing transmissions — thereby negating any
possible societal benefit from mandating their use.
The Court should completely disregard any fact evi-
dence developed prior to the rise of Omicron, including
the original vaccine trials, which showed efficacy
against the original “wild type” virus which is no
longer in circulation.

Presently available vaccines may confer a personal
benefit against severe disease from the Omicron vari-
ant, but do not confer any demonstrable societal ben-
efit, because they do not effectively reduce infections
or transmission. They simply cannot protect workers
from the spread of SARS-CoV-2 in the workplace.

With the Omicron variant now dominant, vaccine
mandates cannot possibly stop viral transmission.
Therefore, they amount to a personal health mandate,
akin to a requirement to eat broccoli, exercise, or any
4

number of personal health measures that the Court
has previously rejected as beyond the scope of legiti-
mate federal power.

ARGUMENT

I. OMICRON IS NOW THE DOMINANT
VARIANT

The Omicron variant now accounts for the major-
ity of new SARS-COV2 infections in the United
States, and is expected to represent substantially all
new infections within weeks.

Below is the CDC official variant projection, called
“NOWCAST,” which shows Omicron represented
95.4% of new cases for the week ending January 1 —
and is still rising:2

2 CDC, COVID Data Tracker, https://covid.cdc.gov/covid-data-
tracker/#variant-proportions (visited Jan. 4, 2022).
5

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wFudieay by

This follows the trajectory in South Africa, where
the Omicron variant was discovered in the Gauteng
6

province on November 22, 2020.2 In South Africa,
Omicron rose to 91% dominance by December 21.4

Given the Omicron trajectory in the United States
and the unprecedented steep rise in cases nationally,
driven by Omicron, it is likely that by the time the
Court decides whether to grant a stay, Omicron will
represent substantially all of the SARS-CoV2 infec-
tions in the United States. That fact renders nearly
all of the fact evidence in the record obsolete.

3 National Institute for Communicable Diseases, Frequently
asked questions for the B.1.1.529 mutated SARS-COV-2 lineage
in South Africa, https://www.nicd.ac.za/frequently-asked-ques-
tions-for-the-b-1-1-529-mutated-sars-cov-2-lineage-in-south-af-
rica/ (visited Jan.4, 2022).

4 https://nextstrain.org/ncov/gisaid/global?f_coun-
try=South%20Africa
Mi

II. OMICRON DOES NOT PRESENT A
GRAVE DANGER

A recent analysis from the South African govern-
ment's National Institute for Communicable Diseases
provides some reason for optimism: S-Gene Target
Failure (presumptive Omicron) cases are 80% less
likely to be hospitalized.

Tabla 1, Multhanable logntic regression analysis evaluating the association between S gene target failure (SGTF) Infeniion, compared to non-SGTF
Infection, and hospliaizatlon, South Afrtes, 1 October - 30 November 2021* |M=11,255)

Hospital adentsabesr* Adjusted odds ratio Pvaiue
ain (8) [95% CH)
GSN Ive ae wis =
“1 PMNS A} Or Dran <0.001
Non SGTF 121/948 (13) fet

The latest data from Scotland also strongly sug-
gests the same optimistic conclusion: “early national
data suggest that Omicron is associated with a two-
thirds reduction in the risk of COVID-19 hospitalisa-
tion when compared to Delta.Ӥ

5 https://www.medrxiv.org/con-
tent/10.1101/2021.12.21.21268116v1.full.pdf

6 https://www.research.ed.ac.uk/en/publications/severity-of-omi-
cron-variant-of-concern-and-vaccine-effectiveness-
8

Table 3: Observed vs expected analysis for risk of hospital admission by S gene status
Bev al hone GoY

Person Hospital Expected Observed/

____| SGene Status | ON Years Admissions Admissions Expected LCL UCL
Allcases | § Positive 119100 4375.1 856 856.9 1 093 1.07
ee s] Negative 22205 «413-4 15 46.6 032 | 019 0.52
Nedataset positive 2199 57.3 7 69 102 045 2
Other 990 33.8 * * 0.79 026 1,88
Unknown 1d? 4R? 14 14k n94 N44 1454

Denmark’s data shows Omicron cases were three
times less likely to end up with hospital admissions
than the previous dominant variant, Delta.7

The United States has not published any compara-
ble data. But, NIAID Director Dr. Anthony Fauci
noted the global evidence of reduced severity at a De-
cember 29, 2021 White House briefing and indicated
unpublished U.S. data show the same trend:

In the United States, we are getting accumula-
tion of data. The spike in cases is out of propor-
tion to the increase in hospitalization. So, if one
looks at 14-day averages, the data, as of last
night, indicate a plus 126 percent increase in
cases [but only] an 11 percent increase in hos-
pitalizations. Now, we must remember that
hospitalizations and deaths are lagging indica-
tors. However, the pattern and disparity be-
tween cases and hospitalization strongly sug-
gest that there will be a lower hospitalization-

7 https://arstechnica.com/science/2021/12/omicron-cases-less-
likely-to-require-hospital-treatment-studies-show/
9

to-case ratio when the situation becomes more
clear.8

Hong Kong University researchers pointed to the
likely reason, or mechanism, for Omicron’s increased
infectiousness but reduced virulence: it replicates far
more efficiently in the bronchus and upper respiratory
tract than Delta, but less efficiently in the lungs:9

Bronchus Lung
wee ow ry **
prong * [| [ |
105- a [| 105- Omicron: we
Omicron: 40 times « Original I Original
105+ 74 times > Deita
1044 I = Delta
104-4 a i
= 10 E 1024 cI Omicron
5 a 10?
1024 oan
word ADDL. DLDLEL- qu
10° T t 10° T '
24 43 24 48
Hours Post Infection Hours Post Infection

But the most compelling evidence of Omicron end-
ing any grave danger from SARS-CoV2 comes from

8 https://www.whitehouse.gov/briefing-room/press-brief-
ings/2021/12/29/press-briefing-by-white-house-covid-19-re-
sponse-team-and-public-health-officials-76/

9 http://www.med.hku.hk/en/news/press/20211215-omicron-
sars-cov-2-infection
10

South Africa, particularly the Gauteng province (pop-
ulation 18 million) where the first recognized Omicron
wave occurred. According to Dr. Harry Moultrie of the
South African government's National Institute for
Communicable Diseases, Gauteng cases peaked on
December 9 at 97 percent of the delta wave. Even
more reassuringly, deaths were only 13 percent of the
delta peak: 10

Normalised cases, admissions and deaths (Gauteng)

«©. |
§
t=
ie
5
ee
Fe
N
ul
01jan2020 ojul2020 Otjan2021 ofjui2021 Otjan202:
| Cases Admissions Deaths |

Cases from NICD NMCSS, admissions and deaths from DATCOV
Cases mclude remlections

Data exported: 27 December2021

Last date included: 22December2021

A recently published working paper by a South Af-
rican team of scientists who were conducting a sero-

10 https://twitter.com/hivepi/status/1475383429403484163
11

epidemiological survey in the Gautang Province con-
firms the conclusion that Omicron infection is sub-
stantially less likely to require hospitalization or in-
duce mortality than infection with other strains.
While cases may rise sharply as a wave of Omicron
sweeps through a region, hospitalizations and deaths
do not follow. The authors conclude:!!

We demonstrate widespread underlying
SARS-CoV-2 seropositivity in Gauteng Prov-
ince prior to the current Omicron-dominant
wave, with epidemiological data showing an
uncoupling of hospitalization and death rates
from infection rate during Omicron circulation.

Based on their Omicron experience, some South
African scientists have effectively declared the pan-
demic over, stating:!2

All indicators suggest the country may have
passed the peak of the fourth wave at a national
level... While the Omicron variant is highly
transmissible, there has been lower rates of
hospitalisation than in previous waves. This
means that the country has a spare capacity for

11 https://www.medrxiv.org/con-
tent/10.1101/2021.12.20.21268096v1

12 https://sacoronavirus.co.za/202 1/12/30/media-release-cabinet-
approves-changes-to-covid-19-regulations/
12

admission of patients even for routine health
services.

In other words, the first country to experience an
Omicron wave has unambiguously concluded that the
dominant variant presents no grave danger.

Early U.S. data is available in a preprint from a
team at Case Western Reserve University, which used
propensity matched-cohort analysis to find markedly
reduced disease severity during the period from De-
cember 14 to December 24, 2021. On an age and risk-
matched basis, they found ER visits were 70% lower
than earlier cohorts, hospitalizations were 56% lower,

ICU admissions were 67% lower, and ventilation were
84% lower.

Age~stratifled comparison of 3-day acute outcomes
in matched patients with SARS~CoV~2 Infections
Emergent Omicron cohort (12/1812/24) vs. Delta cohort (9/1~11/15)

Emergent Omicron Osta

Aga group Outcome jane ao ee RR (96% Ch
0-4 (ne{ 381) ED veal 369% (53) 21.01% (288) mt o 0.19 ffl 14-0 25)
5-14 (ne1 307} ED wsk 3 BO (47) 12.62% (185) — ' 9.20 (0 21-0 39)
12-17 {n=1,246) ED vin 2.00% (26) 49.10% (183) 4 18 0 14-0.24)
18-€4 (n=7,7B1) ED visit 455% (353} 14.91% 41,157) 4 \ 032 9 27-0.M)
9268 {n=2.473} ED visk 7.38% (160} 13.94% (303) oad : 0 53 (0 44-63)
‘
G4 (ne1368)  Haspéaliration 0, 96% (33) 2.85% (36} or] ' 0.36 (0 19-0.88)
5-11 (= 1.207} Hospasiization 0.77% (10) 145% (10) ——es O53 (0.25-1.13)
12-47 (n=1,244) Mospini¢etian 4.21% (15) 1 D3% (24) er aa 0.60 (0.33-1 19)
18-BA (n=7.761) Moapaaiizintion 1.20% (93} 3.785% (203) ond ‘ 0.32 (0 25-0401

>=€5 (n=2.173}  Hospaahzation 6 20% 1195} 2.6755 (210) — \ 0.55 (044-0 681

t T + Tr 7

13

As good as they appear, these reductions substan-
tially understate the reduction of risk represented by
Omicron, because this cohort included a non-negligi-
ble number of Delta infections. According to the au-
thors:

The estimated prevalence of the Omicron vari-
ant during 12/15-12/24 was only 22.5-58.6%,
suggesting that the outcomes for the Omicron
variant may be found to be even milder than
what we report here as the prevalence of the
Omicron variant increases.

Adding to the lack of any grave danger, there is
also strong early evidence that Omicron infection of-
fers robust protection against the Delta variant. This
means that even if the Delta variant still presented a
grave danger, it would be counterproductive to stop or
slow the spreading of the presently dominant Omicron
variant.

Research at the Africa health Research Institute
found:

Importantly, there was an enhancement of
Delta virus neutralization, which increased
4.4-fold. The increase in Delta variant neu-
tralization in individuals infected with Omi-
cron may result in decreased ability of Delta
to re-infect those individuals. Along with
emerging data indicating that Omicron, at
this time in the pandemic, is less pathogenic
14

than Delta, such an outcome may have posi-
tive implications in terms of decreasing the
Covid-19 burden of severe disease.

This substantial reduction of severe disease risk
must be applied to a contextualized understanding of
the already low-risk to working-age individuals.

Since the start of the pandemic, there have been
206,156 COVID-associated deaths among the working
age 18 to 64 population — overwhelmingly in those
above age 50 with pre-existing health conditions — ac-
cording to the preliminary death count at the CDC’s
National Center for Health Statistics: 18

1) pers ims 3 Cha + 1
Lbst yest: Ex > 225 4} 3 ba} i

3 year 734 N bhi 1b a =.
Sayen KY 3 senil setae Lay re: ae
SO-64 yeare 25 $4) 237.65) 1524 OF 19.0%) 128%) i£?%
155 yenrs end ever ? l ns 3] 2077.18) _7506.23 TE ETT) a)
Ay Aged Els BOE 3,520 $16] 32 $8{] 352 set sss] 245 59) 1735 78} 203 4) tooces 102.9%)
CDC NSS Deaths Wonder Popuaton Estimates Free Jaquary i 292010 December 25, 2621 25 of Daembe 25. 2021

Given substantial improvements in treatments, in-
cluding therapeutics that can reduce the risk of hospi-
talization of death by more than 50 percent, we would
expect that even if the virus had not attenuated
deaths in this age group, and even in the absence of
vaccination, deaths would be 50,000 or less per year
going forward.

13 https://data.cdc.gov/resource/9bhg-hcku.csv?sex=All
Sexes
15

Case fatality rates might be an even better way to
conceptualize the risk than other common measures.
As Dr. Jay Bhattacharya of Stanford notes:

It is helpful to provide some context for how
large the mortality risk is posed by COVID
infection relative to the risk posed by other
infectious diseases. Since seroprevalence-
based mortality estimates are not readily
available for every disease, in the figure im-
mediately below, I plot case fatality rates,
defined as the number of deaths due to the
disease divided by the number of identified
or diagnosed cases of that disease. The case
fatality rate for SARS-CoV-2 is ~2% (though
that number has decreased with the availa-
bility of vaccines and effective treatments).
By contrast, the case fatality rate for SARS
is over five times higher than that, and for
MERS, it is 16 times higher than that.
16

Case Fatality Rate -- Selected Infectious Diseases

Ebova PRETO a SA
MERS Dees OE
Srvalipox jas. al: ~ i Nise 4s Cee
Tabercuions jt, at Ef
Teracus naa
SARS ns
Anthrax |
iggoanares Ocecce
Biptneria |
Plague mm
ks Pe
Yenow Fever a
Cholera ; |
A. Inflenzae mm
Rotavirus | |
SARS CAe? COVIO: LM
2 if 23 ag 50 Oo

But the case fatality rate appears to be falling even
more sharply than that. In South Africa, the case fa-
tality rate plunged dramatically when Omicron be-
came dominant. Pieter Streicher of the University of
Johannesburg projects that for Gauteng Province: “C-
19 deaths are expected to total 640 for this wave, 25x
lower compared to Delta (15,400).” 14

The graph below tracks a 7-day moving average of
the case fatality rate of COVID infection from Septem-
ber 1, 2020 to January 1, 2022 in South Africa with

14 https://twitter.com/pieterstreicher/sta-
tus/1475525908475830278
17

data from a well-known COVID data provider, Our
World in Data.15 It confirms the collapse in the case
fatality rate of COVID in South Africa as Omicron be-
came the dominant strain.

|
i
|
ji } |
Pa |
|
> tee -iiaaliaiiaiaddadi DA 29 AEE

16 Our World in Data, Moving-average case fatality rate of
COVID-19, https://ourworldindata.org/explorers/coronavirus-
data-explorer?zoomToSelection=true&time=2020-03-01..lat-
est&facet=none&pickerSort=asc&pickerMetric=location&Met-
ric=Case+fatalityt+rate&Interval=7-day+rollingtaverage&Rela-
tivet+tot+Population=true&Color+by+test+positiv-
ity=false&country=~ZAF (visited Jan. 4, 2022)
18

With Omicron’s observed decline in severity, ex-
pected working-age deaths fall into a range compara-
ble to — or even lower than — the CDC’s modeled
8,000 influenza deaths in 2017-18.16 Quite simply,
the Omicron variant is now a normal respiratory vt-
rus, not an unusual, extraordinary, or grave danger.
There is no evidence in the record specific to Omicron
to support a grave danger finding.

Til. VACCINES ARE INEFFECTIVE AT
PREVENTING OMICRON INFECTIONS

Pfizer and BioNTech are the manufacturers of the
current leading vaccine. They recently admitted that
the existing vaccine does not provide robust protection
against Omicron, saying:

Sera from individuals who received two
doses of the current COVID-19 vaccine did
exhibit, on average, more than a 25-fold re-
duction in neutralization titers against the
Omicron variant compared to wild-type, in-
dicating that two doses of BNT162b2 may
not be sufficient to protect against infection
with the Omicron variant. !7

16 https://www.cdc.gov/flu/about/burden/2017-2018.htm

17 https://www.pfizer.com/news/press-release/press-release-de-
tail/pfizer-and-biontech-provide-update-omicron-variant
19

Moderna, the second-leading manufacturer, simi-
larly admitted that its vaccine does not provide ac-
ceptable efficacy against Omicron, stating:

All groups had low neutralizing antibody lev-
els in the Omicron PsVNT assay prior to
boosting. 18

Similarly, NIH-funded researchers at Duke uni-
versity found in vitro that: "neutralizing titers to Omi-
cron are 49-84 times lower than neutralization titers
to D614G [wild-type SARS-CoV2] after 2 doses of
mRNA-1273 [Moderna], which could lead to an in-
creased risk of symptomatic breakthrough infec-
tions."19

Real-world evidence from at least four countries
with significant experience with Omicron — Den-
mark, the United Kingdom, Germany, and Canada,
all of which provide more detailed and transparent
data than has been made available in the United
States — evidences that these vaccines have substan-
tially zero efficacy at preventing Omicron transmis-
sion, undermining the central rationale for mandating
them in the workplace.

18 https://investors.modernatx.com/news/news-de-
tails/2021/Moderna-Announces-Preliminary-Booster-Data-and-
Updates-Strategy-to-Address-Omicron-Variant/default.aspx

19 https://www.medrxiv.org/con-
tent/10,1101/2021.12.15.21267805v1.full-text
20

The Statens Serum Institut in Copenhagen, Den-
mark analyzed Danish data and found vaccine effi-
cacy turned negative after 91 days following the sec-
ond dose was administered. In other words, vac-
cinated Danes were even more likely than unvac-
cinated Danes to be infected with Omicron after 3
months:29

20 https://www.medrxiv.org/con-
tent/10,1101/2021.12.20.21267966v2.full.pdf
21

Pfizer - BNT162b2 Modema - mRNA-1273
Wkly 1 Dela
£ syd ! s+
z
-
z us
Noy | tte
T T T T T T T T
Fe Fe FP Fe

‘Tiese (days) ace full vacoins. protection (14 days post 2nd dose>

Figure Vaccine effectiveness against SARS-CoV-2 infection with the Delta and Omicron variants, shown #parately for
the BNT162b2 and mRNA-I273 vaccines. Vertical bars indicate 95% confidence intervals.

Table Estimated vaccine effectiveness for BNT162b2 and mRNA-3273 against infection with the SARS-CoV¥-2 Omicron
and Delta variants during November 20- December 12, 20231, Denmark.

Plirer — BNTI G2b2 Moderna - mANA-1273

Time since Omiston Deta Grnitson Deka

vaccine

protection Cases VE, 6 99% Cl: Cases VE, 8 199% CE Cases VE MUSK CE Cases VE, WEDSK ChE

1-30 Ways Ww 55 2:238 73.7% 171 85.7 (B16: 646i ' 37 69.5, 764) #W 85,2 (B31; 91.8:

31 @ days 32 161 MBA17 454 9 0.9)79.0 826; : 0-413 65.4) 1h6 81.5 ]77.7; 84.6;

Gi days us 9.4 +100 261) ait? FRAT 738 as $25-30.8 208 to TR2MA MO
[10 xe 285) 1651-95. 3-595. aa SINE Sh at -793 014-08) uw ou oie ei

1-30 days after booster yaceinsthon

protection 2-5 B80, 70.4 45300 GL 2/792 8291 5 62,8 15R#; 92.9;

= malldence intorealy VE =waccina &lectlvennss VE estimates adjusted for 10-year age groups, tax and regian Jive
geographical regions) Vaccine protection was assumed 14 days post 2™ dose. Insulficemt daa lo estimate MANA-1273 booster ¥E
aint Omicron.

This may be because unvaccinated, COVID-
recovered patients have better protection versus Omi-
cron than vaccinated patients who never previously

had COVID.?!

21 Sivan Gazit, Roei Shlezinger, Galit Perez, Roni Lotan, Asaf
Peretz, Amir Ben-Tov, Dani Cohen, Khitam Muhsen, Gabriel
Chodick, Tal Patalon (2021) Comparing SARS-CoV-2 natural
ummunity to vaccine-induced immunity: reinfections versus
22

In Germany, the most recent detailed report from
the Robert Koch Institute (the German equivalent of
the CDC) found that 78.6 percent (4,020 of 5,117) of
sequenced Omicron cases were in vaccinated Ger-
mans,?2 despite a population vaccination rate of just
70 percent. 23

In the United Kingdom, the UK Health Security
Agency calculated preliminary vaccine effectiveness
estimates remarkably like the Danish findings, with
near-zero vaccine efficacy for both Pfizer-BioNTech
and Moderna vaccines after 20 weeks following the
second dose:24

breakthrough infections, medRxiv (Aug. 25, 2021)
https://doi.org/10.1101/2021.08.24.21262415
22

https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronaviru

s/Situationsberichte/Wochenbericht/Wochenbericht_2021-12-
30.pdf?__blob=publicationFile

23 https://ourworldindata.org/covid-vaccinations

24 https://assets.publishing.service.gov.uk/government/up-
loads/system/uploads/attachment_data/file/1043807/technical-
briefing-33.pdf
23

« . w s iC . . .
©. 6 e @ ¢
Zo @ “8 °
° ® é
°
erent,
°
i @ 9)
Dose 2 BNT162b2 Roustar PARNA 1273 bowster
@ Omicson
OW bats Time tince Vaccine (weeks)
MRNA-1273
1650 =

Vaccine effectiveness (1)
+9

0
2-4 59 1024 15619-2624
bbw Time since Dose 2 (weeks)

Although the UK Health Security Agency clarifies
"It]hese results should be interpreted with caution
due to the low counts and the possible biases related
to the populations with highest exposure to Omicron
(including travellers and their close contacts) which
cannot fully be accounted for," these results are con-
sistent with the epidemiological patterns we are see-
ing in the United States and globally.

In Ontario, Canada, the case rate per 100,000 fully
vaccinated Ontarians has risen sharply above the case
24

rate per 100,000 unvaccinated Ontarians, again sug-
gesting negative vaccine efficacy:25

Unwaccinated ceases. Paruaily vaccinated cases Fully vaccinated cases

inte per 100,000 (7-day avercg¢

rs 2 Q a fo
“ a rg e < —

A test-negative control analysis of Ontario test
data by researchers from Public Health Ontario and
leading Canadian universities found: "observed nega-
tiue VE against Omicron among those who had re-
ceived 2 doses compared to unvaccinated individuals"
(emphasis added).

As the following table shows, the Ontario research-
ers found that after day 60 following the second dose,
vaccine effectiveness was negative, meaning a vac-
cinated person was more likely to be infected than an
unvaccinated person:

25 https://covid-19.ontario.ca/data/case-numbers-and-spread
25

Table 2, Vaccine effectiveness ugainyt Infection by Omicron or Delta among adults aged 216 years by (ime since latest dose

Die Vacclne prmdncts Days since SARS-CHV 2D Omberew- Vaccitie Delia Vaeciine
Jatest theee Hegutive positive etlectivnwess against =o podifive §— cflectiveness apelin
ewuteah, enn Omicron SCH caren Hien (WStS C1)
dex: *TamNA vaccine = S40 14m 4 6125, M) Mm Rh, WM)
OO TF SA Zia Dea £62 51 (39. $2)
(20-179 2H2,977 Hat -3H (OL, -18) 442 80 (39, $1)
180-239 47.187 $22 +42 (68, «199 eas 74192, 781
2240 10.245 te xl 1-62.17) 203 TL (66. 75)
Third dowe = AnymRNA toa Tiss Le TS 7) 7 88 (85, 9)
a 3t.SO0 1l4 N97 419. S04 148 93192, 94)
NT 62b2 thd SAbl 42 2M 6 87 183.90)
Eu 30,269 106 44 (16, 49) iG 93 (91, 94)
mRNAA274 O46 4,747 4 5 (94. 545 ? 93 (6, 97)
fal 6241 8 $9416.80) 2 93.190. 963

Contemporaneous with this development, Ontario
announced a major shift in strategy away from mass
testing. On December 20, 2021, Ontario’s health of-

ficer Kieran Moore said:

We have to pivot, we know there's ongoing
community activity, we know we'll have
transmission risk, that data has to focus to
screen those who need treatment and to pro-
tect those in high-risk settings.?¢

In the United States, studies and data from last
summer showing higher viral transmission in less
vaccinated southern states is now completely obsolete.
As the following CDC table demonstrates, in the Omi-
cron wave there is no observable reduction in case
rates based on vaccination rates:?7

26 https://www.cbc.ca/news/canada/toronto/covid-19-ontario-dec-
30-2021-testing-guidelines-cases-1.6300425

27 https://data.cdc.gov/Case-Surveillance/United-States-COVID-
19-Cases-and-Deaths-by-State-o/9mfq-cb36
https://covid.cde.gov/covid-data-tracker/COV1IDData/getA-
jaxData?id=vaccination_data
26

Ditferunce In Cagag in the Manihot i Dur: Moat d Statns Comp 0 Least Vaceinatad
Cores in Qeemmber . Chinen in Deerinlone

Difference |Fullv Vaccinated Biale 2021
730) 27H 7749) ‘ohle | sue
ue rT ns West Virginia Peal

Fra it thes! [Rennucky Cris a
Ail) ies) he Meniasa acy ?
1a. O85 | 19s} ee Ohiahiome para
32135! Pay [pawth Corotine |
100,008 eS 7
9,084 | <8
47a) uN i a
aoe 17S [Tannessee
ha ay [acheneee
3,008 Ss Deseps
un Fins {heutetone Sh
45.709] raat [Meeereppi mai
ape Tea | 7a) Alahare | 4355?
ICattnenio $oes33| "1,000,508 1% lWyormag ae AT]
Mimnnsuce | ness | e657] Pal [lb Te
MOST VACCINATED STATES awn LEAST VACCINATED STATES

The situation is, as they say, highly fluid. Substan-
tial new factual developments related to the Omicron
variant, which arose subsequent to the filing, briefing,
and arguing of the original cases, substantially under-
mine any possible justification for the government’s

ETS.

Even if SARS-CoV-2 did present a grave danger
justifying the ETS at the time it was published — a
highly controversial assertion in its own right — at
this time, the Omicron virus that presently dominates
the field does not even arguably present a grave dan-
ger. Nor could its transmission be substantially re-
duced through mandatory vaccination even if it did
present a grave danger. Therefore, the OSHA order
27

should be stayed, and the Court should grant certio-
rari before judgment.

Respectfully submitted,

LEONARD E. IRELAND, JR. SELDON J. CHILDERS

18 N.W. 332 CouRT 2135-B 407! TERRACE,
Gainesville, FL 32607 Gainesville, FL 32605
(852) 376-4694 (352) 335-0400
lireland@clayton-john- jchilders@smart-
ston.com bizlaw.com

Counsel of Record Counsel for Movant-Ami-

cus

January 2022

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