Declaration of Peter A. McCullough, MD, MPH — Klaassen v. Indiana University

Record facts

U.S. District Court for the Northern District of Indiana · No. 1:21-cv-00238-DRL-SLC · Doc. 21-5 · 2021-07-12 · Docket on CourtListener

Summary

The declaration of Peter A. McCullough, MD, MPH, marked Exhibit E in Klaassen v. The Trustees of Indiana University, Civ. No. 1:21-cv-238-DRL-SLC, in the U.S. District Court for the Northern District of Indiana, filed July 12, 2021. Made under 28 U.S.C. §1746 and executed June 28, 2021, it opens with his background, certifications, publications and prior legislative testimony, states he is working on the case pro bono, and attaches a curriculum vitae as Exhibit A. It then sets out a herd immunity formula and applies it to Indiana using 753,000 cases, 2,880,635 vaccinated and a population of 6,732,000 to reach 8,408,435, which it says is 125% of the state. It reports Indiana infection rates of 3.1% on June 24, 2021 and 2.7% on June 19, 2021 and a 0% positivity rate at IU-Bloomington. The closing pages state his opinion that the university vaccine mandate is not medically necessary.

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Full text

______________________ 
 
EXHIBIT E 
______________________ 
 
 
 
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United States District Court
Northern District of Indiana
Ryan Klaassen, Jaime Carini, D.J.B., by and
though his next friend and father, Daniel G.
Baumgartner, Ashlee Morris, Seth Crowder,
Macey Policka, Margaret Roth,  and Natalie
Sperazza,
Plaintiffs,
v.
The Trustees of Indiana University, 
Defendant.
Civ. No.    1:21-cv-238-DRL-SLC
 
DECLARATION OF PETER A. MCCULLOUGH, MD, MPH
Pursuant to 28 U.S.C. §1746,  I, Peter A. McCullough, MD, MPH, declare under the penalty
of perjury of the laws of the United States of America, and state upon personal knowledge that:
Background and Qualifications
1.
I am an adult of sound mind, 58 years old, and make this statement voluntarily, based
upon my own personal knowledge, education, facts or data, and experience, and under the
penalty of perjury of the laws of the United States of America.
2.
I am competent to testify as a medical expert to the facts and matters set forth herein. The
facts and matters set forth herein are the type of facts and matters that medical experts rely upon
to reach expert conclusions. A true and accurate copy of my curriculum vitae is attached hereto
as Exhibit A.
3.
After receiving a bachelor’s degree from Baylor University, I completed my medical
degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical
McCullough Decl.
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School in Dallas. I went on to complete my internal medicine residency at the University of
Washington in Seattle, a cardiology fellowship including service as Chief Fellow at William
Beaumont Hospital, and a master’s degree in public health in the field of epidemiology at the
University of Michigan.
4.
I am board certified in internal medicine and cardiovascular disease and hold an
additional certification in clinical lipidology, and previously echocardiography.  I participate in
the maintenance of certification programs by the American Board of Internal Medicine for both
Internal Medicine and Cardiovascular Diseases. I am on the medical staff at Baylor University
Medical Center and Baylor Jack and Jane Hamilton Heart and Vascular Hospital, in Dallas,
Texas. I am also on staff at Baylor Heart and Vascular Institute, which promotes cardiovascular
research and education. I practice internal medicine and clinical cardiology as well as teach,
conduct research, and I am an active scholar in medicine with roles as an author, editor-in-chief
of two peer-reviewed journals, editorialist, and reviewer at dozens of major medical journals and
textbooks. I am Professor of Medicine at Texas A & M University School of Medicine, Baylor
Dallas Campus.
5.
I have led clinical, education, research, and program operations at major academic centers
(Henry Ford Hospital, Oakland University William Beaumont School of Medicine) as well as
academically oriented community health systems. I spearheaded the clinical development of in
vitro natriuretic peptide and neutrophil gelatinase associated lipocalin assays in diagnosis,
prognosis, and management of heart and kidney disease now used worldwide. I also led the first
clinical study demonstrating the relationship between severity of acute kidney injury and
mortality after myocardial infarction. I have contributed to the understanding of the epidemiology
McCullough Decl.
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of chronic heart and kidney disease through many manuscripts from the Kidney Early Evaluation
Program Annual Data Report published in the American Journal of Kidney Disease and
participated in clinical trial design and execution in cardiorenal applications of acute kidney
injury, hypertension, acute coronary syndromes, heart failure, and chronic cardiorenal syndromes.
I participated in event adjudication (involved attribution of cause of death) in trials of acute
coronary syndromes, chronic kidney disease, heart failure, and data safety and monitoring of anti-
diabetic agents, renal therapeutics, hematology products, and gastrointestinal treatments. I have
served as the chairman or as a member of over 20 randomized trials of drugs, devices, and
clinical strategies. Sponsors have included pharmaceutical manufacturers, biotechnology
companies, and the National Institutes of Health. 
6.
I frequently lecture and advise on internal medicine, nephrology, and cardiology to
leading institutions worldwide. I am recognized by my peers for my work on the role of chronic
kidney disease as a cardiovascular risk state. I have over 1,000 related scientific publications,
including the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald’s
Heart Disease Textbook. My works have appeared in the New England Journal of Medicine,
Journal of the American Medical Association, and other top-tier journals worldwide. I am a
senior associate editor of the American Journal of Cardiology.. I have testified before the U.S.
Senate Committee on Homeland Security and Governmental Affairs, the U.S. Food and Drug
Administration Cardiorenal Advisory Panel and its U.S. Congressional Oversight Committee,
The New Hampshire Senate, the Colorado House of Commons, and the Texas Senate Committee
on Health and Human Services.
7.
I am a Fellow of the American College of Cardiology, the American Heart Association,
McCullough Decl.
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the American College of Physicians, the American College of Chest Physicians, the National
Lipid Association, the Cardiorenal Society of America, and the National Kidney Foundation. I
am also a Diplomate of the American Board of Clinical Lipidology.
8.
In 2013, I was honored with the International Vicenza Award for Critical Care
Nephrology for my contribution and dedication to the emerging problem of cardiorenal
syndromes. I am a founding member Cardiorenal Society of America, an organization dedicated
to bringing together cardiologists and nephrologists and engage in research, improved quality of
care, and community outreach to patients with both heart and kidney disease.1  
9.
I am the current President of the Cardiorenal Society of America, a expert organization
dedicated to advancing research and clinical care for patients who have combined heart and
kidney disease. I am the Editor-in-Chief of Cardiorenal Medicine, a primary research journal
listed by the National Library of Medicine which is the only publication with a primary focus on
research concerning patients with combined heart and kidney disease. Finally, I am the Editor-in-
Chief of Reviews in Cardiovascular Medicine, a widely read journal that publishes reviews on
contemporary topics in cardiology and is also listed by the National Library of Medicine. 
10.
My appended curriculum vitae further demonstrates my academic and scientific
achievements and provides a list of publications authored by me in the past 30 years.
11.
Since the outset of the pandemic, I have been a leader in the medical response to the
COVID-19 disaster and have published “Pathophysiological Basis and Rationale for Early
Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection,” the first synthesis of sequenced
1 
See http://www.cardiorenalsociety.org/. 
McCullough Decl.
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multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal
of Medicine and updated in Reviews in Cardiovascular Medicine.2  I have 40 peer-reviewed
publications on the COVID-19 infection cited in the National Library of Medicine. Through a
window to public policymakers, I have contributed extensively on issues surrounding the
COVID-19 crisis in a series of OPED’s for The Hill. I testified on the SARS-CoV-2 outbreak in
the U.S. Senate Committee on Homeland Security and Governmental Affairs on November 19,
2020. I testified on lessons learned from the pandemic response in the Texas Senate Committee
on Health and Human Services on March 10, 2021, and on early treatment of COVID-19 the
Colorado General Assembly on March 31, 2021. Additionally, I testified in the New Hampshire
Senate on legislation concerning the investigational COVID-19 vaccine on April 14, 2020. My
expertise on the SARS-CoV-2 infection and COVID-19 syndrome, like that of infectious disease
specialists, is approximately 18 months old with review of hundreds of manuscript and with the
care of many patients with acute COVID-19, post-COVID-19 long-hauler syndromes, and
COVID-19 vaccine injury syndromes including neurologic damage, myocarditis, and a variety of
2 
McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan KR, Katz N, Lepor NE, Vijay K, Carter H, Singh
B, McCullough SP, Bhambi BK, Palazzuoli A, De Ferrari GM, Milligan GP, Safder T, Tecson KM, Wang DD,
McKinnon JE, O'Neill WW, Zervos M, Risch HA. Pathophysiological Basis and Rationale for Early Outpatient
Treatment of SARS-CoV-2 (COVID-19) Infection. Am J Med. 2021 Jan;134(1):16-22. doi:
10.1016/j.amjmed.2020.07.003. Epub 2020 Aug 7. PMID: 32771461; PMCID: PMC7410805 available at
https://pubmed.ncbi.nlm.nih.gov/32771461/; McCullough PA, Alexander PE, Armstrong R, Arvinte C, Bain AF, Bartlett
RP, Berkowitz RL, Berry AC, Borody TJ, Brewer JH, Brufsky AM, Clarke T, Derwand R, Eck A, Eck J, Eisner RA,
Fareed GC, Farella A, Fonseca SNS, Geyer CE Jr, Gonnering RS, Graves KE, Gross KBV, Hazan S, Held KS, Hight
HT, Immanuel S, Jacobs MM, Ladapo JA, Lee LH, Littell J, Lozano I, Mangat HS, Marble B, McKinnon JE, Merritt
LD, Orient JM, Oskoui R, Pompan DC, Procter BC, Prodromos C, Rajter JC, Rajter JJ, Ram CVS, Rios SS, Risch HA,
Robb MJA, Rutherford M, Scholz M, Singleton MM, Tumlin JA, Tyson BM, Urso RG, Victory K, Vliet EL, Wax CM,
Wolkoff AG, Wooll V, Zelenko V. Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-
risk SARS-CoV-2 infection (COVID-19). Rev Cardiovasc Med. 2020 Dec 30;21(4):517-530. doi:
10.31083/j.rcm.2020.04.264. PMID: 33387997 available at https://pubmed.ncbi.nlm.nih.gov/33387997/; see also
https://ijirms.in/index.php/ijirms/article/view/1100
McCullough Decl.
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other internal medicine problems that have occurred after the mRNA and adenoviral DNA
COVID-19 vaccines. I have formed my opinions in close communications with many clinicians
around the world based on in part our collective clinical experience with acute and convalescent
COVID-19 cases as well has closely following the preprint and published literature on the
outbreak. I have specifically reviewed  key published rare cases and reports concerning possible
recurrence of SARS-CoV-2 in patients who have survived an initial episode of COVID-19
illness. 
12.
My compensation rates are as follows: I am working on this case Pro Bono.
Methodologies and Analysis of COVID Generally 
13.
 The CDC recently reported the lowest number of cases since March of 2020 (the
beginning of the COVID pandemic). Sam Baker & Andrew Witherspoon, COVID-19 cases hit
lowest point in U.S. since pandemic began, AXIOS (June 3, 2021),
https://www.axios.com/coronavirus-cases-infections-vaccines-success-fa7673a1-0582-4e69-aefb
-3b5170268048.html.
14.
Further, according to my research, herd immunity is calculated by a specific formula, as
follows: ((CC*6) + V + (.15*P)) ÷ P = HIN. 
CC= COVID cases in the state
6= the current CDC multiplier3
V= number of vaccinated in the state
15% = the number of people in a given state that will not get COVID
3 Centers for Disease Control and Prevention, Estimated Disease Burden of COVID-19
(May 19, 2021), https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html
McCullough Decl.
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P=Population of a state (i.e. Indiana)
HIN=Herd Immunity Totals
15.
The values subject to variables per state for the formula noted in paragraph 14 for the
State of Indiana are as follows:
CC = 753,0004
V = 2,880,6355
P = 6,732,000
Thus, the HIN for Indiana is 8,408,435, calculated as follows:
(753,000 * 6) +  2,880,635 + (.15 *  6,732,000) = 8,408,435
16.
The HIN for Indiana equals 125% of the state. The HIN is in excess of 100% due to the
overlap of people who were infected with COVID and also received the vaccine, and thus are
counted twice.  This means that the multiplier for suspected COVID19 could be much more
conservative and lower than what is in the current equation.  While neither the CDC nor the State
of Indiana have reported the number of people who have had both COVID and a vaccine for
COVID, the percentage of overlap would have to be over 50% to get below the number for herd
immunity to fall below 70%, which is very unlikely.
17.
Because of inferred herd immunity, infection rates continue to decline. According to the
official Indiana COVID numbers, the infection rate was a mere 3.1% on June 24, 2021, and it
continues to decline daily, as shown in Table 1 below.
4  Indiana State Department of Health, Indiana COVID-19 Dashboard and Map (June 18, 2021),
https://www.coronavirus.in.gov/2393.htm (last visited June 20, 2021).
5  Indiana State Department of Health, Vaccine Dashboard, (June 18, 2021),
https://www.coronavirus.in.gov/vaccine/2680.htm (last visited June 20, 2021).
McCullough Decl.
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Table 1: COVID Positivity Rates in Indiana
Indiana State Department of Health, Indiana COVID-19 Dashboard and Map (June 27, 2021),
https://www.coronavirus.in.gov/2393.htm. 
18.
The June 19, 2021, infection rate was only 2.7%. Id. 
19.
The positivity test rate for new COVID cases at IU-Bloomington was 0%. Indiana
University, IU Bloomington COVID-19 Testing Dashboard,
https://www.iu.edu/covid/dashboard/bloomington (last visited June 27, 2021). The highest IU
infection rate ever was 7.51% on August 30, 2020, and it has steadily declined since then with no
McCullough Decl.
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indication of a new wave. Id. 
20.
In my expert medical opinion, as the COVID case numbers continue to decline, requiring
all IU students to be vaccinated is not reasonable from a policy perspective and is not medically
necessary nor safe from a clinical perspective.
College-Age Individuals and COVID 
21.
In addition, in my expert medical opinion and as the table below shows, there is little to
no risk for serious injury or hospitalization for COVID-19 among college age students.
Table 2: COVID Deaths by Age Group in the U.S. as of June 27, 2021:
Source: https://covid.cdc.gov/covid-data-tracker/#demographics
McCullough Decl.
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22.
Further, the CDC has released charts depicting the risks by age, as shown below.
Table 3: COVID Rate Ratios by Age
Source:
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-
death-by-age.html (Last Checked, June 27, 2021).
McCullough Decl.
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Table 4: Indiana Demographic Data for COVID Deaths
Source: https://www.coronavirus.in.gov/2393.htm (Last Checked June 27, 2021).
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23.
 Indiana COVID deaths total 13,399 from March 16, 2020 through June 23, 2021. Id.
Indiana tracks the numbers of residents by age groups. See Indiana Data Hub, accessed at
https://hub.mph.in.gov/dataset/population-by-age-groups/resource/0aaeb2dc-3702-4a02-aec6-d9e
a8a4fce73. Thus, the COVID death rate per age group in Indiana can be calculated as follows:
(13,399) * (COVID Death Percentage of age group from Table 4)
_________________________________________________
Number of Indiana Residents in the Same Age Group
Using this calculation, the following chart comprises the COVID death rate per age group in
Indiana, as of June 23, 2021:
Age Group
COVID Death Rate per Age Group
0-19
.0008%
20-29
.002%
30-39
.010%
40-49
.029%
50-59
.081%
60-69
.289%
70-79
.898%
80+
2.80%
24.
These tables and charts show the minimal risk 18-29 year olds face across the United
States and in Indiana. For example, for every one 18-29 year old that dies from COVID, four 30-
39 year olds die, ten 40-49 year olds die, thirty-five 50-64 year olds die, ninety-five 65-74 year
olds die, 230 75-84 year olds die, and 610 over 85 years of age die. See Table 3.
25.
Despite a high frequency of COVID infections, as determined by standard testing, serious
COVID cases among college and graduate students is a rare event. Brown University physician
McCullough Decl.
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epidemiologist, Andrew Bostom, MD, MS, compiled data from 100 major university and college
COVID data dashboards, in conjunction with national and local news reports of campus-related
hospitalizations, August 2020 through the November 2020, Thanksgiving holiday break
(11/22/20). See Exhibit 7 to Compl., ECF No. 1-8.
26.
In my expert medical opinion, epidemic spread of COVID, like all other respiratory
viruses, notably influenza,6 is driven by symptomatic persons; asymptomatic spread is trivial and
inconsequential.
27.
 A meta-analysis of contact tracing studies published in The Journal of the American
Medical Association showed asymptomatic COVID spread was 0.7%. Zachary J. Madewell,
PhD; Yang Yang, PhD; Ira M. Longini Jr, PhD; M. Elizabeth Halloran, MD, DSc; Natalie E.
Dean, PhD, Household Transmission of SARS-CoV-2: A Systematic Review and Meta-analysis,
JAMA Network Open, available at
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774102 (last visited June 20,
2021).
28.
Accordingly, a rational and ethical prevention measure to reduce the spread of COVID is
a simple requirement, as part of formal policies, that persons with active symptomatic, febrile
(feverish) respiratory illnesses, like COVID, should isolate themselves. Indeed during the H1N1
influenza A pandemic, fully open, unmasked college campuses were advised by federal health
officials, “Flu-stricken college students should stay out of circulation” and “if they can’t avoid
contact they need to wear surgical masks.” Great Falls Tribune, Advice: Flu-stricken college
6 Eleni Patrozou & Leonard A. Mermel, Does Influenza Transmission Occur from Asymptomatic Infection
or Prior to Symptom Onset?, 124 Pub. Health Rep. 193 (2009). 
McCullough Decl.
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students should stay out of circulation, August 21, 2009, page 5, section A, available at
https://www.newspapers.com/image/243611045.
29.
 Further, college students are not the spreaders of the virus to the community. A recent
study from Dr. Arnold and colleagues that reported the results of a longitudinal serosurvey (blood
sampling) of community residents in Centre County, Pennsylvania, home to Pennsylvania State
University, University Park campus. See Callum R K Arnold, Sreenidhi Srinivasan, Catherine M
Herzog, Abhinay Gontu, Nita Bharti, Meg Small, Connie J Rogers, Margeaux M Schade, Suresh
V Kuchipudi, Vivek Kapur, Andrew Read, Matthew J Ferrari, SARS-CoV-2 Seroprevalence in a
University Community: A Longitudinal Study of the Impact of Student Return to Campus on
Infection Risk Among Community Members, medRXiv (Feb. 19, 2021), available at 
https://pubmed.ncbi.nlm.nih.gov/33619497/ (last visited June 20, 2021).
 30.
The return of approximately 35,000 students to the campus in August 2020 increased the 
county population size by nearly 20%. Id. Over 4,500 cases of COVID infections were detected
among the student population during the Fall 2020 term (before and just after student return). Id.
Between August 7, 2020, and October 2, 2020, these investigators enrolled community residents
and tested their serum for the presence of anti-Spike Receptor Binding Domain (S/RBD) IgG (a
class of immunoglobulin “antibodies”), to confirm prior COVID exposure. Id. This was repeated
in the same community during December 2020 (after the departure of students), and
seroprevalence for both sampling waves was recorded and analyzed. Moreover, returning students
were enrolled in a longitudinal cohort, and IgG seroprevalence results were reported from the first
wave of sampling (between October and November 2020, prior to the end of the term). Here is
how Arnold and colleagues summarized their findings:
McCullough Decl.
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Of 345 community participants, 19 (5.5%) were positive for SARS-
CoV-2 IgG antibodies at their first visit between 7 August and 2
October. Of 625 returning student participants, 195 (31.2%) were
positive for SARS-CoV-2 antibodies between 26 October and 23
November. 28 (8.1%) of the community participants had returned a
positive result by 9 December. Only contact with known SARS-CoV-
2-positive individuals and attendance at small gatherings (20-50
individuals) were significant predictors of IgG antibodies among
returning students (adjusted odds ratio, 95% Confidence Interval: 3.24,
2.14-4.91, p<0.001; and 1.62, 1.08-2.44, p<0.05; respectively).
They concluded: 
Despite high seroprevalence observed within the student population,
seroprevalence in a longitudinal cohort of community residents was
low and stable from before student arrival for the Fall 2020 term to
after student departure, implying limited transmission between these
cohorts...The demographic shift associated with student return to
campus was not associated with increased SARS-CoV-2
seroprevalence in this cohort of community residents.
Id.
31.
College students face little chance of actually catching COVID and little chance of
spreading it to the greater community.
Advances in COVID Treatments
32.
Even if students contract the virus, the treatment of the infection  has improved
tremendously since the advent of COVID. Studies have shown several different treatment
methods, which have proven effective. A combination of medications, supported by the
Association of American Physicians and Surgeons, for a minimum of five days and acutely
administered supplements used for the initial ambulatory patient with suspected and or confirmed
COVID-19 (moderate or greater probability) has proven effective. Brian C Procter, Casey Ross,
Vanessa Pickard, Erica Smith, Cortney Hanson, Peter A McCullough, Clinical outcomes after
McCullough Decl.
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early ambulatory multidrug therapy for high-risk SARS-CoV-2 (COVID-19) infection, Reviews in
Cardiovascular Medicine (December 30, 2020), available at
https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.04.260 (last visited June 26, 2021),
summarized in Table 5 below; see also, https://ijirms.in/index.php/ijirms/article/view/1100
Table 5: COVID Treatments
Agent (drug)
Rationale
Zinc 
Inhibits SARS-CoV-2 RNA synthesis
Hydroxychloroquine 200 mg po bid 
Inhibits endosomal transfer of virions,
anti-inflammatory
Ivermectin (200 mcg/kg) usual dose    
Attenuates importin á/â-mediated nuclear    
12 mg po qd x 3 days
transport of SARS-CoV-2 into nucleus
Azithromycin 250 mg po bid 
Covers respiratory bacterial pathogens in
secondary infection
Doxycycline 100 mg po bid 
Covers respiratory bacterial pathogens in
secondary infection
Inhaled budesonide, Dexamethasone 8 mg IM 
Treats cytokine storm
Folate, thiamine, vitamin B-12 
Reduce tissue oxidative stress
______________________________________________________________________________
Intravenous fluid 
Intravascular volume expansion
33.
 I, along with my colleagues, conducted the study referenced in paragraph 32, which
evaluated patients between the ages of 12 and 89 years. The average age was 50.5 and 61.6% were
women. The study found that primary care physicians can treat COVID patients with low
hospitalization and death. The study showed that administration of the medicines and supplements
shown in Table 5 produces a less than 2% chance of facing hospitalization or death among high
risk adults (age over 50 with medical problems). As this study was done with mainly higher risk
patients at the peak of the pandemic, this is a highly successful treatment plan and just one of the
many new treatments that have been used in the last year. Id.; see also National Institutes of
Health, Therapeutic Management of Adults With COVID-19 (Updated May 24, 2021),
McCullough Decl.
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https://www.covid19treatmentguidelines.nih.gov/management/therapeutic-management/ (last
visited June 21, 2021). 
34.
Treatment has improved so drastically for COVID that according to the CDC, there were
16 deaths in Indiana for young adults aged 18-29 in 2020, but zero in 2021. This is evidence of
better treatment and less risk for college aged students and a generally lowered virulence for the
SARS-CoV-2 strains as the pandemic progresses over time.
35.
 In my expert medical opinion, the combination of lowering COVID rates, the likelihood
of herd immunity in Indiana, the low risk of hospitalization and death among college-aged
students, and the drastically improved treatment options make IU’s Mandate that all IU students
(not exempted) participate in the investigational COVID-19 vaccine sponsored by the US FDA
and CDC, unreasonable from a scientific and medical perspective.
COVID Vaccine Research and Development
36.
The COVID-19 genetic vaccines (Pfizer, Moderna, J&J) skipped testing for genotoxity,
mutagenicity, teratogencity, and oncogenicity.  In other words, it is unknown whether or not these
products will change human genetic material, cause birth defects, reduce fertitility, or cause
cancer.
37.
The Pfizer, Moderna, and JNJ vaccines are considered "genetic vaccines" or vaccines
produced from gene therapy molecular platforms.7,8 They have a dangerous mechanism of action
7 To KKW, Cho WCS. An overview of rational design of mRNA-based therapeutics and vaccines. Expert
Opin Drug Discov. 2021 May 31. doi: 10.1080/17460441.2021.1935859. Epub ahead of print. PMID: 34058918.
8 Doerfler W. Adenoviral Vector DNA- and SARS-CoV-2 mRNA-Based Covid-19 Vaccines: Possible
Integration into the Human Genome - Are Adenoviral Genes Expressed in Vector-based Vaccines? Virus Res. 2021
Jun 1;302:198466. doi: 10.1016/j.virusres.2021.198466. Epub ahead of print. PMID: 34087261; PMCID:
PMC8168329.
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in that they all cause the body to make an uncontrolled quantity of the pathogenic spike protein
from the SARS-CoV-2 virus.  This is unlike all other vaccines where there is a set amount of
antigen or live-attenuated virus. This means for the Pfizer, Moderna, and J&J vaccines it is not
predictable among patients who will produce more or less of the spike protein.  The spike protein
itself has been demonstrated to injure vital organs such as the brain, heart, lungs, as well as
damage blood vessels and directly cause blood clots.  Additionally, because these vaccines infect
cells within these organs, the generation of spike protein within heart and brain cells in particular,
causes the body's own immune system to attack these organs. This is abundantly  apparent with
the burgeoning number of cases of myocarditis or heart inflammation among individuals below
age 30 years.9 The Centers for Disease Control has held emergency meetings on this issue and the
medical community is responding to the crisis and the US FDA has issued a warning on the Pfizer
and Moderna vaccines for myocarditis.10 It is known that myocarditis causes injury to heart
muscle cells and may result in permanent heart damage leading to heart failure, arrhythmias, and
cardiac death.   Because this risk is not predictable and the early reports may represent just the tip
of the iceberg, no individual under age 30 under any set of circumstances should feel any obliged
to take this risk with the current genetic vaccines.
38.
The U.S. FDA has issued information on the J&J COVID-19 vaccine to include an update
9 Abu Mouch S, Roguin A, Hellou E, Ishai A, Shoshan U, Mahamid L, Zoabi M, Aisman M, Goldschmid
N, Berar Yanay N. Myocarditis following COVID-19 mRNA vaccination. Vaccine. 2021 Jun 29;39(29):3790-3793.
doi: 10.1016/j.vaccine.2021.05.087. Epub 2021 May 28. PMID: 34092429; PMCID: PMC8162819.
10 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021
McCullough Decl.
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about a serious type of blood clot for those who received this vaccine.11 12 In these cases, the type
of blood clot is called cerebral venous sinus thrombosis and it was observed in combination with
low levels of blood platelets. Id. All of these cases occurred in women between the ages of 18 - 48
and symptoms occurred 6 -13 days after vaccination. Id.
39.
In general, it is not good clinical practice to widely utilize novel biological products in
populations that have not been tested in registrational trials.  For the COVID-19 vaccines this
includes COVID-19 survivors, those with prior suspected COVID-19 infection, those with
positive SARS-CoV-2 serologies, pregnant women, and women of childbearing potential who
cannot assure contraception.   
40.
It is never good research practice to perform a large-scale clinical investigation without the
necessary structure to ensure safety and protection of human subjects.  These structures include a
critical event committee, data safety monitoring board, and human ethics committee.  These
groups in large studies work to objectively assess the safety of the investigational product and
research integrity with the goal of mitigating risk and protecting human subjects.  It is my
understanding that the COVID-19 vaccine program is sponsored by the CDC and FDA and has
none of these safety structures in place.  It is my assessment, that the COVID-19 clinical
investigation has provided no meaningful risk mitigation for subjects (restricting groups, special
assessment of side effects, follow-up visits, or changes in the protocol to ensure or improve safety
of the program).
11 https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-
covid-19-vaccine
12 https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-
covid-19-vaccine
McCullough Decl.
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COVID Vaccine Risks to College Age Students  
41.
The COVID-19 public vaccination program operated by the CDC and the FDA is a clinical
investigation and under no circumstance can any person receive pressure, coercion, or threat of
reprisal on their free choice of participation.  Violation of this principle of autonomy by any entity
constitutes reckless endangerment with a reasonable expectation of causing personal injury
resulting in damages.
42.
The current COVID-19 vaccines are not sufficiently protective against contracting
COVID-19 to support its use beyond the current voluntary participation in the CDC sponsored
program.  A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported
from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred
in females, and the median patient age was 58 years (interquartile range = 40–74 years). Based on
preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%)
patients were known to be hospitalized, and 160 (2%) patients died. Among the 995 hospitalized
patients, 289 (29%) were asymptomatic or hospitalized for a reason unrelated to COVID-19. The
median age of patients who died was 82 years (interquartile range = 71–89 years); 28 (18%)
decedents were asymptomatic or died from a cause unrelated to COVID-19. Sequence data were
available from 555 (5%) reported cases, 356 (64%) of which were identified as SARS-CoV-2
variants of concern, including B.1.1.7 (199; 56%), B.1.429 (88; 25%), B.1.427 (28; 8%), P.1 (28;
8%), and B.1.351 (13; 4%).  None of these variants are encoded in the RNA or DNA of the
current COVID-19 vaccines. In response to these numerous reports, the CDC announced on May
1, 2021, that community breakthrough cases would no longer be reported to the public and only
those vaccine failure cases requiring hospitalization will be reported, presumably on the CDC
McCullough Decl.
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website (https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm).
43.
In 1990, the Vaccine Adverse Event Reporting Systems (“VAERS”) was established as a
national early warning system to detect possible safety problems in U.S. licensed vaccines.1
VAERS is a passive reporting system, meaning it relies on individuals to voluntarily send in
reports of their experiences to CDC and FDA. VAERS is useful in detecting unusual or
unexpected patterns of adverse event reporting that might indicate a possible safety problem with
a vaccine.
44.
The total safety reports in VAERS all vaccines per year up to 2019 was 16,320.  The total
safety reports in VAERS for COVID Vaccines alone through Jun 18, 2021 is 387,288.
45.
Based on VAERS as of June 18, 2021, there were 6,136 COVID-19 vaccine deaths
reported and over 21,806 hospitalizations reported for the COVID-19 vaccines (Pfizer, Moderna,
J&J). See VAERS COVID Vaccine Data, attached as Exhibit B. By comparison, from 1999, until
December 31, 2019, VAERS received 3167 death reports (158 per year) adult death reports for all
vaccines combined.13  Thus, the COVID-19 mass vaccination is associated with at least 39-fold
increase annualized vaccine deaths reported to VAERS.
46.
COVID-19 vaccine adverse events account for 98% of all vaccine-related AEs from Dec
2020 through present in VAERS. 
47.
There are emerging trends showing that the vaccine is especially risky for those 18-29 in
my expert medical opinion. 
48.
Increasingly the medical community is acknowledging the possible risks and side effects
13 
Pedro L. Moro, Jorge Arana, Mria Cano, Paige Lewis, and Tom T. Shimabukuro, Deaths Reported to the Vaccine
Adverse Event Reporting System, United States, 1997-2013, VACCINES, CID 2015:61 (September 2015).
McCullough Decl.
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including myocarditis, Bell’s Palsy, Pulmonary Embolus, Pulmonary Immunopathology, and
severe allergic reaction causing anaphylactic shock. See Chien-Te Tseng, Elena Sbrana, Naoko
Iwata-Yoshikawa, Patrick C Newman, Tania Garron, Robert L Atmar, Clarence J Peters, Robert B
Couch, Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on
challenge with the SARS virus, https://pubmed.ncbi.nlm.nih.gov/22536382/ (last visited June 21,
2021); Centers for Disease Control and Prevention, Allergic Reactions Including Anaphylaxis
After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States,
December 14–23, 2020 (Jan 15, 2021),
https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm (last visited June 26, 2021). 
49.
Multiple recent studies and news reports detail people 18-29 dying from myocarditis after
receiving the COVID vaccine. According to the CDC, 475 cases of pericarditis and myocarditis14
have been identified in vaccinated citizens aged 30 and younger. See FDA, Vaccines and Related
Biological Products Advisory Committee June 10, 2021 Meeting Presentation, 
https://www.fda.gov/media/150054/download#page=17 (last visited June 21, 2021). 
50.
The FDA found that people 12-24 account for 8.8% of the vaccines administrated, but
52% of the cases of myocarditis and pericarditis reported. Id.
14 Myocarditis is inflammation of the heart muscle, whereas pericarditis is inflammation
of the sac-like tissue around the heart called the pericardium. 
McCullough Decl.
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Table 6: VAERS Report
McCullough Decl.
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51.
 Further, the CDC just announced that the vaccine is “likely linked” to myocarditis.
Advisory Board, CDC panel reports ‘likely association’ of heart inflammation and mRNA
COVID-19 vaccines in young people, (June 24, 2021)
https://www.advisory.com/daily-briefing/2021/06/24/heart-inflammation.
52.
The CDC recently released data stating that there have been 267 cases of myocarditis or
pericarditis reported after receiving one dose of the COVID vaccines and 827 reported cases after
two doses through June 11. There are 132 additional cases where the number of doses received is
unknown. Id.
53.
There have been 1,200 reported cases of myocarditis that have occurred and the median
age is thirty. Id.
54.
The vaccine is also far less safe than previous vaccines like the meningicoccal meningitis
vaccine that is typically required on college campuses. 
55.
For example, the VAERS (Vaccine Adverse Event Reporting System) data from the CDC
shows, for 18-29 year olds, there have been no deaths from the meningicoccal vaccine from 
1999 - 2019. See, United States Department of Health and Human Services (DHHS), Public
Health Service (PHS), Centers for Disease Control (CDC)/Food and Drug Administration (FDA),
Vaccine Adverse Reporting System (VAERS) 1990 - 06/11/2021, CDC WONDER On-line
Database. Accessed at https://wonder.cdc.gov/vaers.html on June 23, 2021 1:43:33 PM, (“Query
Criteria”), Attached as Exhibit C. 
56.
The main side effects people reported from the meningitis vaccine are headache, injection
site pain, nausea, chills, and a fever, and even these were limited as no more than fifteen of each
were reported . Id.
McCullough Decl.
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57.
However, in the brief time the COVID vaccines have been available, there have been
many more serious symptoms and even a death reported for 18-29 year olds in Indiana. See Table
6, below. Nationwide VAERS COVID Vaccine Data through June 18, 2021 is attached as Exhibit
B.15
Table 7: VAERS Data Indiana
15 VAERS may be publicly accessed at https://www.openvaers.com/covid-data.
McCullough Decl.
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58.
The World Health Organization said that children should not be vaccinated for the
moment before they faced tremendous backlash. WHO, COVID-19 Advice for the public: Getting
vaccinated, (Archived from April 8, 2021),
https://web.archive.org/web/20210408183900/https:/www.who.int/emergencies/diseases/novel-co
ronavirus-2019/covid-19-vaccines/advice. 
59.
I have seen and examined college-age patients with post-COVID-19 myocarditis which
typically occurs two days after the injection, most frequently after the second injection of mRNA
products (Pfizer, Moderna).  The clinical manifestations can be chest pain, signs and symptoms of
heart failure, and arrhythmias.  The diagnosis usually requires a clinical or hospital encounter, 12-
lead electrocardiogram, blood tests including cardiac troponin (test for heart muscle damage),
ECG monitoring, and cardiac imaging with echocardiography or cardiac magnetic resonance
imaging.  Given the risks for either manifest or future left ventricular dysfunction, patients are
commonly prescribed heart failure medications (beta-blockers, renin-angiotensin system,
inhibitors), and aspirin.  More complicated patients require diuretics and anticoagulants.  For post-
COVID-19 vaccine myocarditis, I follow current position papers on the topic and restrict physical
activity and continue medications for approximately three months before blood biomarkers and
cardiac imaging are reassessed.  If there is concurrent pericarditis, non-steroidal anti-inflammatory
agents and colcicine may additionally be prescribed.  Multiple medical studies are starting to
come out detailing this problem.16
16 See, e.g., Tommaso D’Angelo MD, Antonino Cattafi MD, Maria Ludovica Carerj MD, Christian Booz
MD, Giorgio Ascenti MD, Giuseppe Cicero MD, Alfredo Blandino MD,
Silvio Mazziotti MD, Myocarditis after SARS-CoV-2 Vaccination: A Vaccine-induced Reaction?, Pre-proof,
Canadian Journal of Cardiology, https://www.onlinecjc.ca/article/S0828-282X(21)00286-5/fulltext (last visited
June 26, 2021); Jeffrey Heller, Israel sees probable link between Pfizer vaccine and myocarditis cases (June 2,
McCullough Decl.
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60.
Further, milder side effects from the vaccine include changes in hormone and menstrual
cycles in women, fever, swelling at the injection site, etc. Jill Seladi-Schulman, Ph.D,, Can
COVID-19 or the COVID-19 Vaccine Affect Your Period? (May 25, 2021),
https://www.healthline.com/health/menstruation/can-covid-affect-your-period#covid-19-and-men
%20strual-cycles (last visited June 26, 2021); Rachael K. Raw, Clive Kelly, Jon Rees, Caroline
Wroe, David R. Chadwick, Previous COVID-19 infection but not Long-COVID is associated with
increased adverse events following BNT162b2/Pfizer vaccination, (pre-print)
https://www.medrxiv.org/content/10.1101/2021.04.15.21252192v1 (last visited June 26, 2021). 
61.
In an urgent report to the United Kingdom’s Medicines and Healthcare Products
Regulatory Agency (“MHRA”) from Dr. Tess Lawrie, Director of the Evidence-Based Medicine
Consultancy, and advisor to the WHO, on the UK’s equivalent of the VAERS systems concluded
that the vaccines were unsafe for use in humans due to the extensive side effects they are causing.
Tess Lawrie, Re. Urgent preliminary report of Yellow Card data up to 26th May 2021, (June 9,
2021), http://www.skirsch.com/covid/TessLawrieYellowCardAnalysis.pdf 
Risks of COVID Vaccines for Those Recovered from COVID 
62.
There is recent research on the fact that the COVID-19 vaccine is dangerous for those who
2021),
https://www.reuters.com/world/middle-east/israel-sees-probable-link-between-pfizer-vaccine-small-number-myoca
rditis-cases-2021-06-01/(last visited June 26, 2021); Tschöpe C, Cooper LT, Torre-Amione G, Van Linthout S.
Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi:
10.1161/CIRCRESAHA.118.313578. PMID: 31120823. Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-
Blanes J, Felix SB, Fu M, Heliö T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen
J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM;
European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of
knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European
Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013
Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3. PMID: 23824828. 
McCullough Decl.
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have already had COVID-19 and have recovered with inferred robust, complete, and durable
immunity.  These patients were excluded from the FDA-approved clinical trials performed by
Pfizer, Moderna, and J&J.  From these trials the safety profile was unknown when the products
for approved for Emergency Use Authorization in 2020.  
63.
A medical study of United Kingdom healthcare workers who had already had COVID and
then received the vaccine found that they suffered higher rates of side effects than the average
population. Rachel K. Raw, et al., Previous COVID-19 infection but not Long-COVID is
associated with increased adverse events following BNT162b2/Pfizer vaccination, medRxiv
(preprint), https://www.medrxiv.org/content/10.1101/2021.04.15.21252192v1 (last visited June
21, 2021).
64.
The test group experienced more moderate to severe symptoms than the study group that
did not previously have COVID. Id.
65.
The symptoms included fever, fatigue, myalgia-arthralgia and lymphadenopathy. Id. Raw
found that in 974 individuals who received the BNT162b2/Pfizer vaccine, those with a prior
history of SARS-CoV-2 or those who had positive antibodies at baseline, had a higher rate of
vaccine reactions than those who were COVID-19 naive. Id.
66.
Mathioudakis et al. reported that in 2020 patients who underwent vaccination with either
mRNA-based, or vector-based COVID-19 vaccines, COVID-recovered patients who were
needlessly vaccinated had higher rates of vaccine reactions.17
67.
Krammer et al. reported on 231 volunteers for COVID-19 vaccination, 83 of whom had
positive SARS-CoV-2 antibodies at the time of immunization.  The authors found:  “Vaccine
17 See https://www.medrxiv.org/content/10.1101/2021.02.26.21252096v1.
McCullough Decl.
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recipients with preexisting immunity experience systemic side effects with a significantly higher
frequency than antibody naïve vaccines (e.g., fatigue, headache, chills, fever, muscle or join pains,
in order of decreasing frequency, P < 0.001 for all listed symptoms, Fisher’s exact test, two-
sided).”   (https://www.medrxiv.org/content/10.1101/2021.01.29.21250653v1).
Natural Immunity to COVID 
68.
To my knowledge, there are no studies demonstrating clinical benefit of  COVID-19
vaccination in COVID-19 survivors or those who have laboratory evidence of prior infection.
69.
It is my opinion that SARS-CoV-2 causes an infection in humans that
results in robust, complete, and durable immunity, and is superior to vaccine immunity.  There are
no studies demonstrating clinical benefit of COVID-19 vaccination in COVID-19 survivors and
there are three studies demonstrating harm in such individuals.  Thus, it is my opinion that the
COVID-19 vaccination is contraindicated in COVID-19 survivors many of whom may be in the
college student population.
70.
Multiple laboratory studies conducted by highly respected U.S. and European academic
research groups have reported that convalescent mildly or severely infected COVID patients who
are unvaccinated can have greater virus neutralizing immunity—especially more versatile, long-
enduring T- cell immunity—relative to vaccinated individuals who were never infected. See
Athina Kilpeläinen, et al., Highly functional Cellular Immunity in SARS-CoV-2 Non-
Seroconvertors is associated with immune protection, bioRxiv (pre-print),
https://www.biorxiv.org/content/10.1101/2021.05.04.438781v1 (last visited June 26, 2021);
Tongcui Ma, et al., Protracted yet coordinated differentiation of long-lived SARS-CoV-2-specific
CD8+ T cells during COVID-19 convalescence, bioRxiv (pre-print),
McCullough Decl.
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https://www.biorxiv.org/content/10.1101/2021.04.28.441880v1 (last visited June 26, 2021);
Claudia Gonzalez, et al., Live virus neutralisation testing in convalescent patients and subjects
vaccinated against 19A, 20B, 20I/501Y.V1 and 20H/501Y.V2 isolates of SARS-CoV-2, medRxiv
(pre-print), https://www.medrxiv.org/ content/10.1101/2021.05.11.21256578v1 (last visited June
21, 2021); Carmen Camara, et al. Differential effects of the second SARS-CoV-2 mRNA vaccine
dose on T cell immunity in naïve and COVID-19 recovered individuals, bioRxiv (pre-print), 
https://www.biorxiv.org/content/10.1101/2021.03.22.436441v1 (last visited June 26, 2021); Ellie
N. Ivanova, et al., Discrete immune response signature to SARS-CoV-2 mRNA vaccination versus
infection, medRxiv (pre-print),
https://www.medrxiv.org/content/10.1101/2021.04.20.21255677v1  (last visited June 26, 2021);
Catherine J. Reynolds, et al, Prior SARS-CoV-2 infection rescues B and T cell responses to
variants after first vaccine dose, (pre-print), https://pubmed.ncbi.nlm.nih.gov/33931567/ (last
visited June 21, 2021); Yair Goldberg, et al., Protection of previous SARS-CoV-2 infection is
similar to that of BNT162b2 vaccine protection: A three-month nationwide experience from
Israel, medRxiv (pre-print),
https://www.medrxiv.org/content/10.1101/2021.04.20.21255670v1(last visited June 26, 2021).  
71.
Cleveland Clinic studied their own employees for the effects of natural immunity in
unvaccinated people. Nabin K. Shrestha, Patrick C. Burke, Amy
S. Nowacki, Paul Terpeluk, Steven M. Gordon, Necessity of COVID-19 vaccination in previously
infected individuals, medRxiv (pre-print),
https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v2 (last visited June 21, 2021).
They found zero SARS-CoV-2 reinfections during 5-month follow-up among n=1359 COVID-19
McCullough Decl.
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recovered employees who remained unvaccinated and concluded such persons are “unlikely to
benefit from covid-19 vaccination.” Id. 
72.
A recently published article in Nature reported that prior infection induces long-lived bone
marrow plasma cells which means the antibodies to prevent reinfection of COVID are long-
lasting. Jackson S. Turner et. al. SARS-CoV-2 infection induces long-lived bone marrow plasma
cells in humans, (May 24, 2021), https://www.nature.com/articles/s41586-021-03647-4 
Conclusion
73.
In my expert medical opinion, the risks of COVID-19 to college age students in 2021 is
significantly lower than in 2020 due to the following factors: rapidly declining COVID-19
infection rate, increasing likelihood of Indiana having reached herd immunity to COVID-19, low
risk to college-aged students of serious complications or death due to COVID-19, low risk of
asymptomatic spread of COVID-19, and vastly improved COVID treatments currently available.
This is especially true because one-third of IU’s populations is already likely to have immunity
from prior infection. A university vaccine mandate or promotional policy that exerts any pressure,
coercion, or threat of reprisal concerning the acceptance of any investigational biologic agent
violates the medical ethics principle of autonomy. It is my clinical opinion that it is not good
research or clinical practice to widely utilize novel biologic therapy (mRNA, adenoviral DNA
COVID-19 vaccines) in populations where there is no safety information generated from the
registrational trials with the FDA, specifically, on the following populations: COVID-19
survivors, suspected COVID-19 recovered, pregnant or women who could become pregnant at
any time after investigational vaccines. Overall in the United States, 21,806 individuals have been
hospitalized or worse after receiving one of the COVID-19 vaccines. In Indiana, among college
McCullough Decl.
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age adults, there have already been 23 hospitalizations or worse after they received COVID-19
vaccinations and far more can be expected if IU’s Mandate is carried out. In my expert medical
opinion, the risks associated with the investigational COVID-19 vaccines are not minor or
unserious and can include hospitalization and death; the well-recognized risks (e.g., myocarditis,
cerebral venous sinus thrombosis) more prevalent among college age students far outweighs any
theoretical benefits. Many of those risks are unpredictable—at this time, the duration and extent of
disability is impossible to calculate. Therefore, in my expert medical opinion, IU’s Mandate that
all non-exempted students take the COVID vaccine creates an unethical, unreasonable, clinically
unjustified, not indicated, and unnecessary medical risk to its students.
I affirm under penalty of perjury that the foregoing is true and correct. Executed on
June 28, 2021.
____________________________
Dr. Peter A. McCullough
McCullough Decl.
32
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28-JUNE-2021
USDC IN/ND case 1:21-cv-00238-DRL-SLC   document 21-5   filed 07/02/21   page 33 of 33
USDC IN/ND case 1:21-cv-00238-DRL-SLC   document 31-18   filed 07/12/21   page 33 of 33

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