HomeMy WebLinkAbout1.3.22 Board Correspondence - FW_ Myocarditis Adverse Events (Scientific Paper) in VARES
From:Paulsen, Shaina
To:Ring, Brian; Pickett, Andy; Alpert, Bruce
Cc:Reaster, Kayla; Valencia, Shyanne
Subject:Board Correspondence - FW: Myocarditis Adverse Events (Scientific Paper) in VARES
Date:Monday, January 3, 2022 8:02:54 AM
Attachments:A Report on Myocarditis Adverse Events in the U.S. Vaccine AdverseEvents Reporting System (VAERS) in Association with COVID19 Injectable Biological Products.pdf
FYI – this was sent to the Board.
Shaina Paulsen
Associate Clerk of The Board
Butte County Administration
25 County Center Drive, Suite 200, Oroville, CA 95965
T: 530.552.3304 | F: 530.538.7120
From: lance dreiss <lancedreiss@att.net>
Sent: Sunday, January 2, 2022 4:59 PM
To: Connelly, Bill <BConnelly@buttecounty.net>; Kimmelshue, Tod <TKimmelshue@buttecounty.net>; Lucero, Debra <DLucero@buttecounty.net>; Clerk of the Board <clerkoftheboard@buttecounty.net>;
District Attorney <District_Attorney@buttecounty.net>; Ritter, Tami <TRitter@buttecounty.net>; Teeter, Doug <DTeeter@buttecounty.net>; Waugh, Melanie <mwaugh@buttecounty.net>
Subject: Myocarditis Adverse Events (Scientific Paper) in VARES
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Board of Supervisors, Clerk of the Board, Public Record, DA Ramsey, Sheriff Honea:
Are you okay with the harming of our children?
Don’t forget the name of the author of this paper: Dr. Rose. You will hear about her in the future if you haven’t already. She’s a HERO! So is Dr. McCullough!
What are you?
Diana Dreiss
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consent.netlify.app/media/A*20Report*20on*20Myocarditis*20Adverse*20Events*20in*20the*20U.S.*20Vaccine*20AdverseEvents*20Reporting*20System*20*28VAERS*29*20in*20Association*20with*20COVID19*20Injecta
ble*20Biological*20Products.pdf__;JSUlJSUlJSUlJSUlJSUlJSUlJSUlJQ!!KNMwiTCp4spf!UyxmCXtamdlMo0fJmuDmUPtP3CYTxE4xKUMo8fXNNnwEVLNGmjSYUh3UdU56vK23EVxO_yJA190$
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A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS)
in Association with COVID-19 iological Products
*
Jessica Rose, PhD, MSc, BSc and Peter A. McCullough, MD, MPH
Institute of Pure and Applied Knowledge, Public Health Policy Initiative (PHPI)
Texas A & M College of Medicine, Baylor Dallas Campus, Dallas TX USA
*
Correspondence: jessicarose1974@protonmail.com (Dr. Jessica Rose)
Pfizer Inc./BioNTechPfizer Inc./BioNTechPfizer Inc./BioNTech BNT162b2
-
-
8 weeks of the public offering ofof the public offering ofof the public offering of COVID-19 products to the 12-15-year-old age group, we
found 19 times the expected number of the expected number of the expected number of myocarditis cases in the vaccination volunteers over
background myocarditis rates for this age grouprates for this age grouprates for this age group.-
--
BNT162b2BNT162b2BNT162b2
-
-
-
--
-
1
---COVID-19-Injection-Related
Myocarditis
1.
Myocarditis is inflammation of the myocardium or musculatureof the heart. \[1,2,3,4\] The
myocardium is made up of many cell types however the greatest mass of tissue is accounted for by
cardiomyocytes. \[4,5,6\] Cardiomyocytes are the principal contractile cells and are supported by Cardiomyocytes are the principal contractile cells and are supported by
specialized conduction and stromal cell types. \[4,5,6,7,8\] Both systole and diastole are active processes Both systole and diastole are active processes Both systole and diastole are
active processes
that expend energetic resources of cardiomyocytes which are organized into myofibrils.which are organized into myofibrils.which are organized into myofibrils. \[8,9,10\]
Myocarditis can manifest as sudden death, chest pain or heart failure. The symptoms of heart failure manifest as sudden death, chest pain or heart failure. The symptoms of heart failure
manifest as sudden death, chest pain or heart failure. The symptoms of heart failure
from myocarditis include effort intolerance, dyspnea, fatigue, fatigue, and ankle swelling. \[1,2,3,4,6,11,12,13\]
The cause is an inflammation of the heart muscle, often following a viral infectioncause is an inflammation of the heart muscle, often following a viral infectioncause is an inflammation
of the heart muscle, often following a viral infectioncause is an inflammation of the heart muscle, often following a viral infection, but not exclusively so.
The damaged muscle is prone to lethal cardiac arrythmias as well as having the potential to develop The damaged muscle is prone to lethal cardiac arrythmias as well as having the potential
to develop The damaged muscle is prone to lethal cardiac arrythmias as well as having the potential to develop
both right and left ventricular dysfunctionboth right and left ventricular dysfunction (cardiomyopathy)(cardiomyopathy)(cardiomyopathy). \[3,4,12,13\]
Myocarditis is a major risk for cardiac deathyocarditis is a major risk for cardiac deathyocarditis is a major risk for cardiac death among the young. \[11\] The high-risk age population
for myocarditis is from puberty through early 30s, and it is the is from puberty through early 30s, and it is the is from puberty through early 30s, and it is the third leading cause
of sudden cardiac
death in children and young adultsyoung adultsyoung adults. 1 per 100,000 children per year are affected by myocarditis and it
has been reported that 0.05% of all pediatric hospitalizations are for myocarditis.has been reported that 0.05% of all pediatric hospitalizations are for myocarditis.has been reported
that 0.05% of all pediatric hospitalizations are for myocarditis. Between 0.5 and 3.5%
of heart failure hospitalizations are due to myocarditis. Most cases of heart failure hospitalizations are due to myocarditis. Most cases of heart failure hospitalizations are due to
myocarditis. Most cases of heart failure hospitalizations are due to myocarditis. Most cases of myocarditis are identified in young
adults with males affected more often than females.adults with males affected more often than females.adults with males affected more often than females. \[12,13,14, 15,16\]
In the context of COVID-19 respiratory illness, there are a significant number of patients who are
otherwise healthy experiencing heart-related complications, including myocarditis, but the majority of
clinical reports and diagnoses claim cardiac injury based on ICU-related-related injury to the heart.
\[17,18,19,20,21,22,23,24,25\] This is relevant in terms of contextualizing the potential risk of myocarditis
from the COVID-19 products against COVID-19 itself and establishing a background rate of myocarditis in
specific contexts. Cardiac injuries associated with COVID-19 respiratory illness reveal a set of parameters
based on a combination of measurements of troponin levels, electrocardiogram (ECG/EKG),
1
echocardiogram readings, cardiac magnetic resonance imaging (MRI) and clinical symptoms that are
different from the clinical picture of vaccine-induced myocarditis. COVID-19-Injection-Related
Myocarditis (CIRM) can be defined as the onset of clinical myocarditis that is temporally associated with
COVID-19 mRNA or adenoviral DNA vaccine administration and in the absence of another known cause.
CIRM presents with clinical symptoms (chest pain, effort intolerance) combined with excessively
elevated troponin levels, EKG changes (diffuse ST segment elevation) and in some cases left and right
ventricular dysfunction on echocardiography. In cases where the echocardiogram is unrevealing, cardiac
MRI can detect changes in tissue characterization consistent with myocardial inflammation.
\[22,23,24,25,26,27\]
-
1
-
An Adverse Event (AE) is defined as any untoward or unfavorable medical occurrence in a An Adverse Event (AE) is defined as any untoward or unfavorable medical occurrence in a An Adverse
Event (AE) is defined as any untoward or unfavorable medical occurrence in a
human study participant, including any abnormal physical exam or laboratory finding, symptom, or human study participant, including any abnormal physical exam or laboratory finding,
symptom, or human study participant, including any abnormal physical exam or laboratory finding, symptom, or
e research, whether or not
considered related to participation in the research. A considered related to participation in the research. A considered related to participation in the research. A considered related
to participation in the research. A serious or severe adverse event (SAE) is defined as
any adverse event that results in death, is life threatening, or places the participant at immediate risk of any adverse event that results in death, is life threatening, or places the
participant at immediate risk of any adverse event that results in death, is life threatening, or places the participant at immediate risk of
death from the event as it occurred, e event as it occurred, requires, or prolongs hospitalization, causes persistent or significant
disability or incapacity, results in congenital anomalies or birth defects or is another condition which
investigators judge to represent significant hazards. \[28,30,31\] These classifications are based on the
Code of Federal Regulations. The VAERS handbook states that approximately 15% of reported AEs are
classified as severe.\[28\] Myocarditis qualifies as an SAE as it is often associated with hospitalization.
1
It must be noted that the reported adverse events as part of the VAERS represent a fraction of the actual number of incidents. Studies have
shown that the percentage of incidents reported can be quite low (1-10%) but, for the purposes of this report, in order to do the necessary
calculations, VAERS numbers were used, and the results should be considered to reveal trends. \[23,24\]
1
The BNT162b2, - products have not been approved or licensed by the
U.S. Food and Drug Administration (FDA), having been authorized instead for emergency use by FDA
under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in
2
individuals 16 years of age and older. \[32,33,34\] Ultimately, the roll-out of COVID-19 injectable
biologicals are actively being monitored, but all of the risks are not yet known.
\[16,17,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46\]
2.
Language and Environment for Statistical ComputingLanguage and Environment for Statistical Computing, R, was used. The
VAERS data set is available for download (https://vaers.hhs.gov/data/datasets)is available for download (https://vaers.hhs.gov/data/datasets)is available for download (https://vaers.hhs.gov/data/data
sets) in three separate
comma-separated values (csv) files representing i) general data general data for each reportfor each reportfor each report; ii) the reported AEs or
, and iii) vaccine data including vaccine manufacturer and lot numberdata including vaccine manufacturer and lot numberdata including vaccine manufacturer and lot number, for each report.
The
VAERS dataset is updated approximately once a week and the uploaded set is approximately one week and the uploaded set is approximately one week and the uploaded set is approximately
one week
behind the reports. Upon individual reporting of vaccine side effects or adverse eventsof vaccine side effects or adverse eventsof vaccine side effects or adverse eventsof vaccine side
effects or adverse events, a VAERS ID
number is provided to the individual to preserve confidentiality, to preserve confidentiality, to preserve confidentiality, and a detailed description of the side
by state, past medical history, allergies
and gender and many other detailsand many other details. In addition, the vaccine lot number, place of vaccination and . In addition, the vaccine lot number, place of vaccination and
manufacturer details are included in the report. manufacturer details are included in the report. manufacturer details are included in the report. In order to maximize the input variables
for my analysis,
the three files were merged byby VAERSVAERS ID that is included as a linking variable in all three files. The
merged data set comprises data data set comprises data data set comprises data collected pertaining to all reported collected pertaining to all reported AEs associated with BNT162b2,
- and products: the three primary vaccine manufacturers responsible for nCoV-
2019 products currently being2019 products currently being2019 products currently being2019 products currently being administered in the U.S. Data was sorted according to vaccine type
(data
reported for COVIDreported for COVIDreported for COVID--19) 19) and relevant variables were sorted including VAERS ID, AEs, age, gender, state,
vaccination date, date of death, vaccination date, date of death, incident of death, dose series, treatment lot number, treatment
manufacturer, hospitalizations, emergency department visits and onset date of AEs. Myocarditis as a
standalone AE was extracted by keyword and cardiac events were grouped by extracting multiple
keywords according to MedDRA nomenclature. Statistical analysis was done using the -Test
to determine statistically significant differences between ages in the myocarditis AE. Skewing in
2
mRNA biologicals are not true vaccines. True vaccines are a preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a
portion of the pathogen's structure that upon administration to an individual stimulates antibody production or cellular immunity against the
pathogen but is incapable of causing severe infection. Vaccines undergo an extremely rigorous testing time-dependent protocol to ensure
safety and efficacy typically enduring between 10 and 15 years. The mRNA biologicals do not satisfy either these requirements and are thus
more akin to experimental gene therapy.
1
distribution of data was tested using Pearson's Skewness Index, I, which is defined as I = (mean-
mode)/standard deviation. The data set is
2.1 Results: General information
To date, approximately 56
th
COVID-19. As of July 9, 2021, 397,262 AEs have been reported in the VAERS system. This number is
very atypical and large when compared to frequencies of AE reports from previous years. Figure 1
illustrates the stark contrast between what the count would be if the trend of past 30 years continued the trend of past 30 years continued
through to the end of 2021: ~65,000 for the entire 2021 year as opposed to ~400,000 as opposed to ~400,000 as opposed to ~400,000 over 6 months.
There are almost 4,000 different AE types reported (to date) in the context of COVIDin the context of COVIDin the context of COVID-19 products and
among them, many SAES. As previously stated, the VAERS handbook maintains that ~15% of he VAERS handbook maintains that ~15% of he VAERS handbook maintains that ~15% of all the AEs
should classify as SAEs yet the percentage holds at 18% for COVID% for COVID% for COVID-19-related AEs.
Among these SAEs are cardiac AEs that includethat includethat include cardiac arrest, myocardial infarction, and
myocarditis. Myocarditis reports in the context of the COVIDin the context of the COVIDin the context of the COVID-19 products are atypically high in the
context of prior vaccine rollouts and in the context of baseline levelsand in the context of baseline levelsand in the context of baseline levels with respect to high-risk groups.
The number of cases of myocarditisyocarditis reported to the VAERS database reported to the VAERS database dramatically outnumber case
counts seen in previous yearsseen in previous years with 1 single case having been reported in 2019 and 1 singlwith 1 single case having been reported in 2019 and 1 singlwith 1 single
case having been reported in 2019 and 1 single case being
reported in 2020 (Refer to Section 1.4Refer to Section 1.4Refer to Section 1.4). Figure 2 shows the absolute numbers of myocarditis cases
reported for 2021 as per Onset Date1 as per Onset Date1 as per Onset Date. It is clear from this bar plot that the frequency of myocarditis cases
reported to VAERS reported to VAERS reported to VAERS has increased has increased has increased starting at the beginning of June. This is just shortly after the roll-out of
injections into children aged 12injections into children aged 12injections into children aged 12-15 began. On May 10, 2021, the Food and Drug Administration (FDA)
issued an Emergency mergency Use Authorization (EUA) for BNT162b2 vaccine in children aged 12-15. Of note, 67%
of myocarditis cases were in the context of administration of BNT162b2.
2.2 Incidence rates of myocarditis in youths
th
As of July 9, 2021, a total of 559 myocarditis AEs (0.14% of all AEs) have been reported.
1
--
Figure 3 shows the distribution of
myocarditis cases by age grouped by decade. 41% of all myocarditis reports were made for children
aged 10 through 20 and 72% of all myocarditis reports were made for young adults aged 10-30 years of
age. The distribution is right-skewed toward the younger age groups, and this is statistically significant
(I=1.61). This provides strong evidence to support our hypothesis.
th3
As of May 18, 2021, 600,000 children aged 12-15 had been injected with COVID-19 products.
\[14\] The CDC estimated that 3,430,741 children aged 12-15 have received at least one dose of the
th4
COVID-19 products as of June 7, 2021. Since 1 per 100,000 children per yearchildren per year are affected by
5
myocarditis then, statistically, we would expect ~5 myocarditis cases myocarditis cases if we calculate the expected if we calculate the expected
thnd
number of cases using the June 7 CDC sample. To date (up to and including July To date (up to and including July To date (up to and including July 2, 2021), 97 children
aged 12-15 have had reports submitted to VAERS representing 17.4% of all myocarditis reports 15 have had reports submitted to VAERS representing 17.4% of all myocarditis reports 15 have
had reports submitted to VAERS representing 17.4% of all myocarditis reports and
these are merely the cases that we are aware of. Thus, after after 8 8 weekweeks of roll-out into the 12-15 years-old
age group, we are at ~19 times the expected number of cases within this samplethe expected number of cases within this samplethe expected number of cases within this samplethe expected
number of cases within this sample. Thus, the number of
VAERS-reported cases far outnumber what would typically be expected to date.reported cases far outnumber what would typically be expected to date.reported cases far outnumber what would
typically be expected to date. It is important to note
that of the 559 myocarditis VAERS reports, 6 died (1.1%) and 33% of these deaths werethat of the 559 myocarditis VAERS reports, 6 died (1.1%) and 33% of these deaths werethat of the
559 myocarditis VAERS reports, 6 died (1.1%) and 33% of these deaths were in individuals
under 20 years of age: 1 individual was 13 and one was 19 years of age.under 20 years of age: 1 individual was 13 and one was 19 years of age.under 20 years of age: 1 individual was
13 and one was 19 years of age.
2.3 -
-
The distribution is right-skewed toward the younger age groups, and this is
statistically significantsignificant (I=1.28), and males represent 80% of all cases. The most frequent occurrences
were in 15-year-old boys (N= 44) and 18-year-old girls (N= 6).
3
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention
4
VRBPAC-06.10.21-Meeting-Presentation-COVID-19-Adolescent-Vaccination.pdf
5
Myocarditis in children: incidence, clinical characteristics, and outcomes. Jul 29, 2020. MYOCARDITIS FOUNDATION
1
--BNT162b2
BNT162b2
--
BNT162b2 ---
6
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the high-risk age population for myocarditis is from puberty through early 30sis from puberty through early 30sis from puberty through early 30s, myocarditis
should be considered diagnostically in any young adultin any young adult who experienceswho experiences shortness of breath,
palpitations or chest pain following injection with dose 1with dose 1with dose 1with dose 1 of any COVIDof any COVID-19 injectable product.
-
-
About 1.5 million cases of acute bout 1.5 million cases of acute bout 1.5 million cases of acute myocarditis occurred in 2013. In 1990, 294,000 individuals died
from cardiomyopathy (including myocarditis) which increased to from cardiomyopathy (including myocarditis) which increased to from cardiomyopathy (including myocarditis) which increased
to 354,000 deaths in 2015. Myocarditis is
a rare disease andand typically presents in males and younger individuals as previously stated. The trigger
for myocarditis is considered idiopathic but generally thought to be the result of infection or toxin. \[2\]
However, in the context of vaccine-induced myocarditis, report numbers have typically been very low.
That is, however, until recently. Consider that 2021 is the only year we have been able to collect AE data
for the COVID-19 products and prior years are exclusively non-COVID products, except for 2 weeks in
December 2020.
6
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
1
The average number of myocarditis reports in VAERS in the context of all vaccines combined for
the past 3 years is 4: 11 (0.02% of total) reports were made in 2018, and 1 report was made for 2019
(0.002% of total) and 2020 (0.002% of total), respectively. The number of myocarditis case reports for
2021 are at 559 (0.14%); far higher than last year for all vaccine products combined as shown in Figure 6.
Myocarditis case rates for 2018-2021 reveal that the rates of myocarditis, when normalized to the
number of fully vaccinated/injected individuals, are exceedingly higher in 2021 than for previous years
as shown in Table 1.
-
-
3.
In the context of COVIDIn the context of COVIDIn the context of COVID-19, and according to Dr. Leslie Cooper, there are a significant number of
patients who presentpresent clinically as healthy who are experiencing heart-related complications, including
7
myocarditis. \[2,17,18,19\] There is a high risk of cardiac involvement both from COVID-19 infection and
from COVID-19 injectable products and the risks of the latter must be further assessed and evaluated.
Because of the spontaneous reporting of events to VAERS, we can assume that the cases reported thus
far are not rare, but rather, just the tip of the iceberg. Again, -
The only way to understand how common myocarditis is
7
Dr. Leslie T. Cooper, Chair, Enterprise Department of Cardiovascular Medicine for Mayo Clinic and the Executive Medical Director and founder
of the Myocarditis Foundation
1
after COVID-19 vaccination, is to perform a prospective cohort study where all vaccinated individuals
undergo clinical assessment, ECG, and troponin measurement at regular intervals post-administration.
--
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---
-
During phase III clinical trials for the mRNA COVIDfor the mRNA COVIDfor the mRNA COVID-19 products, safety was assessed based on a
ƒğǣźƒǒƒ observation period of 6 monthsobservation period of 6 monthsobservation period of 6 months. TThis is not his is not adequate to assess long-term safety outcomes as
8
it is a requirement, even in an accelerated timeline setting, to spend up to 9 months in Phase III trialsit is a requirement, even in an accelerated timeline setting, to spend up to
9 months in Phase III trialsit is a requirement, even in an accelerated timeline setting, to spend up to 9 months in Phase III trials.
The typical timeline is up to 10 years for safety and efficacy assessment. \[47The typical timeline is up to 10 years for safety and efficacy assessment. \[47The typical timeline is
up to 10 years for safety and efficacy assessment. \[47,48\] There are many
examples of biological product recalls historically. examples of biological product recalls historically. examples of biological product recalls historically. In 2010, rotavirus vaccines
licensed in the U.S were found
to contain Porcine circovirusPorcine circovirus ((PCVPCV) type 1 and were subsequently suspended. In 2009, an increased risk of
narcolepsy was found fonarcolepsy was found following vaccination with a monovalent H1N1 influenza vaccine that was used in several llowing vaccination with a monovalent H1N1 influenza
vaccine that was used in several llowing vaccination with a monovalent H1N1 influenza vaccine that was used in several
European countries during the H1N1 influenza pandemicEuropean countries during the H1N1 influenza pandemicEuropean countries during the H1N1 influenza pandemic. Between 2005 and 2008,
a meningococcal vaccine was
suspected to cause suspected to cause GuillainGuillain-Barré Syndrome (GBS). In 1998, a vaccine designed to prevent rotavirus gastroenteritis
was associated with childhood intussusception after being vaccinated. Also in 1998, a hepatitis B vaccine product
was linked to multiple sclerosis (MS). \[49\] It is also vital to address that pregnant woman were in the exclusion
criteria list for the Phase III trials (ref: NCT04368728) and thus it is unclear how a safety assessment can be made
for pregnant women when the products were only tested for 6 months. \[50\] In this context, it is worth
reiterating that BNT162b2, -and the products have not been approved or
licensed by the U.S. Food and Drug Administration (FDA), having been authorized instead for emergency
8
https://coronavirus.jhu.edu/vaccines/timeline
1
use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-
19), and was originally meant for use in individuals 16 years of age and older. \[32,33,34\]
mRNA platforms have never before been implemented for use in human subjects on a global
scale in the context of viruses and it has recently been shown that the spike protein itself systemically
traffics inducing damage within cells, at the cell surface, and through circulation with endothelial
damage and thrombosis. \[44,45\] It is unknown which cells and organs are seeded with mRNA, the
cellular half-life of the products, duration of spike protein production, reverse transcription, future
regulation, and ultimate disposal of mRNA technology. \[51,52\] Safety is always a point of relevance with
regards to new biological agents and given these new findings, it would be prudent to pay particular and given these new findings, it would be prudent to pay particular
attention to the AEs being reported to the VAERS system in the context of these experimental productsbeing reported to the VAERS system in the context of these experimental productsbeing
reported to the VAERS system in the context of these experimental products
with known dangerous mechanisms of action. When evidence of harm appears, we need to When evidence of harm appears, we need to When evidence of harm appears, we need to follow the
evidence and immediately take steps to mitigate risks.
-
BNT162b2
28 1228 12-1515-yearyear-olds
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deviations in ST and T waves, PR and QT intervals and T wave
inversion
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4. Conclusions
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--
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Efficacy of these products needs to be assessed by immunological assays and long-term studies
are required, while safety needs to be evaluated by rigorous clinical, laboratory and imaging
assessments of severe reported adverse events such as CIRM. Autopsies should be done in cases of
cardiovascular-related deaths temporally associated with COVID-19 injectables.
1
-
As part of any risk/benefit analysis which must be completed in the context of experimental As part of any risk/benefit analysis which must be completed in the context of experimental
products, the points herein must be considered before a decision can be made pertaining to agreeing to products, the points herein must be considered before a decision can be made pertaining
to agreeing to products, the points herein must be considered before a decision can be made pertaining to agreeing to
2-dose injections of these experimental COVID-19 products, es19 products, especially into children and by no means, pecially into children and by no means, pecially into children and
by no means,
should parental consent be waived under any circumstancescircumstances to avoid children volunteering for injections to avoid children volunteering for injections to avoid children volunteering
for injections
with products that do not have proven safety or efficacywith products that do not have proven safety or efficacy. .
Future work may include on-site clinical observatiosite clinical observatiosite clinical observations of Troponin, BNP, galectin-3, ST2, IL-6 and
D-dimer levels to corroborate temporal effects of onset of myocarditis following injections with dimer levels to corroborate temporal effects of onset of myocarditis following injections
with dimer levels to corroborate temporal effects of onset of myocarditis following injections with
particular COVID-19 products. Delineation betweenDelineation betweenDelineation between COVID-19 respiratory infection with mild ICU-related
cardiac injury and true CIRM using theseusing theseusing these and other clinical diagnosticand other clinical diagnostic markers would be incredibly useful
for clinicians and should become the standard for and should become the standard for and should become the standard for differential diagnosis of suspected CIRM.
-
1
Supplementary Materials
Supplementary Table 1 : List of cardiac AEs used to produce general compact list of AEs related
myocarditis
1
Figure 1. Time series plots all VAERS reports in association with all vaccines administered to the U.S. all VAERS reports in association with all vaccines administered to the U.S.
population by year (left) and VAERS reports in association witpopulation by year (left) and VAERS reports in association witpopulation by year (left) and VAERS reports in association
witpopulation by year (left) and VAERS reports in association with COVIDh COVID-19 products for 2021 (right).
Figure 2. Bar plot showing the number myocarditis cases reported from January 1st to July 9th, 2021.
1
Figure 3. Histogram showing the number of reported VAERS cases of myocarditis by age group.Histogram showing the number of reported VAERS cases of myocarditis by age group.Histogram
showing the number of reported VAERS cases of myocarditis by age group.
Figure 4. Histogram showing Myocarditis cases reported in VAERS following injection with COVID-19
products according to age and gender.
1
Figure 5. Histogram showing Myocarditis cases reported in VAERS following injection with COVIDHistogram showing Myocarditis cases reported in VAERS following injection with COVIDHistogram
showing Myocarditis cases reported in VAERS following injection with COVID-19
products according to age and dose.
Figure 6. Bar plot showing Myocarditis cases reported in VAERS by year. *2021: up to and including July
9th, 2021.
1
Figure 7. Histogram showing Cardiac cases reported in VAERS by year.Histogram showing Cardiac cases reported in VAERS by year.Histogram showing Cardiac cases reported in VAERS by year.
Table 1. Case rates of myocarditis per year based on estimated numbeCase rates of myocarditis per year based on estimated numbeCase rates of myocarditis per year based on estimated number
of doses per year with respect to
the population size for the season normalized to the number of doses administered per vaccine. the population size for the season normalized to the number of doses administered per vaccine.
the population size for the season normalized to the number of doses administered per vaccine.
910
*Population data extracted from Worldometer*Population data extracted from Worldometer*Population data extracted from Worldometer and vaccine data extracted from Our World in Data
11
and CDC database. \[45,46,48\]. \[45,46,48\]
Year Rate/million doses
2018 0.067
2019 0.006
2020 0.024
2021 3.092
9
https://www.worldometers.info
10
https://ourworldindata.org/covid-vaccinations
11
https://www.cdc.gov/vaccines/
1
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