KPE162 - PECO Assignment

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University of Toronto *

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Dec 6, 2023

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1 1. Identify the principal / primary truth claim made in the assigned publication from a popular medium using the PECO format. In so doing, you must clearly specify what Population, Exposure, Comparator, and Outcome are involved (or whether that is unclear or indeterminate based on what is said in the publication). If the publication makes more than one truth claim, choose whatever you think the primary claim made is (that is, choose one to analyze). (2 marks) Overall truth claim: An overactive immune response (elevated inflammatory cytokine levels) to the mRNA Covid vaccines is the cause of rare cases of myocarditis in some young men. Population : young men, specifically 23 patients (mostly male: 87%) ages 13 to 21 Exposure : Pfizer-BioNTech or Moderna vaccine. Control : Unstated in the popular press article (healthy vaccinated patients) Outcome : elevated cytokine levels in blood samples of those exposed to the vaccine → plays a role in tissue inflammation which is claimed to cause inflammation of heart tissue and myocarditis 1. Does the scholarly article referenced by the popular medium address the PECO question identified in question 1? Briefly explain how or why it does or does not address the PECO question identified in question 1. (1 mark) The scholarly article referenced by the popular medium does well in addressing the PECO question of the underlying mechanisms that cause myocarditis, regarding the SARS-CoV- 2 mRNA vaccines. The truth claim made by the popular press article suggests that myocarditis can be attributed to inflammation due to elevated cytokine levels. This is reflected in the study, stating that, “our results demonstrate up-regulation in inflammatory cytokines and corresponding lymphocytes with tissue-damaging capabilities, suggesting a cytokine-dependent pathology,” (Barmada et al. , 2023). 2. Does the truth claim identified above involve correlation, causation, or both? Does the scholarly article involve descriptive or experimental studies, or both? Briefly justify your answers. (1 mark) The truth claim identified above involves correlation. It seeks to identify the specific mechanisms of myocarditis arising from the COVID-19/SARs vaccine, however this is not possible with the nature of the study conducted. There was no independent variable being directly manipulated, rather researchers were observing different dependent variables between two groups; healthy vaccinated individuals and patients with myopericarditis. This is characteristic of a descriptive study, and studies of this nature are unable to yield insight into the direct cause-relationship between the claims being made. It yielded insight into the correlation between elevated inflammatory cytokines and myocarditis, however the direct causation of myocarditis is yet to be confirmed. 3. Does the popular medium publication accurately reflect, exaggerate, or misrepresent the scholarly literature it refers to? Briefly justify your answer. (1

2 mark) The popular medium publication slightly misrepresents the scholarly literature it refers to. This is because the popular medium population suggests a direct causation type relationship between myocarditis and elevated cytokine levels, “overactive immune response to the mRNA Covid vaccines may be the culprit in rare cases of heart inflammation,” (Lovelace, 2023). This is slightly inaccurate as the information in the scholarly source does not provide a direct conclusion into the causation relationship between vaccines, cytokine levels, and myocarditis, but rather yields insight into the correlation between these occurrences. Despite this slight misrepresentation, the information that the article presents is nevertheless mostly accurate.

3 References Alami, A., Villeneuve, P. J., Farrell, P. J., Mattison, D., Farhat, N., Haddad, N., Wilson, K., Gravel, C. A., Crispo, J. A. G., Perez-Lloret, S., & Krewski, D. (2023). Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective. Journal of clinical medicine, 12(15), 4971. https://doi.org/10.3390/jcm12154971 Barmada, A., Klein, J., Ramaswamy, A., Brodsky, N. N., Jaycox, J. R., Sheikha, H., Jones, K. M., Habet, V., Campbell, M., Sumida, T. S., Kontorovich, A., Bogunovic, D., Oliveira, C. R., Steele, J., Hall, E. K., Pena-Hernandez, M., Monteiro, V., Lucas, C., Ring, A. M., … Lucas, C. L. (2023). Cytokinopathy with aberrant cytotoxic lymphocytes and profibrotic myeloid response in SARS-CoV-2 mRNA vaccine–associated myocarditis. Science Immunology , 8 (83), eadh3455–eadh3455. https://doi.org/10.1126/SCIIMMUNOL.ADH3455 Bozkurt, B., Kamat, I., & Hotez, P. J. (2021). Myocarditis With COVID-19 mRNA Vaccines. Circulation , 144 (6), 471–484. https://doi.org/10.1161/CIRCULATIONAHA.121.056135 Cadegiani F. A. (2022). Catecholamines Are the Key Trigger of COVID-19 mRNA Vaccine-Induced Myocarditis: A Compelling Hypothesis Supported by Epidemiological, Anatomopathological, Molecular, and Physiological Findings. Cureus, 14(8), e27883. https://doi.org/10.7759/cureus.27883 Cushion, S., Arboleda, V., Hasanain, Y., Demory Beckler, M., Hardigan, P., & Kesselman, M. M. (2022). Comorbidities and Symptomatology of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)-Related Myocarditis and SARS-CoV-2 Vaccine-Related Myocarditis: A Review. Cureus, 14(4), e24084. https://doi.org/10.7759/cureus.24084

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4 Delıce, A. (2010). The sampling issues in quantitative research. Kuram Ve Uygulamada Eğitim Bilimleri, 10(4), 2001-2018. http://myaccess.library.utoronto.ca/login?qurl=https%3A %2F%2Fwww.proquest.com%2Fscholarly-journals%2Fsampling-issues-quantitative- research%2Fdocview%2F1431011942%2Fse-2%3Faccountid%3D14771 1 Hromić-Jahjefendić, A., Sezer, A., Aljabali, A. A. A., Serrano-Aroca, Á., Tambuwala, M. M., Uversky, V. N., Redwan, E. M., Barh, D., & Lundstrom, K. (2023). COVID-19 Vaccines and Myocarditis: An Overview of Current Evidence. Biomedicines, 11(5), 1469. https://doi.org/10.3390/biomedicines11051469 Hsieh, M. H., & Yamaguchi, Y. (2022). Immune Response in Regard to Hypersensitivity Reactions after COVID-19 Vaccination. Biomedicines, 10(7), 1641. https://doi.org/10.3390/biomedicines10071641 Husby, A., Hansen, J. V., Fosbøl, E., Thiesson, E. M., Madsen, M., Thomsen, R. W., Sørensen, H. T., Andersen, M., Wohlfahrt, J., Gislason, G., Torp-Pedersen, C., Køber, L., & Hviid, A. (2021). SARS-CoV-2 vaccination and myocarditis or myopericarditis: population based cohort study. BMJ (Clinical research ed.), 375, e068665. https://doi- org.myaccess.library.utoronto.ca/10.1136/bmj-2021-068665 Kim, I. C., Kim, H., Lee, H. J., Kim, J. Y., & Kim, J. Y. (2021). Cardiac Imaging of Acute Myocarditis Following COVID-19 mRNA Vaccination. Journal of Korean medical science, 36(32), e229. https://doi- org.myaccess.library.utoronto.ca/10.3346/jkms.2021.36.e229 Kyaw, T., Drummond, G., Bobik, A., & Peter, K. (2023). Myocarditis: causes, mechanisms, and evolving therapies. Expert opinion on therapeutic targets, 27(3), 225–238. https://doi.org/10.1080/14728222.2023.2193330 1 Source was used in part 4- Reflection on Evidentiary Support, and is unrelated to the truth claim.

5 Maisch, B. (2023). SARS-CoV-2, vaccination or autoimmunity as causes of cardiac inflammation. Which form prevails? Herz, 48(3), 195–205. https://doi.org/10.1007/s00059-023-05182-6 Marrama, D., Mahita, J., Sette, A., & Peters, B. (2022). Lack of evidence of significant homology of SARS-CoV-2 spike sequences to myocarditis-associated antigens. EBioMedicine, 75, 103807. https://doi.org/10.1016/j.ebiom.2021.103807 Marschner, C. A., Shaw, K. E., Tijmes, F. S., Fronza, M., Khullar, S., Seidman, M. A., Thavendiranathan, P., Udell, J. A., Wald, R. M., & Hanneman, K. (2023). Myocarditis Following COVID-19 Vaccination. Heart failure clinics, 19(2), 251–264. https://doi.org/10.1016/j.hfc.2022.08.012 Morgan, M. C., Atri, L., Harrell, S., Al-Jaroudi, W., & Berman, A. (2022). COVID-19 vaccine-associated myocarditis. World journal of cardiology, 14(7), 382–391. https://doi.org/10.4330/wjc.v14.i7.382 Patel, H., Sintou, A., Chowdhury, R. A., Rothery, S., Iacob, A. O., Prasad, S., Rainer, P. P., Martinón-Torres, F., Sancho-Shimizu, V., Shimizu, C., Dummer, K., Tremoulet, A. H., Burns, J. C., Sattler, S., Levin, M., & DIAMONDS consortium (2023). Evaluation of Autoantibody Binding to Cardiac Tissue in Multisystem Inflammatory Syndrome in Children and COVID-19 Vaccination-Induced Myocarditis. JAMA network open, 6(5), e2314291. https://doi- org.myaccess.library.utoronto.ca/10.1001/jamanetworkopen.2023.14291 Piché‐Renaud, P., Morris, S. K., & Top, K. A. (2022). A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID‐19 mrna vaccination. British Journal of Clinical Pharmacology,

6 89(3), 967–981. https://doi.org/10.1111/bcp.15625 Pillay, J., Gaudet, L., Wingert, A., Bialy, L., Mackie, A. S., Paterson, D. I., & Hartling, L. (2022). Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review. BMJ (Clinical research ed.), 378, e069445. https://doi.org/10.1136/bmj-2021-069445 Power, J. R., Keyt, L. K., & Adler, E. D. (2022). Myocarditis following COVID-19 vaccination: incidence, mechanisms, and clinical considerations. Expert review of cardiovascular therapy, 20(4), 241–251. https://doi.org/10.1080/14779072.2022.2066522 Tschöpe, C., Ammirati, E., Bozkurt, B., Caforio, A. L. P., Cooper, L. T., Felix, S. B., Hare, J. M., Heidecker, B., Heymans, S., Hübner, N., Kelle, S., Klingel, K., Maatz, H., Parwani, A. S., Spillmann, F., Starling, R. C., Tsutsui, H., Seferovic, P., & Van Linthout, S. (2021). Myocarditis and inflammatory cardiomyopathy: current evidence and future directions. Nature reviews. Cardiology, 18(3), 169–193. https://doi.org/10.1038/s41569-020-00435-x Yonker, L. M., Swank, Z., Bartsch, Y. C., Burns, M. D., Kane, A., Boribong, B. P., Davis, J. P., Loiselle, M., Novak, T., Senussi, Y., Cheng, C. A., Burgess, E., Edlow, A. G., Chou, J., Dionne, A., Balaguru, D., Lahoud-Rahme, M., Arditi, M., Julg, B., Randolph, A. G., … Walt, D. R. (2023). Circulating Spike Protein Detected in Post-COVID-19 mRNA Vaccine Myocarditis. Circulation, 147(11), 867–876. https://doi- org.myaccess.library.utoronto.ca/10.1161/CIRCULATIONAHA.122.061025 Zirkenbach, V. A., Ignatz, R. M., Öttl, R., Cehreli, Z., Stroikova, V., Kaya, M., Lehmann, L. H., Preusch, M. R., Frey, N., & Kaya, Z. (2023). Effect of SARS-CoV-2 mRNA-Vaccine on the Induction of Myocarditis in Different Murine Animal Models. International journal of molecular sciences, 24(5), 5011. https://doi.org/10.3390/ijms240550

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7 3 - Search Strategy Library database(s) searched: - PubMed, UofT Library database: Gerstein Through creating a concept map, I created a table with the two principal concepts regarding the topic: vaccine and myocarditis. I also thought that it would be fitting to include the third principal concept of inflammatory cytokines within my research as that is part of the truth claim made in the popular medium article. Table 1: Key Concepts Within the Scope of The Truth Claim Concept 1: myocarditis Concept 2: COVID-19 and SARS-CoV-2 Vaccination Concept 3: Cytokines Myocarditis Vaccination Cytokines Pericarditis Vaccine Spike proteins I used this table to create a Boolean expression, using and/or statements in my search. I first grouped the concepts using “or” (ie: pericarditis or myocarditis), and linked it to the cause using “and”. For certain terms, I utilized its truncated from, such as vaccine* instead including its various forms such as vaccination. - eg: “(pericarditis or myocarditis) and (vaccinations or vaccines)” and (cytokines or spike proteins) When using the Gerstein database, I utilized the search filters and set certain database limits. The articles I found were then automatically filtered by the exclusion criterion of being peer reviewed, in the English language, and also filtered the subject to include only articles regarding SARS-CoV-2 and COVID-19. This eliminated irrelevant articles about different pathologies such as smallpox. 4 - Reflection on Evidentiary Support After review of the current literature regarding the mechanism behind vaccine induced myocarditis, a large degree of evidence has been found in favor of the truth claim presented in the popular press article. To verify the veracity of the truth claim made in the article, first one must understand the mechanism behind typical cases of myocarditis. Current evidence suggests

8 that myocarditis is caused by inflammation of myocardium, typically caused by viruses and immune checkpoint inhibitors (ICI), (Kyaw et al. , 2023). In relation to the truth claim, there is also a large margin of evidence indicating that elevated inflammatory cytokine levels lead to inflammation, (Rose, 2011). In regards to scholarly articles directly relevant to the claim made in the popular press article, there is a large amount of relevant literature researching the mechanisms between the SARs-CoV-2 and COVID-19 vaccine and myocarditis. The issue is that the quality of evidence reported in the articles is thematically low. This statement is regarding the conclusions drawn in the articles; no concrete conclusions have been made regarding the mechanisms of mRNA vaccine induced myocarditis. Furthermore, the majority of the scholarly articles were descriptive studies, which are unable to provide evidence of causation. Understanding this, I can now examine the actual information being presented in the scholarly articles. In one article agreeing with the truth claim made by the popular press article, the descriptive study proposed a similar mechanism that myocarditis is caused by a combination of immune response to mRNA and irregular cytokine expression, (Bozkurt et al , .2021). This article was especially relevant as it also included a proposed reason for male predominance in myocarditis incidence. This is relevant to the truth claim made by the popular press article as the population of the PECO claim was young men. However, a key issue appeared within the article and remained a major theme throughout other review articles. This was a small sample size of only 16 patients. Despite confidence levels and P-values being satisfactory, the lowest sample size for a relational survey design should be a minimum of 30, (Delice, 2010). This was a key issue throughout other articles as well, as they had mostly sample sizes under 30. On the other hand, there were also some articles with differing proposed mechanisms of

9 myocarditis. One such article suggests catecholamines as the primary trigger of COVID-19 mRNA vaccine induced myocarditis. However, upon closer inspection, the article makes many statements that the mechanisms of myocarditis are multifaceted and that this was merely the main trigger of COVID-19 mRNA vaccine induced myocarditis. It is stated that, it is unlikely catecholamine activity acted alone to cause myocarditis, but “acted synergistically with other dysfunctions, including abnormal immunological and inflammatory responses, as they alone may cause myocarditis only during extreme catecholamine exposure,” (Cadegiani, 2022). Thus, due to the multifaceted nature of human physiology and mechanisms of pathology, even if the primary trigger for myocarditis is something unrelated to the truth claim, the claim can still remain factual as it can be a secondary factor in the development of myocarditis. In essence, after reviewing some of the current scientific literature regarding the truth claim made in the popular press article, it is difficult to determine the veracity of the claim made. Based on the quality of the current evidence provided in the literature and the uncertain conclusions the articles make, the actual mechanism of mRNA induced myocarditis is still unknown. However, the claim made by the popular press article seems to be the most compelling hypothesis, with the majority of the literature agreeing.

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