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Myocarditis After SARS-Cov-2 Vaccination: True, True, and … Related? Sean T

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Myocarditis After SARS-Cov-2 Vaccination: True, True, and … Related? Sean T Myocarditis After SARS-CoV-2 Vaccination: True, True, and … Related? Sean T. O’Leary, MD, MPH,a,b Yvonne A. Maldonado, MDc In this month’s issue of Pediatrics, compiled cases through personal Marshall et al report a case series communication rather than through describing seven 14- to 19-year-old a systematic surveillance system. male individuals who developed Clearly, this approach could symptomatic myocarditis after the introduce reporting bias, and a case second dose of the Pfizer-BioNTech series cannot establish causality. coronavirus disease 2019 (COVID- Another critical point to consider is 19) vaccine.1 The authors report that that the reported cases mirror the the symptoms began between 2 and seasonal prevalence, sex, and age 4 days after the second dose and that profile of background cases of aAdult and Child Consortium for Health Outcomes all 7 patients experienced rapid myocarditis, thereby complicating an Research and Delivery Science, Anschutz Medical Campus, resolution of symptoms. This case assessment of a potential association University of Colorado and Children’s Hospital Colorado, Aurora, Colorado, bDepartment of Pediatrics, Anschutz series is published in the context of with SARS-CoV-2 vaccines. The Medical Campus, University of Colorado, Aurora, Colorado, other media reports of myocarditis authors themselves note in their cDepartment of Pediatrics, School of Medicine, Stanford in young adults, mostly male, from discussion the high background rate University, Stanford, California 2 the US military and from Israel as of myocarditis in adolescent and Opinions expressed in these commentaries are those of well as a recent increase in reports young adult male individuals,4 the authors and not necessarily those of the American Academy of Pediatrics or its Committees. of myocarditis after serious acute precisely the population in this case DOI: https://doi.org/10.1542/peds.2021-052644 respiratory syndrome coronavirus 2 series. Thus, a causal relationship (SARS-CoV-2) vaccines to the Food between the Pfizer-BioNTech vaccine Accepted for publication Jun 1, 2021 and Drug Administration (FDA) and and myocarditis based on sporadic Address correspondence to Sean T. O’Leary, MD, MPH University of Colorado, Department of Pediatrics Mail Stop the Centers for Disease Control and clinical reports must be promptly F443 13199 E Montview Blvd, Suite 300 Aurora CO 80045. Prevention (CDC) Vaccine Adverse investigated further by using a E-mail: [email protected] 3 PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, Event Reporting System (VAERS). robust and structured surveillance 1098-4275). As such, this case series offers useful platform, such as that provided by Copyright © 2021 by the American Academy of Pediatrics preliminary information on clinical CDC VAERS. FINANCIAL DISCLOSURE: The authors have indicated and therapeutic details regarding they have no financial relationships relevant to this myocarditis among adolescents. Because of the severity of the article to disclose. pandemic and the urgent need for FUNDING: No external funding. Although the authors are quick to suppression and control, vaccines POTENTIAL CONFLICT OF INTEREST: Dr Maldonado is the point out that a causal relationship against SARS-CoV-2 have been site Principal Investigator for a Pfizer COVID-19 vaccine clinical trial in children and a Pfizer respiratory between vaccination and myocarditis delivered to the US population with syncytial virus vaccine clinical trial in pregnant women. has not been established, the unprecedented speed and scale, She is a member of a Data Safety Monitoring Board for aPfizer non-COVID-19 vaccine clinical trial. Dr O’Leary temporal association of these cases undoubtedly saving many thousands has no relevant conflicts of interest to disclose. with vaccination as well as the of lives as a result. Although there COMPANION PAPER: A companion to this article can be striking similarity in the clinical and was consensus among the scientific found online at www.pediatrics.org/cgi/doi/10.1542/ 2021-052478. laboratory presentations raise the and public health communities that possibility for such a relationship. rapid dissemination of SARS-CoV-2 To cite: ’ However, the authors also vaccines was necessary after O Leary ST, Maldonado YA. Myocarditis After SARS-CoV-2 Vaccination: True, True, and … acknowledge that a significant Emergency Use Authorization by the Related?. Pediatrics. 2021;148(3):e2021052644 limitation in their report is that they FDA, there were potential risks in Downloaded from www.aappublications.org/news by guest on September 29, 2021 PEDIATRICS Volume 148, number 3, September 2021:e2021052644 COMMENTARY doing so. Specifically, clinical trials Datalink, as well as new systems following smallpox vaccination.” In for vaccines, or any biological such as V-Safe that added further fact, although myocarditis has been product, are highly unlikely to surveillance capacity. Indeed, the reported as an adverse event after detect rare adverse events. The identification of a rare risk of other vaccinations, smallpox clinical trials for SARS-CoV-2 anaphylaxis after the Pfizer- vaccination is the only vaccine that vaccines were actually larger than BioNTech and Moderna vaccines7,8 has ever been conclusively linked to for most vaccines and certainly most and of cerebral venous sinus myocarditis on the basis of a medications, with 30 000 to thrombosis after the Janssen significantly higher relative risk.10 It 9 45 000 participants for each of the 3 vaccine within literally a matter of is worth noting that smallpox is a vaccines currently authorized in the days after rollout validate the live vaccine and is associated with United States. Safety profiles in efficacy of the US safety surveillance more adverse events than vaccines those trials were very favorable, systems. in the routine schedule.11 Thus, if which is reassuring, but the sample myocarditis after vaccination were sizes of the trials were not large Both VAERS and Vaccine Safety confirmed to be a causally related enough to detect possible adverse Datalink have rapidly provided rare adverse event after SARS-CoV-2 events with an incidence of, for information to the general US vaccination, it would be unique population about specific potential example, 1 case in 100 000 doses. among nonlive vaccines, so that adverse events consequent to SARS- Thus, the risk of such rare adverse gaining an understanding of the CoV-2 vaccines (known as events must be outweighed by the underlying biological mechanism “prespecified outcomes” in the benefits of the proposed would be important. Typically, the vaccine safety system).6 Among intervention. With >4 million pathogenesis of viral myocarditis these outcomes are myocarditis and COVID-19 cases diagnosed in involves direct viral infection of the pericarditis. According to the CDC, children <18 in the United States myocardium, which could not be as of May 28, 2021, >166 million that resulted in >15 000 invoked as a cause in these reported doses of COVID-19 vaccines have hospitalizations and between 300 cases. In vaccinia-associated been administered in the United and 600 deaths, the benefits of myopericarditis, an autoimmune States, with 2.5 million doses of the vaccination in this population far phenomenon is suspected,12 but the Pfizer-BioNTech delivered to exceed the risks of rare adverse time to onset of symptoms after adolescents 12 to 15 years of age in events.5 vaccination is typically >1 just the 2 weeks since it was 13,14 approved for use in this age group week, much longer than the Because vaccines are generally and 4 million doses given to 16 to current case series. If a causal administered to healthy populations, 18 years since FDA Emergency Use relationship between myocarditis they are held to a much higher Authorization approval in December and SARS-CoV-2 vaccination is safety standard than most other 2020. Despite this widespread and identified, a different biological biological products that might be rapid vaccine uptake especially mechanism is likely responsible and given as therapeutics. However, among children <18 years of age, on will need investigation. recognizing that rare side effects of the basis of their surveillance data, vaccines may only be detected after While we await more definitive data FDA and CDC have not judged that administration to large numbers of myocarditis is causally related to regarding the nature of the individuals, over the last several SARS-CoV-2 vaccination, suggesting relationship between the Pfizer- decades the US FDA and the CDC that a causal association, if it exists, BioNTech vaccine and myocarditis, have in concert developed robust is likely extraordinarily rare and there are some concerns regarding postlicensure vaccine safety may exist only in a subset of the this case series that might suggest a surveillance systems, continuously population, for example among causal relationship and therefore monitoring potential adverse events young adult and adolescent male warrant further analysis through 6 to assure the safety of vaccines. individuals, in which the majority of established surveillance systems. These systems were especially current cases appear to be reported, First, the consistent timing of valuable when rapid and extensive mirroring the background symptoms in these 7 cases after the safety monitoring was called for prevalence of myocarditis. second vaccination suggests a with the advent of SARS-CoV-2 uniform biological process. Second, vaccines. Surveillance for these The
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