A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID‐19 mRNA vaccination

Abstract

Vaccines have had a tremendous impact on reducing the burden of infectious diseases; however, they have the potential to cause adverse events following immunization (AEFIs). Prelicensure clinical trials are limited in their ability to detect rare AEFIs that may occur in less than one per thousand individuals. While postmarketing surveillance systems have shown COVID‐19 mRNA vaccines to be safe, they led to the identification of rare cases of myocarditis and pericarditis after COVID‐19 vaccination that were not initially detected in clinical trials. In this narrative review, we highlight concepts of vaccine pharmacovigilance during mass vaccination campaigns and compare the approaches used in the context of myocarditis and pericarditis following COVID‐19 vaccination to historical examples. We describe mechanisms of passive and active surveillance, their strengths and limitations, and how they interacted to identify and characterize the safety signal of myocarditis and pericarditis after COVID‐19 mRNA vaccination. Articles were synthesized from a PubMed search using relevant keywords for articles published on vaccine surveillance systems and myocarditis and pericarditis after COVID‐19 vaccination, as well as the authors' collections of relevant publications and grey literature reports. The global experience around the identification and monitoring of myocarditis and pericarditis after COVID‐19 mRNA vaccination has provided important lessons for vaccine safety surveillance and highlighted its importance in maintaining public trust in mass vaccination programmes in a pandemic context.

Incidence of myopericarditis after mRNA COVID-19 vaccination: A meta-analysis with focus on adolescents aged 12–17 years

“…Experience with vaccine safety issues from previous large-scale vaccination campaigns has led to the establishment and strengthening of active and passive vaccine safety surveillance systems around the world [32] . Improvements made to these systems in preparation for the COVID-19 vaccination campaign have allowed for the rapid identification of cases of myocarditis, pericarditis, and myopericarditis after mRNA COVID-19 vaccination and evaluation of these vaccine safety signals [32] . Compared to active surveillance systems, passive surveillance systems are prone to reporting bias (including underreporting and stimulated reporting) [32] .…”

“…Improvements made to these systems in preparation for the COVID-19 vaccination campaign have allowed for the rapid identification of cases of myocarditis, pericarditis, and myopericarditis after mRNA COVID-19 vaccination and evaluation of these vaccine safety signals [32] . Compared to active surveillance systems, passive surveillance systems are prone to reporting bias (including underreporting and stimulated reporting) [32] . Among the 14 studies used in our overall analyses, 5 used pharmacovigilance data from active surveillance systems [19] , [15] , [16] , 6 from passive surveillance systems [12] , [13] , [17] , [18] , [23] , [24] , and 3 from surveillance systems of unknown types [6] , [20] , [25] .…”

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

“…Severe side effects of COVID-19 vaccination have particularly an overlap with symptoms of COVID-19. For example, myocarditis and pericarditis have been found in association with COVID-19 [148] , [149] , [150] , [151] , [152] , [153] , [154] , [155] , [156] and COVID-19 vaccination [46] , [148] , [157] , [158] , [159] , [160] , [161] , [162] , [163] , [164] , [165] , [166] , [167] , [168] , [169] , [170] , [171] , [172] , [173] , [174] with the onset of cardiovascular symptoms after vaccination normally occurring a few days after vaccination [158] , [160] , [161] , [162] , [174] , [175] . While COVID-19 vaccine induced myocarditis/pericarditis generally fall in the category ACVS, cases in the category PACVS seem to occur too (e.g.…”

Anesthetic Management of Suspected COVID-19 Vaccination Pericarditis/Myocarditis Scheduled for a Pericardial Window: A Case Report and Literature Review

“…The anesthetic used should aim to reduce myocardial depression and arrhythmogenic potential. To minimize hemodynamic instability and myocardial depression, regional anesthetic methods such as thoracic epidural or paravertebral blocks may be preferred over general anesthesia [ 8 , 9 ]. If general anesthesia is required, short-acting agents such as propofol and remifentanil may be preferred over long-acting medications to reduce the duration of cardiac depression [ 9 ].…”

“…To minimize hemodynamic instability and myocardial depression, regional anesthetic methods such as thoracic epidural or paravertebral blocks may be preferred over general anesthesia [ 8 , 9 ]. If general anesthesia is required, short-acting agents such as propofol and remifentanil may be preferred over long-acting medications to reduce the duration of cardiac depression [ 9 ]. Inhaled anesthetics such as sevoflurane may also be used; however, excessive doses should be avoided to avoid hypotension and myocardial depression.…”