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A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID-19 mRNA vaccination.
Piché-Renaud, Pierre-Philippe; Morris, Shaun K; Top, Karina A.
  • Piché-Renaud PP; Division of Infectious Diseases, The Hospital for Sick Children, Toronto, Ontario, Canada.
  • Morris SK; Division of Infectious Diseases, The Hospital for Sick Children, Toronto, Ontario, Canada.
  • Top KA; Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada.
Br J Clin Pharmacol ; 89(3): 967-981, 2023 03.
Article in English | MEDLINE | ID: covidwho-2244231
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pericarditis / Vaccines / COVID-19 Vaccines / COVID-19 / Myocarditis Type of study: Observational study / Prognostic study / Reviews Topics: Vaccines Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2023 Document Type: Article Affiliation country: Bcp.15625

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pericarditis / Vaccines / COVID-19 Vaccines / COVID-19 / Myocarditis Type of study: Observational study / Prognostic study / Reviews Topics: Vaccines Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2023 Document Type: Article Affiliation country: Bcp.15625