PERSPECTIVE article
Front. Drug Saf. Regul.
Sec. Vaccine Safety and Regulation
Volume 5 - 2025 | doi: 10.3389/fdsfr.2025.1607642
This article is part of the Research TopicPandemic Preparedness in Vaccine Safety and RegulationView all 7 articles
The Role of MedDRA in Global Pharmacovigilance and Public Health during COVID-19: Pandemic Preparedness and Response
Provisionally accepted
- 1MedDRA Maintenance and Support Services Organization, Herndon, Virginia, United States
- 2MedDRA Maintenance and Support Services Organization (MSSO), Cairo, Beni Suef, Egypt
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The COVID-19 pandemic has had a profound impact on global public health, infecting over 770 million individuals and resulting in more than 6.9 million deaths worldwide. In response, the rapid development of novel vaccines became critical to controlling the spread of the virus and safeguarding public health. The accelerated rollout of these vaccines required an expedited evaluation of their quality, efficacy, and safety. This article highlights the role of the Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization (MedDRA MSSO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the terminology owner, in addressing the pandemic's challenges. The authors discuss MSSO's swift adaptation of its standard procedures to the pandemic's needs to develop and maintain MedDRA COVID-19 terms and tools. Through close collaboration with the ICH and expert working groups, the MSSO facilitated the development and timely updating of MedDRA terms and tools tailored to COVID-19, supporting global efforts in diagnosis, prognosis, and novel vaccine safety monitoring. The integration of these MedDRA terms and tools has been crucial in the timely reporting, coding, and analysis of adverse events following immunization (AEFIs), thereby facilitating public health responses worldwide and enabling the ongoing evaluation and safety assurance of COVID-19 vaccines.
Keywords: MedDRA, ICH Terminology, Pandemic Response, Medical coding, Safety analysis, Standardised MedDRA Queries (SMQ), System organ class, COVID-19 vaccine
Received: 07 Apr 2025; Accepted: 03 Oct 2025.
Copyright: © 2025 O’Hare, Ibrahim and Revelle. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Heba Ibrahim, heba.ibrahim@meddra.org
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