The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response

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.