In culmination of intensive efforts in 2024 to address critical gaps in vaccine safety surveillance and support emerging manufacturers in implementing robust pharmacovigilance (PV) systems, the Pharmacovigilance Working Group has reached an important milestone with the publication of their article, “Active vaccine safety surveillance in low- and middle-income countries: Challenges for vaccine manufacturers from emerging countries,” in the journal Vaccine at the start of 2025.
The article highlights the challenges faced by DCVMN member companies in adopting Active Vaccine Safety Surveillance (AVSS), particularly in LMICs where such practices are not yet well-established. While most members are familiar with passive surveillance and maintain functional PV systems, the need for advanced risk management planning and active safety measures is increasingly recognized.
A key driver for this initiative was the rapid development of COVID-19 vaccines, which underscored the importance of Risk Management Plans (RMPs) for novel vaccines targeting new diseases and those developed using innovative platforms. To support this need, DCVMN launched a hands-on risk management project in 2021/2022, guiding 10 member companies in preparing RMPs aligned with international guidelines like ICH E2E Pharmacovigilance Planning and European Good Vigilance Practice.
Building on this foundation, the “learn-by-doing” AVSS project was initiated by the PV Working Group. This initiative empowered representatives from member companies, PV-qualified personnel, managers, and analysts, to deepen their understanding of AVSS concepts, methodologies, and barriers. The project provided essential education on preparing active post-approval safety activities, which are increasingly required by regulatory authorities and WHO prequalification processes for novel vaccines.
The publication not only reflects the group’s commitment to addressing these challenges but also underscores the pivotal role of education and capacity-building in strengthening PV systems in LMICs. By fostering understanding and collaboration among DCVMN members, the AVSS project is helping to ensure vaccine safety and efficacy, bolstering public confidence in immunization programs worldwide.
Access the full article here ➡️ https://doi.org/10.1016/j.vaccine.2025.126727
