Pharmacovigilance capacity and readiness of vaccine manufacturers in low- and middle-income countries: a maturity-based assessment of the pharmacovigilance system.

The Developing Countries' Vaccine Manufacturers Network (DCVMN) plays a vital role to ensure equitable inclusive, accountable, and timely access to safe, effective, high quality, and affordable vaccines in low- and middle-income countries (LMICs). Given the pivotal responsibility of vaccine manufacturers and marketing authorization holders (MAHs) for ensuring product safety and effectiveness throughout the product lifecycle, robust pharmacovigilance (PV) systems are essential. Efficient and effective PV systems are crucial to vaccine manufacturers/MAHs to ensure safety and efficacy as well as a positive benefit-risk balance during the entire lifecycle of their vaccines. However, implementing PV systems in LMICs is frequently contained by regulatory, infrastructural, and technical limitations. Stringent regulatory legislation with clearly defined and harmonized regulatory requirements is essential for vaccine manufactures/MAHs for setting up a robust PV system aligned with the standards of the World Health Organization Global Benchmark Tool (WHO GBT) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In 2024, the DCVMN PV Working Group conducted a survey to evaluate the maturity of the DCVMN member companies' PV systems across six domains: adverse event (AE) case management, aggregate reporting, signal management, risk management, safety governance, and use of PV tools. Data was collected through a structured survey, where companies self-assessed their PV system maturity levels for each functional area as Basic, Developing, Functional, or Mature. The results revealed a heterogenous landscape; while some companies have established systems meeting international standards, using advanced PV tools, AI-supported case management, standardized risk management protocols and global safety databases, others faced challenges related to infrastructure, regulatory constraints, and limited resources as barriers to progress. These findings highlight the need for enhanced regulatory harmonization, capacity-building, and infrastructure investment to strengthen PV capabilities and improve effective vaccine safety surveillance and subsequently patient safety in LMICs.