Developing Countries Vaccine Manufacturers Network (DCVMN) is an alliance of vaccine developers, manufacturers, and marketing authorization holders (MAHs) from low- and middle-income countries (LMICs) that plays a vital role in ensuring equitable, inclusive, accountable, and timely access to affordable, high-quality vaccines in these countries. Besides research and development, this network promotes manufacturing and global supply chains for effective strengthening of regulatory and pharmacovigilance activities. Traditionally, vaccine safety surveillance systems in LMICs rely on spontaneous reporting. However, especially in resource-limited settings, robust passive surveillance is lacking, and active vaccine safety surveillance (AVSS) can complement passive surveillance by actively collecting adverse events at sentinel sites or via formally designed observational (non-interventional) studies. The rapid introduction of novel vaccines during the COVID-19 pandemic with rather limited safety information at deployment accelerated the need for comprehensive AVSS in LMICs to detect potential safety concerns that may not have been identified in pre-licensure trials. In this context, national regulatory agencies (NRAs) and the World Health Organization (WHO) prequalification team requested risk management plans (RMPs) in line with Pharmacovigilance Planning guideline. The submitted RMPs contained the companies' commitments to pharmacovigilance activities encompassing both post-approval routine surveillance (passive) and additional active surveillance activities. These AVSS activities were either committed voluntarily by the manufacturers/MAHs or imposed by the NRA/WHO prequalification in case of important identified or potential risks, or important missing information. Unlike passive surveillance, AVSS relies on various epidemiological methodologies that require resources and expertise. DCVMN initiated a "learn-by-doing" project to support manufacturers/MAHs in performing AVSS. This project focused on improving the understanding of AVSS and its tools, investigated the support needs, opportunities, challenges, and barriers to performing AVSS activities in LMICs, and proposed solutions that could be used to mitigate the main challenges in performing AVSS activities in these countries.
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