Enhancing Disease Surveillance and Pharmacovigilance Practices for RTS,S/AS01E Malaria Vaccine Rollout in Ghana, Kenya, and Malawi: Strategies, Impact, Challenges, and Lessons Learned

The rollout of new vaccines in low- and middle-income countries often faces significant challenges due to underdeveloped disease surveillance and pharmacovigilance practices for monitoring vaccine safety and effectiveness. In 2019, RTS,S/AS01E, the first malaria vaccine to demonstrate efficacy, was piloted in selected regions of Ghana, Kenya, and Malawi to evaluate RTS,S/AS01E real-world safety, effectiveness, impact, and operational feasibility. To strengthen safety monitoring and to gather additional data during rollout, several phase IV studies were conducted that included a capacity-building initiative to enhance disease surveillance and pharmacovigilance practices among healthcare professionals. Here, we describe the capacity-building experience, including targeted training strategies and accompanying paper-based and digital tools developed to improve detection, diagnosis, and reporting of adverse events of special interest (AESIs) and adverse events following immunization (AEFIs). We summarize the impact of the initiative, challenges, and actions taken, and share lessons learned to guide future capacity-building initiatives in low- and middle-income countries. The initiative included tailored, frequent, 2-day in-person training sessions for both medical and non-medical professionals in hospital and community settings, complemented by online courses, practical job aids, a tele-expertise platform, and a mobile alert system to improve adverse event reporting. The initiative reached approximately 5000 community healthcare professionals and 1000 study staff. Knowledge assessments after the trainings indicated marked improvements, with scores increasing from 41