Enhancing Disease Surveillance and Pharmacovigilance Practices for RTS,S/AS01_E Malaria Vaccine Rollout in Ghana, Kenya, and Malawi: Strategies, Impact, Challenges, and Lessons Learned.

Authors

Valérie Haine, Tene-Alima Essoh, Caroline Perrin Franck, Miloje Savic

Published in

Drug safety. Jul 14, 2026. Epub Jul 14, 2026.

Abstract

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/AS01_E, the first malaria vaccine to demonstrate efficacy, was piloted in selected regions of Ghana, Kenya, and Malawi to evaluate RTS,S/AS01_E 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% to 72% among medical professionals and from 38% to 68% among non-medical professionals after initial training; similar gains were observed after refresher training (45% to 74% and 45% to 72%, respectively). Across the three countries involved in the pilot implementation, 90% of reported AESIs and AEFIs were documented through the phase IV studies. Trainings were generally well received; however, digital tools were underutilized due to the perceived operational burden and user preferences. The repeated use of similar training materials across sessions required the introduction of new clinical cases and knowledge quizzes to maintain participant engagement. In addition, resource limitations, including intermittent connectivity and logistical constraints, posed practical challenges.
This experience highlights the importance of tailored training, flexibility, collaboration, and prior alignment on integrating new tools into existing procedures. Overall, our approach may offer valuable insights for future pharmacovigilance capacity-building efforts in low- and middle-income countries to support safer vaccine rollout.

PMID:
42446783
Bibliographic data and abstract were imported from PubMed on 14 Jul 2026.

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