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

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

  • By

  • Valérie Haine

  • Tene-Alima Essoh

  • Caroline Perrin Franck

  • Miloje Savic

  • July 14, 2026

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Clinical Report: Improving Disease Monitoring and Drug Safety Practices for the RTS,S/AS01E Malaria Vaccine Implementation

Overview

The implementation of the RTS,S/AS01E malaria vaccine in Ghana, Kenya, and Malawi involved tailored training for healthcare professionals. Challenges such as resource limitations and over-familiarity with training materials were noted.

Background

Malaria remains a significant public health issue in sub-Saharan Africa, particularly affecting young children. The RTS,S/AS01E vaccine represents a critical advancement in malaria prevention, necessitating effective monitoring of its safety and efficacy.

Data Highlights

No numerical data is available in the source material.

Key Findings

  • Tailored training improved knowledge and reporting of adverse events among healthcare professionals.
  • Challenges included resource limitations and limited uptake of digital tools.
  • Post-approval studies aimed to gather additional data on RTS,S/AS01E safety and effectiveness.
  • Pharmacovigilance systems in the pilot countries were underdeveloped, complicating safety monitoring.
  • Previous initiatives showed that training healthcare professionals enhances adverse event reporting.

Clinical Implications

Healthcare professionals should be equipped with adequate training and resources to monitor vaccine safety effectively. Addressing the challenges faced during the RTS,S/AS01E rollout can enhance future vaccine implementation strategies.

Conclusion

The experiences from the RTS,S/AS01E vaccine implementation provide insights for improving vaccine safety monitoring.

Related Resources & Content

  1. Infection, Springer, 2024 -- Efficacy, Safety, and Community Attitudes Towards Malaria Vaccines in Africa: A Comprehensive Review of Recent Empirical Research
  2. The Journal of Infectious Diseases, 2024 -- Efficacy of RTS,S/AS01E Only Seen in Baseline Parasitemic and Not Baseline Aparasitemic Plasmodium falciparum-Exposed, Drug-Treated Kenyan Adults
  3. Drug Safety, 2020 -- Improving Drug Safety Monitoring in Sub-Saharan Africa: A GSK Pilot Training Program in Malawi
  4. Drug Safety, 2018 -- Real-World Safety Assessment of Injectable Artesunate in Ghana and Uganda: Findings from a Modified Cohort Event Monitoring Study (CEMISA)
  5. WHO, 2024 -- Malaria vaccine: WHO position paper – May 2024
  6. PMC, 2026 -- Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial
  7. ScienceDirect, 2025 -- Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study
  8. Malaria vaccine: WHO position paper – May 2024
  9. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial - PMC
  10. Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study - ScienceDirect

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