Assessing safety in the RTS,S/AS01 malaria vaccine implementation programme: an overview and comparison of methods

Key Points

• This research aims to assess the safety of the RTS,S/AS01 malaria vaccine via various monitoring methods.
• Utilized sentinel hospital and community-based mortality surveillance for safety signal evaluation.
• Employed strengthened pharmacovigilance to identify rare unanticipated signals.
• Implemented cohort event monitoring for rare conditions of special interest.
• Strengths and weaknesses of different safety monitoring methods were identified.
• Complementary approaches enhanced the understanding of vaccine safety.
• Insights gathered could inform future vaccine implementation strategies.

Abstract