Evaluates safety signals in malaria vaccine implementation, suggesting improvements in monitoring methods.
The RTS,S/AS01 malaria vaccine implementation programme evaluated safety signals from the phase 3 trial using sentinel hospital and community-based mortality surveillance. Strengthened pharmacovigilance was used to identify rare, unanticipated signals related to vaccination. Cohort event monitoring was designed to identify rare conditions of special interest. We summarise the strengths and weaknesses of these complementary approaches to safety monitoring.
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Schellenberg et al. (2026) studied this question.
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