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

David Schellenberg; Mary Hamel; Patricia Njuguna; Eliane Furrer; Nicolas Praet; Madhava Ram Balakrishnan; Sujeet Jain; Diadie Maiga; Lode Schuerman; Cynthia G. Whitney

doi:10.1186/s12936-026-05887-z

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

David Schellenberg
, Mary Hamel
, Patricia Njuguna
, Eliane Furrer
, Nicolas Praet
, Madhava Ram Balakrishnan
, Sujeet Jain
, Diadie Maiga
, Lode Schuerman
, Cynthia G. Whitney

Pharmaceutical Public Health

Research output: Contribution to journal › A1: Peer-reviewed journal articles › peer-review

Abstract

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.

Original language	English
Article number	195
Journal	Malaria Journal
Volume	25
Issue number	1
Number of pages	7
ISSN	1475-2875
DOIs	https://doi.org/10.1186/s12936-026-05887-z
Publication status	Published - 25-Apr-2026

Keywords

Malaria
Pilot
Rts,s/as01e
Safety assessment
Vaccine
Malaria Vaccines/adverse effects
Vaccines, Synthetic/adverse effects
Malaria/prevention & control
Humans
Malaria, Falciparum/prevention & control
Pharmacovigilance

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10.1186/s12936-026-05887-zLicence: CC BY

Cite this

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AU - Schellenberg, David

AU - Hamel, Mary

AU - Njuguna, Patricia

AU - Furrer, Eliane

AU - Praet, Nicolas

AU - Balakrishnan, Madhava Ram

AU - Jain, Sujeet

AU - Maiga, Diadie

AU - Schuerman, Lode

AU - Whitney, Cynthia G.

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KW - Safety assessment

KW - Vaccine

KW - Malaria Vaccines/adverse effects

KW - Vaccines, Synthetic/adverse effects

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

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Keywords

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