Assessing safety in the RTS,S/AS01 malaria vaccine implementation programme: an overview and comparison of 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.
Authors
- Nicolas Praet (ORCID: https://orcid.org/0000-0002-6680-9588)
- Sujeet Jain
- Madhava Ram Balakrishnan
- Cynthia G. Whitney (ORCID: https://orcid.org/0000-0002-1056-3216)
- Lode Schuerman (ORCID: https://orcid.org/0000-0003-0697-6242)
- Eliane Furrer
- Diadié Maïga
- Mary Hamel
- David Schellenberg
- Patricia Njuguna
Institutions
- Emory University (US)
- London School of Hygiene & Tropical Medicine (GB)
- World Health Organization (CH)
- Kenya AIDS Vaccine Initiative (KE)
- ProDigest (Belgium) (BE)
- Instituut voor Tropische Geneeskunde (BE)
Publication Details
- Journal
- Malaria Journal
- Published
- 2026-04-25
- DOI
- https://doi.org/10.1186/s12936-026-05887-z
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00