Evidence map›Paper›PMID 42035128›Full record

ReviewMalaria journal2026

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, Diadié Maiga, Lode Schuerman, Cynthia G Whitney

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Malaria journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

David SchellenbergLondon School of Hygiene and Tropical Medicine, London, UK. david.schellenberg@lshtm.ac.uk.
Mary HamelDepartment of Immunizations, Vaccines, and Biologicals, World Health Organization, Geneva, Switzerland.
Patricia NjugunaPATH Center for Vaccine Innovation and Access (CVIA), Nairobi, Kenya.
Eliane FurrerDepartment of Immunizations, Vaccines, and Biologicals, World Health Organization, Geneva, Switzerland.
Nicolas PraetInstitute of Tropical Medicine, Antwerp, Belgium.
Madhava Ram BalakrishnanPharmacovigilance Unit, World Health Organization, Geneva, Switzerland.
Sujeet JainPharmacovigilance Unit, World Health Organization, Geneva, Switzerland.
Diadié MaigaDepartment of Regulation and Prequalification, World Health Organization, Geneva, Switzerland.
Lode SchuermanIndependent Consultant, Diest, Belgium.
Cynthia G WhitneyEmory University, Atlanta, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Malaria, FalciparumMalaria VaccinesHumansPharmacovigilanceVaccines, SyntheticMalaria VaccinesRTS,S-AS01 vaccineVaccines, SyntheticMalariaPilotRTS,S/AS01ESafety assessmentVaccine

Identifiers

PMID42035128
PMCPMC13147597

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.