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Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

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

David Schellenberg¹, Mary Hamel², Patricia Njuguna³

¹London School of Hygiene and Tropical Medicine, London, UK. david.schellenberg@lshtm.ac.uk.

Malaria Journal

|April 26, 2026

Summary

The RTS,S/AS01 malaria vaccine program used multiple safety monitoring methods. These approaches helped identify potential vaccine risks and ensure participant safety during the trial.

Keywords:

Malaria Pilot RTS,S/AS01E Safety assessment Vaccine

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Area of Science:

Vaccinology
Public Health
Epidemiology

Background:

The RTS,S/AS01 malaria vaccine underwent extensive clinical trials.
Post-implementation safety surveillance is crucial for any vaccine program.
Understanding safety profiles of malaria vaccines informs public health strategies.

Purpose of the Study:

To evaluate the safety monitoring systems used in the RTS,S/AS01 malaria vaccine implementation program.
To assess the strengths and weaknesses of different safety surveillance methods.
To inform future vaccine safety monitoring strategies.

Main Methods:

Utilized sentinel hospital and community-based mortality surveillance for general safety signals.
Employed strengthened pharmacovigilance to detect rare, unexpected vaccine-related events.
Implemented cohort event monitoring to identify specific rare conditions of interest.

Main Results:

The study describes the application of complementary safety monitoring approaches.
Identified strengths and limitations inherent in each surveillance method.
Provided insights into the practicalities of real-world vaccine safety evaluation.

Conclusions:

Combined safety surveillance methods offer a comprehensive approach to vaccine monitoring.
Each method has unique strengths and weaknesses for detecting different types of safety signals.
Effective safety monitoring is essential for the successful implementation of malaria vaccines.