Beyond trials: Implementation research that strengthens health systems

Irene Nailain Nkumama, PhD

Malaria Programme Manager, European Vaccine Initiative

Elena Ambrosio, PhD

Senior Project Manager, European Vaccine Initiative

Developing a safe and effective vaccine is only part of the challenge. Ensuring it reaches the right people, at the right time and that its performance in real settings is rigorously documented, is equally critical.

This is the work of implementation research, which bridges clinical evidence and public health impact, and one that European Vaccine Initiative (EVI) has increasingly placed at the heart of its mission.

Actionable guidance through implementation research

As malaria vaccine rollout expands across Africa, the need for evidence to guide policy and optimise delivery has never been greater. The MVPE-CC consortium addressed this through case-control studies across Kenya, Malawi and Ghana to evaluate the safety, effectiveness and optimal dosing schedule of the RTS,S vaccine in routine immunisation settings.

In 2025, WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) and Malaria Policy Advisory Group (MPAG) drew on MVPE-CC evidence in reaffirming the recommendation for a four-dose RTS,S schedule, confirming that a four-dose schedule provides higher protection against clinical and severe malaria than a three-dose schedule in moderate to high transmission settings.

The findings offered reassurance that, where the delivery of the fourth dose may temporarily be impossible, children would still benefit from three doses until obstacles to the fourth dose’s delivery are resolved*. Evidence generated in communities across these African countries shaped a global policy recommendation that will influence how millions of children are vaccinated.

A vaccine’s value is only fully realised when
the systems, evidence and strategies needed to
deliver it equitably and effectively are in place.

Initiatives to progress malaria vaccine implementation

Through OPT-MVAC, 14 West and Central African countries’ national immunisation, malaria and pharmacovigilance programmes, working alongside leading African and European research institutions, are conducting implementation research tailored to local contexts, sharing data and learning across borders to strengthen delivery systems at scale.

Separately, a new study in Guinea and Benin is evaluating whether a seasonal intensification approach to malaria vaccination is feasible, cost-effective and could improve coverage and burden in highly seasonal transmission areas, findings that could reshape how and when vaccines are delivered in some of the highest-burden settings.

These reflect a core principle: a vaccine’s value is only fully realised when the systems, evidence and strategies needed to deliver it equitably and effectively are in place.