4 September 2026 – Europe’s challenge is no longer whether childhood vaccines work, but whether every child can be reached, protected and appropriately followed up.
A new position paper from the European Academy of Paediatrics (EAP), developed in collaboration with experts from the WHO Regional Office for Europe, calls for stronger and more coordinated action to improve paediatric immunisation coverage across Europe. Published in The Lancet Regional Health – Europe, the paper moves beyond broad support for vaccination to set out practical, measurable priorities for health systems.
These figures illustrate the consequences of widening immunity gaps and delayed vaccination.
The paper emphasises that under-vaccination cannot be explained by vaccine confidence alone. Access and acceptance are closely interconnected. Missed opportunities for vaccination, fragmented records, mobility, socioeconomic barriers and difficulties navigating health systems may coexist with misinformation, distrust and concerns about vaccine safety.
For paediatricians and other professionals involved in immunisation, the paper highlights an increasingly important role. Clinical expertise must include not only knowledge of vaccine safety and effectiveness, but also the ability to identify missed vaccination opportunities, communicate effectively with hesitant families and understand the behavioural and structural factors that influence uptake.
The EAP and WHO/Europe contributors underline that protecting children from vaccine-preventable disease requires equitable access, trusted healthcare professionals, reliable and interoperable data, and policy decisions firmly grounded in evidence.
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
