The European Academy of Paediatrics (EAP), as a full member of the Coalition for Vaccination, supports the Coalition’s call urging European countries to increase vaccination coverage and actively tackle misinformation and disinformation
Vaccine hesitancy, vaccine shortages, misinformation and disinformation, and structural barriers within healthcare systems continue to undermine immunisation programmes. Losing the protection achieved through decades of vaccination could have serious consequences for individuals and population groups — particularly children and vulnerable communities.
The Coalition supports the continued efforts of the European Commission, in collaboration with Member States, the European Centre for Disease Prevention and Control (ECDC), and the European Medicines Agency (EMA), to:
Provide clear, accessible and evidence-based information
Actively counter misinformation and disinformation
Support national vaccination strategies based on scientific evidence
Strengthen education and continuing professional development for healthcare professionals
Monitor the performance of immunisation programmes
Advance a European digital vaccination card
Improve transparency in vaccine approval processes
Strengthen independent vaccine safety surveillance at national and EU levels
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.
