Brussels, 23rd August 2021
As children and adolescents around Europe prepare to return to school after the summer break, the European Academy of Paediatrics calls for their vaccination against COVID-19 in order to achieve herd immunity and stop the pandemic. Preliminary studies carried out have shown that the vaccination of children and adolescents is highly effective and safe.
In a joint statement published today in Frontiers, the European Academy of Paediatrics (EAP) and the European Confederation of Primary Care Paediatricians (ECPCP) stress the numerous health benefits provided by the vaccination of children and adolescents against COVID-19, including the return to regular paediatric care and routine vaccinations against other infectious diseases, which were severely disrupted during the pandemic.
Vaccinating children and adolescents will also drive their regular school learning and peer interaction, which is vital to reverse the educational, developmental and psychological problems caused by the lockdown of over 1.5 billion young people worldwide.
The joint statement also presents recommendations to foster immunity and address vaccination in children and adolescents. Among others, EAP recommends that the vaccination of children and adolescents against COVID-19 should be promoted and encouraged worldwide, and paediatric associations should develop national strategies of vaccination into existing vaccination schedules.
Although COVID-19 infection in children is rarely severe, a newly described syndrome (pediatric inflammatory multisystem syndrome) has been observed shortly after infection. Preliminary evidence also shows that long-standing effects of COVID-19 may be seen up to 6 months after infection (including fatigue, muscle and joint pain, insomnia, respiratory problems, and palpitations).
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.
