MYKKE Registry – Registration of Children and Adolescents with Suspected Myocarditis after COVID-19 Vaccination

Dr Dirk Mentzer, Head of the Pharmacovigilance 1 Unit at the Paul-Ehrlich-Institut and paediatrician emphasises: "We are pleased to gain further valuable information regarding the safety of COVID-19 vaccines for children and adolescents through this collaboration in a prospective study."

Professor Dr Stephan Schubert, MYKKE study leader, Clinic for Paediatric Cardiology and Congenital Heart Defects, Heart and Diabetes Centre North Rhine-Westphalia says: "The entire MYKKE team and the German Society for Paediatric Cardiology and Congenital Heart Defects are extremely pleased about this important cooperation with the Paul-Ehrlich-Institut. Together, we want to record and characterise the intensity and also possible consequences of myocarditis after COVID-19 vaccination with a research network that has been established for years. Only this will create the facts and transparency necessary for all colleagues in this special age group in order to be able to continue to advise and treat patients well."

PD Dr Daniel Messroghli, MYKKE study director, German Heart Centre Berlin, adds: "The media reports about heart muscle inflammations after COVID-19 vaccination in children and adolescents have caused uncertainty and concern among many parents. With the cooperation now agreed, we can make an important contribution to informing the population on the basis of scientifically proven findings."

"A network of paediatric cardiology centres in Germany, Austria and Switzerland that has been built up over many years is now benefiting us in view of an urgent clinical issue," adds study physician Dr med Franziska Seidel, German Heart Centre Berlin. "At this point we would like to thank all colleagues involved for their cooperation."

Dr Stefan Renz, Vice President of the Professional Association of Paediatricians and Adolescents (Berufsverband der Kinder- und Jugendärzte e.V., BVKJ), emphasises the great benefit of the project: "The BVKJ expressly welcomes this cooperation. It will be a great gain of information for us to be able to better advise the children and adolescents as well as their parents. Reliable statements can only be made with valid data. We absolutely need to know what the course is after myocarditis, whether there are risks for cardiac arrhythmias."

Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, emphasises: "It is important to follow up even very rare serious reactions to COVID-19 vaccinations and to ensure that no permanent damage occurs. The cooperation of our Institute with registries and their support is a great help here, for which I am grateful."

Background - MYYKE Registry

The MYKKE Registry was established in 2013 by the Clinic for Congenital Heart Defects - Paediatric Cardiology at the German Heart Centre Berlin. Currently, 29 paediatric heart centres and paediatric hospitals in Germany, Austria and Switzerland are participating. This makes it the largest paediatric registry for patients with suspected myocarditis worldwide.

Data on anamnesis, diagnostics, therapy and course are recorded in a standardised manner. The infrastructure for data collection and provision of data for research is provided by the National Registry for Congenital Heart Defects (Nationale Register für angeborene Herzfehler e.V., NR AHF). NR AHF serves as the infrastructure for data collection and provision for research. Since 2017, the infrastructure of the MYKKE Registry has been supported by donations from the Community for the Support of German Children’s Heart Centres, the "Children’s Hearts" (Fördergemeinschaft Deutsche Kinderherzzentren e.V., "Kinderherzen").

Background - Myocarditis in children and adolescents after COVID-19 vaccination

On 28 May 2021, the marketing authorisation was extended for the COVID-19 vaccine Comirnaty from BioNTech/Pfizer and on 23 July 2021, the marketing authorisation was extended for the COVID-19 vaccine Spikevax from Moderna for children and adolescents aged 12 years and older for protection against COVID-19 disease. Until then, the vaccines were authorised from the age of 18 years. On 16 August 2021, the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) issued the COVID-19 vaccine recommendation for all children and adolescents from the age of 12 years, thus extending the initial recommendation to vaccinate only children with certain pre-existing conditions with these approved COVID-19 vaccines.

It is known that myocarditis (inflammation of the heart muscle) can occur in connection with the use of the mRNA vaccines. The STIKO has pointed out these risks in its recommendations for COVID-19 vaccination of children and adolescents and has taken these adverse events into account in its risk-benefit assessment. Based on current safety data from the Paul-Ehrlich-Institut and other international data, the STIKO updated its COVID-19 vaccination recommendation on 18 November 2021 and recommends that persons under 30 years of age be vaccinated exclusively with Comirnaty and no longer with Spikevax. The reason for this is recent reporting analyses showing that heart muscle inflammations were observed more frequently in boys and young men as well as in girls and young women under 30 years of age with Spikevax than after vaccination with Comirnaty.

Boys and young men mostly a few days after the second vaccination were affected significantly more often than older men, girls and women. In the majority of cases, the patients were hospitalised with myocarditis, but in large part had an initially uncomplicated course under appropriate medical care.

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