It was recently discovered that the mRNA vaccines from Biontech/Pfizer and Moderna can lead to heart muscle inflammation in very rare cases. How often do these complaints now occur in children and adolescents? This is what the Paul Ehrlich Institute (PEI) and the MYKKE registry wanted to find out. MYKKE is considered the largest registry for heart muscle inflammation in children and adolescents worldwide.
mRNA vaccines can trigger heart muscle inflammation
Weeks ago, Israeli and American studies had concluded that the use of mRNA vaccines can lead to the development of heart muscle inflammation in very rare cases. These cases are very rare and were observed in only 1.3 cases per 100,000 vaccinations. In the age group between 16 and 19 years, however, this side effect occurs much more frequently. In this age group, 13.7 cases per 100,000 vaccinations were observed. In the meantime, the mRNA vaccine is also being used in Europe to vaccinate children aged 12 and older. The vaccine is expected to be approved for use in children over the age of 5 relatively soon. It is therefore no wonder that the Paul Ehrlich Institute (PEI) and the Federal Institute for Vaccines and Biomedical Products, as well as the “MYKKE” registry, are interested in obtaining data as quickly as possible that show how often myocarditis is to be expected in this age group. The “MYKKE” registry has been in existence since 2013 and registers all myocarditis cases in children and adolescents.
Data from the registry will be used for evaluation
Now, data will draw on the long-standing infrastructure of the “MYKKE” registry to evaluate data from children and adolescents who report myocraditis following vaccination against Covid-19. The study, which will be conducted in cooperation between the Paul Ehrlich Institute and the “MYKKE” registry, will analyse the frequency and, above all, the long-term course of heart disease after Covid-19 vaccination. This will be ensured by ensuring that all patients are diagnosed and treated according to uniform standards. Twelve-month follow-ups will be done afterwards. “Although this study will not enable us to make a definitive statement on the percentage incidence of myocarditis following vaccination against COVID-19, we hope to gain valuable insights into the severity and course of the disease so that we can treat our patients in the best possible way and avoid subsequent damage. We would like to take this opportunity to thank all colleagues involved in the MYKKE registry for their participation,” explains study physician Dr. Franziska Seidel from the German Heart Institute Berlin.
Myocarditis in children and adolescents after Corona vaccination
In May 2021 and July 2021, respectively, the vaccines from BioNTech/Pfizer and “Spikevax” from Moderna were approved for children and adolescents who are 12 years or older. In addition, according to scientific observations, it is considered certain that heart muscle inflammation can occur in very rare cases when using the mRNA vaccines. This is another reason why the Standing Committee on Vaccination (Stiko) refers to this topic in its recommendation for the vaccination of children and adolescents. Most recently, it was recommended that all persons under 30 years of age be vaccinated with the Biontech vaccine because there have apparently been fewer cases of heart muscle inflammation than with the Moderna vaccine. Boys and young men in particular are more frequently affected by the side effect than girls and young women. So far, however, all patients in Germany have been treated in time, so that the disease has taken an uncomplicated course.