- Sahn B, Lu Y, Hui-Yuen JS, Fishbein J, Gottlieb BS, Eberhard BA, et al. The safety of COVID-19 vaccination in immunocompromised children and young adults with immune-mediated inflammatory disease. Acta Paediatr. 2023;00:1–8.
The study included 190 children, adolescents, and young adults aged 6 to 21 years, 71 percent of whom were girls and women. Most (55 percent) suffered from juvenile idiopathic arthritis or rheumatoid arthritis, others from lupus erythematosus or Crohn's disease. A total of 78 percent received immunomodulatory treatment.
All received three vaccinations (most with BioNTech or Moderna) and were asked about possible side effects after each dose. Sixty-five percent reported at least one side effect, mostly after the second and third vaccination.
Local pain at the injection site was the most common (59 percent), followed by fatigue (54 percent) and headache (39 percent). Severe side effects such as anaphylaxis or myocarditis were absent.
The underlying disease had no influence on the side effect rate, nor did the immunomodulator therapy. With one exception: corticosteroids. Taking them was associated with a lower number of side effects.
The study authors were also interested in the course of the autoimmune disease. Here, too, the all-clear could be given: Only three people had a disease flare-up after the vaccination, whereby the disease activity was already high in two of them before the vaccination.
Finally, the question remains as to whether the vaccination is effective. For this purpose, the antibody titers against the spike protein of SARS-CoV-2 were determined. A high titer of ≥250 U/ml was found in all subjects who were not treated with immunomodulatory drugs, as well as in 85 percent of those who were treated with medication. Thirteen percent of them had lower antibody titers <200 U/ml. Only three of the children and adolescents did not build up sufficient titers. All three were treated with rituximab.
One shortcoming of the study however, was that limited number of participants. Possible rare and severe side effects could therefore not be recorded.
COVID-19 vaccination appears to be effective and safe even for minors suffering from an autoimmune disease. Neither the side effect rate increased, nor was the underlying disease significantly affected by the vaccination. However, immunomodulatory therapy can reduce vaccination success.