Humoral and cellular immunogenicity, effectiveness and safety of COVID-19 mRNA vaccination in patients with pediatric rheumatic diseases: A prospective cohort study

• Published in: Vaccine Vol. 42; no. 5; pp. 1145 - 1153
• Main Authors: Hamad Saied, Mohamad, van Straalen, Joeri W., de Roock, Sytze, Verduyn Lunel, Frans M., de Wit, Jelle, de Rond, Lia G.H., Van Nieuwenhove, Erika, Vastert, Bas J., van Montfrans, Joris M., van Royen-Kerkhof, Annet, de Joode-Smink, Gerrie C.J., Swart, Joost F., Wulffraat, Nico M., Jansen, Marc H.A.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 15.02.2024; Elsevier Limited
• Subjects: Antibodies; Antibodies, Viral; Arthritis; Arthritis, Juvenile - complications; Cellular immunogenicity; Child; Cohort analysis; Cohort study; COVID-19; COVID-19 - prevention & control; COVID-19 mRNA vaccines; COVID-19 vaccines; COVID-19 Vaccines - administration & dosage; Drug therapy; Effectiveness; Electronic health records; Electronic medical records; Epidemiology; Humans; Humoral immunogenicity; IgG antibody; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulin G; Juvenile idiopathic arthritis; Lymphocytes T; mRNA; mRNA vaccines; Multisystem inflammatory syndrome in children; Patients; Pediatric rheumatic diseases; Pediatrics; Prospective Studies; Regression analysis; Rheumatic Diseases; Rheumatology; RNA, Messenger; Safety; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Tumor necrosis factor-TNF; Vaccination; Vaccine effectivity; Vaccine safety; Vaccines; Cellular immunogenicity; Vaccine effectivity; Humoral immunogenicity; Cohort study; COVID-19 mRNA vaccines; Vaccine safety; Pediatric rheumatic diseases; Epidemiology; Juvenile idiopathic arthritis
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2024.01.047

To evaluate immunogenicity, effectiveness and safety of COVID-19 vaccination in patients with pediatric autoimmune inflammatory rheumatic disease (pedAIIRD). A prospective cohort study was performed at the pediatric rheumatology department of the Wilhelmina Children’s Hospital in Utrecht, the Netherlands. Vaccination dates, COVID-19 cases and vaccine-related adverse events (AEs) were registered for all pedAIIRD patients during regular clinic visits from March 2021 – August 2022. SARS-CoV-2 IgG antibody levels and T-cell responses were measured from serum samples after vaccination, and clinical and drug therapy data were collected from electronic medical records. Rate of COVID-19 disease was compared between vaccinated and unvaccinated patients in a time-varying Cox regression analysis. A total of 157 patients were included in this study and 88 % had juvenile idiopathic arthritis (JIA). One hundred thirty-seven patients were fully vaccinated, of which 47 % used biological agents at the time of vaccination, and 20 patients were unvaccinated. Geometric mean concentrations (GMCs) of post-vaccine antibody levels against SARS-CoV-2 were above the threshold for positivity in patients who did and did not use biological agents at the time of vaccination, although biological users demonstrated significantly lower antibody levels (adjusted GMC ratio: 0.38, 95 % CI: 0.21 – 0.70). T-cell responses were adequate in all but two patients (9 %). The adjusted rate of reported COVID-19 was significantly lower for fully vaccinated patients compared to non-vaccinated patients (HR: 0.53, 95 % CI: 0.29 – 0.97). JIA disease activity scores were not significantly different after vaccination, and no serious AEs were reported. COVID-19 mRNA vaccines were immunogenic (both cellular and humoral), effective and safe in a large cohort of pedAIIRD patients despite their use of immunosuppressive medication.