Humoral response and safety of BNT162b2 mRNA vaccine in children with rheumatic diseases

Abstract

Objectives The vaccine represents a cornerstone in tackling the COVID-19 pandemic and with the approval of the BNT162b2 mRNA vaccine in December 2020, it has become a beacon of hope for people around the world, including children. This study aimed to present the data on the humoral response and safety of vaccine in a cohort of patients with pediatric rheumatic diseases (PedRD) receiving immunomodulatory treatments. Methods Forty-one children with PedRD were included and were vaccinated with the BNT162b2 m-RNA vaccine (two doses of 30 µg administered three to four weeks apart). To assess the humoral response, IgG antibodies developed against the S1/Receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at baseline and 3-4 weeks after the second dose were measured. The possible local and systemic side effects and disease activity scores were evaluated during the study period. Results After the second dose of vaccine, markedly elevated anti-RBD IgG titers were observed in all patients with a median titre of 20474 AU/ml (IQ range:6534–36151) with a good safety profile. The median disease duration was 4.3 (IQ: 3.5-5.6) years. In the cohort, 14 (34.1%) received cDMARDs, 16 (39%) received bDMARDs and 11 (26.8%) received a combined therapy (cDMARDs and bDMARDs). Patients treated with combined therapy (median 4695 [IQR:2764-26491]) had significantly lower median titers of anti-RBD IgG than those receiving only cDMARDs. Conclusion PedRD patients receiving immunomodulatory treatments were able to mount an effective humoral response after two dose regimens of BNT162b2 mRNA vaccine safely without interrupting their current treatments.

Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis

“…Of the 88 articles included, there were 12 RCTs, two non-randomized clinical trials, 40 cohort studies, 19 cross-sectional studies, and 15 case‒control studies. In the studies included, 16 articles were available for immunogenicity analysis (Supplementary Table 2) [ 14 , 15 , 18 , 31 – 43 ]; 38 articles were available for effectiveness analysis (Supplementary Table 3) [ 14 , 17 , 19 , 31 , 44 – 77 ]; and 49 articles were available for safety analysis (Supplementary Table 4) [ 14 – 16 , 18 , 20 – 24 , 31 , 34 , 35 , 37 , 41 , 43 , 45 , 47 , 50 , 55 , 78 – 107 ]. Children and adolescents are involved in 27 countries, including the United States, China, Australia, Argentina, Italy, Israel, France, Denmark, and South Korea, which have larger cohorts (> 100,000 people).…”

Immunogenicity, Safety and Effectiveness of COVID-19 Pfizer-BioNTech (BNT162b2) mRNA Vaccination in Immunocompromised Adolescents and Young Adults: A systematic Review and Meta-Analyses

“…Rheumatic disorders were studied in four studies, and type 1 diabetes, Down syndrome, solid tumor, neurodisability, and cystic fibrosis were studied in one each. Eight studies (Akgün 2022; Dimopoulou 2022; Heshin-Bekenstein 2022; King 2022; Michos 2022; Piccini 2022; Riviere 2021; Valentini 2022)[3,4,8–10,22–24] employed a cohort design, whereas one used a cross-sectional design(Haslak 2022)[6]. Most investigations were undertaken in Europe ( Supplementary Table 2 ).…”

“…The assessment of RoB for these studies was conducted using ROBINS-I (Supplementary Table 3). Six studies had an unclear overall risk of bias (Akgün 2022…”

“…The pandemic has afflicted all population groups, including children, adolescents, and young adults (AYA), despite their milder course [2]. Children and AYA with comorbidities such as chronic lung disorders, obesity, cardiovascular disease, kidney disease, solid organ transplant, malignancies, or rheumatic diseases, as demonstrated in adult populations, have a higher risk of severe diseases with outcomes such as multi-system inflammatory syndrome in children (MIS-C), intensive care unit (ICU) or life support needs, and increased hazards of death [3][4][5][6][7]. Furthermore, COVID-19 clinical presentation in AYA with comorbidities is uncommon and may not follow the conventional epidemiological profile.…”

Vaccinology in pediatric rheumatology: Past, present and future

“…The rate of disease flare was 4.4% after the second mRNA vaccine dose ( 64 ). A study that examined the BNT162b2 mRNA vaccine in 41 adolescents with AIIRD reported that patients who received immunomodulatory treatments safely achieved an effective humoral response after two-dose regimen vaccine, without interrupting their current treatments ( 65 ). A 2022 publication reported a good safety profile in a cohort of 228 children aged 12–18 years ( 66 ).…”