key: cord-0761667-atfpea7f
authors: Dimopoulou, Dimitra; Spyridis, Nikos; Vartzelis, George; Tsolia, Maria N.; Maritsi, Despoina N.
title: Safety and tolerability of the COVID‐19 mRNA‐vaccine in adolescents with juvenile idiopathic arthritis on treatment with TNF‐inhibitors
date: 2021-09-07
journal: Arthritis Rheumatol
DOI: 10.1002/art.41977
sha: 66c274257116410817c2ca1f5fd27e2a70d37b7a
doc_id: 761667
cord_uid: atfpea7f

Patients with rheumatic and musculoskeletal diseases (RMDs) on immunosuppressants are considered a vulnerable group in COVID‐19 pandemic and vaccination is the mainstay for the prevention of this infection (1). To date, recommendations and data for COVID‐19 vaccination in adolescent patients with RMDs are lacking (2). International societies and post‐authorization safety reports of the novel mRNA COVID‐19 vaccines are generally reassuring; nonetheless their safely profile in adolescents with RMDs on immune‐modulating treatment is unknown, since these individuals were excluded from the vaccine trials (3‐5).

This article is protected by copyright. All rights reserved Financial Disclosure: The authors have no financial relationships relevant to this article to disclose.

The authors have no potential conflicts of interest to disclose.

To the Editor:

Patients with rheumatic and musculoskeletal diseases (RMDs) on immunosuppressants are considered a vulnerable group in COVID-19 pandemic and vaccination is the mainstay for the prevention of this infection (1) . To date, recommendations and data for COVID-19 vaccination in adolescent patients with RMDs are lacking (2) . International societies and post-authorization safety reports of the novel mRNA COVID-19 vaccines are generally reassuring; nonetheless their safely profile in adolescents with RMDs on immune-modulating treatment is unknown, since these individuals were excluded from the vaccine trials (3) (4) (5) . Furthermore, there is a theoretical risk for RMDs flare, however the estimated risks and benefits clearly favor vaccination (1, 2) . In the adult population, it has been demonstrated that the vast majority of patients with RMDs using non-Bcell-depleting therapy, who received 2 doses of the COVID-19 mRNA vaccine, developed a positive antibody response though data on relative amount of antibody response are still lacking and presented only minor side effects with no apparent disease exacerbation/flare (6). This study aims to evaluate the safety and tolerability of the BNT162b2 COVID-19 vaccine in adolescents with juvenile idiopathic arthritis (JIA) on TNF-inhibitor treatment.

This single-center study involved adolescents aged 16-21 years old with stable JIA who have been 

This article is protected by copyright. All rights reserved were planned at 1, 2 and 3 months after vaccination. All participants were observed for 30 min after the injection and were given a diary card to record the occurrence of local or systemic symptoms for the following 14 days. Adverse reactions were defined as any reaction that lasted for >7 days after the vaccination and serious adverse reactions as any reaction requiring medical attention or hospitalization. Disease activity was evaluated by using the Juvenile Arthritis Disease Activity Score (JADAS-27) (7). Data were analyzed using SPSS 18.0 software. P-value<0.05 was considered statistically significant. This is the first study demonstrating that mRNA vaccines appear safe and well tolerated in adolescents with JIA on TNF-inhibitors. Although our sample size was small and a restricted number of patients were included within each JIA-type and treatment groups, it may be concluded that the vaccine assures an adequate safety and tolerability profile and not provoking disease flare.

As there is no evidence about COVID-19 vaccination in this population, further studies are needed to evaluate the immune response, analyze the immunogenicity of the two-dose schedule, and determine the real duration of immune protection.

Vaccination of patients with inflammatory rheumatic diseases against SARS-CoV-2: considerations before widespread availability of the vaccines

Point of view on the vaccination against COVID-19 in patients with autoimmune inflammatory rheumatic diseases

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 1. Arthritis Rheumatol

View-points on SARS-CoV-2 vaccination in patients with RMDs

Guidelines and Recommendations. PRES update regarding COVID-19 vaccines in pediatric rheumatic patients