OBJECTIVE: Considering the concerns regarding the coronavirus disease-2019 (COVID-19) vaccine safety among pediatric patients with inflammatory rheumatic diseases (IRD) due to a lack of data, an urgent need for studies evaluating safety profiles of vaccines emerged. METHODS: Among participants vaccinated by CoronaVac inactive SARS-CoV-2 or BNT162b2 messenger RNA (mRNA) COVID-19 (Pfizer-BioNTech) vaccine, healthy children under 18 and patients under 21 with an at least 1-year follow-up period in our department for a childhood-onset rheumatic disease were included into this cross-sectional study. RESULTS: Overall, 246 subjects (141 [57.3%] females) (biologic group: 43, non-biologic group: 180, healthy control group: 23) were eligible for the study. The median age was 15.34 (12.02-20.92) years. The most common adverse events were fatigue (n = 68, 27.6%), headache (n = 44, 17.9%), myalgia (n = 38, 15.4%), arthralgia (n = 38, 15.4%), and fever (n = 35, 14.2%). Only 3 subjects (2 patients with familial Mediterranean fever, and one healthy child) were considered to experienced serious adverse events, since they required hospitalization. Local reactions were seen in 20 (8.13%), and 27 patients (12.1%) had disease flares within 1 month after the vaccines. Although it was significantly higher in those who received the BNT162b2 mRNA vaccine (P < .001), there was no significant relationship between adverse event frequency and age, gender, the existing diseases, ongoing treatment regimens and pre-vaccination COVID-19 histories. CONCLUSION: Although immunogenicity studies for efficacy of the vaccines and long-term follow-up studies for adverse events monitoring are required, our study indicates an acceptable safety profile of COVID-19 vaccines and encourages children with IRD to be vaccinated.
OBJECTIVE: Considering the concerns regarding the coronavirus disease-2019 (COVID-19) vaccine safety among pediatric patients with inflammatory rheumatic diseases (IRD) due to a lack of data, an urgent need for studies evaluating safety profiles of vaccines emerged. METHODS: Among participants vaccinated by CoronaVac inactive SARS-CoV-2 or BNT162b2 messenger RNA (mRNA) COVID-19 (Pfizer-BioNTech) vaccine, healthy children under 18 and patients under 21 with an at least 1-year follow-up period in our department for a childhood-onset rheumatic disease were included into this cross-sectional study. RESULTS: Overall, 246 subjects (141 [57.3%] females) (biologic group: 43, non-biologic group: 180, healthy control group: 23) were eligible for the study. The median age was 15.34 (12.02-20.92) years. The most common adverse events were fatigue (n = 68, 27.6%), headache (n = 44, 17.9%), myalgia (n = 38, 15.4%), arthralgia (n = 38, 15.4%), and fever (n = 35, 14.2%). Only 3 subjects (2 patients with familial Mediterranean fever, and one healthy child) were considered to experienced serious adverse events, since they required hospitalization. Local reactions were seen in 20 (8.13%), and 27 patients (12.1%) had disease flares within 1 month after the vaccines. Although it was significantly higher in those who received the BNT162b2 mRNA vaccine (P < .001), there was no significant relationship between adverse event frequency and age, gender, the existing diseases, ongoing treatment regimens and pre-vaccination COVID-19 histories. CONCLUSION: Although immunogenicity studies for efficacy of the vaccines and long-term follow-up studies for adverse events monitoring are required, our study indicates an acceptable safety profile of COVID-19 vaccines and encourages children with IRD to be vaccinated.
Authors: Saskia Lawson-Tovey; Pedro M Machado; Anja Strangfeld; Elsa Mateus; Laure Gossec; Loreto Carmona; Bernd Raffeiner; Inita Bulina; Daniel Clemente; Julija Zepa; Ana M Rodrigues; Xavier Mariette; Kimme L Hyrich Journal: RMD Open Date: 2022-07