Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children

Abstract

ImportanceData are limited regarding adverse reactions after COVID-19 vaccination in patients with a history of multisystem inflammatory syndrome in children (MIS-C). The lack of vaccine safety data in this unique population may cause hesitancy and concern for many families and health care professionals.ObjectiveTo describe adverse reactions following COVID-19 vaccination in patients with a history of MIS-C.Design, Setting, and ParticipantsIn this multicenter cross-sectional study including 22 North American centers participating in a National Heart, Lung, and Blood Institute, National Institutes of Health–sponsored study, Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC), patients with a prior diagnosis of MIS-C who were eligible for COVID-19 vaccination (age ≥5 years; ≥90 days after MIS-C diagnosis) were surveyed between December 13, 2021, and February 18, 2022, regarding COVID-19 vaccination status and adverse reactions.ExposuresCOVID-19 vaccination after MIS-C diagnosis.Main Outcomes and MeasuresThe main outcome was adverse reactions following COVID-19 vaccination. Comparisons were made using the Wilcoxon rank sum test for continuous variables and the χ2 or Fisher exact test for categorical variables.ResultsOf 385 vaccine-eligible patients who were surveyed, 185 (48.1%) received at least 1 vaccine dose; 136 of the vaccinated patients (73.5%) were male, and the median age was 12.2 years (IQR, 9.5-14.7 years). Among vaccinated patients, 1 (0.5%) identified as American Indian/Alaska Native, non-Hispanic; 9 (4.9%) as Asian, non-Hispanic; 45 (24.3%) as Black, non-Hispanic; 59 (31.9%) as Hispanic or Latino; 53 (28.6%) as White, non-Hispanic; 2 (1.1%) as multiracial, non-Hispanic; and 2 (1.1%) as other, non-Hispanic; 14 (7.6%) had unknown or undeclared race and ethnicity. The median time from MIS-C diagnosis to first vaccine dose was 9.0 months (IQR, 5.1-11.9 months); 31 patients (16.8%) received 1 dose, 142 (76.8%) received 2 doses, and 12 (6.5%) received 3 doses. Almost all patients received the BNT162b2 vaccine (347 of 351 vaccine doses [98.9%]). Minor adverse reactions were observed in 90 patients (48.6%) and were most often arm soreness (62 patients [33.5%]) and/or fatigue (32 [17.3%]). In 32 patients (17.3%), adverse reactions were treated with medications, most commonly acetaminophen (21 patients [11.4%]) or ibuprofen (11 [5.9%]). Four patients (2.2%) sought medical evaluation, but none required testing or hospitalization. There were no patients with any serious adverse events, including myocarditis or recurrence of MIS-C.Conclusions and RelevanceIn this cross-sectional study of patients with a history of MIS-C, no serious adverse events were reported after COVID-19 vaccination. These findings suggest that the safety profile of COVID-19 vaccination administered at least 90 days following MIS-C diagnosis appears to be similar to that in the general population.

COVID-19 mRNA BNT162b2 vaccine safety and B-cell and T-cell reactogenicity among children with a history of paediatric multisystem inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) - preliminary study

“…Wisniewski et al also did not observe subsequent cases of MIS-C after vaccination against COVID-19 of 15 adolescents over 12 years old with such a history, in a mean preceding 189.5 days [66] . More recently, a larger retrospective analysis also showed a good safety profile of COVID-19 vaccines in 185 children with a history of PIMS-TS aged ≥ 5 years vaccinated with at least one dose of COVID-19 vaccine [67] . Similarly to our results, local reactions were most common and no cases of MIS-C/PIMS-TS or myocarditis were reported after vaccination.…”

Predictors of Parents’ Willingness to Vaccinate Their Children Against COVID-19 in India: A Web-Based Cross-Sectional Survey

“…The evidence shows that COVID-19 vaccine can protect the children against MIS-C, long, and severe form of COVID-19. 10 ‐ 13 There is a need to bring mindfulness among parents about the advantages presented by Coronavirus immunization in children.…”

“… 10 Children are at risk of getting “long COVID-19” means long lasting symptoms (headache, and fatigue) from weeks to months. The latest research shows that COVID-19 vaccine protect the children from risk of getting sick, long COVID-19, and MIS-C. 11 ‐ 13 Also the vaccine protects development of severe form of COVID-19 among children with underlying health problems. 14 …”

Multi-Inflammatory Syndrome in Children (MIS-C) in 2023: Is It Time to Forget about It?

“…Indeed, when the SARS-CoV-2 vaccine became available for children, there were some concerns that vaccination might cause a MIS-C relapse in patients recovering from the disease [ 62 ]. There are now sufficient data from multiple cohorts to affirm that the SARS-CoV-2 vaccine is safe in patients who have already had MIS-C [ 63 , 64 , 65 ]. The Centers for Disease Control and Prevention (CDC) and the European Academy of Allergy and Clinical Immunology (EAACI) recommend considering vaccination for patients who have recovered from MIS-C (with the restoration of cardiac function) and at least 90 days after the MIS-C diagnosis, although the final decision has to be taken on a case-by-case basis [ 66 , 67 ].…”