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Abstract Number: 2193

Prospective Evaluation of Reactogenicity and Safety Following COVID-19 Vaccination in Children with a History of MIS-C

Mariana Sanchez Villa1, Jessica Nguyen2, Danielle Guffey3, Leila Sahni4, Miriah Gillispie-Taylor5, Marietta De Guzman2, S. Kristen Sexson Tejtel2, Sridevi Devaraj4, Flor Munoz4 and Tiphanie Vogel2, 1Baylor college of Medicine, Huffman, TX, 2Baylor College of Medicine, Houston, TX, 3Baylor College of Medicine, Houston, 4Baylor COM, Houston, TX, 5Baylor College of Medicine/Texas Children's Hospital, Houston, TX

Meeting: ACR Convergence 2024

Keywords: immunology, Pediatric rheumatology

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Session Information

Date: Monday, November 18, 2024

Title: Pediatric Rheumatology – Clinical Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: A rare subset of children who contract SARS-CoV-2 later develop the hyperinflammatory condition known as multisystem inflammatory syndrome in children (MIS-C). There has been hesitation to vaccinate these children against COVID-19 due to concerns for a recurrence of hyperinflammation. As part of post-MIS-C follow-up care, we have advocated for COVID-19 vaccination. We aimed to prospectively evaluate reactogenicity and safety following COVID-19 mRNA vaccination among patients with a history of MIS-C compared to healthy children (HC) without a history of inflammatory disease.

Methods: From February 2023 to February 2024, patients 6 months to 20 years of age with a history of MIS-C or HC were enrolled in an IRB-approved study and monitored for 6 months following COVID-19 mRNA vaccination, administered according to age-specific recommendations (standard of care). Prospective reactogenicity data and accompanying impact on quality of life (severity) were collected by survey daily for 7 days following receipt of each vaccine. Pairwise comparisons were performed using Wilcoxon rank-sum for continuous variables and Fisher’s exact test for categorical variables. 

Results: We enrolled 33 patients with a history of MIS-C and 30 HC in the Serial Assessment Following Vaccination After MIS-C (SAF-VAC) study.  Patients with MIS-C were diagnosed a median of 30.2 months prior to SAF-VAC vaccination [IQR: 25.9, 32.7]. There were no differences in age, sex, or insurance coverage between the two groups; however, fewer HC were Non-Hispanic Black and White and more were Hispanic compared to patients with a  history of MIS-C (p< 0.001).  9 of 30 (30%) HC reported a documented previous COVID-19 infection a median of 17.1 months [IQR 6.9, 30.1] prior to SAF-VAC vaccination. Median time between last known COVID-19 infection and SAF-VAC vaccination in patients with a history of MIS-C was 27.8 months [IQR: 20.2, 31.1]. In total, 427 of 441 (97%) reactogenicity surveys from 33 patients with a history of MIS-C and 30 HC were returned. There were no differences in self-reported reactogenicity or severity following COVID-19 vaccination, or in timing of any reported reaction between the two groups (Table I). Most enrolled individuals had been previously vaccinated: 27 (82%) patients with a history of MIS-C 14.9 [IQR: 10.1, 21.5] months prior to SAF-VAC vaccination, and 24 (80%) HC 14.7 [IQR: 10.6, 18] months prior to SAF-VAC vaccination (p=0.591). Among the 6 vaccine naïve individuals in each group, there were no differences in reactogenicity (p=1). There were no concerns for flares of hyperinflammation among patients with a history of MIS-C during 5.8 [IQR: 5.5, 6.6] months of monitored followup.

Conclusion: This cohort of prospectively followed patients with a history of MIS-C tolerated COVID-19 mRNA vaccination with no increase in reactogenicity compared to HC, and without evidence of inflammatory flares.  Our results suggest that patients with a history of MIS-C can safely receive COVID-19 mRNA vaccination. These results are especially reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is recommended.

Supporting image 1

Table I: Serial Assessment Following Vaccination After MIS-C (SAF-VAC)


Disclosures: M. Sanchez Villa: None; J. Nguyen: None; D. Guffey: None; L. Sahni: None; M. Gillispie-Taylor: None; M. De Guzman: None; S. Sexson Tejtel: None; S. Devaraj: None; F. Munoz: None; T. Vogel: AstraZeneca, 5, Moderna, 2, Pfizer, 2, SOBI, 2.

To cite this abstract in AMA style:

Sanchez Villa M, Nguyen J, Guffey D, Sahni L, Gillispie-Taylor M, De Guzman M, Sexson Tejtel S, Devaraj S, Munoz F, Vogel T. Prospective Evaluation of Reactogenicity and Safety Following COVID-19 Vaccination in Children with a History of MIS-C [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/prospective-evaluation-of-reactogenicity-and-safety-following-covid-19-vaccination-in-children-with-a-history-of-mis-c/. Accessed .
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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