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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

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cris.lastimport.scopus2024-02-12T19:02:56Z
dc.abstract.enTo assess the safety of Pfizer-BioNTech COVID-19 mRNA BNT162b2 vaccine (Comirnaty®) among patients with the anamnesis of paediatric inflammatory syndrome temporally associated with COVID-19 (PIMS-TS), we conducted a prospective cohort study of 21 patients with history of PIMS (PIMS group, median age 7.4 years, 71% male) and 71 healthy controls without such an anamnesis (CONTROL group, median age 9.0 years, 39% male) aged 5–18 years. Among them, 85 patients (all PIMS patients and 64 CONTROL patients) completed the two dose schedule of vaccination administered 21 days apart and 7 children in the CONTROL group received a single, age appropriate dose of a COVID-19 mRNA BNT162b2 vaccine during the study period. The frequency and character of reported adverse events (AEs) after each dose and results of flow cytometry (FC) 3 weeks after a second dose were compared between those groups. COVID-19 mRNA BNT162b2 vaccine safety profile was very good and comparable in both groups. No severe AEs were observed. 30% of all patients reported some general AE after any vaccine dose and 46% - some local AE. Frequency of reported AEs did not differ between groups except for local hardening at injection site, more common in PIMS group (20% vs 4% after any vaccine dose, p = 0,02). All AEs were benign, general AEs lasted up to 5 days and localised - up to 6 days after a vaccine dose. COVID-19 mRNA BNT162b2 vaccine did not induce any PIMS-like symptoms in any patient. We did not observe any significant T cells or B cells subset abnormalities in the PIMS group compared to the CONTROL group three weeks after a second dose except for terminally differentiated effector memory T cells that were higher in PIMS group (p < 0.0041). To sum up COVID-19 mRNA BNT162b2 vaccine in children with PIMS-TS was safe. Further studies are required to support our findings.
dc.affiliationUniwersytet Warszawski
dc.contributor.authorMatkowska-Kocjan, Agnieszka
dc.contributor.authorWójcik, Marta
dc.contributor.authorSzenborn, Filip
dc.contributor.authorWielgos, Katarzyna
dc.contributor.authorLudwikowska, Kamila
dc.contributor.authorPopiel, Aneta
dc.contributor.authorOlbromski, Mateusz
dc.contributor.authorBiela, Mateusz
dc.contributor.authorZaryczański, Janusz
dc.contributor.authorKursa, Miron
dc.contributor.authorPielka-Markiewicz, Ewa
dc.contributor.authorSzenborn, Leszek
dc.date.accessioned2024-01-24T20:54:24Z
dc.date.available2024-01-24T20:54:24Z
dc.date.copyright2023-03-02
dc.date.issued2023
dc.description.accesstimeAT_PUBLICATION
dc.description.financePublikacja bezkosztowa
dc.description.number13
dc.description.versionFINAL_PUBLISHED
dc.description.volume41
dc.identifier.doi10.1016/J.VACCINE.2023.02.072
dc.identifier.issn0264-410X
dc.identifier.urihttps://repozytorium.uw.edu.pl//handle/item/103866
dc.identifier.weblinkhttp://dx.doi.org/10.1016/j.vaccine.2023.02.072
dc.languageeng
dc.pbn.affiliationbiological sciences
dc.relation.ispartofVaccine
dc.relation.pages2289-2299
dc.rightsCC-BY-NC
dc.sciencecloudnosend
dc.titleCOVID-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
dc.typeJournalArticle
dspace.entity.typePublication