PMID- 36870876 OWN - NLM STAT- MEDLINE DCOM- 20230328 LR - 20230421 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 41 IP - 13 DP - 2023 Mar 24 TI - 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. PG - 2289-2299 LID - S0264-410X(23)00227-X [pii] LID - 10.1016/j.vaccine.2023.02.072 [doi] AB - To assess the safety of Pfizer-BioNTech COVID-19 mRNA BNT162b2 vaccine (Comirnaty(R)) 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. CI - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Ludwikowska, Kamila M AU - Ludwikowska KM AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. Electronic address: kama.ludwikowska@gmail.com. FAU - Popiel, Aneta AU - Popiel A AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland; Department of Histology and Embryology, Department of Human Morphology and Embryology, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. FAU - Matkowska-Kocjan, Agnieszka AU - Matkowska-Kocjan A AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. FAU - Olbromski, Mateusz J AU - Olbromski MJ AD - Department of Histology and Embryology, Department of Human Morphology and Embryology, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. FAU - Biela, Mateusz AU - Biela M AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. FAU - Wojcik, Marta AU - Wojcik M AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. FAU - Szenborn, Filip AU - Szenborn F AD - Faculty of Electronics, Wroclaw University of Science and Technology, Stanislawa Wyspianskiego 27, 50-370 Wroclaw, Poland. FAU - Wielgos, Katarzyna AU - Wielgos K AD - Department of Paediatrics, J. Gromkowski Regional Specialist Hospital in Wroclaw, Koszarowa 5, 51-149 Wroclaw, Poland. FAU - Pielka-Markiewicz, Ewa AU - Pielka-Markiewicz E AD - University Clinical Hospital in Opole Pediatric Ward, Wincentego Witosa 26, 46-020 Opole, Poland. FAU - Zaryczanski, Janusz AU - Zaryczanski J AD - Department of Paediatrics, Institute of Medical Sciences, University of Opole, Wincentego Witosa 26, 46-020 Opole, Poland. FAU - Kursa, Miron B AU - Kursa MB AD - Interdisciplinary Centre for Mathematical and Computational Modelling, University of Warsaw, Pawinskiego 5A, 02-106 Warsaw, Poland. FAU - Szenborn, Leszek AU - Szenborn L AD - Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wroclaw, Poland. LA - eng PT - Journal Article DEP - 20230302 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (BNT162 Vaccine) RN - 0 (RNA, Messenger) RN - pediatric multisystem inflammatory disease, COVID-19 related SB - IM MH - Humans MH - Child MH - Male MH - Female MH - *COVID-19/prevention & control MH - BNT162 Vaccine MH - Prospective Studies MH - T-Lymphocytes MH - RNA, Messenger/genetics PMC - PMC9977623 COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2023/03/05 06:00 MHDA- 2023/03/28 19:05 PMCR- 2023/03/02 CRDT- 2023/03/04 22:08 PHST- 2022/11/08 00:00 [received] PHST- 2023/02/20 00:00 [revised] PHST- 2023/02/22 00:00 [accepted] PHST- 2023/03/28 19:05 [medline] PHST- 2023/03/05 06:00 [pubmed] PHST- 2023/03/04 22:08 [entrez] PHST- 2023/03/02 00:00 [pmc-release] AID - S0264-410X(23)00227-X [pii] AID - 10.1016/j.vaccine.2023.02.072 [doi] PST - ppublish SO - Vaccine. 2023 Mar 24;41(13):2289-2299. doi: 10.1016/j.vaccine.2023.02.072. Epub 2023 Mar 2.