دورية أكاديمية
أعرض في EDS

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Ludwikowska KM; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland. Electronic address: kama.ludwikowska@gmail.com., Popiel A; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland; Department of Histology and Embryology, Department of Human Morphology and Embryology, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland., Matkowska-Kocjan A; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland., Olbromski MJ; Department of Histology and Embryology, Department of Human Morphology and Embryology, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland., Biela M; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland., Wójcik M; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland., Szenborn F; Faculty of Electronics, Wroclaw University of Science and Technology, Stanisława Wyspiańskiego 27, 50-370 Wrocław, Poland., Wielgos K; Department of Paediatrics, J. Gromkowski Regional Specialist Hospital in Wroclaw, Koszarowa 5, 51-149 Wroclaw, Poland., Pielka-Markiewicz E; University Clinical Hospital in Opole Pediatric Ward, Wincentego Witosa 26, 46-020 Opole, Poland., Zaryczański J; Department of Paediatrics, Institute of Medical Sciences, University of Opole, Wincentego Witosa 26, 46-020 Opole, Poland., Kursa MB; Interdisciplinary Centre for Mathematical and Computational Modelling, University of Warsaw, Pawinskiego 5A, 02-106 Warsaw, Poland., Szenborn L; Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland.
المصدر: Vaccine [Vaccine] 2023 Mar 24; Vol. 41 (13), pp. 2289-2299. Date of Electronic Publication: 2023 Mar 02.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: COVID-19*/prevention & control, Humans ; Child ; Male ; Female ; BNT162 Vaccine ; Prospective Studies ; T-Lymphocytes ; RNA, Messenger/genetics
مستخلص: To 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.
Competing Interests: 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.
(Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
References: Proc Natl Acad Sci U S A. 2020 Oct 13;117(41):25254-25262. (PMID: 32989130)
Lancet. 2020 May 23;395(10237):1607-1608. (PMID: 32386565)
Clin Infect Dis. 2023 Feb 8;76(3):e90-e100. (PMID: 35924406)
Vaccine. 2021 May 21;39(22):3037-3049. (PMID: 33640145)
Nature. 2022 Oct;610(7931):246-248. (PMID: 36220929)
JAMA Netw Open. 2021 Jun 1;4(6):e2116420. (PMID: 34110391)
Cell. 2020 Nov 12;183(4):982-995.e14. (PMID: 32991843)
World J Pediatr. 2022 Oct;18(10):700-705. (PMID: 35972716)
Eur J Pediatr. 2011 May;170(5):599-609. (PMID: 20972688)
JAMA Netw Open. 2023 Jan 3;6(1):e2248987. (PMID: 36595296)
N Engl J Med. 2021 Jul 15;385(3):239-250. (PMID: 34043894)
N Engl J Med. 2020 Jul 23;383(4):334-346. (PMID: 32598831)
BMJ Case Rep. 2021 Jul 29;14(7):. (PMID: 34326117)
JAMA. 2020 Jul 21;324(3):259-269. (PMID: 32511692)
Front Immunol. 2021 Feb 24;12:640093. (PMID: 33717193)
N Engl J Med. 2021 Jul 1;385(1):11-22. (PMID: 34133854)
Circulation. 2021 Jan 5;143(1):21-32. (PMID: 33166189)
Int J Mol Sci. 2021 Apr 26;22(9):. (PMID: 33925779)
MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. (PMID: 34968370)
Emerg Infect Dis. 2022 May;28(5):990-993. (PMID: 35275051)
MMWR Morb Mortal Wkly Rep. 2022 Jan 14;71(2):52-58. (PMID: 35025852)
Clin Infect Dis. 2022 Aug 24;75(1):e741-e748. (PMID: 34849680)
Nat Immunol. 2021 Nov;22(11):1452-1464. (PMID: 34611361)
Pediatrics. 2022 Aug 1;150(2):. (PMID: 35614536)
J Pediatric Infect Dis Soc. 2022 Oct 25;11(10):471-473. (PMID: 35904132)
Lancet Infect Dis. 2022 Sep;22(9):1293-1302. (PMID: 35753318)
Pediatr Infect Dis J. 2022 Mar 1;41(3):e87-e89. (PMID: 34978781)
Nat Med. 2022 May;28(5):1050-1062. (PMID: 35177862)
BMJ. 2022 Apr 11;377:e068898. (PMID: 35410884)
Cell. 2020 Nov 12;183(4):968-981.e7. (PMID: 32966765)
Lancet Reg Health Eur. 2022 Aug;19:100443. (PMID: 35945929)
J Clin Invest. 2021 Jul 15;131(14):. (PMID: 34032635)
Pediatr Infect Dis J. 2022 Mar 1;41(3):e93-e94. (PMID: 34955518)
Nat Med. 2020 Dec;26(12):1819-1824. (PMID: 33139949)
Vaccines (Basel). 2021 Nov 18;9(11):. (PMID: 34835284)
Lancet Child Adolesc Health. 2022 May;6(5):303-312. (PMID: 35216660)
Pediatr Allergy Immunol. 2021 Nov;32(8):1857-1865. (PMID: 34331778)
Pediatrics. 2021 Aug;148(2):. (PMID: 34266903)
Front Public Health. 2022 Nov 08;10:1002992. (PMID: 36424958)
BMC Pediatr. 2022 May 2;22(1):241. (PMID: 35501710)
Sci Rep. 2021 Dec 7;11(1):23562. (PMID: 34876594)
Sci Immunol. 2021 Mar 2;6(57):. (PMID: 33653907)
Lancet. 2020 Jun 6;395(10239):1771-1778. (PMID: 32410760)
J Pediatr. 2022 Sep;248:114-118. (PMID: 35598642)
N Engl J Med. 2022 Jan 6;386(1):35-46. (PMID: 34752019)
JAMA. 2022 Jun 28;327(24):2452-2454. (PMID: 35588048)
Lancet Reg Health Eur. 2022 Jun;17:100393. (PMID: 35505833)
N Engl J Med. 2020 Jul 23;383(4):347-358. (PMID: 32598830)
Lancet Child Adolesc Health. 2021 May;5(5):323-331. (PMID: 33711293)
JAMA Netw Open. 2022 Mar 1;5(3):e224750. (PMID: 35344047)
Euro Surveill. 2020 Jun;25(22):. (PMID: 32524957)
Pediatr Int. 2022 Jan;64(1):e15084. (PMID: 34863003)
المشرفين على المادة: 0 (BNT162 Vaccine)
0 (RNA, Messenger)
SCR Disease Name: pediatric multisystem inflammatory disease, COVID-19 related
تواريخ الأحداث: Date Created: 20230304 Date Completed: 20230328 Latest Revision: 20230421
رمز التحديث: 20230421
مُعرف محوري في PubMed: PMC9977623
DOI: 10.1016/j.vaccine.2023.02.072
PMID: 36870876
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2023.02.072