{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T16:14:20Z","timestamp":1758816860568,"version":"3.40.5"},"reference-count":40,"publisher":"Deutscher Arzte-Verlag GmbH","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"DOI":"10.3238\/arztebl.m2025.0032","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T09:21:28Z","timestamp":1746609688000},"source":"Crossref","is-referenced-by-count":1,"title":["The long-term tolerability of BNT162b2 in children and adolescents (The CoVacU18 Study)"],"prefix":"10.3238","author":[{"given":"Vivien","family":"Grieshaber","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Strumann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Holzwarth","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Toepfner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wolfgang Carl Gustav","family":"von Mei\u00dfner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikos","family":"Konstantopoulos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"von Poblotzki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kai O.","family":"Hensel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthias B.","family":"Moor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cho-Ming","family":"Chao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"11437","published-online":{"date-parts":[[2025,5,16]]},"reference":[{"key":"10.3238\/arztebl.m2025.0032_ref1","doi-asserted-by":"crossref","unstructured":"Toepfner N, von Meissner WCG, Strumann C, et al.: Comparative safety of the BNT162b2 messenger RNA COVID-19 vaccine vs other approved vaccines in children younger than 5 years. JAMA Netw Open 2022; 5: e2237140","DOI":"10.1001\/jamanetworkopen.2022.37140"},{"key":"10.3238\/arztebl.m2025.0032_ref2","unstructured":"Bundesministerium f\u00fcr Gesundheit: COVID-19-Impfung in Deutschland bis zum 8. April 2023 \u2013 \u00dcbersicht zum Impfstatus, www.impfdashboard.de\/ (last accessed on 19 July 2024)."},{"key":"10.3238\/arztebl.m2025.0032_ref3","unstructured":"Piechotta V, Koch J, Berner R, et al.: Aktualisierung der COVID-19-Impfempfehlung in den allgemeinen Empfehlungen der STIKO 2024 und die dazugeh\u00f6rige wissenschaftliche Begr\u00fcndung. Epid Bull 2024; 2: 3\u201319."},{"key":"10.3238\/arztebl.m2025.0032_ref4","doi-asserted-by":"crossref","unstructured":"Watanabe A, Kani R, Iwagami M, Takagi H, Yasuhara J, Kuno T: Assessment of efficacy and safety of mRNA COVID-19 vaccines in children aged 5 to 11 years: A systematic review and meta-analysis. JAMA Pediatr 2023; 177: 384\u201394","DOI":"10.1001\/jamapediatrics.2022.6243"},{"key":"10.3238\/arztebl.m2025.0032_ref5","doi-asserted-by":"crossref","unstructured":"Piechotta V, Siemens W, Thielemann I, et al.: Safety and effectiveness of vaccines against COVID-19 in children aged 5\u201311 years: A systematic review and meta-analysis. Lancet Child Adolesc Health 2023; 7: 379\u201391","DOI":"10.1016\/S2352-4642(23)00078-0"},{"key":"10.3238\/arztebl.m2025.0032_ref6","doi-asserted-by":"crossref","unstructured":"Wu Q, Tong J, Zhang B, et al.: Real-world effectiveness of BNT162b2 against infection and severe diseases in children and adolescents. Ann Intern Med 2024; 177: 165\u201376","DOI":"10.7326\/L24-0049"},{"key":"10.3238\/arztebl.m2025.0032_ref7","doi-asserted-by":"crossref","unstructured":"Sacco C, Del Manso M, Mateo-Urdiales A, et al.: Effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection and severe COVID-19 in children aged 5\u201311 years in Italy: A retrospective analysis of January-April, 2022. Lancet 2022; 400: 97\u2013103","DOI":"10.1016\/S0140-6736(22)01185-0"},{"key":"10.3238\/arztebl.m2025.0032_ref8","doi-asserted-by":"crossref","unstructured":"Walter EB, Talaat KR, Sabharwal C, et al.: Evaluation of the BNT162b2 covid-19 vaccine in children 5 to 11 years of age. N Engl J Med 2022; 386: 35\u201346","DOI":"10.1056\/NEJMc2118775"},{"key":"10.3238\/arztebl.m2025.0032_ref9","doi-asserted-by":"crossref","unstructured":"Munoz FM, Sher LD, Sabharwal C, et al.: Evaluation of BNT162b2 covid-19 vaccine in children younger than 5 years of age. N Engl J Med 2023; 388: 621\u201334","DOI":"10.1056\/NEJMoa2211031"},{"key":"10.3238\/arztebl.m2025.0032_ref10","doi-asserted-by":"crossref","unstructured":"Frenck RW Jr, Klein NP, Kitchin N, et al.: Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents. N Engl J Med 2021; 385: 239\u201350","DOI":"10.1056\/NEJMoa2107456"},{"key":"10.3238\/arztebl.m2025.0032_ref11","doi-asserted-by":"crossref","unstructured":"Hu M, Wong HL, Feng Y, et al.: Safety of the BNT162b2 COVID-19 vaccine in children aged 5 to 17 Years. JAMA Pediatr\u00a02023; 177: 710\u20137","DOI":"10.1001\/jamapediatrics.2023.1440"},{"key":"10.3238\/arztebl.m2025.0032_ref12","doi-asserted-by":"crossref","unstructured":"Copland E, Patone M, Saatci D, et al.: Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England. Nat Commun 2024; 15: 3822","DOI":"10.1038\/s41467-024-47745-z"},{"key":"10.3238\/arztebl.m2025.0032_ref13","unstructured":"EMA \u2013 European Medicines Agency, Science Medicines Health: ICH guidline for good clinical practice E6(R2) \u2013 Step 5. www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-guideline-good-clinical-practice-e6r2-step-5_en.pdf (last accessed on 27 November 2024)."},{"key":"10.3238\/arztebl.m2025.0032_ref14","unstructured":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte: Arzneimittelinformationssystem, Datenbankinformationen AMIce Chargenpr\u00fcfung, Modul Chargeninformation, www.portal.dimdi.de\/amguifree\/chp\/search.xhtmlde (last accessed on 19 July 2024)."},{"key":"10.3238\/arztebl.m2025.0032_ref15","unstructured":"Produktinformation Comirnaty: Anhang I \u2013 Zusammenfassung der Merkmale des Arzneimittels. www.ema.europa.eu\/de\/documents\/product-information\/comirnaty-epar-product-information_de.pdf (last accessed on 6 December 2024)."},{"key":"10.3238\/arztebl.m2025.0032_ref16","doi-asserted-by":"crossref","unstructured":"Hause AM, Marquez P, Zhang B, et al.: COVID-19 mRNA vaccine safety among children aged 6 months-5 years\u2014United States, June 18, 2022-August 21, 2022. MMWR Morb Mortal Wkly Rep 2022; 71: 1115\u201320","DOI":"10.15585\/mmwr.mm7135a3"},{"key":"10.3238\/arztebl.m2025.0032_ref17","doi-asserted-by":"crossref","unstructured":"Raethke M, van Hunsel F, Thurin NH, et al.: Cohort event monitoring ofadverse reactions to COVID-19 vaccines in seven european countries: pooled results on first dose. Drug Saf 2023; 46: 391\u2013404","DOI":"10.1007\/s40264-023-01281-9"},{"key":"10.3238\/arztebl.m2025.0032_ref18","doi-asserted-by":"crossref","unstructured":"Donze C, Min V, Ninove L, et al.: BNT162b2 COVID-19 vaccines in children, adolescents and young adults with cancer-A 1-year follow-up. Vaccines (Basel) 2023; 11: 989","DOI":"10.3390\/vaccines11050989"},{"key":"10.3238\/arztebl.m2025.0032_ref19","doi-asserted-by":"crossref","unstructured":"Katoto PDMC, Brand AS, Byamungu LN, et al.: Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12\u201317 years: A systematic review and meta-analysis. Hum Vaccin Immunother 2022; 18: 2144039","DOI":"10.1080\/21645515.2022.2144039"},{"key":"10.3238\/arztebl.m2025.0032_ref20","doi-asserted-by":"crossref","unstructured":"Heshin-Bekenstein M, Ziv A, Toplak N, et al.: Safety and immunogenicity following the second and third doses of the BNT162b2 mRNA COVID-19 vaccine in adolescents with juvenile-onset autoimmune inflammatory rheumatic diseases: A prospective multicentre study. Vaccines (Basel) 2023; 11: 819","DOI":"10.3390\/vaccines11040819"},{"key":"10.3238\/arztebl.m2025.0032_ref21","doi-asserted-by":"crossref","unstructured":"Ahmadizar F, Luxi N, Raethke M, et al.: Safety of COVID-19 vaccines among the paediatric population: analysis of the European Surveillance Systems and Pivotal Clinical Trials. Drug Saf 2023; 46: 575\u201385.","DOI":"10.1007\/s40264-023-01304-5"},{"key":"10.3238\/arztebl.m2025.0032_ref22","unstructured":"Nurhani MA, Farah HMS, Ili NMA, et al.: COVID-19 vaccine safety and side effects in children aged 5\u201311 years: A cross-sectional study. Med J Malaysia 2023; 78: 803\u20137."},{"key":"10.3238\/arztebl.m2025.0032_ref23","doi-asserted-by":"crossref","unstructured":"Hause AM, Shay DK, Klein NP, et al.: Safety of COVID-19 vaccination in United States children ages 5 to 11 years. Pediatrics 2022; 150: e2022057313.","DOI":"10.1542\/peds.2022-057313"},{"key":"10.3238\/arztebl.m2025.0032_ref24","doi-asserted-by":"crossref","unstructured":"Matsumoto N, Shimizu J, Yokoyama Y, Tsukahara H, Yorifuji T: Adverse reactions and attitudes toward the BNT162b2 COVID-19 vaccine in children 5 to 11 years of age in Japan. J Epidemiol 2023; 33: 110\u20131.","DOI":"10.2188\/jea.JE20220265"},{"key":"10.3238\/arztebl.m2025.0032_ref25","doi-asserted-by":"crossref","unstructured":"Hesse EM, Hause A, Myers T, et al.: COVID-19 vaccine safety first year findings in adolescents. Pediatrics 2023; 151: e2022060295.","DOI":"10.1542\/peds.2022-060295"},{"key":"10.3238\/arztebl.m2025.0032_ref26","doi-asserted-by":"crossref","unstructured":"Smith LE, Sim J, Sherman SM, et al.: Psychological factors associated with reporting side effects following COVID-19 vaccination: A prospective cohort study (CoVAccS\u2014Wave 3). J Psychosom Res 2023; 164: 111104.","DOI":"10.1016\/j.jpsychores.2022.111104"},{"key":"10.3238\/arztebl.m2025.0032_ref27","doi-asserted-by":"crossref","unstructured":"Sch\u00e4fer I, Oltrogge JH, Nestoriuc Y, et al.: Expectations and prior experiences associated with adverse effects of COVID-19 vaccination. JAMA Netw Open\u00a02023; 6: e234732.","DOI":"10.1001\/jamanetworkopen.2023.4732"},{"key":"10.3238\/arztebl.m2025.0032_ref28","doi-asserted-by":"crossref","unstructured":"Riad A, Pokorn\u00e1 A, Attia S, Klugarov\u00e1 J, Ko\u0161&#269;\u00edk M, Klugar M: Prevalence of COVID-19 vaccine side effects among healthcare workers in the Czech Republic. J Clin Med 2021; 10: 1428.","DOI":"10.3390\/jcm10071428"},{"key":"10.3238\/arztebl.m2025.0032_ref29","doi-asserted-by":"crossref","unstructured":"Klugar M, Riad A, Mekhemar M, et al. Side effects of mRNA-Based and viral vector-based COVID-19 vaccines among german healthcare workers. Biology 2021; 10: 752.","DOI":"10.3390\/biology10080752"},{"key":"10.3238\/arztebl.m2025.0032_ref30","doi-asserted-by":"crossref","unstructured":"Raethke M, van Hunsel F, Luxi N, et al.: Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study. Vaccine 2024; 42: 2357\u201369.","DOI":"10.1016\/j.vaccine.2024.03.001"},{"key":"10.3238\/arztebl.m2025.0032_ref31","doi-asserted-by":"crossref","unstructured":"Moor J, Toepfner N, von Mei\u00dfner WCG, et al.: Sex differences in symptoms following the administration of BNT162b2 mRNA COVID-19 vaccine in children below 5 years of age in Germany (CoVacU5): A retrospective cohort study. Biol Sex Differ 2024; 15: 74.","DOI":"10.1186\/s13293-024-00651-x"},{"key":"10.3238\/arztebl.m2025.0032_ref32","doi-asserted-by":"crossref","unstructured":"Scholkmann F, May CA: COVID-19, post-acute COVID-19 syndrome (PACS, \u201elong COVID\u201c) and post-COVID-19 vaccination syndrome (PCVS, \u201epost-COVIDvac-syndrome\u201c): similarities and differences. Pathol Res Pract 2023; 246: 154497.","DOI":"10.1016\/j.prp.2023.154497"},{"key":"10.3238\/arztebl.m2025.0032_ref33","doi-asserted-by":"crossref","unstructured":"Finsterer J: A case report: long post-COVID vaccination syndrome during the eleven months after the third moderna dose. Cureus 2022; 14: e32433.","DOI":"10.7759\/cureus.32433"},{"key":"10.3238\/arztebl.m2025.0032_ref34","unstructured":"Finterer J, Scorza FA: A retrospective analysis of clinically confirmed long post-COVID vaccination syndrome. J Clin Transl Res 2022; 8: 506\u20138."},{"key":"10.3238\/arztebl.m2025.0032_ref35","doi-asserted-by":"crossref","unstructured":"Mundorf AK, Semmler A, Heidecke H, et al.: Clinical and diagnostic features of post-acute COVID-19 vaccination syndrome (PACVS). Vaccines 2024; 12: 790.","DOI":"10.3390\/vaccines12070790"},{"key":"10.3238\/arztebl.m2025.0032_ref36","doi-asserted-by":"crossref","unstructured":"Semmler A, Mundorf AK, Kuechler AS, et al.: Chronic fatigue and dysautonomia following COVID-19 vaccination is distinguished from normal vaccination response by altered blood markers. Vaccines (Basel) 2023; 11: 1642.","DOI":"10.3390\/vaccines11111642"},{"key":"10.3238\/arztebl.m2025.0032_ref37","doi-asserted-by":"crossref","unstructured":"Matson RP, Niesen MJM, Levy ER, et al.: Paediatric safety assessment of BNT162b2 vaccination in a multistate hospital-based electronic health record system in the USA: A retrospective analysis. Lancet Digit Health 2023; 5: e206\u2013e16.","DOI":"10.1016\/S2589-7500(22)00253-9"},{"key":"10.3238\/arztebl.m2025.0032_ref38","doi-asserted-by":"crossref","unstructured":"Bloise S, Marcellino A, Frasacco B, et al.: Cross-sectional survey on BNT162b2 mRNA COVID-19 vaccine serious adverse events in children 5 to 11 years of age: A monocentric experience. Vaccines (Basel) 2022; 10: 1224.","DOI":"10.3390\/vaccines10081224"},{"key":"10.3238\/arztebl.m2025.0032_ref39","doi-asserted-by":"crossref","unstructured":"Yan MM, Zhao H, Li ZR, et al.: Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS. Front Pharmacol 2022; 13: 921760.","DOI":"10.3389\/fphar.2022.921760"},{"key":"10.3238\/arztebl.m2025.0032_ref40","doi-asserted-by":"crossref","unstructured":"Katoto PDMC, Byamungu LN, Brand AS, et al.: Systematic review and meta-analysis of myocarditis and pericarditis in adolescents following COVID-19 BNT162b2 vaccination. NPJ Vaccines 2023; 8: 89.","DOI":"10.1038\/s41541-023-00681-3"}],"container-title":["Deutsches \u00c4rzteblatt international"],"original-title":[],"link":[{"URL":"https:\/\/www.aerzteblatt.de\/10.3238\/arztebl.m2025.0032","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T09:21:48Z","timestamp":1746609708000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.aerzteblatt.de\/10.3238\/arztebl.m2025.0032"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,16]]},"references-count":40,"URL":"https:\/\/doi.org\/10.3238\/arztebl.m2025.0032","relation":{},"ISSN":["1866-0452"],"issn-type":[{"value":"1866-0452","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,16]]}}}