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31. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

21.11. - 22.11.2024, Bonn

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CoVacU18-Study: Long-Term Safety of mRNA-based COVID-19 vaccine BNT162b2 in Children under 18 Years in Germany

CoVacU18-Studie: Sicherheit des mRNA-basierten COVID-19-Impfstoffs BNT162b2 in der Langzeitbeobachtung bei Kindern unter 18 Jahren in Deutschland

Meeting Abstract

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  • author presenting/speaker Vivien Grieshaber - Universität Witten/Herdecke, Fakultät für Gesundheit, Witten, Germany
  • Christoph Strumann - Institut für Familienmedizin, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
  • Sarah Holzwarth - Klinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany
  • Nicole Toepfner - Klinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany
  • Wolfgang C. G. von Meissner - Hausärzte am Spritzenhaus, Baiersbronn, Germany
  • Nikos Konstantopoulos - Praxis die Kinderaerzte, München, Germany
  • Martina von Poblotzki - Praxis die Kinderaerzte, München, Germany
  • Kai O. Hensel - Zentrum für Kinder- und Jugendmedizin, Helios Universitätsklinikum Wuppertal, Wuppertal, Germany
  • Matthias B. Moor - Karolinska Institutet, CLINTEC Division of Renal Medicine, Huddinge, Sweden
  • corresponding author Cho-Ming Chao - Zentrum für Kinder- und Jugendmedizin, Helios Universitätsklinikum Wuppertal, Wuppertal, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 31. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn, 21.-22.11.2024. Düsseldorf: German Medical Science GMS Publishing House; 2024. Doc24gaa11

doi: 10.3205/24gaa11, urn:nbn:de:0183-24gaa117

Veröffentlicht: 13. November 2024

© 2024 Grieshaber et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

Background: Safety data on the use of the messenger-RNA(mRNA)-based COVID-19 vaccine BNT162b2 in under 18-year-olds are limited to observation periods ≤6 months.

Materials and Methods: This investigator initiated longitudinal cohort study retrospectively assessed the tolerability and safety of BNT162b2 in children under 18 years in Germany using an online questionnaire addressed to the legal guardians of vaccinated children. Between May 25th and July 11th, 2023 we contacted over 15423 E-Mail-addresses registered in databases of vaccination centres in Germany. Children who received at least one BNT162b2 vaccination since October 1st, 2021 and before the age of 18 years were included. Study inclusion was only possible by using a valid participation code. The tolerability and safety of the vaccine were assessed on the basis of 11 symptom categories (local reactions, general reactions, fever, symptoms of the musculoskeletal, gastrointestinal, otolaryngological, cardiovascular, pulmonary, neurological, psychological and dermatological system including lymph nodes). In addition to hospitalisations and deaths, persistent post-vaccinal symptoms ≥90 days were defined as severe adverse events (SAE). An internal comparator analysis was performed using logistic regression models to compare the safety and tolerability of BNT162b2 to non-SARS-CoV-2 vaccines.

Results: 3228 children (median age, 5.7 years; male, 49.6%) were followed up over a median observation period of 524 days. Study results are reported in four age groups. Including all age groups, the internal comparative analysis revealed significant deviations in six of eleven symptom categories. Long term health impairment due to a symptom duration ≥90 days after BNT162b2 administration were reported in 1.27 % (n = 41). These mainly affected the neurological, psychological and dermatological systems. SAE were reported more frequently for children/adolescents with female gender (OR = 4.55; 95% confidence interval: [2.10;9.88] or long term medication (OR = 3.67 [1.39;9.69]).

Conclusion: BNT162b2 is well tolerated by 98 % of children, but specific symptoms occur significantly more frequently than in non-SARS-CoV-2 vaccines. In 1.27 % post-vaccinal symptoms after BNT162b2 administration persisted ≥90 days. Question of causality should further be scrutinized in future prospective studies.

Gliederung

References

1.
Toepfner N, von Meißner WCG, Strumann C, Drinka D, Stuppe D, Jorczyk M, Moor J, Püschel J, Liss M, von Poblotzki E, Berner R, Moor MB, Chao CM. Comparative Safety of the BNT162b2 Messenger RNA COVID-19 Vaccine vs Other Approved Vaccines in Children Younger Than 5 Years. JAMA Netw Open. 2022 Oct 3;5(10):e2237140. DOI: 10.1001/jamanetworkopen.2022.37140 Externer Link
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Riad A, Pokorná A, Attia S, Klugarová J, Košcík M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428 Externer Link
3.
Moor J, Toepfner N, von Meißner 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 [Preprint]. medRxiv. 2024. DOI: 10.1101/2024.03.08.24303999 Externer Link