gms | German Medical Science

29th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

24.11. - 25.11.2022, Münster

Do systemic adverse events following the first dose of mRNA vaccine BNT162b2 administered early to a hospital staff sample differ from the approval study sample?

Meeting Abstract

  • Francisca Bunila-Yuwang - Paracelsus Medical University Nuremberg, Nürnberg, Germany
  • Cosima Brucker - Paracelsus Medical University Nuremberg, Nürnberg, Germany
  • Anette Sattler - Paracelsus Medical University Nuremberg, Nürnberg, Germany
  • corresponding author presenting/speaker Isabel Hach - Paracelsus Medical University Nuremberg, Nürnberg, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 29. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Münster, 24.-25.11.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. Doc22gaa16

doi: 10.3205/22gaa16, urn:nbn:de:0183-22gaa160

Published: November 21, 2022

© 2022 Bunila-Yuwang et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: German hospital workers were vaccinated as early as 12/27/20, i.e. directly after approval of the BNT162b2 Covid-19-vaccine in Germany, as this group had to care for seriously ill Covid-19 patients. Hospital staff is mostly female and of younger age. The report on the efficacy and safety of the BNT162b2 Covid-19-vaccine did not disaggregate by gender. In general, reports about approval studies of vaccinations do not. Our study evaluates age and gender differences of adverse events (AEs) in a hospital staff sample (vaccinated Dec 20 – Jan 21) as well as differences between this sample and the approval study sample.

Materials and Methods: Each employee of the Nuremberg hospital vaccinated with BNT162b2 was offered the opportunity to participate in our study and to provide anonymized information on health status (e.g., previous and actual illnesses) and adverse events within one week following the first vaccination. We used standardized questionnaires designed as the adverse event reporting in the pivotal study to record local and systemic adverse drug reactions. In addition we asked sleep disturbances and nervousness. The study was approved by the local institutional review board. As the direct comparison with the phase III study sample was a main goal of our study, we evaluated only personnel vaccinated during the early phase of vaccination (Dec. 20 – Jan. 21). Statistical analysis was carried out anonymously using methods of descriptive analysis and procedures on sample comparisons.

Results: Our sample (N=148) consists of 120 females (81%; 18-55years: N=91, >56 years: N=29) and 28 males (19%; 18-55 years: N=14, >56 years: N=14). The most frequently reported systemic AEs of the approval study, namely “fatigue” and “headaches”, occurred significantly less frequently in younger participants of our sample (p<0.05). Overall, within our study sample these AEs occurred more often in 18-55 y/o females than in males, resulting in a female/male AE ratio of 3.4 for headache and 2.4 for fatigue. 18-55 y/o hospital workers showed systemic muscle pain significantly more often after the first injection than >56 y/o participants of our sample and as well as the 16-55 y/o participants of the approval study sample. The AEs sleep disturbances, nervousness, chills, and diarrhoea were only reported by female participants.

Conclusion: Our results suggest the need to report (vaccine) AEs in approval studies by gender. We will discuss possible reasons for the overall good tolerability of the vaccine in our participants.


References

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Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Polack FP, Zerbini C, Bailey R, Swanson KA, Xu X, Roychoudhury S, Koury K, Bouguermouh S, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Yang Q, Liberator P, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Gruber WC, Jansen KU; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Nov 4;385(19):1761-1773. DOI: 10.1056/NEJMoa2110345 External link