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Abstract

BACKGROUND

In May 2022, first cases of mpox clade IIb were detected in Germany, and MVA-BN vaccine was available from June 2022 onwards. Vaccination has been recommended by the Standing Committee on Vaccination (STIKO) since June 2022 to contain monkeypox virus infection and prevent disease.

AIM

Our primary aim was to evaluate the safety of the mpox vaccine Jynneos (modified Vaccinia Ankara, Bavaria-Nordic, MVA-BN) after the rollout of the vaccination campaign in Germany from June 2022 to February 2024; a secondary aim was to describe mpox cases and vaccinations.

METHODS

To identify cases and persons with adverse events following immunisation (AEFIs), we used existing surveillance systems. A voluntary system was implemented in June 2022 to monitor mpox vaccination. We performed a descriptive analysis of cases, vaccinations, individual case safety reports (ICSRs) and AEFIs.

RESULTS

Until 29 February 2024, 3,807 mpox cases were notified (data retrieved July 2024). According to the voluntary mpox vaccination monitoring, a total of 78,739 mpox vaccine doses of Jynneos were administered. A search of the national AEFI database identified 32 ICSRs, of which seven were serious. A total of 87 AEFIs were reported, most of which were local or systemic reactions that are generally associated with vaccination. The overall adverse event reporting rate adjusted for missing information on vaccine utilisation in one of 16 federal states was 98.7 adverse events per 100,000 doses.

CONCLUSION

The safety profile of the MVA-BN vaccine was in line with the summary of product characteristics. No new safety signals were identified.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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/content/10.2807/1560-7917.ES.2026.31.30.2500843
2026-07-30
2026-08-11
/content/10.2807/1560-7917.ES.2026.31.30.2500843
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References

  1. World Health Organization (WHO). Global mpox trends. 5. Global situation. Geneva: WHO. [Accessed: 9 Apr 2026). Available from: https://worldhealthorg.shinyapps.io/mpx_global/#sec-global
  2. Hoffmann C, Jessen H, Boesecke C. Monkeypox in Germany. Dtsch Arztebl Int. 2022;119(33-34):551-7.  https://doi.org/10.3238/arztebl.m2022.0287  PMID: 35912445 
  3. Titanji BK, Hazra A, Zucker J. Mpox clinical presentation, diagnostic approaches, and treatment strategies: a review. JAMA. 2024;332(19):1652-62.  https://doi.org/10.1001/jama.2024.21091  PMID: 39401235 
  4. Soheili M, Nasseri S, Afraie M, Khateri S, Moradi Y, Mahdavi Mortazavi SM, et al. Monkeypox: Virology, pathophysiology, clinical characteristics, epidemiology, vaccines, diagnosis, and treatments. J Pharm Pharm Sci. 2022;25:297-322.  https://doi.org/10.18433/jpps33138  PMID: 36130588 
  5. Simadibrata DM, Lesmana E, Pratama MIA, Annisa NG, Thenedi K, Simadibrata M. Gastrointestinal symptoms of monkeypox infection: a systematic review and meta-analysis. J Med Virol. 2023;95(4):e28709.  https://doi.org/10.1002/jmv.28709  PMID: 36975777 
  6. Statistisches Bundesamt. Zensus 2022. [2022 Census]. Wiesbaden: Statistisches Bundesamt. [Accessed: 9 Apr 2026). German. Available from: https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoelkerung/Zensus2022/_inhalt.html
  7. US Federal Drug Administration (FDA). BLA approval. Silver Spring: FDA; 2019. Available from: https://www.fda.gov/media/131079/download?attachment
  8. European Medicines Agency (EMA). Imvanex smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara). Amsterdam: EMA; 2022. Available from: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imvanex-ii-76_en.pdf
  9. European Medicines Agency (EMA). Mpox (monkeypox). Amsterdam: EMA. [Accessed:10 Jul 2026). Available from: https://www.ema.europa.eu/en/mpox-monkeypox?utm
  10. Ständige Impfkommission. Beschluss der STIKO für die Empfehlung zur Impfung gegen Affenpocken mit Imvanex (MVA-Impfstoff). [STIKO resolution regarding the recommendation of vaccination against mpox with Imvanex (MVA vaccine)]. Epid Bull;25/26:3-4 . German. https://doi.org/10.25646/10213 
  11. Liu H, Wang W, Zhang Y, Wang F, Duan J, Huang T, et al. Global perspectives on smallpox vaccine against monkeypox: a comprehensive meta-analysis and systematic review of effectiveness, protection, safety and cross-immunogenicity. Emerg Microbes Infect. 2024;13(1):2387442.  https://doi.org/10.1080/22221751.2024.2387442  PMID: 39082272 
  12. Bundesamt für Justiz. Gesetz zur Verhütung und Bekämpfung von Infektionskrankheiten beim Menschen. [Law on the prevention and control of infectious diseases in humans]. Bonn: Bundesamt für Justiz. [Accessed: 9 Apr 2026]. German. Available from: https://www.gesetze-im-internet.de/ifsg
  13. Robert Koch Institute (RKI). Falldefinitionen des RKI 2026: Mpox (MPX-Virus). [RKI case definitions 2026: Mpox (MPX virus)]. Berlin: RKI; 2023. German. Available from: https://www.rki.de/DE/Themen/Infektionskrankheiten/Meldewesen/Falldefinitionen/Downloads/Mpox.pdf?__blob=publicationFile&v=3
  14. Stratil JM, Hofmann A, Bremer V, Siedler A, Jansen K, Koppe U. Aufbau, Struktur und Ergebnisse eines freiwilligen Mpox-Impfmonitorings in Deutschland. [Structure and results of a voluntary Mpox vaccination monitoring program in Germany]. Epid Bull. 2023;43:3-12. German.  https://doi.org/10.25646/11740 
  15. Bundesamt für Justiz. Gesetz über den Verkehr mit Arzneimitteln. [Law on the Marketing of Medicinal Products]. Bonn: Bundesamt für Justiz. [Accessed: 9 Apr 2026). German. Available from: https://www.gesetze-im-internet.de/amg_1976
  16. Medical Dictionary for Medical Affairs (MedDRA). Welcome to MedDRA. Herndon: MedDRA. [Accessed: 9 Apr 2026). Available from: https://www.meddra.org
  17. European Medicines Agency (EMA). ICH Topic E 2 A Clinical Safety data management: Definitions and standards for expedited reporting (CPMP/ICH/377/95). Amsterdam: EMA; 1995. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-clinical-safety-data-management-definitions-and-standards-expedited-reporting-step_en.pdf
  18. World Health Organization (WHO). Causality assessment of an adverse event following immunization (AEFI): User manual for the revised WHO classification. 2nd. Geneva: WHO; 2019. Available from: https://iris.who.int/bitstream/handle/10665/340802/9789241516990-eng.pdf
  19. Kröger ST, Lehmann MC, Treutlein M, Fiethe A, Kossow A, Küfer-Weiß A, et al. Mpox outbreak 2022: an overview of all cases reported to the Cologne Health Department. Infection. 2023;51(5):1369-81.  https://doi.org/10.1007/s15010-023-01997-x  PMID: 36787016 
  20. United States Food and Drug Administration (FDA). JYNNEOS. Silver Spring: FDA. [Accessed: 9 Apr 2026]. Available from: https://www.fda.gov/vaccines-blood-biologics/jynneos
  21. Bavarian Nordic A/S. Imvanex - Summary of Product Characteristics. Hellerup: Bavarian Nordic A/S. [Accessed: 9 Apr 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/imvanex-epar-product-information_en.pdf
  22. Muller MP, Navarro C, Wilson SE, Shulha HP, Naus M, Lim G, et al. Prospective monitoring of adverse events following vaccination with Modified vaccinia Ankara - Bavarian Nordic (MVA-BN) administered to a Canadian population at risk of Mpox: A Canadian Immunization Research Network study. Vaccine. 2024;42(3):535-40.  https://doi.org/10.1016/j.vaccine.2023.12.068  PMID: 38199921 
  23. Deng L, Lopez LK, Glover C, Cashman P, Reynolds R, Macartney K, et al. Short-term adverse events following immunization with modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine for mpox. JAMA. 2023;329(23):2091-4.  https://doi.org/10.1001/jama.2023.7683  PMID: 37145654 
  24. Duffy J, Marquez P, Moro P, Weintraub E, Yu Y, Boersma P, et al. Safety monitoring of JYNNEOS vaccine during the 2022 mpox outbreak - United States, May 22-October 21, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(49):1555-9.  https://doi.org/10.15585/mmwr.mm7149a4  PMID: 36480476 
  25. Pang Y, Cao D, Zhu X, Long Q, Tian F, Long X, et al. Safety and efficacy of the modified Vaccinia Ankara-Bavaria Nordic vaccine against mpox in the real world: systematic review and meta-analysis. Viral Immunol. 2024;37(4):216-9.  https://doi.org/10.1089/vim.2023.0147  PMID: 38717823 
  26. Ambrosius W, Michalak S, Kozubski W, Kalinowska A. Myelin oligodendrocyte glycoprotein antibody-associated disease: current insights into the disease pathophysiology, diagnosis and management. Int J Mol Sci. 2020;22(1):100.  https://doi.org/10.3390/ijms22010100  PMID: 33374173 
  27. Lee S, Jo H, Lee H, Lee H, Lee J, Kim HJ, et al. Global estimates on the reports of vaccine-associated myocarditis and pericarditis from 1969 to 2023: Findings with critical reanalysis from the WHO pharmacovigilance database. J Med Virol. 2024;96(6):e29693.  https://doi.org/10.1002/jmv.29693  PMID: 38859751 
  28. Duffy J, Myers TR, Marquez P, Rouse D, Brown H, Zhang B, et al. JYNNEOS vaccine safety surveillance during the 2022 mpox outbreak using the vaccine adverse event reporting system and V-safe, United States, 2022 to 2023. Sex Transm Dis. 2024;51(8):509-15.  https://doi.org/10.1097/OLQ.0000000000001978  PMID: 38647241 
  29. Streit R, Mentzer D. Daten zur Pharmakovigilanz von Impfstoffen aus den Jahren 2022 und 2023. [Pharmacovigilance data for vaccines from 2022 and 2023]. Bulletin zur Arzneimittelsicherheit; 2024:4–11. German. Available from: https://www.pei.de/SharedDocs/Downloads/DE/newsroom/bulletin-arzneimittelsicherheit/2024/3-2024.pdf?__blob=publicationFile&v=5
  30. Engels D, Mader S, Förderreuther S, Reindl M, Havla J, Meinl E, et al. MOG-IgG-associated bilateral optic neuritis in temporal relation to monkeypox vaccination. Ann Neurol. 2023;93(6):1216-7.  https://doi.org/10.1002/ana.26664  PMID: 37089005 
Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Doris+Oberle&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Oberle Doris</a>, <a href="/search?value1=Alexandra+Hofmann&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hofmann Alexandra</a>, <a href="/search?value1=Klaus+Jansen&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Jansen Klaus</a>, <a href="/search?value1=Uwe+Koppe&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Koppe Uwe</a>, <a href="/search?value1=Raskit+Lachmann&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Lachmann Raskit</a>, <a href="/search?value1=Renz+Streit&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Streit Renz</a></span>. Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024. <a href="/content/ecdc">Euro Surveill.</a> 2026;31(30):pii=2500843. <a href="https://doi.org/10.2807/1560-7917.ES.2026.31.30.2500843" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2026.31.30.2500843</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 03 Nov 2025;&nbsp;&nbsp; <span class="generated">Accepted</span>: 05 May 2026 </span> </p>
/content/10.2807/1560-7917.ES.2026.31.30.2500843
/content/10.2807/1560-7917.ES.2026.31.30.2500843
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