Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024

BACKGROUNDIn 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.AIMOur 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.METHODSTo 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.RESULTSUntil 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.CONCLUSIONThe safety profile of the MVA-BN vaccine was in line with the summary of product characteristics. No new safety signals were identified.