The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, has published the latest Pharmacovigilance Report for Immunological Veterinary Medicinal Products. This report provides an overview of suspected adverse event (AE) reports submitted in Germany in 2024 following the use of immunological veterinary medicinal products. The immunological veterinary medicinal products under the responsibility of the Paul-Ehrlich-Institut include all vaccines, sera, immunotherapeutics (e.g. monoclonal antibodies, advanced therapies), and animal allergens. The report is published annually in the German Veterinary Journal (Deutsches Tierärzteblatt).
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In 2024, the Paul-Ehrlich-Institut received a total of 1,852 reports of suspected adverse events (side effects and suspected lack of efficacy) following the use of immunological veterinary medicinal products in Germany. As in previous years, the majority of suspected cases concerned dogs and pigs. The number of reports concerning cattle and small ruminants increased significantly in 2024 compared to 2023. This increase is due to the wave of infections with bluetongue virus (BTV) of serotype 3 (BTV-3) and the associated vaccinations. It is unclear whether vaccinations against BTV-3 or infections with BTV-3 itself were the cause of the observed symptoms in a high proportion of reports concerning suspected insufficient efficacy or fatalities in ruminants. This situation is due to the ongoing BTV-3 epidemics and the often very limited information from laboratory studies. The vaccines against BTV offer an overall positive benefit-risk profile and the Standing Veterinary Committee on Vaccination (StIKo Vet) recommends seasonally timely vaccination of ruminants against BTV-3.
Any medicinal product can have adverse effects alongside its desired effects. This is also true of immunological veterinary medicinal products. Although a variety of safety and efficacy studies take place before marketing authorisation is granted, the individual risks of veterinary medicinal products can only be identified when they have been used on a larger number of animals under practical conditions, e.g. very rare reactions or unknown medicine interactions.
The reporting, systematic recording, and evaluation of suspected side effects takes place within the framework of the spontaneous reporting system. This system is a central pillar in the monitoring of veterinary medicinal product safety because it allows for the timely detection of new safety signals and for the initiation of any necessary risk-minimising measures.
In accordance with the respective professional codes of the federal states, veterinarians are obliged to report suspected side effects to the Medicines Commission of the German Veterinarians Association (Bundestierärztekammer, BTK) and to the competent higher federal authority. In the case of immunologicals, the Paul-Ehrlich-Institut is the competent higher federal authority, and in the case of pharmaceutical medicines it is the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL). In addition, every pet owner can report a suspected side effect directly to the Paul-Ehrlich-Institut or the BVL via the online reporting portal and thus make a direct contribution to veterinary medicines safety and animal health.
Updated: 23.09.2025
