The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, has published the latest pharmacovigilance report for immunological veterinary medicinal products. This report summarises reports of suspected adverse reactions to immunological veterinary medicinal products submitted in Germany in 2023. Human and animal vaccines are included in the medicinal products that fall under the remit of the Paul-Ehrlich-Institut. The report on immunological veterinary medicinal products is published annually in the German Veterinary Journal (Deutsches Tierärzteblatt).
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In 2023, a total of 1,731 suspected adverse events involving immunologicals (immunologically active medicinal products) used in veterinary medicine were reported to the Paul-Ehrlich-Institut in Germany. The majority of suspected cases (51.9%) involved dogs. Pigs were involved in 24.7% of reported reactions and cattle in 6.2%. All three animal species are kept in large numbers in Germany as pets or farm animals. Anaphylaxis and hypersensitivity reactions that occurred in temporal proximity to vaccination were reported particularly frequently.
Medicinal products for animals are also subject to high standards of pharmaceutical quality, safety, and efficacy. Nevertheless, adverse and unexpected reactions may occur during their use.
Unexpected adverse reactions often only occur after the marketing of a veterinary medicinal product when it has been used on a larger number of animals under normal, everyday conditions. Widespread use can also lead to the detection of very rare reactions, unknown drug interactions, or special sensitivities.
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 (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 (BVL). In addition, every pet owner can also 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: 18.09.2024
