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 2022. All vaccines are included in the list of immunological veterinary medicinal products under the responsibility of the Paul-Ehrlich-Institut. The report is published annually in the German Veterinary Journal (Deutsches Tierärzteblatt).
In 2022, a total of 2,693 suspected cases of side effects involving immunological veterinary medicinal products in Germany were reported to the Paul-Ehrlich-Institut. The reporting volume has thus more than doubled compared to the previous year (2021: 1,258 reports). The majority of suspected cases concerned dogs, with 54.3%. 24.5% of reported reactions were in pigs, 7.4% in cats. 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.
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 maximises the benefit of the medicinal products for animals.
Medicinal products for animals are subject to high standards of pharmaceutical quality, safety, and efficacy. Nevertheless, unwanted 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.
In accordance to 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, this is the Paul-Ehrlich-Institut, and in the case of pharmaceutical medicines, 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.
2022 Pharmacovigilance Report for Immunological Veterinary Medicinal Products (German only)
Online reporting portal www.vet-uaw.de (German only)
Selected Publications Pharmacovigilance (veterinary)
Updated: 01.11.2023
