The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, has published the latest pharmacovigilance report for immunological veterinary medicines. This report summarises the suspected case reports on adverse reactions to immunological veterinary medicines reported in Germany in 2020. The immunological veterinary medicines for which the Paul-Ehrlich-Institut is responsible primarily include vaccines. The report is published annually in the German Veterinary Journal (Deutsches Tierärzteblatt).
In 2020, a total of 1,335 suspected cases of adverse reactions were reported to the Paul-Ehrlich-Institut for immunologicals in veterinary medicine from Germany. The online reporting form available at www.vet-uaw.de was increasingly used. With about 30% each, the majority of the reports concerned reactions in dogs or pigs. Both animal species are kept in large numbers as pets and livestock in Germany. Hypersensitivity reactions in temporal proximity to a vaccination were reported particularly often.
The reporting, systematic collection and evaluation of suspected cases of adverse reactions is carried out within the framework of the spontaneous reporting system. It is a central pillar in the monitoring of veterinary medicines safety, because with this system new risk signals can be detected promptly and the benefit of the medicines for the animal can be maximised.
Medicines for animals are subject to high standards of pharmaceutical quality, safety and efficacy. Nevertheless, adverse and unexpected reactions can occur during their use.
Unexpected reactions often occur after a veterinary medicinal product has been introduced to the market, when it is used in a larger number of animals under normal everyday conditions. This may also reveal very rare reactions, unknown drug interactions or particular sensitivities.
According to the respective professional regulations of the German Länder, veterinarians are obliged to report suspected cases of adverse drug reactions to the Drug Commission of the German Veterinary Medical Association (Bundestierärztekammer, BTK) and to the competent higher federal authority - in the case of immunologicals this is the Paul-Ehrlich-Institut, in the case of all other drugs the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL). In addition, every animal owner can report a suspected adverse reaction directly to the Paul- Ehrlich-Institut or the BVL and thus make a direct contribution to the safety of veterinary medicinal products and thus to animal health.
Pharmacovigilance Report Immunological Veterinary Medicines 2020 (German only)
www.vet-uaw.de (German only)
Updated: 16.09.2021
