Authorisation Holder:
LABORATORIOS HIPRA, S.A
Avda. La Selva 135
17170 Amer (Girona)
Spain
Problem Or Issue:
Since early 2022, an increase in the incidence of anaphylactic-type reactions in cattle has been observed after the use of the vaccine Hiprabovis IBR Marker Live.
Within the period from 1 March 2022 to 31 May 2022, a total of 27 cases involving 175 animals that had an anaphylactic-type reaction, and 8 animals that have died, have been reported. In at least 5 of the animals that have died, the animals had anaphylactic-type reactions with a fatal outcome.
Most of the cases have been reported in specific geographic regions of Spain (19/27) and Italy (7/27). Within this period, more than 641,075 doses have been administered in 14 EU countries. This situation has not been observed in Ireland or in other EU countries where the vaccine is currently used.
A clear root cause has not been identified yet and investigations are ongoing. The product information is being updated on the frequency and severity of hypersensitivity / anaphylactic-type reactions.
Actions To Be Taken:
The HPRA advises veterinary practitioners to follow the updated conditions of the relevant marketing authorisations, as set out above) pending the availability of new stock with updated labelling and package leaflet reflecting the changes outlined above.
In case an anaphylactic-type reaction occurs, an appropriate symptomatic treatment should be administered.
As with all veterinary medicines, any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.