The FAMHP authorises the use of the immunological veterinary medicinal product Hepizovac (suspension for injection from the company CZ Vaccines S.A.U.) intended for cattle.
The use of the immunological veterinary medicinal product is authorised under Article 110 (2) of Regulation 2019/6, for a period of one year or until an immunological veterinary medicinal product for epizootic haemorrhagic disease virus with marketing authorisation is available.
As vaccination will be voluntary, normal distribution channels can be used.
A Regulatory Decree will follow in October 2024 that will impose the following conditions for the use of the abovementioned vaccine.
1. The obligation to report adverse reactions to the FAMHP
Given the emergency situation and the limited data available, the reporting of adverse reactions is mandatory to get a clearer picture of the safety and efficacy of the vaccine in question.
Veterinarians should report any adverse reaction directly via the FAMHP's national reporting system for medicinal products for veterinary use.
2. Vaccine distribution in Belgium
The distribution of this vaccine will follow the regular distribution chain and will be limited to distribution to the veterinarian's depot.
Ceva will be a distributor and will supply to wholesalers in Belgium.