The European Medicines Agency (EMA) has recommended approval for Hepizovac, marking a significant milestone as the first vaccine against epizootic haemorrhagic disease (EHD) to be authorized in the European Union for cattle. The vaccine specifically targets serotype 8 of the epizootic haemorrhagic disease virus (EHDV), which has been responsible for recent outbreaks across Europe.
EHD is an infectious disease primarily affecting domestic and wild ruminants that spreads through the bites of infected midges. Infected cattle can develop severe clinical manifestations including fever, oral and nasal lesions, excessive salivation, eye inflammation, and respiratory distress, with some cases proving fatal. Despite its severity in animals, EHDV poses no known risk to human health.
Vaccine Composition and Efficacy
Hepizovac contains an inactivated form of EHDV serotype 8 combined with adjuvants designed to enhance immune response. The product is formulated as a ready-to-use suspension for injection.
Clinical evaluation of the vaccine demonstrated promising results. In comparative studies between vaccinated and unvaccinated calves, animals receiving two doses of Hepizovac 21 days apart showed a significant reduction in viremia—the amount of virus present in the bloodstream.
Expedited Approval Process
The Committee for Medicinal Products for Veterinary Use (CVMP) recommended approval of Hepizovac under exceptional circumstances, acknowledging that while certain safety, quality, and efficacy data were not fully available, the urgent need for intervention outweighed these limitations.
"The approval was granted due to the urgent need for a solution to control the spread of this disease, which has had a significant impact on animal health and agricultural economies," noted the EMA in its announcement.
Impact on Agricultural Industry
The emergence of EHDV serotype 8 in Europe has created substantial challenges for cattle producers, with no previous vaccines available to combat outbreaks. The disease has caused economic losses and animal welfare concerns across affected regions.
Risk assessment conducted during the evaluation process indicates that Hepizovac is not expected to pose risks to human or animal health or the environment when used according to product guidelines.
Regulatory Next Steps
The CVMP's positive opinion will now be forwarded to the European Commission for final decision on EU-wide marketing authorization. Once approved, Hepizovac will provide veterinarians and cattle producers with the first authorized tool specifically designed to combat EHD outbreaks in European cattle populations.
This development represents an important advancement in veterinary medicine's response to emerging infectious diseases affecting livestock in Europe.
