EMA Recommends Approval of Hepizovac Vaccine for Cattle Disease

The European Medicines Agency (EMA) has recommended the approval of Hepizovac, the first vaccine against epizootic haemorrhagic disease (EHD) authorised in the EU for use in cattle. This new vaccine provides protection against the recently emerged serotype 8 of the epizootic haemorrhagic disease virus (EHDV), which has been responsible for recent outbreaks in Europe.

EHD is an infectious disease that primarily affects domestic and wild ruminants, like deer. The virus is transmitted through the bite of midges that have fed on infected animals. Infection with EHDV can lead to severe clinical signs in cattle, including fever, nose and mouth sores, drooling, eye inflammation, and respiratory distress. In some cases, it can result in death. Despite the severity of the disease in affected animals, the EHDV is not a risk to human health, as it is not known to cause disease in humans under any conditions.

Hepizovac contains an inactivated form of the EHDV serotype 8 along with adjuvants to help stimulate the immune response. The vaccine is available as a ready-to-use suspension for injection.

The efficacy of the vaccine was assessed in a study that compared the protection against EHDV in vaccinated and unvaccinated calves. After two doses, given 21 days apart, vaccinated animals showed a significant reduction in the amount of virus present in the blood.

Hepizovac was approved under exceptional circumstances considering recent outbreaks of EHD in cattle herds, for which no vaccines were previously available. 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. Although certain safety, quality, and efficacy data were not fully available, the Committee for Medicinal Products for Veterinary Use (CVMP) determined that the benefit of the immediate availability of the vaccine outweighed these risks.

Based on the risk assessment conducted as part of the evaluation of all veterinary products, the vaccine is not expected to pose a risk to human or animal health or the environment, if used according to the product information.

The CVMP opinion will now be sent to the European Commission for the adoption of the decision on the EU-wide marketing authorisation of Hepizovac.

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