EMA Recommends Bovilis Lumpyvax Vaccine for Cattle Lumpy Skin Disease

Lumpy skin disease is a viral infection that can severely affect cattle, leading to significant animal welfare issues. The disease is primarily transmitted through biting insects and can lead to challenging outbreaks. Vaccination has been critical in managing the disease in Europe, though it poses no risk to human health.

Bovilis Lumpyvax contains a live attenuated strain of the lumpy skin disease virus known as Neethling. This vaccine prompts the cattle's immune system to recognize the virus, enabling a quicker and more effective response should the animal become infected in the future.

To evaluate the vaccine's safety and efficacy, the EMA’s Committee for Veterinary Medicinal Products (CVMP) reviewed studies from the applicant, which were bolstered by field condition data. Findings indicated that the vaccine effectively reduced clinical signs and blood virus levels starting three weeks post-vaccination, with effects lasting up to one year.

The CVMP has recommended Bovilis Lumpyvax for authorization under exceptional circumstances to ensure timely access across Europe. The vaccine is typically well tolerated, with side effects occurring in 1 to 10 out of every 1,000 treated cattle. Reported side effects include swelling at the injection site, reduced milk production, and loss of appetite.

Furthermore, the vaccine is deemed safe for those administering it and for the environment when used as directed in the product specifications. The CVMP has concluded that the advantages of Bovilis Lumpyvax outweigh any associated risks. This recommendation will now be forwarded to the European Commission for a legally binding decision across the EU.

The applicant for Bovilis Lumpyvax is Intervet International B.V.