EMA recommends Intervet's Bovilis Lumpyvax for lumpy skin disease

EMA recommendation

The European Medicines Agency’s veterinary medicines committee (CVMP) recommended granting a marketing authorisation in the EU for Bovilis Lumpyvax to protect cattle against lumpy skin disease. The CVMP concluded the benefits outweigh the risks and has sent its recommendation to the European Commission, which will issue a legally binding EU decision.

Vaccine composition and purpose

Bovilis Lumpyvax contains a live attenuated (weakened) Neethling strain of the lumpy skin disease virus. The vaccine stimulates the immune system to recognise and respond more rapidly and effectively if animals are exposed to the virus. Lumpy skin disease is viral, spread mainly by biting insects, affects cattle welfare and can cause outbreaks that are hard to control; it does not affect humans.

Efficacy

The CVMP assessment relied on studies provided by the applicant and supported by field‑use data. Results showed the vaccine reduced clinical signs and levels of virus in the blood starting three weeks after vaccination, with protection lasting for one year.

Safety and availability

The vaccine is generally well tolerated; side effects are uncommon (occurring between 1 and 10 out of 1,000 treated cattle) and can include injection site swelling, decreased milk production and anorexia. It is also considered safe for people administering it and for the environment when used in accordance with the summary of product characteristics. The recommendation was issued under exceptional circumstances to support timely availability across Europe.

Applicant

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