EMA recommends authorisation of veterinary vaccine for lumpy skin disease in cattle

9 October 2026

Bovilis Lumpyvax helps protect cattle against serious viral infection

EMA has recommended granting a marketing authorisation in the EU for Bovilis Lumpyvax, a vaccine to protect cattle against lumpy skin disease by reducing clinical signs and the amount of virus in the blood. 

Lumpy skin disease is a viral disease of cattle that can cause serious illness and has a significant impact on animal welfare. It is spread mainly by biting insects and can cause outbreaks that are difficult to control. Vaccination has played an important role in protecting animals and helping manage the disease in Europe. The disease does not affect humans. 

Bovilis Lumpyvax contains a live attenuated (weakened) strain of the lumpy skin disease virus called Neethling. The vaccine stimulates the cattle’s immune system to recognise and defend itself against the virus. This allows the immune system to respond more rapidly and effectively if the animal is infected with the virus in the future.

To assess the safety and efficacy of the vaccine, the EMA’s veterinary medicines committee (CVMP) considered studies provided by the applicant, which were supported by data from experience with the vaccine under field conditions. 

The data showed that the vaccine reduced clinical signs of lumpy skin disease and levels of the virus in the blood, starting three weeks after vaccination and lasting for one year.

Bovilis Lumpyvax was recommended for authorisation in exceptional circumstances to support timely availability of the product across Europe. 

The vaccine is generally well tolerated. Side effects are uncommon (occurring between 1 and 10 out of 1,000 treated cattle) and include injection site swelling, milk production decrease, and anorexia (loss of appetite).

The vaccine is also considered safe for people administering it and for the environment when used in accordance with the summary of product characteristics.

The CVMP therefore concluded that the benefits of Bovilis Lumpyvax outweigh its risks. The CVMP’s recommendation to authorise the vaccine will now be sent to the European Commission, which will issue a legally binding EU-wide decision.

---

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