EMA Backs a Live Vaccine Against Lumpy Skin Disease in Cattle

The European Medicines Agency (EMA) has recommended the authorisation of Bovilis Lumpyvax, a live attenuated vaccine designed to protect cattle against lumpy skin disease (LSD).

The positive recommendation was adopted by EMA's Committee for Veterinary Medicinal Products (CVMP) on October 8, 2026. The vaccine contains a weakened Neethling strain of lumpy skin disease virus and is intended to reduce clinical signs and the level of virus in the blood of infected cattle.

The recommendation comes as European authorities continue to strengthen measures against lumpy skin disease, a viral cattle disease that can cause serious illness, affect animal welfare and reduce livestock productivity.

EMA Recommends Bovilis Lumpyvax

Bovilis Lumpyvax is a veterinary immunological product containing a live attenuated lumpy skin disease virus, Neethling strain.

The vaccine is intended for active immunisation of cattle to reduce clinical signs and viraemia caused by lumpy skin disease virus. EMA's assessment concluded that the product has a favourable benefit-risk balance and recommended its authorisation under exceptional circumstances.

The recommendation was submitted by Intervet International B.V., which is the applicant for the veterinary medicine.

Vaccine Provides One Year of Immunity

Studies submitted to the agency, together with field experience, showed that vaccination reduced clinical signs of lumpy skin disease and lowered levels of the virus in the blood.

This makes the vaccine potentially useful as part of coordinated disease-control programs, particularly in areas where cattle populations face a risk of LSD outbreaks.

Lumpy Skin Disease Primarily Affects Cattle

Lumpy skin disease is a viral disease affecting cattle. It can cause fever, skin lesions and other clinical symptoms and can have significant consequences for animal health and livestock production.

The disease is transmitted mainly by biting insects, making outbreaks particularly challenging to control because transmission can occur between animals through vectors. EMA states that lumpy skin disease does not affect humans.

The economic impact can nevertheless be significant for livestock producers because infected animals may experience reduced productivity and require treatment and disease-control measures.

Live Attenuated Vaccine Uses the Neethling Strain

Bovilis Lumpyvax uses a live but weakened strain of the lumpy skin disease virus known as Neethling.

The weakened virus is intended to stimulate the cattle's immune system without producing the disease in the same way as the pathogenic virus. This allows the immune system to develop a response that can react more effectively when vaccinated animals encounter lumpy skin disease virus.

The European Commission notes that live attenuated homologous vaccines based on the Neethling strain have demonstrated strong protection in large-scale coordinated vaccination campaigns.

Safety Profile Considered Acceptable

EMA's assessment found that Bovilis Lumpyvax is generally well tolerated.

Adverse reactions were considered uncommon, occurring in approximately 1 to 10 animals per 1,000 treated cattle. Reported reactions include swelling at the injection site, decreased milk production and anorexia, or loss of appetite.

EMA also concluded that the vaccine is considered safe for people administering it and for the environment when used according to the product's specified conditions.

Recommendation Comes Under Exceptional Circumstances

The CVMP recommended authorisation under exceptional circumstances to support timely availability of the vaccine across Europe.

Under this type of authorisation, certain specific obligations apply and are subject to annual review. EMA's product information states that the European Commission must still issue the legally binding marketing-authorisation decision following the positive CVMP opinion.

Therefore, the EMA recommendation should not be described as the final EU-wide marketing authorisation.

Vaccination Remains an Important LSD Control Measure

European authorities already consider vaccination an important tool for controlling lumpy skin disease.

The European Commission states that several homologous and heterologous attenuated-virus vaccines are commercially available and that vaccination is essential for controlling LSD. It also highlights the effectiveness of coordinated cross-border vaccination campaigns using live attenuated vaccines based on the Neethling strain.

EU rules also establish conditions for the use of vaccination and the movement of vaccinated animals and their products.

The availability of an additional authorised vaccine could therefore strengthen Europe's ability to respond rapidly when disease-control measures are required.

European Authorities Continue Monitoring LSD

The latest vaccine recommendation comes against a broader backdrop of continued European efforts to monitor and control lumpy skin disease.

The European Commission supports surveillance and early detection activities in high-risk areas and maintains EU-level vaccine and diagnostic reagent resources to support vaccination campaigns against certain serious animal diseases, including LSD.

These measures are designed to improve preparedness and reduce the likelihood that outbreaks will spread across livestock populations and national borders.

Next Step Is European Commission Decision

Following the CVMP's positive opinion, the recommendation will move to the European Commission for a legally binding decision.

If the Commission grants the marketing authorisation, Bovilis Lumpyvax will become available under the conditions established for its use in cattle.

For livestock producers and veterinary authorities, the development provides another potential tool for managing lumpy skin disease, alongside surveillance, movement controls and coordinated vaccination programs.

Sources:

https://www.ema.europa.eu/en/news/ema-recommends-authorisation-veterinary-vaccine-lumpy-skin-disease-cattle?