Marketing authorisation for vaccine against bluetongue virus serotype 3

Additionally, the Health Products Regulatory Authority (HPRA), has granted a marketing authorisation in exceptional circumstances (Article 25, 26 EU Reg 2019/6) for BULTAVO® 3 in Ireland.

BTV-3 causes high mortality in sheep and reproduction and lactation issues in cattle. Outbreaks of Bluetongue can result in severe economic losses for livestock farmers, affect international trade and restrict food supplies. Consequently, the need for effective disease control strategies, including vaccination, remains high.

To date, more than 40 million doses of BULTAVO® 3 have been distributed in Europe to help limit the spread of BTV-3 and its devastating impact. A recent field data published by the German reference laboratory Friedrich-Loeffler-Institut (FLI) showed that vaccination of sheep and cattle with BULTAVO® 3 induces immunity against the virus. According to their findings, animals vaccinated with BULTAVO® 3 consistently showed evidence of a protective antibody response to BTV-3, although animals vaccinated with other BTV-3 vaccines did not.

Boehringer is currently compiling comprehensive data to obtain a full marketing authorisation in accordance with Article 8 of EU Regulation 2019/6.

“BULTAVO® 3 plays a vital role in protecting the health of cattle and sheep and safeguarding livelihoods of those who care for them. This marketing authorisation demonstrates our dedication to supporting farmers and authorities in combating BTV-3”, says Findlay MacBean, Head of Livestock at Boehringer Ingelheim Animal Health UK and Ireland.

Findlay added: “Transboundary animal diseases, such as bluetongue, foot-and-mouth disease and avian influenza continue to pose a significant threat, underscoring the need for long-term preventive solutions to protect our livestock.”

In the 2024 Annual Report (published on 2 April 2025), Dr Armin Wiesler, Member of the Board of Managing Directors with responsibility for the Animal Health Business Unit, said “To effectively combat zoonotic and transboundary animal diseases, it is essential for government agencies, academic research institutes, farmers, and companies like ours to work together. By predicting and preparing proactively for future outbreaks and crises, we can mitigate their impact more efficiently.”

As part of their deep-rooted commitment to animal health and welfare, Boehringer Ingelheim in the UK also supports the Battle Bluetongue campaign run by the Ruminant Health and Welfare Group. The campaign encourages farmers to assess their risk, protect their business and defend their stock. The website has advice and tools for farmers and vets Bluetongue Virus - Ruminant Health & Welfare.

Bluetongue: A threat to animals and farmers’ livelihood

BTV-3 is a virus that is transmitted by the Culicoides midge. Because it requires the presence of an infected midge for transmission, it is a seasonal disease, meaning it has low incidence in winter and spring and increasing incidence in summer and autumn. There are 29 different serotypes of BTV which primarily infect ruminants such as cattle and sheep. BTV serotype 3, which has been spreading across Europe since autumn 2023, has been observed to have a significant impact on sheep and cattle farms.

Typically, BTV infection results in more severe clinical signs in sheep, and this has been evident during the current outbreak of BTV-3. Clinical signs include fever, lethargy, hypersalivation, ulcerations and erosions of the oral and nasal mucous membranes, facial oedema, lesions of the coronary band, shedding of the hoof horn, lameness and death. In the Netherlands in 2023, mortality in sheep was high, with fatality rates of over 70% reported in animals showing clinical signs of infection.

The clinical signs observed in cattle include fever, lethargy, conjunctivitis, nasal discharge, erosion and crusting of the lips and nose, ulceration and erosions of the oral mucosa, oedema of the nose, inflammation of the coronary band and superficial necrosis of the teats. 3 In the Netherlands mortality of adult cattle in BTV-3 infected herds was 1.7 times higher than in unaffected herds between September to December 2023, during the peak of the initial outbreak.

The impact of BTV-3 following infection of cows during pregnancy has also been recognised. A recent report from the East of England described reduced fertility, abortion, stillbirth and the birth of ‘dummy‘ calves with congenital brain lesions on three suckler farms in Jan 2025 associated with BTV-3 infection. Between 5 and 17% of calves born were affected, and on one farm 20% of the breeding animals were found to be barren.

BTV-3 infections are accompanied by considerable pain and suffering in the affected animals. In addition to the impact on the animals, BTV can cause severe economic losses for producers and has an impact on international trade.