Boehringer Ingelheim's Bultavo 3 bluetongue vaccine has been given provisional UK marketing authorisation by the Veterinary Medicines Directorate.

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

The company says that so far, more than 40 million doses of Bultavo 3 have been distributed in Europe to help limit the spread of BTV-3.

Boehringer points to a recent field study published by the German reference laboratory Friedrich-Loeffler-Institut (FLI), which showed that vaccination of sheep and cattle with Bultavo 3 induces immunity against the virus¹.

According to the study, 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 not¹.

Boehringer says it is now compiling the data needed to obtain a full marketing authorisation in accordance with Article 8 of EU Regulation 2019/6.

Reference

1. Friedrich-Loeffler-Institut, Serologische Studien zum Nachweis von BTV-3-Impfantikörpern – eine erste Zusammenfassung und Bewertung durch das Nationale Referenzlabor für Blauzungenkrankheit, December 2024.

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