18 February, 2025

Syvazul® BTV3 to receive emergency use authorization in France

The French National Agency for Veterinary Medicinal Products (ANMV) has also authorized the use of Syvazul® BTV 3 on its territory.

While France is simultaneously facing unprecedented epidemics of vector-borne diseases – including Bluetongue (BT) and Epizootic Haemorrhagic Disease (EHD) – the veterinary health authorities have granted emergency use authorization for the vaccine Syvazul® BTV 3 in sheep, under Article 110, paragraph 2, of Regulation (EU) 2019/6.

This emergency and temporary use procedure allows authorities in each European country to bypass the usual market authorization process. It enables rapid action against a disease that significantly impacts not only the health and welfare of animals but also the financial and psychological well-being of farmers.

The ANMV has determined that the submission contains sufficient data on the safety, quality, and efficacy of the vaccine to approve its use in sheep.

This emergency use authorization is valid at national level. However, it is important to note that on January 15, 2025, the Committee for Veterinary Medicinal Products (CVMP) has adopted a positive opinion recommending the granting of a marketing authorization at the European level for Syvazul® BTV 3.

Bluetongue (BT), a threat across Europe

Bluetongue (BT) is a viral disease transmitted by biting midges called Culicoides. The peak activity period of these midges extends from June to October. It primarily affects ruminants, especially sheep and cattle. It is not contagious and cannot be transmitted to humans.

Currently, 27 serotypes of the virus have been identified. They do not generate cross-immunity, meaning a vaccine effective against one serotype will not be effective against another.

Several serotypes are currently circulating in Europe: BTV-1, BTV-3, BTV-4, BTV-8, and BTV-12. Vaccination is the most effective way to control the disease. It is especially effective if carried out before the peak activity period of the midges and on healthy animals.

About Syvazul® BTV3

Syvazul® BTV 3 is administered to sheep in a single 2 ml subcutaneous injection. It is available in vials of 80 ml (40 doses) and 200 ml (100 doses).

For more information, visit the product page on our website

ABOUT SYVA

Since its founding in 1941, the Spanish company Laboratorios Syva has been committed to scientific research and development to innovate and provide efficient solutions for the animal health sector. This capacity to adapt drives its growth strategy and the maintenance of state-of-the-art bioengineering and manufacturing facilities to produce vaccines, first-line anti-infectives and other essential medicines for animal health and welfare, which are distributed in almost 70 countries worldwide.

Press contact : comunicacion@syva.es

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