Lyon, France – 9 August, 2013 – Merial, the animal health division of Sanofi, today announced the grant of a Market Authorization under exceptional circumstances for SBVvax in France, a new inactivated vaccine against Schmallenberg Virus (SBV) disease.
SBV is an entirely new virus first identified at the end of 2011. The virus has been detected in wide range of animals but impact primarily domestic ruminants such as sheep and cattle. SBV is spreading rapidly and extensively throughout Europe. There have been more than 8,000 farms with confirmed cases SBV in Europe from September 2011 – April 2013. 
The disease includes acute cases in adult animals associated to milk drop, diarrhea and fever but the key consequences are congenital cases in offspring inducing malformations. Despite a clear underreporting of cases and a lack of supportive data for such a new disease, preliminary studies on the impact of SBV on reproduction and productivity performance in cattle and sheep have shown a significant economic impact due to issues including still births, malformed newborns, low milk production and adult animal deaths. A report from France recorded that, in highly impacted farms by SBV, 41% of lambs were born malformed.
SBV is vector-borne and not a contagious disease. Vector-borne diseases spread quickly and can infect any animal from the herd. There is no known treatment for SBV disease, so vaccination is the key tool to prevent the spread within herds whatever the vector or the transmission.
SBVvax is indicated for active immunization to prevent viremia due to the Schmallenberg virus in sheep and cattle.
 In clinical efficacy studies, SBVvax showed prevention of viremia in 100% of the infected lambs and calves. The vaccination protocol for the inactivated injectable vaccine is one shot of 1ml for sheep, and two shots of 1ml for cattle, 3 weeks apart. SBVvax will be available as suspension in a 50ml bottle.
For over 50 years, Merial, has partnered with veterinary health authorities throughout the world to prevent and control the spread of infectious animal diseases of major social and economic importance.

When SBV arrived, we did everything we could to offer to our customers a high quality vaccine in a record time. After having successfully developed the leading vaccine against the emergent Bluetongue serotypes in Europe, Merial is now applying that expertise to the newly-emerging problem of Schmallenberg Virus disease.

Dr. Silke Birlenbach, head of Veterinary Public Health

The first priority for us was to have a solution to protect herds, now we are looking forward to partnering with veterinarians, and the livestock and research community to enhance our understanding of this novel disease.

Dr. Silke Birlenbach
SBVvax doses will be available to veterinarians before October in France. 
The vaccine is also under review in the UK by VMD. The official indication and availability of doses will be communicated when the provisional license is granted. 

For further information please contact:

Natasha Mahanes              
+1 - 678-638-3690     

About Merial

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Its 2012 sales were over $2.2 billion.

Merial is the animal health division of Sanofi.