The Veterinary Medicines Directorate has granted a provisional marketing authorisation for Bovilis SBV, the first vaccine specifically targeting SBV in cattle and sheep.
The UK will be the first country in Europe to have a new vaccine for the Schmallenberg virus (SBV).
MSD Animal Health has announced today that the Veterinary Medicines Directorate (VMD) has granted the company a provisional marketing authorisation for Bovilis SBV, the first vaccine specifically targeting SBV in cattle and sheep.
The virus, which emerged in late 2011, is transmitted via insect vectors, mainly midges and causes transient clinical symptoms in adult cattle and sheep, such as fever, diarrhoea and reduced milk yield, as well as congenital malformation in newborn calves and lambs.
As of March 31, 2013 there have been 1,753 cases of SBV confirmed throughout the UK. The virus has now been detected in every county in England and Wales.
Andras Bolcskei, country manager for MSD Animal Health UK, said: “On behalf of Merck MSD, we would like to thank the VMD for its partnership and support to fast track the availability of Bovilis SBV to the market.
“There was a tremendous urgency for a SBV vaccine in the UK especially given the marked increase in confirmed cases over the past year and the increasing importance to help control this devastating disease.”
Studies in support of the provisional marketing authorisation reported that all animals responded with formation of virus neutralising antibodies. During the studies, reduced viraemia against SBV was observed in sheep vaccinated once and prevention of viraemia was observed in cattle vaccinated twice, whereas all animals in the control groups developed infection and became viraemic. In studies to date, Bovilis SBV has been shown to be efficacious in cattle and sheep.
The vaccine is based on wild-type SBV that has been inactivated and contains an adjuvant that stimulates the immune response. The vaccine will be available in 20ml and 100ml vials. Bovilis SBV is indicated for the active immunisation of cattle to prevent viraemia against SBV and for the active immunisation of sheep to reduce viraemia against SBV.