The Veterinary Medicines Directorate (VMD) has said it is considering an application by MSD Animal Health for its Scmallenberg virus vaccine Bovilis SBV.Though the date of its commercial release is unknown, the executive agency of the Department for Environment, Food and Rural Affairs (Defra) said MSD submitted the application at the end of August.The results of several studies were presented at a symposium on the virus during the 6th Annual Meeting of EPIZONE (an international network of veterinary research institutes working on epizootic animal diseases), which took place in Brighton in last June.The vaccine is based on wild-type Schmallenberg virus that has been inactivated and contains an adjuvant that stimulates the immune response.The virus continues to cause concern as the lambing and calving season progresses causing widespread interest in the development of the vaccine."In our studies we looked at the serological response as well as viremia and we have now reported that all vaccinated animals responded with formation of virus neutralizing antibodies" said Veronique Moulin, research scientist at the virological R&D department at MSD Animal Health."During the trials, all vaccinated animals were protected against Schmallenberg virus infection (complete blockage of viremia), whereas all controls developed viremia after challenge. Moreover, we found a good correlation between antibody titers and viremia."The Veterinary Medicines Directorate, the agency responsible for regulating and issuing marketing authorisations, has responded to the urgency of the situation by taking the unprecedented step of providing an update on the progress of an application – that submitted by MSD for its ‘Bovilis SBV’ vaccine."The VMD is not usually able to comment on whether or not it has received a specific application for a veterinary medicine, equally it is unable to comment on the progression of a particular application" the agency said."Despite the good progress, at this stage it is not possible to provide an indication of when the vaccine may be authorised. The VMD recognises the impact on individual animals and farmers a disease such as Schmallenberg can have."Dr. Rene Aerts, vice president Global Biologicals R&D Animal Health said: "Using our experience gained a few years ago during the fast-track development of the first vaccine against bluetongue 8 virus in just 21 months, we are now on track to develop a vaccine against Schmallenberg virus in an even shorter time." "After we isolated the virus last December, we have diligently worked in an integrated and interdisciplinary team at BioSciences Center Boxmeer and our manufacturing site in Burgwedel to develop this vaccine. We anticipate, pending regulatory approvals, to have a vaccine available for our customers by the end of this year."Since the emergence of the Schmallenberg virus late summer of 2011, it has spread across several countries in Europe. Sheep sector confidence 'at rock bottom'Livestock representatives from the UK farming unions have been meeting in London to discuss the on-going challenges facing the sheep industry.The summit was called following a challenging year for producers which has seen farms hit by poor weather, a longer finishing period, rising costs, disease challenges and a marked drop in lamb prices over the past year.Recent reports have confirmed farmers' worries over a return of the virus in sheep and cattle with figures indicating up to 60% loss being suffered by early lambing flocks.The disease, which leads to lambs and calves being stillborn or deformed, has led to farmers complaining over a lack of information about the virus which has been confirmed on more than 1,200 UK farms.NFU livestock board chairman Charles Sercombe, a sheep farmer in Leicestershire, has seen Schmallenberg in his own flock.He said concern was growing across the industry and that a vaccine must be made available to give farmers the ability to safeguard future lamb crops."Any infection present on farm now will have taken place last year and there is nothing that can be done to alleviate issues at the moment" he said."But it is important that a vaccine is made available this year to give our sheep farmers the choice of whether to vaccinate their flocks against this disease.""The other issue to address is a lack of official data to see how things are developing. We are therefore working closely with Eblex, AHVLA and other industry organisations on a lambing survey which will be released shortly and that I would urge sheep farmers to complete."While not particularly worrying in adult animals, the clinical signs in foetuses infected during gestation are, however, alarming: abortion, hydrocephalus, muscular atrophy. A team from the University of Liège’s Pathology Laboratory is closely monitoring this new epidemic. "The symptoms observed in adult animals aren't very specific and only last about a week" said Mutien-Marie Garigliany, doctor in veterinary medicine and research assistant at ULg's Pathology Laboratory, led by Professor Daniel Desmecht."On the other hand, this new pathogen can cause abortions and serious malformations, especially in the nervous system of young animals infected during gestation."Researchers at the Friedrich Loeffler Institute (FLI), the main federal German research organisation for animal health, were therefore quick to begin looking for the causes of the epidemic.