MSD Animal Health allows Veterinary Medicines Directorate to release details of application to licence a Schmallenberg vaccine.
The Veterinary Medicines Directive (VMD) has confirmed it is looking at a possible Schmallenberg vaccine, following renewed calls from the farming industry.
For reasons of commercial confidentiality the VMD is
not usually able to comment on whether or not it has received a specific application for a veterinary medicine or comment on the progression of a particular application.
However, in view of the considerable media interest surrounding MSD’s application for a provisional marketing authorisation for Bovilis SBV, the company has allowed the VMD to share the following information regarding the progression of their application:
- VMD received an application for a provisional marketing authorisation at the end of August 2012.
- Following provision of further data so that the application was complete, it passed validation mid September 2012.
- The VMD completed its initial assessment and sent questions to the company towards the end of November 2012.
- MSD provided responses to questions at the end of January 2013 and these are currently being assessed by the VMD.
A VMD spokesman 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. The VMD will operate timelines for the remaining stages of consideration of the application mindful of this while ensuring, through our rigorous scientific assessment process, that proper care is taken to ensure that any vaccine is safe for the relevant livestock.”