The European Commission has shortened its vaccine approval working time in order to grant full marketing authorisation for Merial’s BTVPUR AlSap8.
Approval for the product – the only bluetongue vaccine so far to have received full approval by the Commission – was announced on March 16. The EC took five days for the written procedure part of the approval process – a move that cut some six weeks from the expected approval time.
The Summary of Product Characteristics (SPC) that accompanies the marketing authorisation indicates BTVPUR AlSap 8 not only reduces clinical signs of bluetongue in sheep and cattle but also prevents viraemia. This is highly important in preventing circulating virus and therefore the spread of disease. The product can be used during pregnancy in ewes. In cows, results already demonstrate safety in at least the last trimester of pregnancy.
One injection is sufficient for sheep, a second injection, three to four weeks after the first is indicated for cattle. The SPC recognizes the desirability of early vaccination for naïve animals that have no maternal antibodies to protect them compared with those born to immune mothers.
BVA president Nicky Paull welcomed the news as a confidence boost for the livestock industry. She said: “The fact that the VMD has given a full license to at least one Bluetongue vaccine will help give more confidence to vets and farmers in vaccinating against the disease: the more clear and positive information that can be provided the better.
“There have been lots of rumours about various side-effects and adverse reactions to vaccination and this license will help reassure the industry that it is safe to use throughout pregnancy in sheep. Many farmers have felt concerned when asked to sign a form to say they are using a product off-license, but this is not required when using a fully-licensed vaccine.”
Kathryn England from Merial said: “This rapid move from a positiveopinion in February to full approval a month later indicates howimportantly the Commission views BTVPUR AlSap 8’s role in protectingflocks and herds against bluetongue. The bluetongue season is fastapproaching; now vets and farmers know there is a product availablewith the data behind it for full approval.”