The European Commission has shortened its vaccine approval working time in order to grant full marketing authorisation for Merial’s BTVPUR AlSap8.  This recognizes the key role of vaccination in responding to the threat of bluetongue. 

Approval for Merial’s BTVPUR AlSap 8 - the only bluetongue vaccine so far to have received full approval by the Commission - was announced on Monday, 16^th March.  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[1].  This is highly important in preventing circulating virus and therefore the spread of disease.

BTVPUR AlSap8 can be used during pregnancy in ewes.  In cows, results already demonstrate safety in at least the last trimester of pregnancy.  Further data will follow.  The vaccine’s safety profile is a result not just of its design but also the Merial manufacturing process with its emphasis on purification.

One injection is sufficient for sheep, a second injection, 3-4 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[2]. 

Said Kathryn England of Merial:  “This rapid move from a positive opinion in February to full approval a month later indicates how importantly the Commission views BTVPUR AlSap 8’s role in protecting flocks and herds against bluetongue.  The bluetongue season is fast approaching; now vets and farmers know there is a product available with the data behind it for full approval.”

British Veterinary Association’s President Nicky Paull has welcomed the news as a confidence boost for the livestock industry. She commented: “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.

Klaas Johan Osinga, vice chair of the Animal Health & Welfare Working Group of the European Farmers and Co-operatives organization (COPA-COGECA) said “I have long been convinced with bluetongue that the only solution for livestock farmers is vaccination.  It was great when the EU allowed trade in properly-vaccinated animals and it is great again to see the Commission speed up its procedures, while still maintaining safeguards for safety and efficacy.  I hope the way bluetongue has been tackled provides a good example for any other infectious, vector-borne diseases before they arrive.”