BTVPUR

The vaccine is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to young animals as two injections under the skin. The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal’s mother is already immune to the disease and has bluetongue virus antibodies. The second injection is given three to four weeks later. For a vaccine containing only bluetongue virus serotype 2 or 4 (or both together) in sheep, one injection is sufficient.

For more information about using BTVPUR see the package leaflet or contact your veterinarian or pharmacist.

BTVPUR is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. BTVPUR contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep and cattle, the animals’ immune systems recognise the viruses as ‘foreign’ and make antibodies against them. In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly. This will help to protect them against the disease.

BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 2, 4 and 8. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) that enhance the response of the immune system.

The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age. Further laboratory studies were conducted in calves using a vaccine containing bluetongue serotype 2 and in sheep and calves using a vaccine containing bluetongue serotype 4. The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.

The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8. The studies also showed that the vaccine reduces the signs of the disease in sheep and prevents viraemia in sheep and cattle from one month of age that are infected with bluetongue virus serotype 2.

The studies also showed that the vaccine can be used in pregnant and lactating sheep and cattle.

Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks. There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before milk may be used for human consumption. The withdrawal period for meat and milk from sheep and cattle treated with BTVPUR is ‘zero’ days, which means that there is no mandatory waiting time.

The European Medicines Agency decided that BTVPUR’s benefits are greater that its risks and it can be authorised for use in the EU.

BTVPUR is developed using data from the vaccine BTVPUR AlSap 1-8 originally authorised under ‘exceptional circumstances’ on 17 December 2010 because limited information was available at the time of approval. As the company had supplied additional information requested, the ‘exceptional circumstances’ ended on 6 May 2013. In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need. In 2018 a fourth possible serotype was added still with one or two serotypes selected depending on the need.

BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.