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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/622534/2010

EMEA/V/C/002231

EPAR summary for the public¹

BTVPUR

Bluetongue disease virus vaccine (containing either serotypes 1 , 4 or 8) (inactivated)

This document is a summary of the European Public Assessment Report (EPAR) for BTVPUR. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.

For practical information about using BTVPUR, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is BTVPUR and what is it used for?

BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.

The vaccine contains inactivated (killed) bluetongue virus. The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these.

How is BTVPUR used?

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. The second injection is given three to four weeks later. For a vaccine containing only bluetongue virus serotype 4 in sheep, one injection is sufficient.

How does BTVPUR work?

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, 4 and 8. The vaccine also contains 'adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.

What benefits of BTVPUR have been shown in studies?

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 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 can be used in pregnant and lactating sheep and cattle.

What are the risks associated with BTVPUR?

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.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat or milk used for human consumption. The withdrawal period for BTVPUR AlSap 1-8 for meat and milk for sheep and cattle is zero days, which means that there is no mandatory waiting time.

Why is BTVPUR approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that BTVPUR's benefits are greater that its risks and recommended that it be approved for use in the EU.

BTVPUR is developed from 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.

Other information about BTVPUR:

The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR on 12 April 2016.

The full EPAR for BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with BTVPUR, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in February 2016.

BTVPUR

EMA/622534/2010

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Previously known as BTVPUR AlSap 1-8_

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