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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/50530/2011

EMEA/V/C/000156

EPAR summary for the public

Bluevac BTV8

Bluetongue Virus Serotype 8 vaccine

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal's medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Bluevac BTV8?

Bluevac BTV8 is a vaccine. It is a suspension for injection that contains inactivated bluetongue serotype 8 virus.

What is Bluevac BTV8 used for?

Bluevac BTV8 is used in cattle and sheep for the active immunisation against bluetongue virus disease. Bluetongue disease is an infection that is transmitted by midges and caused by the bluetongue virus (serotype 8). The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle.

The vaccine is given to young animals from two and a half months of age onwards as two injections administered subcutaneously with an interval of three weeks.

The vaccine will only be used as part of an approved national disease control programme. This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission.

How does Bluevac BTV8 work?

Bluevac BTV8 is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Bluevac BTV8 contains a bluetongue virus that has

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been inactivated so that it cannot cause the disease. When it is given to cattle and sheep, the animals' immune system recognises the virus as 'foreign' and produces antibodies against it. In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

Bluevac BTV8 contains bluetongue viruses of one type ('serotype 8'). The vaccine also contains 'adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.

How has Bluevac BTV8 been studied?

The safety of the vaccine was studied in several laboratory studies in cattle and sheep at the minimum age of two and a half months and during pregnancy in ewes and cows. In cattle, safety during pregnancy was extrapolated from a study that was conducted in pregnant cows with a similar vaccine to Bluevac BTV8 which contained a different serotype (serotype 1).

The efficacy of the vaccine was demonstrated in a number of laboratory trials in sheep and cattle of the minimum recommended age. The main measures of the efficacy of the vaccine were viraemia and clinical signs in animals that took part in the studies. In all studies the vaccinated sheep and cattle were compared with animals that were not (controls).

What benefit has Bluevac BTV8 shown during the studies?

The studies showed that the vaccine is safe for both sheep and cattle from two and a half months of age onwards. It prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.

Bluevac BTV8 was shown to be safe for use in pregnant ewes and cattle. Vaccination was also shown to be safe for use during lactation in ewes and cattle.

What is the risk associated with Bluevac BTV8?

Sheep and cattle vaccinated with Bluevac BTV8 may have a slightly raised body temperature (between 0.5 and 1.0°C) which lasts no longer than one to two days. They may also have temporary swellings at the injection that may last for over two weeks.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days for both sheep and cattle.

What is the time to allow before milk can be taken from the animal for human consumption?

Milk can be taken immediately for both sheep and cattle.

Why has Bluevac BTV8 been approved?

The CVMP concluded that the benefits of Bluevac BTV8 outweigh the risks for the active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by bluetongue virus serotype 8, and recommended that Bluevac BTV8 be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Bluevac BTV8 has been authorised under 'exceptional circumstances'. This means that it has not been possible to obtain complete information about Bluevac BTV8. Every year, the European Medicines Agency (EMA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.

Which information is still awaited for Bluevac BTV8?

Additional information on quality, safety and efficacy is awaited. An action plan together with timelines for addressing the issues that need to be resolved before the authorisation can revert to normal status will also be submitted.

Other information about Bluevac BTV8:

The European Commission granted a marketing authorisation valid throughout the European Union, for Bluevac BTV8 to CZ Veterinaria S.A. on 14 April 2011. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 14 April 2011.

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Bluevac BTV8

EMA/50530/2011