Zulvac BTV
Authorised
This medicine is authorised for use in the European Union
bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Zulvac BTV is a veterinary 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 contains inactivated (killed) bluetongue virus. When used in sheep or cattle the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8. The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
The vaccine can prevent the presence of serotypes 1 or 8 and reduce levels of serotype 4 in the blood in sheep, and prevent the presence of serotypes 1, 4 or 8 in the blood in cattle.
The vaccine is available as a suspension for injection and can only be obtained with a prescription.
The vaccine is given as two injections under the skin for sheep and in the muscle for cattle. The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later. The amount in each injection is 2 ml except for the serotype 4 injection for cattle which is 4 ml.
For more information about using Zulvac BTV, including how long protection lasts, see the package leaflet or contact your veterinarian or pharmacist.
Zulvac BTV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease. When it is given to sheep or cattle, their immune system recognises the virus as ‘foreign’ and makes antibodies against it. 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.
Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype. Further laboratory studies showed protection lasts for one year for each serotype. A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Laboratory studies were conducted with the individual serotypes 1, 4 and 8 in cattle and these studies showed that the animals were protected from day 15 after completion of the initial vaccination course of two injections for serotype 1, from day 14 after completion of the initial vaccination course of two injections for serotype 4 and from day 25 after completion of the initial vaccination course of two injections for serotype 8. Further laboratory studies showed protection lasts for one year for serotypes 1 and 8 and 6 months for serotype 4.
Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6?C, during the 2 days after vaccination and local reactions at the injection site. In most cases the reactions are diffuse swellings at the injection site which last no longer than one week. They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7?C, during the 2 days after vaccination. The local reactions lasted up to 25 days for the 2 ml dose and no more than 8 days for the 4 ml dose.
For the full list of restrictions, see the package leaflet.
None
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 Zulvac BTV is ‘zero’ days, which means there is no mandatory waiting time.
The European Medicines Agency decided that Zulvac BTV’ benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Product information
Latest procedure affecting product information:
II/0004
20/05/2021
Product details
- Name of medicine
- Zulvac BTV
- Active substance
- One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
- International non-proprietary name (INN) or common name
- bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
- Species
- Sheep
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA
Pharmacotherapeutic group
- Immunologicals
- Immunologicals for Bovidae
- Inactivated viral vaccines
- bluetongue virus
- SHEEP
Therapeutic indication
Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8, and for the reduction of viraemia caused by bluetongue virus, serotype 4 and active immunisation of cattle from 12 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8.
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