News item | 26-04-2024 | 07:00
The first vaccine against the bluetongue virus has been approved for use on an accelerated basis. This concerns a ‘decision to authorize use’ of the vaccine Syvazul BTV 3 from manufacturer Laboratorias Syva. The Minister of Agriculture, Nature and Food Quality (LNV) issued the decision following a positive advice from the Veterinary Medicines Bureau of the Agency’s Medicines Evaluation Board (aCBG) and the Committee for the Authorization of Veterinary Medicines (Ctd).
When a decision is made to grant permission for use, the data is assessed on the most critical points of quality, safety and efficacy. This way the vaccine can become available as quickly as possible. A decision like this can only be made in emergency situations.
Judgement
The vaccine has been assessed for efficacy, safety and quality. This included laboratory research with the vaccine in sheep, specifically aimed at the bluetongue virus serotype 3. The virus that causes the problems in the Netherlands.
To assess the efficacy in cattle and the safety of the vaccine, data from a comparable bluetongue vaccine from manufacturer Syva was examined. This vaccine targets a different serotype, but is made in the same way and with the same ingredients.
Erik den Hertog, veterinary epidemiologist and clinical assessor at the Veterinary Medicines Agency (aCBG):
The vaccine has been carefully assessed for the most critical aspects of safety, efficacy and quality. In this way, an unregistered vaccine can become available more quickly. Now we have an important tool in the fight against illness and death from the bluetongue virus.
About the vaccine
The bluetongue vaccine Syvazul BTV 3 is an inactivated virus vaccine. The serotype 3 (BTV-3) virus is used in this vaccine. The virus is modified in such a way that it can no longer make an animal sick. The vaccine will cause the body to mount an immune response against the virus. Will the body come into contact with the virus again later? This immune response then ensures that the animal does not become ill or becomes less seriously ill.
Use in sheep and cattle
Disease caused by the bluetongue virus mainly occurs in ruminants. The authorization for use of the vaccine applies specifically to sheep and cattle.
The vaccine is administered by veterinarians. Sheep receive one dose of the vaccine. Cattle are vaccinated twice, several weeks apart. It takes about four weeks for the animals to be protected.
After vaccination, animals may experience side effects, such as a slightly increased body temperature and swelling at the injection site.
When will the vaccine be available?
The Minister of Agriculture, Nature and Food Quality has indicated that 1 million doses of the vaccine are expected to be available within a week. Because the small flies (midges) that transmit the bluetongue virus from animal to animal become active in warm weather, there is hope that enough vaccinations can be administered in the coming weeks. This prevents serious illness and death from the bluetongue virus in the summer.
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Image: Judith Prins/Unsplash
About the Veterinary Medicines Agency
The Veterinary Medicines Agency is the veterinary branch of the Agency’s Medicines Evaluation Board (aCBG). The Veterinary Medicines Agency acts on behalf of the Minister of Agriculture, Nature and Food Quality (LNV), who is the official competent authority.
The Veterinary Medicines Agency assesses applications for marketing authorizations for veterinary medicines and reports to the Committee on the Authorization of Veterinary Medicines (Ctd). The Ctd then advises on the granting of the trade license to the Ministry of Agriculture, Nature and Food Quality.
