EMA has recommended the approval of the vaccines Bluevac-3 and Syvazul BTV 3 to protect sheep against bluetongue disease. Bluevac-3 is also approved for use in cattle. The disease is caused by the bluetongue virus, of which different types exist. These vaccines are shown to protect against the newly emerged serotype-3 bluetongue virus (BTV3), responsible for recent outbreaks in Europe, and against which vaccines currently approved at EU wide-level show little protection. For this reason, the vaccines were recommended for approval under exceptional circumstances.Bluetongue is an infectious disease that affects wild and domestic ruminants including sheep, goats and cattle. It is contracted through the bite of Culicoides flies that have fed on infected animals. In this way, it can spread through herds and across different species. The disease severity varies for different animals and is worst in sheep, for whom it can often be fatal.There is no public health risk associated with bluetongue disease, as the virus is not transmitted to humans through contact with animals or wool, or through consumption of milk or meat. However, vaccination can control disease spread, reducing economic losses, protecting livestock trade and preventing animal suffering.Both Bluevac-3 and Syvazul BTV 3 contain an inactivated form of BTV3. While the inactivated form cannot cause the disease, it can still elicit an immune response, protecting vaccinated animals against infection and reducing disease spread. Both are available as ready-to-use suspensions for injection and contain adjuvants to help stimulate the immune response.The efficacy of Bluevac-3 was investigated in two studies comparing the protection against the disease in vaccinated and unvaccinated lambs and calves. In both species, after two doses of the vaccine given 21 days apart, the vaccinated animals showed a reduction in the amount of virus in the blood. Lambs also showed a decrease in the severity of symptoms and in mortality. The efficacy of Syvazul BTV 3 was assessed through two studies in vaccinated sheep exposed to the virus. These showed a reduction in the amount of virus in the blood, in disease symptoms and mortality.Based on the risk assessment conducted as part of the evaluation of all veterinary products, the vaccines are not expected to pose a risk to human or animal health or the environment, if used according to the product information.The CVMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation of the two vaccines.
Brief
"On January 17, 2025, the European Medicines Agency (EMA) issued an update regarding Two new vaccines against bluetongue recommended for approval. The EMA has recommended the approval of Bluevac-3 and Syvazul BTV 3 to protect sheep against bluetongue disease, with Bluevac-3 also approved for use in cattle. These vaccines are shown to protect against the newly emerged serotype-3 bluetongue virus (BTV3) responsible for recent outbreaks in Europe."
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Purpose
The European Medicines Agency (EMA) has recommended the approval of two vaccines, Bluevac-3 and Syvazul BTV 3, to protect sheep against bluetongue disease. These vaccines have been shown to be effective in protecting against the newly emerged serotype-3 bluetongue virus (BTV3), which is responsible for recent outbreaks in Europe. The approval of these vaccines under exceptional circumstances aims to control the spread of this disease and prevent economic losses, protect livestock trade, and reduce animal suffering.
Effects on Industry
The approval of Bluevac-3 and Syvazul BTV 3 will have a significant impact on the sheep farming industry in Europe. With the ability to vaccinate against the newly emerged serotype-3 bluetongue virus (BTV3), farmers can take proactive measures to protect their livestock, reducing the risk of disease spread and economic losses. This approval is expected to boost confidence among farmers, veterinarians, and other stakeholders involved in the sheep farming industry.
Furthermore, the availability of these vaccines will create new opportunities for veterinary practices and animal health companies to provide vaccination services and supply vaccines, respectively. This can lead to increased revenue and growth in these sectors.
Relevant Stakeholders
The approval of Bluevac-3 and Syvazul BTV 3 affects various stakeholders, including:
- Sheep farmers and breeders: The ability to vaccinate against the newly emerged serotype-3 bluetongue virus (BTV3) will provide them with a valuable tool to protect their livestock.
- Veterinarians: They will have new vaccines available for use in sheep, which can help prevent disease spread and reduce economic losses.
- Animal health companies: The approval of these vaccines creates opportunities for the supply and distribution of these products.
- Regulatory authorities: EMA’s recommendation for approval is an important step in ensuring that effective measures are taken to control the spread of bluetongue disease.
Next Steps
Following the EMA’s recommendation, the CVMP opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation of the two vaccines. This decision will provide official approval for the use of Bluevac-3 and Syvazul BTV 3 in sheep farming across Europe.
Farmers, veterinarians, and animal health companies should prepare themselves for the upcoming availability of these vaccines by educating themselves about their benefits and requirements. Regulatory authorities will also need to ensure that guidelines are updated to reflect the approved status of these vaccines.
Any Other Relevant Information
Bluetongue disease is a significant concern in Europe, particularly among sheep farmers. The approval of Bluevac-3 and Syvazul BTV 3 provides a critical tool for controlling the spread of this disease and protecting animal health and welfare.
In addition to their use in sheep farming, these vaccines are also approved for use in cattle, which highlights the importance of taking proactive measures to prevent disease spread among livestock. The EMA’s recommendation for approval under exceptional circumstances underscores the urgency of addressing this public health concern.
As the marketing authorisation process unfolds, relevant stakeholders should remain informed about developments and updates related to the availability and use of these vaccines.
