EMA Recommends Approval of Bluevac-3 and Syvazul BTV 3 Vaccines for Bluetongue Disease

• The EMA has recommended Bluevac-3 and Syvazul BTV 3 for sheep protection against the bluetongue virus, specifically the newly emerged serotype-3 (BTV3).
• Bluevac-3 is also approved for use in cattle, offering a broader application in ruminant livestock affected by the bluetongue virus.
• Clinical trials demonstrated that both vaccines reduce the amount of virus in the blood, decrease disease symptoms, and lower mortality rates in vaccinated animals.
• The vaccines, containing an inactivated form of BTV3, are not expected to pose risks to human or animal health when used according to product guidelines.

The European Medicines Agency (EMA) has recommended the approval of Bluevac-3 and Syvazul BTV 3, two vaccines designed to protect sheep against bluetongue disease. Bluevac-3 has also been recommended for use in cattle, marking a significant step forward in combating the disease that has caused recent outbreaks in Europe.

Addressing the Bluetongue Threat

Bluetongue is an infectious disease affecting wild and domestic ruminants, including sheep, goats, and cattle. Transmitted through the bite of Culicoides flies, the disease can spread rapidly, leading to significant economic losses and animal suffering. The newly emerged serotype-3 bluetongue virus (BTV3) has been particularly challenging, as existing vaccines offer limited protection against it. The severity of the disease varies, with sheep often experiencing the most severe and potentially fatal outcomes.

Vaccine Characteristics and Mechanism

Both Bluevac-3 and Syvazul BTV 3 contain an inactivated form of BTV3. This inactivated form stimulates an immune response without causing the disease, thereby protecting vaccinated animals from infection and reducing disease spread. The vaccines are administered as ready-to-use suspensions for injection and include adjuvants to enhance the immune response.

Clinical Efficacy

The efficacy of Bluevac-3 was evaluated in two studies involving lambs and calves. Vaccinated animals, receiving two doses 21 days apart, exhibited a significant reduction in the amount of virus in their blood. Lambs also showed a decrease in the severity of symptoms and mortality rates. Similarly, Syvazul BTV 3's efficacy was assessed in sheep, demonstrating a reduction in viral load, disease symptoms, and mortality following vaccination.

Safety Profile and Regulatory Path

According to the risk assessment conducted by the EMA, these vaccines are not expected to pose a risk to human or animal health or the environment when used as directed. The EMA's Committee for Medicinal Products for Veterinary Use (CVMP) opinion will now be forwarded to the European Commission for a final decision on EU-wide marketing authorization.

The introduction of Bluevac-3 and Syvazul BTV 3 represents a crucial advancement in the fight against bluetongue disease, offering a much-needed tool for protecting livestock and mitigating the economic impact of outbreaks.