At its meeting on 14 and 15 January 2025, the Committee for Medicinal Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA) recommended that the European Commission issued a marketing authorisation in exceptional circumstances for two vaccines against bluetongue virus (BTV) serotype 3. The BLUEVAC-3 vaccine from CZ Vaccines S.A.U. (Spain) is intended for use in sheep and cattle. The vaccine is used in sheep for active immunisation to reduce viraemia (the presence of viruses in the blood), mortality, and clinical symptoms caused by BTV3. In cattle, the vaccine is intended to reduce viraemia caused by BTV3. The Syvazul BTV 3 vaccine from Laboratories Syva S.A. (Spain) is intended for use in sheep and is used for active immunisation to reduce viraemia, mortality, clinical symptoms, and lesions (injuries) caused by BTV3. The final decision on authorisation is taken by the European Commission.
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The marketing authorisation was recommended as part of procedures for the assessment of medicinal products in accordance with Article 25 of European Regulation (EC) 2019/6. Such applications for marketing authorisation in exceptional circumstances are related to public health or animal health. The benefit of immediate availability of the veterinary medicinal products on the European market outweighs the risk posed by the fact that certain quality, safety, or efficacy documents cannot yet be provided. In light of this, the quality, safety, and efficacy of the two vaccines were tested and evaluated positively by the CVMP. A marketing authorisation in exceptional circumstances is initially valid for a period of one year.
In June 2024, the Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL) authorised three BTV3 vaccines, including BLUEVAC-3 and Syvazul BTV 3, with an emergency decree for use in the protection of sheep and cattle in Germany. The Paul-Ehrlich-Institut had previously designated these vaccines following an accelerated benefit-risk assessment. The permission was originally limited to six months, ending on 6 December 2024. This time limit was lifted by the BMEL at the end of November 2024 until the authorisation of a vaccine against bluetongue serotype 3. The use of the permitted BTV3 vaccines had thus far shown that timely and proper primary vaccination of susceptible animals with the BTV3 vaccines protects these animal populations from the harmful effects of BTV3 infection on animal health, such as serious illness or death.
Updated: 17.01.2025
