The Belgian federal medicines agency, FAMHP, has now also authorised the use of the BTV3 vaccine developed by the Syva laboratories.
We are pleased to announce that, while Dutch veterinarians began mass vaccination on Monday 6 May, the Belgian veterinary health authorities on Wednesday 8 May authorised the use of Laboratories Syva’s BTV3 vaccine under Article 110(2) of Regulation (EU) 2019/6.
This procedure for the emergency use of a vaccine in an exceptional situation allows the competent authorities within the European Union and in each country affected by the risk of an epidemic to derogate from the usual marketing authorisation. This enables rapid preventive action to be taken in the case of an imminent risk of a disease such as bluetongue having a major impact on the health and welfare of livestock. This was the case in the Netherlands between September 2023 and January 2024, causing numerous deaths and severe disease in sheep herds and serious symptoms in cows, with major economic consequences. However, as some of the testimonies gathered from Dutch vets emphasised, the disease also had a considerable social and psychological impact on farming communities and vets, which should not be underestimated.
As we mentioned in our previous press release, AnimalHealthEurope launched a Europe-wide appeal in December 2023. Following that, and our decision to give priority to the search for a rapid, safe and effective solution to protect millions of cows and sheep, contacts were established with representatives of the main countries affected by outbreaks of BTV3. Since the announcement of the authorisation for the use of our vaccine, and the first million doses delivered to the Netherlands, our teams have seen the pace of contacts and discussions accelerate.
As a result, the Belgian Federal Agency for Medicines and Health Products (FAMHP) undertook a very close analysis of the data and studies carried out as part of the registration dossier we submitted for approval.
Based on various official reports monitoring the activity of the culicoides, the biting insects and vectors responsible for BTV3, the high degree of certainty that large-scale outbreaks of bluetongue are likely to occur from the end of June, and the fact that there is currently no vaccine available for this highly aggressive strain of BTV, the Belgian health authorities have decided to speed up the analysis of the dossier submitted to them by Syva.
The FAMHP, having analysed the dossier in detail, considered that the results available from the clinical studies carried out provided sufficient data on the safety, quality and efficacy of the vaccine from Laboratoires Syva to authorise its use in sheep and cattle, and to allow vaccination to be carried out as quickly as possible before the season of activity of the midges carrying the virus.
We can reassure Belgian vets and breeders that, as a result of this authorisation to use our vaccine, all our teams are once again doing their utmost to ensure the production of the batches of vaccine and packaging required to comply with the conditions of use in Belgium.
We would like to thank our teams once again for their unfailing commitment over the months since we decided to take on this remarkable health challenge.
We are grateful to the Belgian authorities for placing their trust in us and enabling us to provide this solution, which gives meaning to what we do every day together with Belgian farmers and vets.
More information:
Syva press release of 26 April 2024
Communiqué of the Belgian Agency 7 May 2024
Communiqué of the Belgian Agency 8 May 2024
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