In April 2024 Syva Laboratories announced that its vaccine against bluetongue serotype 3 (BTV3) has been authorised for emergency use in the Netherlands. This announcement is the culmination of “intensive work” by the team, “excellent coordination” with a CRO, and “efficient communication with the authorities in the Netherlands”. The authorisation comes under Article 110 (2) of Regulation (EU) 2019/6. It is hoped that this progress will alleviate farmers’ anxiety and support efforts to control the outbreaks.
Responding to an emergency
As we noted in September 2023, the first severe clinical outbreaks of BTV3 were reported in the Netherlands at the end of last year. Since then, the rate of spread of the serotype “appears to be even faster” than the spread reported during the BTV8 epidemic of 2006-2008. Reports indicated that on badly affected farms, mortality could reach 40%. Syva decided to intervene and prioritise a vaccine.
“Given the severity of the clinical situation and the speed at which this new serotype 3 was spreading in the Netherlands and was starting to spread in neighbouring countries, we could not remain indifferent to the damage caused by this particularly aggressive BTV serotype.”
Syva steps up
Managing Director of Syva Laboratories is César Carnicer, who commented on the rapid assessment of production capacity and human resources that led to a quick decision to prioritise vaccine development.
“As you can imagine in such a situation, it’s very complicated to assess the needs of different countries, and whether the strain we obtained was going to be sufficiently productive to provide the quantity of doses needed to achieve vaccine coverage in what everyone hopes would be a short space of time.”
Although there were “many unknowns”, the team “decided to take the risk”. Despite Syva’s success in vaccine development for various serotypes of bluetongue, the team was cautious about predicting success. After establishing contacts with Dutch authorities, it became apparent that a solution was needed before the next “wave” of Culicoides, the vector.
Racing the clock
Hans de Smit, Syva’s Director of R&D, reflected that the team had possession of the virus strain “by the end of October” and started preparing the registration file with “essential clinical trials” to provide the European regulatory authorities with information to “assess the vaccine’s safety and efficacy data”.
“Our reference for complying with the requirements was our experience with the dossier submitted in 2019 for authorisation at European level of our combined BTV vaccine.”
Within “just over 6 months”, Syva achieved the result of an effective and safe vaccine and says “well done Team and thank you” to everyone involved.
Opportunities abroad
Farmers Weekly states that Phil Stocker, chief executive of the National Sheep Association (NSA), is excited by this “great news” and intends to encourage the Veterinary Medicines Directorate (VMD) to explore the possibility of working with Syva to bring it to the UK.
“We were being told that there would be no hope of any BTV-3 vaccine available in the UK until 2025.”
Not only does Syva’s vaccine increase the chance of farmers in the UK having access to a solution, but it “will dampen down and reduce the risk of the virus spreading across the Channel” from the Netherlands and Belgium.
“We hope there will be a really good take-up.”
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