First Vaccine Against Swine Dysentery Recommended for Approval

The European Medicines Agency (EMA) has issued a positive opinion for Biobhyo, the first vaccine recommended for approval to protect pigs from swine dysentery. This disease, caused by the bacterium Brachyspira hyodysenteriae, leads to severe dysenteric diarrhoea in pigs and currently lacks an authorised vaccine in the European Union (EU).

Swine dysentery is a highly contagious gastrointestinal disease that can affect up to 90% of pigs in infected herds, with a mortality rate of 30-50%. The disease presents significant challenges for veterinarians and farmers worldwide, threatening both animal welfare and farm productivity. Biobhyo contains an inactivated strain of Brachyspira hyodysenteriae along with an adjuvant to enhance the immune response. It is administered as a ready-to-use emulsion injection for pigs.

The vaccine's efficacy was evaluated through two studies conducted on commercial farms in two European countries, comparing the incidence of dysenteric diarrhoea in vaccinated and non-vaccinated pigs. Pigs received the first dose at five weeks of age, followed by a second dose at eight weeks. The results showed a reduction in dysenteric diarrhoea caused by Brachyspira hyodysenteriae in the vaccinated animals.

Following a thorough risk assessment, the vaccine has been deemed safe for both human and animal health, as well as the environment, when used according to the product guidelines.

The Committee for Medicinal Products for Veterinary Use (CVMP) will now forward its opinion to the European Commission for a final decision on granting EU-wide marketing authorisation for Biobhyo.