EU set to approve first vaccine for swine dysentery
EMA backs Biobhyo to protect pigs from deadly diarrhoeal disease
19 June 2025
1 minute read
By: The European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Biobhyo, the first vaccine in the European Union (EU) aimed at protecting pigs from swine dysentery, according to recent EMA press release.
Caused by the bacterium Brachyspira hyodysenteriae, swine dysentery is a highly infectious gastrointestinal disease that affects up to 90% of pigs in infected herds and can result in mortality rates of 30% to 50%. The condition significantly impacts both animal welfare and farm productivity.
Biobhyo contains an inactivated strain of the bacterium along with an adjuvant to enhance immune response. The injectable vaccine is administered in two doses—one at five weeks of age and another at eight—and has shown effectiveness in reducing the incidence of dysenteric diarrhoea in field trials conducted in two European countries.
The vaccine is not expected to pose risks to human or animal health or the environment when used as directed. The Committee for Medicinal Products for Veterinary Use (CVMP) will forward its opinion to the European Commission for final approval and EU-wide marketing authorisation.
