The European Medicines Agency (EMA) has issued a positive opinion for the approval of Biobhyo, marking a significant milestone as the first vaccine authorized in the European Union to protect pigs against swine dysentery disease. No vaccine is currently authorized in the EU against this highly infectious gastrointestinal condition that poses substantial challenges to veterinarians and farmers worldwide.
Disease Impact and Unmet Medical Need
Swine dysentery represents a critical veterinary health challenge, caused by the bacterium Brachyspira hyodysenteriae. The disease demonstrates severe impact on pig populations, affecting up to 90% of pigs in infected herds with a mortality rate ranging from 30-50%. This infectious condition causes dysenteric diarrhea in pigs, significantly impacting both animal welfare and farm productivity across affected operations.
Vaccine Composition and Mechanism
Biobhyo contains an inactivated strain of Brachyspira hyodysenteriae combined with an adjuvant designed to stimulate immune response. The vaccine is formulated as a ready-to-use emulsion for injection, providing a practical administration method for veterinary use in pig populations.
Clinical Efficacy Demonstration
The vaccine's efficacy was evaluated through two comprehensive studies that compared the incidence of dysenteric diarrhea in vaccinated versus non-vaccinated pigs across commercial farms in two different European countries. The vaccination protocol involves administering the first dose at five weeks of age, followed by a second dose at eight weeks of age. This two-dose regimen demonstrated a reduction in dysenteric diarrhea caused by Brachyspira hyodysenteriae in the studied pig populations.
Safety Assessment
Based on the comprehensive risk assessment conducted as part of the evaluation process for all veterinary products, Biobhyo is not expected to pose risks to human health, animal health, or environmental safety when used according to the product information guidelines.
Regulatory Pathway Forward
The positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP) will now advance to the European Commission for adoption of decisions regarding EU-wide marketing authorization of the vaccine. This regulatory milestone represents the culmination of the scientific evaluation process and positions the vaccine for potential commercial availability across European markets.
