0
The European Medicines Agency (EMA) has recommended the approval of the first vaccine against swine dysentery. The vaccine, called Biobhyo, was developed by the Spanish biotechnology company Aquilón CyL. It is intended to reduce the incidence of dysenteric diarrhea caused by the bacterium Brachyspira hyodysenteriae in finishing pigs.
The Spanish Agency of Medicines and Health Products (AEMPS) served as the rapporteur for the scientific evaluation of the vaccine, advising the company from the early stages of research through to its regulatory assessment.
The vaccine is administered as an injectable emulsion containing an inactivated strain of Brachyspira hyodysenteriae and an adjuvant to stimulate the animal’s immune response. It is the first vaccine targeting this disease to receive a positive recommendation for authorization within the European Union, and it has also been classified as a new active substance.
Its efficacy was evaluated in two studies comparing the incidence of dysenteric diarrhea in vaccinated and unvaccinated pigs on commercial farms in two European countries. Pigs received the first dose at five weeks of age and a second dose at eight weeks, leading to a reduction in dysenteric diarrhea caused by this bacterium. Based on the risk assessment conducted during the evaluation, the vaccine is not expected to pose any risk to human or animal health, consumers, or the environment when used as indicated in the product information.
The favorable opinion issued by the EMA’s Committee for Veterinary Medicinal Products (CVMP), of which the AEMPS is a member, will now be forwarded to the European Commission to continue the process of granting marketing authorization for Biobhyo across the EU.
June 23, 2025/ AEMPS/ Spain.
https://www.aemps.gob.es
