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EMA has issued a positive opinion for the approval of a vaccine named Biobhyo, indicated to protect pigs from swine dysentery, a disease that causes dysenteric diarrhoea in pigs. No vaccine is currently authorised in the European Union (EU) against this disease.
Swine dysentery is a highly infectious gastrointestinal disease caused by the bacterium Brachyspira hyodysenteriae. It affects up to 90% of pigs in infected herds, with a mortality rate of 30-50%. The disease poses significant challenges to veterinarians and farmers worldwide, impacting both animal welfare and farm productivity. Biobhyo contains an inactivated strain of Brachyspira hyodysenteriae and an adjuvant that helps stimulate the immune response. The vaccine is available as ready-to-use emulsion for injection for pigs.
Its efficacy was evaluated in two studies comparing the incidence of dysenteric diarrhoea in vaccinated and non-vaccinated pigs in commercial farms in two different European countries. Pigs received their first dose at five weeks of age and a second dose at eight weeks, leading to a reduction in dysenteric diarrhoea caused by Brachyspira hyodysenteriae.
Based on the risk assessment conducted as part of the evaluation of all veterinary products, the vaccine is not expected to pose a risk to human or animal health or the environment, if used according to the product information.
The opinion of the Committee for Medicinal Products for Veterinary Use (CVMP) will now be sent to the European Commission for adoption of the decisions on an EU-wide marketing authorisation of the vaccine.
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