Prevtec Microbia Inc. (“Prevtec”) is pleased to announce that five million doses of its bivalent vaccine Coliprotec® F4/F18 have been sold in the European Union (EU) since its commercial market authorization in 2017.
The product is a live bacterial vaccine containing a combination of two non-pathogenic E. coli strains for active immunization of pigs against post-weaning diarrhea (PWD) caused by E. coli. It is given orally to pigs as a single dose either as a drench or by addition to drinking water.
The European Medicines Agency (EMA) considers Coliprotec F4/F18 to have the potential to change the current practice to give antibiotics to control infection in pig herds.(1) On 27 July 2016, the EMA recommended that colistin-containing medicines should only be used as a second line treatment in animals and that their sales should be minimized (reduction of 65%) across all EU Member States to reduce the risk of antimicrobial resistance. The advice updates EMA guidance from 2013 and takes into account a decision to withdraw the marketing authorizations (MAs) for veterinary medicines containing zinc oxide administered orally to food producing species. Member states have been given up to five years, from the date of adoption of the Commission Decision, to withdraw existing national MAs for these products. Colistin and zinc oxide are both widely used across the EU to control PWD.
“The bivalent vaccine developed by Prevtec Microbia and distributed by Elanco in the EU and in Canada is a great innovation which meets our customers’ needs. This sales threshold of five million doses is significant and we plan to bring this product to the next level in the coming years”, said Dr. Ralph Heuser, Elanco Vice President Operations, Europe, Middle East & Africa.
Michel Fortin, President and CEO of Prevtec added: “We are proud of our swine vaccine portfolio and the achievement of this sales milestone. Post-weaning diarrhea caused by E. coli has a negative effect on animals’ well-being and can cause major economic losses in pig production. We are demonstrating, with great success, that our product is an alternative to antibiotics to improve animal health in the European Union and in Canada with the support of our distribution partner Elanco.”
(1) Veterinary Medicines Highlights / www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/01/WC500220067