January 11, 2021
Boehringer Ingelheim's Enterisol Ileitis confirmed to mitigate salmonella infections at slaughter
Boehringer Ingelheim announced that the Paul Ehrlich Institute (PEI) - which serves as the competent authority of Reference Member State Germany under the Mutual Recognition procedure (MR) - has accepted new language on the label of the company's Enterisol® Ileitis that mitigates occurrences of salmonella.
PEI is the Federal Institute for Vaccines and Biomedicines in Germany. As a federal regulatory authority active in the field of pharmaceuticals, the organisation's work is in the service of public health.
The national marketing authorisation is granted pursuant to the Animal Health Act (TierGesG) and the Animal Vaccine Regulation. The PEI confirmed that Enterisol® Ileitis reduces prevalence of salmonella infection and salmonella seroprevalence at slaughter.
The request for a variation to Enterisol® Ileitis' Summary of Product Characteristics to add new wording in the section "Immunological Properties" was accepted by PEI and following completion of the MR procedure, identical authorisations will be granted in all EU Member States that have been included in the registration.
Ileitis caused by Lawsonia intracellularis is a costly disease affecting the digestive system of pigs in all pig rearing countries. According to Boehringer Ingelheim, Enterisol® Ileitis is the only global oral live Lawsonia intracellularis vaccine to control Ileitis in swine. Salmonella infections in swine can lead to both clinical disease, production losses and food safety risks in pork.
"This additional label language for Enterisol® Ileitis has been possible due to submission of both challenge studies and field observations in several countries. The studies showed that in pigs co-infected with both Lawsonia and salmonella, vaccination with Enterisol® Ileitis reduced the prevalence of salmonella infection and salmonella seroprevalence at slaughter," said Dr. Ricarda Deitmer, enterics technical manager (Germany) at Boehringer Ingelheim Animal Health.
Meanwhile, authorities have also confirmed that the oral administration of the live vaccine is leading to a modulation of the intestinal microbiome. The positive effect on the microbiome results in more short chain fatty acids producing bacteria, which in turn reduces salmonella infections..
- Boehringer Ingelheim