The safety of overdose and repeat administrations of BCG Danish strain 1331 vaccine in calves and pregnant heifers

• DOI: 10.1016/j.heliyon.2024.e34683
• Publication Date: 2024-07-16T00:46:57Z
• Authors: Gareth A. Williams; David Allen; Jacqueline Brewer; Francisco J. Salg...; Steve Houghton; H. Martin Vorderm...
• Keywords: Danish; Strain (injury)

Bovine tuberculosis (bTB), caused by Mycobacterium bovis infection, is a zoonotic disease in cattle that represents significant ongoing challenge to farming productivity and the livelihoods of livestock farmers UK. Vaccination with BCG could directly target ability M. proliferate within vaccinates, restricting bTB pathogenesis onward transmission, represent step change tools available help control farmed cattle. A Marketing Authorisation (MA) required before vaccine be sold supplied as veterinary medicine UK this requires comprehensive data supporting quality, efficacy and, most importantly, its safety. We carried out two independent Good Laboratory Practice (GLP) studies which safety vaccination was stringently tested through overdose repeat administrations young calves pregnant heifers. Mild generally short-lived reactions vaccinations were observed some animals, commonly increases body temperature swelling at injection sites, but these did not have negative impact on overall health status vaccinates. shed saliva, faeces, milk or urine from vaccinated animals dissemination limited site tissues associated lymph nodes. Overall, heifers remained good general health, had normal pregnancies gave birth healthy calves. Obtaining for critical milestone progress towards eventual use an additional tool UK; pivotal GLP generated detailed essential animal needed support this.