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Development of an oral BCG vaccine for badgers - regulatory component - SE3247

Description
There was an estimated 225% increase in the number of bovine tuberculosis (TB) incidents in Great Britain between the years 1996 and 2006. This adversely affects animal health and welfare, and is a cause of considerable economic loss to farmers and Government. Although transmission of Mycobacterium bovis between cattle is an important factor in spread of the disease, the Eurasian badger (Meles meles) represents an additional wildlife source of recurrent M. bovis infection to cattle in both the UK and Ireland. Following the recent Ministerial statement that badgers would not be culled as part of control measures for bovine TB (http://www.defra.gov.uk/corporate/ministers/statements/hb080707.htm), the vaccination of badgers against TB has come to the fore as a possible means to reduce and control bovine TB alongside other control measures.

It has long been recognised that delivery of vaccine in oral bait holds the best prospect for vaccinating badgers over a wide geographical area and has proved highly successful for mass vaccination of other wildlife species against rabies. In the short to medium term, M. bovis Bacille Calmette-Guérin (BCG) vaccine represents the best available option for vaccination of badgers against TB. Options for the formulation of BCG in bait will be explored under a complementary research project. This project will focus on experimental work using the oral vaccine in order to generate data for the licensing of the vaccine. There are defined steps to achieve this as follows, and each of these requirements form part of this project:

• Experimental safety study on captive badgers performed to Good Laboratory Practice (GLP) accreditation.
• A field safety study on wild badgers performed to Good Clinical Practice (GCP).
• Demonstration of the effectiveness of the vaccine to badgers in experimental infection studies.

Another important element to this project and related to the safety of the vaccine, is assessment of the likelihood and consequences of exposure of non-target species to the oral bait vaccine. EU Directive 92/18/EEC requires that the potential risk to unvaccinated animals of the target or any other potentially exposed species shall be evaluated. The Veterinary Medicines Directorate (VMD) will be responsible for evaluating the application to obtain a National Marketing Authorisation for the oral badger vaccine. The most significant non-target species from the perspective of TB control is cattle. There is a need to quantify and determine the risks associated with exposure of cattle to the badger bait vaccine in advance of decisions over whether to vaccinate badgers orally as part of TB control policy, and make recommendations about precautions that can be taken to reduce the risk. The first element of this process will be addressed in the complementary research project, where the palatability of various candidate baits to cattle is being evaluated in a natural grazing situation using camera surveillance. In this project, we will evaluate uptake in the higher risk situation where baits are deployed at setts to which cattle have access, and then move towards an evaluation of the means of reducing this exposure risk.
Time-Scale and Cost
From: 2010

To: 2020

Cost: £11,990,129
Contractor / Funded Organisations
Veterinary Laboratories Agency
Keywords
Animal Diseases              
Animal Health              
Badgers              
Plants and Animals              
Tuberculosis              
Vaccines              
Fields of Study
Animal Health