1. Developing policy for the use of TB vaccines in badgers and cattle in England Vaccination in the control of bovine tuberculosis Thursday, 3 rd October 2013 Zoological Society of London

2. Vaccination Vaccination of both badgers and cattle, while not solutions to the huge problem of bovine TB in England, are potentially important components of what is necessarily a comprehensive, multi- faceted eradication programme. The barriers to wider use of the currently available injectable badger vaccine and deployment of a cattle vaccine and oral badger vaccine are sizeable and will take time to overcome. In the meantime, it is important that other means are used to bear down on the disease. Environment, Food and Rural Affairs Committee - Written evidence submitted by the Department for Environment, Food and Rural Affairs

3. Cattle vaccination: a reasonable legal obstacle As regards vaccination, current EU rules do not allow the use of vaccines against bTB in cattle (Article 13 of Council Directive 78/52/EEC) mainly because of the interference with the only available official test (skin test) and the suboptimal effectiveness of existing vaccines. If a candidate vaccine were to be developed that would show sufficient protection and no interference with diagnostic tests, to be able to use such a vaccine in practice, EU and international rules will first need to be amended. European Parliamentary Question E-010251-12

4. Cattle vaccination: potentially valuable tool but not a panacea The vaccination of cattle with BCG is no panacea – it can never be more than one component of a control programme; The continuing presence of a reservoir of infection external to the cattle population (in wildlife) imposes a constraint on what the vaccination of cattle can achieve; The vaccination of cattle with BCG has a potentially valuable role to play in the bovine TB control programmes of Wales and England (and possibly beyond);

5. Tentative timeline from Commission Substantial experimental research and long-lasting (2- 5 years) field trials Scientific consensus on conditions for use; EFSA opinion; marketing authorisation Debate on conditions for use, possibly end with new EU rules Practical experience on use of vaccine and DIVA test EU rules on vaccinated animals and herds to enter into intra-Union trade, amendments of international standard (OIE manuals)

6. Roadmap towards field trials Initial preparatory work Autumn 2013 – Summer 2014 Studies to fill pre-ATC data gaps identified by VMD Field trial design work Apply to VMD for ATC  Legal basis for field trials would be an Animal Test Certificate (ATC) which can be issued by VMD  Indicative timetable WORK IS IN PROGRESS

7. Oral badger vaccine: no guarantee of success A vaccine that can be delivered orally is a potentially cheaper and more practical way of vaccinating large numbers of badgers in the wild than an injectable vaccine. But R&D phase more demanding and no guarantee of success. Even when we have identified an efficacious licensable vaccine candidate we still have 4-5 years of further work to do to complete regulatory studies, transfer technology to manufacturer and scale up, and get the product licensed. Nevertheless, the work continues at pace.

8. Badger vaccination has an impact but speed of impact of policy interventions is important 4 year safety field-study demonstrated that BCG vaccination of wild badgers in a naturally infected population results in a statistically significant 73.8% reduction in the incidence of positive results to a badger antibody blood test for TB. Defra veterinary and scientific advice is that culling in high cattle TB incidence areas, carried out in line with strict evidence-based licence criteria, will reduce the number of infected badgers and thus the weight of TB infection in badger populations in the treatment area more quickly than vaccination.

9. Badger vaccination - part of the solution in the context of policy where others bear the cost For most farmers, badger culling is likely to be the preferred option, leading to a higher uptake. This is an important consideration in the context of a policy which requires the industry to bear the direct costs of badger control. But the Government recognises that some farmers and landowners may prefer to use vaccination to reduce the prevalence of TB infection in badgers, despite the limitations. The Government, therefore, sees a role for both badger culling and badger vaccination as part of a comprehensive and balanced package of measures to tackle TB in cattle.

10. Ability to deliver is crucial – Government helps Badger vaccination can consume a lot of scarce resources – money and time. There is no sizeable army of public sector vaccinators. Defra-funded Badger Vaccine Deployment Project (BVDP) in Gloucestershire aims to build confidence in the principle and practicalities of vaccination, develop practical know-how and provide capacity to train lay vaccinators. To encourage the use of badger vaccination, we will make available up to £250,000 per year in funding in the form of a grant scheme, allowing farmers and landowners to bid for funding to support planned vaccination activity.

11. Marshalling enthusiasm for vaccination There is a debate to be had on the ways in which the Government can be the catalyst for increased use of the injectable badger vaccine. The capacity of others with whom the Government might share responsibility for vaccination is similarly constrained. The uptake of the badger vaccination fund this year is evidence of that. So it is important to look more closely at ways in which capacity can be built and the good intentions of many turned into practical action.