Environment, Food and Rural Affairs CommitteeWritten evidence submitted by the NFU

1. The NFU is pleased to make a submission to the Environment, Food and Rural Affairs committee on the issue of TB vaccination. The NFU represents around 55,000 members, many of whom are affected directly and indirectly by bovine TB (bTB). Almost 35,000 cattle were slaughtered across Great Britain in 2011 as a consequence of the spread of the disease in cattle and wildlife.

2. The NFU strongly believes that a holistic approach is needed to control and ultimately eradicate bTB. No single solution can tackle the disease alone and a mix of solutions—testing and cattle controls, culling of infected wildlife and, in time, vaccination, must all play a part.

3. There has been a tendency amongst some groups to present vaccination of either cattle or badgers as a ready-made alternative to culling of infected wildlife, primarily badgers. From our perspective, vaccination must be seen as a complementary long-term strategy. Further work is needed to bring about effective and efficient deployment of vaccination for both badgers and cattle. Unfortunately, we believe that significant obstacles prevent vaccination from making a meaningful contribution to disease eradication in the short-term. It remains our view that a science-led proactive cull of badgers in TB hotspot areas is absolutely necessary in order to tackle bTB in both badgers and cattle. The organisation is committed to overseeing the execution of pilot culls in 2013 and wider roll-out of culling beyond.

4. To address what we perceive to be a gap the availability of independent information on bTB vaccination, the NFU believes there is a case for government to provide clear public information on vaccination, including research developments and progress towards developing usable vaccines. Above all, investment in research and development in UK field conditions is vital to delivering effective vaccines for cattle and badgers. We understand that government has invested around £23 million in such research since 1998 but it is critical to ensure continued funding is made available to allow vaccination to be deployed effectively in future.

Injectable Badger Vaccines

5. It is important to state from the outset that vaccination of already infected badgers will do nothing to prevent transmission of bTB to other badgers and cattle. Nevertheless, a number of field scale attempts have been made in recent years to deploy injectable vaccines amongst badgers in England and Wales, using the existing BCG vaccine.1 At this stage, there is a lack of data thus far to verify the effectiveness of vaccine use in endemic areas. Ultimately, we believe that vaccination of badgers is likely to have the greatest potential for use in areas that do not yet have endemic disease in the badger population but may be considered at risk.

6. There are important practical constraints to deploying injectable vaccine over a wide area. Injecting a badger with vaccine must be done annually and requires considerable skill and expertise. What is more, trapping badgers in sufficient numbers is far from easy. Whilst there are now a reasonable number of trained lay-vaccinators, the cost of starting up as a commercial operator can be prohibitive.

7. Some funding has been introduced by Defra to assist voluntary organisations with the costs of training badger vaccinators. Nevertheless, in the absence of significant government funding, wider deployment of injectable vaccination will rely heavily on private commercial operators offering vaccination as a service. Farmers are not entitled to funding to complete the course themselves, yet it is their land on which access is required to undertake vaccination of badgers. This, combined with a degree of caution about allowing unknown volunteers onto private land, may be playing a small part in holding back potential to see more widespread take-up of injectable vaccine across the largest areas of land where commercial cattle herds are kept. We believe that Defra should reconsider the funding that is currently available to make it less cost prohibitive for a wider range of people to train as a lay vaccinator.

8. Under any circumstances, deployment of injectable badger vaccine is likely to be a costly exercise given the training required, traps, time involved and requirement to repeat the exercise annually to build immunity. The NFU has some practical experience having trained two lay-vaccinators to provide vaccination for farmers and landowners. Feedback from our members who have enquired into feasibility of vaccination has indicated that costs can vary from £2,500 to over £4,000 per square kilometre of land covered. According to information that we have received from the Food and Environment Research Agency (FERA), the total costs of the government-led Badger Vaccination Deployment Project (BVDP) in Gloucestershire have approached £1.5 million on an area just under 100 square kilometres. In our experience, a large proportion of the cost is incurred by the resource required to pre-bait a trapping point, with most vaccinators having to travel many miles for a series of days. These costs have made vaccination an unattractive investment for many farmers and landowners.

9. In order to make vaccination a more affordable option, in some cases farmers have been encouraged to pre-bait cage traps. This lowers the cost of vaccination but if the cost of the farmer”s time is included, total costs still amount to £1,736 per km2 (excluding travel and subsistence).

10. The ability to successfully trap and inject badgers can also be hampered by climatic and other conditions. Between May and October 2012, the NFU undertook trapping on six separate premises in Gloucestershire and Somerset representing a land area of over 8.66 km2 using a combination of two in-house and one private lay-vaccinator. Due to extremely poor weather, the initial trapping rounds had a low capture rate and further trapping was required. After all trapping had been carried out by the end of the season eight badgers had been successfully caught and vaccinated.

11. At this stage, there is limited research available to demonstrate the effectiveness of badger vaccination in terms of disease incidence in cattle. A recent paper produced by FERA officials2 based on research in Gloucestershire appears to present some encouraging signs of immunity build up in young badgers as part of a vaccination deployment project, there is still as yet no demonstrable impact on disease in cattle.

12. In view of this and the high-costs of injectable vaccination of badgers, the likelihood is that many farmers will opt to make precious investments in other disease management methods such as badger proofing of buildings.

Oral Badger Vaccine

13. Of all the approaches to vaccination the NFU believes that an oral baited vaccine is likely to make the most important contribution to the long-term eradication of TB and is the only way in which widespread vaccination of badgers can realistically be achieved due to its ease of deployment. In considering the long-term eradication of bTB, it is essential that government understands and seeks to remove the obstacles that lie in the way of being able to deliver an oral baited vaccine to badgers. It must also consider how best such a vaccine could be deployed to give the greatest impact. For instance, it would seem most appropriate for an oral vaccine to be used in areas free of endemic TB that lie on the frontier of disease spread to protect a healthy badger population.

14. The current state of play with regard to deployment of an effective oral vaccine is unclear but appears to remain some way into the future. Feedback from AHVLA and FERA suggests that there remain technical difficulties in creating a suitable vaccine for badgers, in particular the ability to make an ingestible and stable version of the BCG that remains both viable and palatable to badgers. It is vitally important that Government makes available sufficient resources in terms of research that is necessary to accelerate the availability and deployment of an oral baited vaccine that is cost effective and easy to deploy.

Cattle Vaccines

15. The NFU is keen to see a cattle vaccine brought to the market as soon as possible. Nevertheless, even were an effective vaccine available to protect healthy cattle, steps would still be needed to tackle the reservoir of disease in wildlife. Without this, eradication of the disease will remain impossible as there will always be a source of reinfection.

16. Cattle keepers continue to harbour concerns over the efficacy cattle vaccines. Previous research indicates that the efficacy of the existing BCG vaccine in cattle is questionable at between 56% and 68% and has not been field tested in UK conditions.3

17. In addition to concerns over efficacy, there are two major hurdles over the use of existing bTB vaccines in cattle. The first concerns the need for a test to distinguish vaccinated from infected animals (a so-called DIVA test). Without this, it is likely that vaccinated cattle would respond to the current skin test, leading to more herds losing officially tuberculosis free (OTF) status. We understand that a test has been developed and approval in principal is being sought by AHVLA.

18. The second major obstacle concerns the need to amend EU legislation (Directive 78/52) surrounding the control of bTB which does not currently permit member states to deploy vaccination in cattle (due to the difficulties of distinguishing vaccinated from infected animals). A change to this legislation would require the European Commission to bring forward a proposal, which would carry support from other member states, the vast majority of whom do not currently have major problems with bTB in cattle. It is not clear from our discussions with the Commission that it is yet minded to consider tabling such a proposal. Indeed, we understand that with current levels of efficacy, it is unlikely that the Commission would propose the approval of cattle vaccination. What is more, any change to legislation could take a number of years.

19. Following discussions with Defra and the Commission”s directorate general for health and consumer protection (DG Sanco), it is likely that a large-scale UK based field trial would be required before a cattle vaccine is available commercially. This could take considerable time although we believe it is appropriate for the Government to consider now how such a trial could be undertaken.

20. Without a change in legislation to permit cattle vaccination, the UK risks losing export markets worth over £1 billion were it to go ahead and use vaccination in cattle. Such a move could prove devastating to the industry without viable alternative markets.

21. Directive 64/432/EEC stipulates that raw milk and colostrum must come from cows belonging to a herd which is officially tuberculosis free. Milk from cows that have reacted positively to the tuberculin test cannot enter the food chain and must be destroyed by the farmer. Therefore, should animals react to the skin test due to vaccination this could result in milk being unnecessarily discarded.

22. Vaccination of cattle would come at a significant cost to producers (around £8.50 per unit, to be boosted annually). In terms of forward planning it is important that Government sought funding from the EU to pay for a contribution towards the costs of vaccination.

23. Further consideration will need to be given as to the most appropriate deployment of cattle vaccine to provide the best level of immunity.

24. Due to the fact that it would not be cost effective to vaccinate cattle in areas where there is a low disease risk, or that may be going to slaughter, there is a need to also keep a clear record of which animals have been vaccinated. This will ensure that the DIVA test does not have to be used on cattle that have not been vaccinated. It is vital that a record of vaccination remains with each animal throughout its life, during which it may make a number of movements.

25. The NFU would be delighted to discuss any of these points further and provide additional information on any aspects that the committee may be interested in exploring.

January 2013

1 A notable example is the Badger Vaccine Deployment Project organised by the Food and Environment Research Agency (FERA) in Gloucestershire http://www.fera.defra.gov.uk/wildlife/ecologyManagement/bvdp/.

2 See Carter et al. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0049833#pone.0049833.s006

3 Defra : Options for vaccinating cattle against bovine tuberculosis

Prepared 5th June 2013