UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE
To be published as HC 981-iv

House of COMMONS

Oral EVIDENCE

TAKEN BEFORE the

Environment, Food and Rural Affairs Committee

Bovine TB vaccination

Wednesday 6 March 2013

Professor Glyn Hewinson and Simon Hall

Evidence heard in Public Questions 307-414

USE OF THE TRANSCRIPT

1.

This is an uncorrected transcript of evidence taken in public and reported to the House. The transcript has been placed on the internet on the authority of the Committee, and copies have been made available by the Vote Office for the use of Members and others.

2.

Any public use of, or reference to, the contents should make clear that neither witnesses nor Members have had the opportunity to correct the record. The transcript is not yet an approved formal record of these proceedings.

3.

Members who receive this for the purpose of correcting questions addressed by them to witnesses are asked to send corrections to the Committee Assistant.

4.

Prospective witnesses may receive this in preparation for any written or oral evidence they may in due course give to the Committee.

Oral Evidence

Taken before the Environment, Food and Rural Affairs Committee

on Wednesday 6 March 2013

Members present:

Miss Anne McIntosh (Chair)

George Eustice

Barry Gardiner

Mrs Mary Glindon

Iain McKenzie

Sheryll Murray

Neil Parish

Dan Rogerson

________________

Examination of Witnesses

Witnesses: Professor Glyn Hewinson, Chief Scientist, and Simon Hall, Veterinary Director, Animal Health and Veterinary Laboratories Agency, gave evidence.

Q307 Chair: Good afternoon gentlemen, and welcome. Thank you very much for being here today and contributing to our inquiry into bovine TB vaccination. Would you like to introduce yourselves, starting with Professor Hewinson, and giving your names and positions for the record?

Professor Hewinson: I am Professor Glyn Hewinson, and I am the Chief Scientist at the Animal Health and Veterinary Laboratories Agency.

Simon Hall: I am Simon Hall, Veterinary Director of that same agency.

Chair: Thank you. I think we met at dinner last week.

Simon Hall: We did, yes.

Q308 Chair: We are very grateful to you for being here. I will start off by asking: is there a particular reason why the UK seems to have the highest concentration of bovine TB in Europe?

Professor Hewinson: There are probably many reasons that may have conspired to create the situation. You probably know that we got TB fairly under control into the 1970s, and since the 1990s we have seen exponential growth in TB. There are a number of things that have happened during those times. One is the protection of badgers; another is the changing of the tuberculin we used to control TB. Thirdly, the genetics of the herd has also changed. Another is the size of the herds, which makes diagnostic tests and identification of all infections greater, along with the movement of herds and the whole farming situation. There are many different circumstances that may have conspired to increase the level of TB. This is a real evidence gap, but teasing out the things that have produced this situation is quite difficult. One of the real evidence gaps is how much TB is given from cattle to badgers, how much TB is given from badgers to badgers, how much TB is given from badgers to cattle, and how much TB is given from cattle to cattle. Without being able to quantify that, it is very difficult to tease out exactly what the reasons are.

Q309 Chair: Which organisation will be best placed to plug the evidence gap in that regard?

Professor Hewinson: There are many organisations that would need to come together. Firstly, clearly Fera have played a leading role in understanding TB in badgers. AHVLA have now brought together the animal health side, which was part of the control, and the science and diagnostic parts, so we have much of the cattle side of the evidence. It is pulling it all together that is crucial.

Q310 Chair: I am particularly interested in knowing if we are the only European Union country that gave protected status to badgers in the 1970s.

Professor Hewinson: I am not sure of that. We would have to check that.

Q311 Chair: We have a map here from the Defra website, which shows that in 1986 there really was not much density of bovine TB in the herd. By 2009 there was this massive concentration in the west and south-west. Have you done any research into that, Professor Hewinson, that would help our understanding?

Professor Hewinson: Well, I can try to help with it. One of the things that we introduced was doing molecular typing of strains of TB that you get from cattle, and indeed badgers, which we can talk about later. Although that map shows, as you see, the spread of TB across the country and it gets blacker and blacker, there are two things that are happening; it is not just one epidemic. What the molecular typing has shown is that you have one progenitor strain-one parent strain, if you like-that has spread across the country, but that it is throwing off daughter strains in different areas of the country. Although your map there looks as though it is just M. bovis, in fact, in different parts of the country there are different strains of TB causing that spread. So, in fact, you have geographical localisation of different strains of M. bovis that have arisen from one bacterium. So it started off as one bacterium, and then we call it "clonal expansion"; TB is expanding in those small geographic areas. Therefore, local epidemics are happening.

Part of what might have been happening is, as TB decreased, the testing regimes became less frequent, and the areas in which you tested were at the parish level. I think what happened for a while was that we were revealing an infection that was already there, rather than showing that there was an explosive infection in real time. One of the responses to that is that we have a very large area that has now gone on annual testing to try to get ahead of the epidemic rather than behind the epidemic. Part of the modelling, when you look at the molecular typing, is suggesting that the strains in badgers and cows are the same. Clearly there has been a bottlenecking of the TB, probably spread from cows into badgers, and it is now being spread out again, but then you have a complex situation where you have got badger to badger, badger to cow, and cow to cow spread in high prevalence areas, and quantifying that is difficult. So I cannot give you a definitive reason for why that spread has happened, but I can tell you that they are local epidemics. The other thing you should know is that the British Isles has its own strain of bovine TB, a clonal complex that is different from the European strain.

Q312 Chair: Other colleagues will want to come in on this point, but I will just ask this. Obviously we have got a very large back-stop industry, so in those areas like North Yorkshire that are currently free of bovine TB, should we be worried that a similar epidemic might reach us?

Professor Hewinson: At the moment, I think the evidence suggests that, in low prevalence areas, the tests, slaughter and tracing that go on seem to control the disease, which is one of the reasons why Scotland has become officially TB-free, and why, even after the introduction of infected cattle into areas after restocking following foot and mouth, TB has been brought under control by the current tests in low prevalence areas. Of course, the tests may behave differently in a high prevalence area to a low prevalence area. That is consistent with the maintenance of a plateau from the 70s to the late 80s. In low prevalence areas you seem to be able to control TB, and in high prevalence areas that is more of a challenge. The question is: has TB got into wildlife in those areas, and will it take a long time to spill back into cattle? The answer is: I do not know, but I think that the evidence from Scotland and, as I say, from these other areas, shows that at least at the moment those low prevalence areas seem to be maintaining their low prevalence. Part of the reason is that when we find an infection we throw everything at it; we throw a gamma interferon test and a skin test to try to stop the disease from getting into wildlife.

Q313 Chair: When a badger is run over and left at the side of the road in areas like North Yorkshire, should we be testing those for TB?

Professor Hewinson: When they looked at the road traffic accident badgers in the past before the Randomised Badger Culling Trial, the information, because there were so few badgers, was not that informative about the prevalence of TB in badgers in those areas. I think that is an evidence gap. I have to say, from my perspective, we do not know whether TB is in badgers in areas where there is no cattle TB, and some of the work in Ireland suggests that there is TB in badgers in both high prevalence and low prevalence areas; it is just the level of TB in those badgers that is the difference.

Q314 Chair: Did I understand you to say that the tuberculin has changed over the years?

Professor Hewinson: From the 1960s until 1975, they used a tuberculin that was made from human tuberculosis-Mycobacterium tuberculosis, the same tuberculin that was used for skin testing humans. In 1975, they introduced a tuberculin made from Mycobacterium bovis, the organism that causes TB in cattle, as a way of improving specificity. This was a strain that was isolated from a cow in the UK and then grown on glycerol. Usually bovis does not grow on glycerol, but they grew it on glycerol and it created mutations in the AN5 strain, which meant that it could grow very quickly, and so you could produce enough M. bovis to make a tuberculin. That has been adopted across Europe using this AN5 strain.

Q315 Chair: I have had family members who caught TB from cows’ milk 30 or 40 years ago. Are we confident that the present strain of TB cannot pass into humans?

Professor Hewinson: Do you mean Mycobacterium bovis?

Chair: Yes.

Professor Hewinson: We have been looking at Mycobacterium bovis in humans. Most of the strains that we have seen-and we work closely with the Health Protection Agency on this-are due to reactivation of TB from older people, and, interestingly, the strain profile is slightly different to the profile we see now. The strains we saw in humans are closer to the European-type strains. However, we have seen some recent outbreaks; there have been at least two documented. There you saw human to human transmission, but there were immunosuppressed individuals involved in that. It is rare, but it can happen. Simon, did you want to say anything?

Simon Hall: I will just make the simple point that yes, bovine TB can infect people. That is why, on the whole, milk is pasteurised, and why, where there is a dairy herd with a TB problem, they do not have the option of selling unpasteurised milk in England. Fresh meat can also potentially lead to infection, but, again, that is one of the purposes of the meat inspection service that is run by the Food Standards Agency, so that beyond a certain point meat from an infected animal cannot be put into the human food chain. It is their responsibility, and they have carried out risk assessments to satisfy themselves that this is satisfactory.

Q316 Dan Rogerson: Coming back to the characteristics of the pockets of disease that you were talking about, and the different localised types, one thing that we hear from people who perhaps do not look at this in this detail is that, "It’s all about cattle. It’s cattle to cattle transfer. It’s going on across the country." What do you think the situation you have described says to the argument that it is not about the wildlife at all?

Professor Hewinson: I think it says that both cattle to cattle and badger to cattle infection is going on. The evidence is clear that that is the case. I would say that the model you probably saw was bottlenecking of TB into a stable population, because if it was all cattle movement you would see mixing of strains. You have a geographical localisation, but, on top of that, most movement of cattle is local, so it is actually very difficult to tease out whether it is badger to cow or cow to cow, or how much is due to either vector. However, the evidence is fairly clear that badgers do contribute to bovine TB, as do cattle.

Q317 Neil Parish: Can I ask you a loaded question? Basically, if you test all the cattle, you clean the cattle, because you take out the infected animals; is it logical then to put those clean cattle back into a field where they can be infected by badgers carrying the disease?

Professor Hewinson: If the prevalence in badgers is high enough to spill back into cattle then, yes, you would get spillback. The difficulty is quantitating the level of infection-

Neil Parish: And how infectious these badgers are.

Professor Hewinson: -and how infectious it is. Yes, it would depend. Clearly, other countries have cleared up TB through depopulation of cattle and then restocking, without a wildlife risk.

Q318 George Eustice: Some of the evidence we have had around the tuberculin test-the skin test that we have at the moment-has raised doubts about the reliability of that. What is your assessment of how reliable it is?

Professor Hewinson: There are clear figures on how well it performs, in terms of the sensitivity and the specificity of the test, and those are average figures. I do not want to obfuscate, but actually the answer is, "It depends". I will give you some examples.

Q319 George Eustice: First of all, what are those figures? What is the range?

Professor Hewinson: At an individual level, again, the sensitivity of the test will vary depending on the prevalence of infection. The specificity of the test will be fixed. The specificity of the comparative skin test is about 99.99%; so one in every 1,000 animals might give you a false positive, or one in every 100,000.

Simon Hall: I will just give Glyn a little rest. What we have been discussing in the last couple of minutes are individual animal figures. If you take a typical figure for sensitivity of the test of 80%, that says in theory that you miss one in five infected animals, which sounds really quite bad, but practical experience is that this test is fit for purpose to eradicate TB in places like Scotland, for example. Why is that? It is to do with the strategies with which you deploy the test; when you start using at a herd level rather than an individual animal level it becomes much more effective. For example, where you test a herd of cattle and find one positive animal, yes, you kill and destroy that animal, but you put the whole herd under restriction. You retest the herd with the test usually recalibrated to make it more sensitive, and, by using these types of strategies, you can make very effective use of the test, where, if you just look at the simple individual animal sensitivity figure, it may not appear to be very good.

Q320 George Eustice: Is there no case for using the gamma interferon test alongside it?

Professor Hewinson: Yes, in fact we do. Perhaps I should tell you what happens during an infection. When you have an infection of TB, it has evolved along with its host, so it has very clever ways of avoiding immune responses. For most infections, usually you have an explosive infection, and you have a lot of antibody response, so most diagnostic tests are based on antibody responses. TB has evolved to go inside the host’s own immune cells, the macrophages, and hide from antibodies. It grows slowly, so you have a much slower response to infection. Hiding in a macrophage means that the body has to induce a different type of response, called the cellular response, and the first wave of responses that you see are the gamma interferon responses. They are the first signs that there is an infection, so they identify infection early, and are the most sensitive.

Q321 George Eustice: What circumstances is that used in?

Professor Hewinson: The way we use the gamma interferon test at the moment is in areas where there is no TB-so where cows that are infected with TB have moved into TB-free areas. We identify an infection, and we then throw both tests at it. The skin test picks up the fact that there is an infection, and then we use the gamma interferon test, because the gamma interferon test added to the skin test gives an increased sensitivity and pulls out animals that are at an earlier stage of infection. What you are trying to do is to mop up infection quickly before it gets into the wildlife population.

Q322 George Eustice: Coming back to what you were saying, about how the whole herd response is what makes a skin test acceptable, what if it is only a couple of cattle that have got it, when they are skin tested, and those both slip under the radar? That means you have got infected cattle potentially still moving around the national herd.

Simon Hall: That can happen.

Professor Hewinson: That does happen.

Q323 George Eustice: Is the skin test a much more expensive test? Is it too expensive to use as the default test?

Professor Hewinson: In EU legislation, it is not the recognised frontline test. I think you were talking to the Commission about other tests last week. There has just been an EFSA opinion on the gamma interferon test, looking at whether the gamma could be used as a frontline test, and the findings of that are that they have similar sensitivities and specificities, but they would like to see how it operates in the context of mixed infections.

Simon Hall: Perhaps I will just fill in. In very round figures, the standard tuberculin skin test done by the vet on farm is about £3 a head. For the gamma interferon test, the lab cost is about £30, and it requires special conditions for transport of the samples to the lab, so that is a cost. If you remember, for the tuberculin test, the specificity is extremely good. There are only about one in 1,000 false positives, whereas with the gamma interferon test you get a few more false positives, and if you slaughter those and pay compensation for them, the overall cost of using that test as a widespread first line screening test really would mount up very considerably.

Q324 George Eustice: Finally on this point, have you done any modelling to look at the impact of larger herd size, and whether the element of unreliability causes a particular problem with larger herds?

Professor Hewinson: With larger herds you are less likely to identify all infected animals. There is modelling that we can send to the Committee.

Q325 George Eustice: But it is still your position that it does not matter because you have got a whole herd.

Simon Hall: Well, it works both ways. If you have a large herd of cattle and there is a proportion of infected animals, you have got a better chance of identifying the herd as a whole of being infected. So actually, if you have got a small herd, the statistics say that the herd level infection is easier to miss. However, when you have got a very large herd of cattle, yes, picking out the individual infected animals is harder, but we recognise that, and that is why we use the second-line test, which is the more sensitive interpretation of the skin test, and/or the gamma interferon blood test, in order to address that problem.

Professor Hewinson: I think the take-home message is that two tests are better than one at identifying all infected animals, but that comes at a cost, so you might need to do a cost-benefit analysis on how to use the best combination of those two tests in a given epidemiological situation.

Q326 Chair: Were you surprised that EFSA’s opinion was not favourable to the gamma interferon test?

Professor Hewinson: I thought they were favourable to it. I thought they are now considering it as a frontline test.

Q327 Chair: So they will. Would you normally use both tests in all circumstances?

Professor Hewinson: No.

Q328 Chair: Only in the circumstances that you described?

Professor Hewinson: My own feeling is that one approach does not fit all situations, and you actually have to have a much better understanding of the infection process, of what is going on in that herd at the local level, to really make the decisions on how you use your tests most effectively.

Q329 Neil Parish: On gamma interferon, when that first came in that was going to be the magic test, and it then turned out that it threw up a lot of false positives. I think you almost played down the number of false positives. Have you got any numbers on that?

Simon Hall: It is Glyn’s expertise, but what the farmer may perceive as a false positive and what truly is in the biological sense may be different.

Professor Hewinson: Shall I step in here? When you do a specificity trial, to see how specific the trial is, in negative animals, you find that the specificity of the gamma interferon test is about 97%. If you used it as a complete screening test in negative areas, that would be three animals in a hundred that you would identify as a false positive, in areas where there was no TB. If you go into a herd where you know there is already TB, the likelihood of a positive response being a positive response is much higher, because you know there is infection in that herd, and you need to clear it out.

There is another misconception about the gamma interferon test, which led to this idea of there being a lot of false positives. As I was saying, the first response you see in infection is a gamma interferon response. As the disease progresses, you then start seeing a skin test response, and much later you might see an antibody response. That is linked to the progression of the disease. Your earliest infection is detected by a gamma interferon response, when you have no lesions and very few bugs, and where you cannot find any sign of infection. That does not mean the infection is not there; it just means that you are identifying animals at that very early stage, before they have developed disease and become infectious. For me, the ideal test would be to identify animals that have no visible lesions, because that means they are less likely to have transmitted disease. By the time they have developed lesions, they are more likely to have spread disease.

Q330 Neil Parish: It’s a bit late when you slaughter them, they have not got the lesions and they have not got the disease. They are dead.

Professor Hewinson: In a herd where you know there is TB, it is most likely that that positive response is due to infection.

Q331 Neil Parish: I want to take you on the BCG vaccine and how effective it is. There have been some small tests done in Mexico and Ethiopia. It has been found to be only 56-68% effective. With the BCG vaccine in cattle, do factors such as the presence of other diseases impact also on its efficacy?

Professor Hewinson: On the efficacy of the vaccine, or on the efficacy of the diagnostic test?

Neil Parish: This is a vaccine.

Professor Hewinson: On the efficacy of the vaccine?

Neil Parish: Yes.

Professor Hewinson: I think this plays to the next steps in vaccine development in that, as you say, these are very small research studies. They give you some indication of the fact that not all animals are protected, but some are protected from infection. The reason, as the Commission outlined in its letters, that you need to do large-scale trials is to take into account the facts that you may be trying to protect different breeds, different populations exposed to different diseases. It is only when you get to that field study stage that you start to observe those effects. It is difficult to do. You cannot do that in the laboratory. It requires large scale-field trials.

Q332 Neil Parish: Is it possible to achieve herd immunity? This is if you are using the vaccine. What percentage of cattle would need to be vaccinated, how often, and how long would the programme need to last? It is only a simple question.

Professor Hewinson: We come back to the question of how much TB is spread from cattle to cattle, how much is coming from cattle to badgers, and how much badger to badger, and the performance characteristics of the vaccine under UK conditions. So the answer is that we do not know. Those are unknown parameters.

Q333 Neil Parish: How big a field trial would we need to be able to try to sort that out? Some people say that the vaccine is the magic bullet, but is it or isn’t it?

Professor Hewinson: The answer is that it is not a magic bullet; it is just another tool. Coming back to your question, the first thing you can do is model what might happen. If you model what a vaccine does in cattle, you can make up whatever efficacy you want when you are doing a model. When you model what happens during vaccination with cattle, at the beginning you do see quite a dramatic decrease of TB over a few years. However, you come to a plateau, and that plateau depends on the contribution of badger to cattle infections. If it was all cattle to cattle you might conceivably get herd immunity, and in fact in the old days, where they used some BCG vaccination strategies on the continent, they found that you could probably eradicate TB from a herd. It took about eight years to do so.

Q334 Neil Parish: Provided the disease was just in the cattle and not in the wildlife.

Professor Hewinson: Exactly. Your plateau will be determined by the efficacy of the vaccine. So the more efficacious the vaccine, the lower the plateau. The more badger to cow contribution there is, the less likely it is that you will get herd immunity, as you talk about it, and you will not get eradication.

Q335 Neil Parish: So if-and it is a big if-we had a vaccine that we could use now, in your view, we would still have to do some control of the disease in wildlife, either by culling, vaccination or whatever, in order to get to an immunity situation.

Professor Hewinson: In order to eradicate, because you will get spillover from the wildlife host. Of course, that depends also on the contribution of cow to badger infection, and badger to cow infection.

Q336 Neil Parish: Is there any evidence that vaccinated cattle might contribute to the spread of disease, for example, by shedding TB bacteria? Say for instance it was only a 50% take, is there a problem with those that have had a vaccination that has not worked?

Professor Hewinson: Yes, we do see that some animals are not protected at all. About 10% of animals seem to be refractory to vaccination, and we are trying to look at why that might be at the moment. The point that you do not have a perfect vaccine is the reason that you need a test that differentiates between vaccinated animals and infected animals-

Neil Parish: Which we have not got.

Professor Hewinson: -so that you can remove the infected animals.

Neil Parish: Have we got that test?

Chair: We are coming on to that.

Q337 Neil Parish: Sorry, I will not take you there, but I have just one final point. If you have vaccinated an animal and it has not given it immunity from TB, could that vaccinated animal then be shedding TB bacteria?

Professor Hewinson: If it becomes infected, just like a non-vaccinated animal, it will-

Q338 Neil Parish: But the vaccine itself will not create that, because it is dead, is it? Is the disease dead?

Professor Hewinson: Do you mean, will the vaccine be shed?

Q339 Neil Parish: If you have vaccinated an animal and the vaccine has not worked, is it possible that instead of actually stopping the animal from having TB, for want of a better way of putting it, it gives it TB and it sheds it?

Professor Hewinson: No, it would not give the animal TB. Do you mean, would the vaccine revert to virulence and become virulent?

Neil Parish: Yes, that is right.

Professor Hewinson: All I can say about BCG is that it has been used in 8 billion people and more children than any other vaccine, and they have not seen a reversion to virulence in humans. That is part of the reason you would look at BCG, because of its safety record. You still have to do some formal safety studies.

Neil Parish: Have you any idea of cost, if the vaccine was available?

Chair: I think we will come on to that.

Neil Parish: Do we come on to that? All right, I will leave it there. Thank you.

Q340 Chair: Professor Hewinson, it appeared to be a caveat to the questions that Mr Parish has just put that we do not have the information as to how TB is spread from cattle to cattle, from cattle to badger. Is that quite an important caveat?

Professor Hewinson: When you are trying to model how useful a vaccine would be, ideally you would want to quantify how much TB is coming from badgers to cattle, how much TB has been spread cow to cow, and how much is being spread from badger to badger, because that would then help you to answer those questions about whether you would be able to achieve herd immunity.

Q341 Chair: We are not there yet.

Professor Hewinson: No, we have not quantified that.

Q342 Chair: When might we be in a position to quantify?

Professor Hewinson: It is a very difficult thing to quantify. I know that there are some published results now that suggest approximately 50% of TB might come from badgers to cows.

Chair: 50%?

Professor Hewinson: But the confidence intervals are very wide.

Q343 Sheryll Murray: Could I just turn to licensing? When will you respond to the Veterinary Medicines Directorate’s further questions regarding the application for "in principle" marketing authorisation of the cattle vaccine?

Professor Hewinson: As soon as we have got the letter, we will start replying to their questions and putting the response together.

Q344 Sheryll Murray: I understood that they have asked further questions, and are currently waiting for your response.

Professor Hewinson: No, we put in our responses, and they have now had a meeting, I think last week, with the Veterinary Products Committee. I think that, on the basis of that meeting, they will be sending out a letter to us, to highlight what further work might be required.

Q345 Dan Rogerson: Are you surprised at the EU Health Commissioner’s request for more studies to address food safety concerns over the cattle vaccine? What action are you taking to deal with that?

Professor Hewinson: A lot of those issues are dealt with through the Veterinary Medicines Directorate, so we are waiting to see.

Dan Rogerson: We’re back to this question.

Professor Hewinson: We come back to that question. We are waiting to see what other studies might be required. What happens for all vaccines is that you look at the safety data that is generated in the laboratory, which is then submitted to the VMD for an Animal Test Certificate, or a Provisional Marketing Authorisation, which of course we cannot have because of the illegality of vaccination at the moment. You then do the second phase. In this case, for the Animal Test Certificate, you would do field trials to see whether the safety aspects that had been generated in the laboratory were consistent in the field. You would do what is called ‘pharmacovigiliance’; you would look at what happens in the field under all these uncontrolled circumstances, to see whether the safety profiles that you had seen experimentally were realised in the field. You do need field trials to create a safety portfolio. It is not a surprise; in fact, when we did the badger vaccination we had to do a field trial that was about the safety of the vaccine in the field.

Q346 Dan Rogerson: But the question was specifically about food safety. Obviously the issue with badgers is slightly less; we have had a few interesting ingredients in food recently, but I am not aware of badgers being on the menu at the moment. I have one constituent who has been on television who does eat them but that is another matter. With regard to food safety concerns in particular, the process that you are describing is the standard process that we would go through. Is there anything that the Commission has asked for over and above that standard process that surprised you?

Professor Hewinson: The Commission have not asked for any detail. You have seen what they have asked for in that letter. What they want is reassurance that it would be safe.

Q347 Dan Rogerson: They want lots of cover. The Commission have also said that marketing authorisation cannot happen until field trials have been completed, which is what you are saying. How would future field trials impact on the "in principle" application that you have already submitted?

Professor Hewinson: I guess the "in principle" application was in fact to tease out what data would be required from the VMD for licensing. You will see that the letter also says that we would need a marketing authorisation eventually. One of the reasons behind putting in the "in principle" application was to identify what data sets we would need to create in order to get a marketing authorisation. It is, if you like, a dummyrun to getting a marketing authorisation.

Q348 Dan Rogerson: Just to finish off on this line of questioning, we have a triangle going on between the Commission, the Directorate and yourselves, of feeling your way towards approval of something. For those people who are very interested in what is going on, and in what we are saying here, there is a danger that this could look like something that could drag on forever. What is the way for all the legs of that tripod to get to a stable base where we can move forward? Or is it going to be a buck passed between all three?

Professor Hewinson: I do feel very sympathetic, but we are in uncharted territory in some ways because of the anti-tuberculosis legislation, so it means that you cannot follow the pathway that you would normally follow to get a vaccine licensed. It does require much larger and more extensive field trials to reassure our European colleagues of all the things that the Commissioner lays out in his letter. Did you want to say anything, Simon?

Simon Hall: Just to simplify, it is obviously very important, if any vaccine is going to be used in a food-producing animal, that it is safe from a public health perspective, and that it is not going to do any disproportionate harm to the individual animal. Our own VMD and the Commission have the same concerns, and we will all want to be reassured of that before any deployment was carried out. Next, a series of field trials are required to gather additional information in order to build on that safety case, to understand the efficacy of the vaccine and to understand the sort of strategies that you might use to deploy it. Helpfully, what the Commission have effectively said is that there is no fundamental barrier in European law to that occurring, because it is clear in the directive about eradication programmes that you cannot use BCG and tuberculosis vaccines as part of an eradication programme. That could be side-stepped; it is implicit in the trade and food safety legislation. However, as a field trial under the close control of the competent authorities-that is us-there is a way in which it can be used, and enter into a cycle of learning by doing. Then you ultimately arrive at an end point, which might be 10 years away, where everybody, including the Commission, other member states and ourselves, has sufficient confidence in the characteristics of the vaccine that it could become a normal thing to use, and that live, vaccinated animals could be traded freely within the EU. However, you can do a lot along the way to that.

Q349 Chair: What the Commission officials did actually say to us was that they are coming up with a new EU animal health regulation, which they explained would expedite the adoption of a TB vaccine for cattle. Do you share that optimism?

Simon Hall: Yes. The EU legislation can be constructed as people see fit, but before worrying too much about that, there is a legitimate concern that in deploying such a vaccine, we must not do anything that results in TB spreading more widely within the UK and into TB-free regions and member states. There is the fundamental science and the strategies for applying this vaccine, which are a bigger hurdle to get over. Yes, it would be good if the legislative process was slightly slicker, but I do not think that is the primary consideration.

Q350 George Eustice: I just wanted to probe that a bit, because it seems that one of the really frustrating things in this is that it feels like we have a vaccine that is almost ready to go, but it is the bureaucratic process that is slowing things down. You said that the legislative process could be slicker. If you were just to remove it and pretend there was no such thing as EU law for a while, but you were serious about taking the threat to food safety seriously, how quickly could you agree to use a vaccine? How quickly could you do all the relevant testing needed? Is it a decade? Do we actually need a decade, or is it more like four or five years, assuming it is a commonsense world?

Professor Hewinson: With other vaccines, you can get vaccines into the field quite quickly. So you just have to generate the level of assurance through your field trials and, as Simon says, you are learning as you go along.

Q351 George Eustice: On this particular vaccine, roughly how long do you think that is? Is it roughly 10 years, or is it roughly three years, if you pretend that there is no such thing as EU marketing or authorisation, or anything else you have to jump through?

Professor Hewinson: It is hard to comment, because we do not yet know all the things that we would need our field trials to show. At the moment, we are still awaiting feedback from the VMD. From the tone of the letter from the Commission, I think they will be substantial field trials, and will need to last for a number of years.

Q352 George Eustice: I will turn to the DIVA test. We talked about the tuberculin skin test. One of the other things that is important here is that you have a DIVA test that can distinguish the virulent TB from the vaccine. How accurate do you think that test is at the moment?

Professor Hewinson: You can create your sensitivity data on M. bovis infected animals, so you can look at the animals that are already infected with M. bovis, and you can see how well the test performs on those. You can look at uninfected animals and see how well the test performs on those, and that gives you sensitivity and specificity in unvaccinated populations. You need field trials, because unfortunately the number of animals that you have to perform these tests on in vaccinated populations is large. We have not been about to do field trials. I can tell you what the sensitivity and specificity of the test is on limited populations in unvaccinated animals. What the field trial will need to do is give the data in vaccinated animals. Sorry, have I been clear enough?

Q353 George Eustice: Well, some of the evidence we have had has said that the DIVA test has been around for 10 years. I suppose the question is: if this has been around for 10 years, why has it not been possible to do all the box ticking, the field trials and everything necessary to clear these hurdles sooner?

Professor Hewinson: Although we have got a more sensitive DIVA test, the DIVA tests are available for humans. BCG vaccinated humans already have DIVA tests, which are very similar to what we use in cows. The DIVA test has been in development, and we have looked at the performance characteristics.

Q354 Chair: For cattle?

Professor Hewinson: In cattle, but not in vaccinated cattle, and of course you need to get the vaccine to a stage where you can do field trials. We needed to do the safety studies and some of the experimental efficacy studies, and to put the dossier together to give to the VMD, in order to be allowed to do the field trials in vaccinated animals, which would then generate the performance characteristics of that test in a vaccinated population.

Q355 George Eustice: Is it the information you give them that will determine the scale of field trials required, for both this and the vaccine? I pressed them on the same point, and they said, "Well, we can’t really say how long a field trial will be, because it’ll depend on what we are told about how much evidence we need." There is a sort of vicious circle, where no one is willing to say, "The gaps in the knowledge are X, therefore it’s Y number of years to fill that gap." I know it is difficult.

Professor Hewinson: I know you want a date. It is difficult, because there will be feedback from the VMD that might highlight experiments we need to do before we can do a field trial. We will then look at designing those field trials to create the data that is robust enough, firstly, to go through the process for OIE validation, because I think the Commission said that we had to go through the OIE. There is a set and prescribed data requirement.

Q356 George Eustice: There was no way we could have applied to the OIE prior to this date, given that this has been around.

Professor Hewinson: No, because the very first thing that you have to do in an application to the OIE is to say how you will use that test. Until you know how you will use that test, you cannot validate against that test. Then you need a population of animals that you will do that test on to generate the data in order to validate it. Without the field trials, you cannot create the data.

Q357 George Eustice: Has there been no similar challenge in the last 20 or 30 years, where a vaccine has been developed from scratch, authorised and used in a particular timescale, where you can say that "It took X number of years for that. Therefore it should be something similar to this"? What would you compare it to? Is it bluetongue, or something like that?

Professor Hewinson: This comes back to what I was saying at the beginning about TB having co-evolved with the hosts. It uses strategies to subvert the immune response that is responsible for protection in most vaccines. Most vaccines that have been successful are antibody based, and there are very good and well-tried technologies to create vaccines that require antibodies. You have a compound that makes the immune response better called an adjuvant, and the safety data on that adjuvant has been created over years. Then you can either get an inactivated virus or the part of the virus that you know gives you protection.

That is how bluetongue etc works. For many vaccines where we know what the basis of protection is, we can create vaccines quite quickly. With TB, you are on the cutting edge of human knowledge, in terms of development of human TB vaccines or bovine vaccines, because of the way it lives within the macrophage. There are very few vaccines that have been produced that stimulate the T-cell part of the immune response. Many of the vaccines have been produced against diseases where it is easy to produce a vaccine, but you are now into a situation with HIV, malaria and TB where you need a different arm of the immune response, so you are right at that cutting edge. It is a much more difficult task that we are facing than with something like bluetongue.

Q358 Neil Parish: The European Commission told us that they are waiting for the UK Government to submit plans for conducting field trials for the vaccine and the DIVA test. Have you had any confirmation from the Commission that field trials can take place in the UK, despite the EU ban on vaccinated cattle?

Simon Hall: The letter appears to say that, doesn’t it?

Professor Hewinson: The letter would say that. There are a number of levels; we have to wait for the feedback from the VMD in order to get an Animal Test Certificate, so we might need to generate some more data to get the Animal Test Certificate, which would allow field trials. We are then looking at what field trials might look like in terms of the data we need to generate; it might be safety data, DIVA test data or vaccine efficacy data. It is slightly too early to answer that question. The thinking processes have started, but we are not quite sure what the output should be yet.

Q359 Neil Parish: All right. We do go round in circles on this one; I can understand partly why. If a field trial takes place in this country, and if those animals are dairy cows, I imagine you can carry on using the milk. Can you? If they are beef cattle, there is no way that those cattle could then go into the food chain as the law stands. They certainly could not be exported. Going back to foot and mouth in the Netherlands, they vaccinated a whole load of cattle, and then they had to slaughter them afterwards. They did not have the disease, but because the vaccine was not recognised under IOE rules they were all slaughtered. I think we have to get to grips with where we are going with this.

Chair: I think it was a question, not a statement.

Neil Parish: No, it is important, Madam Chairman, because what are we going to do with these vaccinated animals once we have vaccinated them?

Simon Hall: As this is an unprecedented situation, and because EU law is not actually explicit in all these respects, this is a matter for negotiation between the UK authorities, Defra and the European Commission, to arrive at a plan that will meet everybody’s legitimate concerns-and there are some. First of all, Glyn has explained why the BCG is not really quite the same as the bluetongue vaccine. This is a disease with public health implications and international trade implications. Because of the characteristics of the disease and the vaccine, there is a legitimate concern that if you go into a herd of cattle with the wrong strategy, you may not build up herd immunity and eradicate the disease. You may conceal the disease and allow it to spread within the herd, which then presents a risk to the wider community. What will we have to do? What is the thinking of the Commission? You look at analogies; for TB control purposes, you pasteurise the milk. Is that sufficient for milk from cattle in a vaccine trial? Well, it is a good point to argue, but it will need to be backed up with scientific data.

Q360 Neil Parish: You not even know whether you could use the milk.

Simon Hall: Well, today, no.

Q361 Neil Parish: Sorry to keep on about this, but if I was the farmer, why on earth would I enter into a trial to have my cattle vaccinated, when firstly, I would not be sure whether I could sell my milk, and secondly, I do not know what the hell I am going to do with the cattle when I have vaccinated them? It is a no-brainer. Until you can actually tell us what you are going to do with these cattle, this is why we are going round in circles, Madam Chairman, over the vaccine. It is no good saying this vaccine is a marvellous thing if we cannot even test it.

Professor Hewinson: I agree with you that before you embark on field trials you need to know exactly what you would do with the milk and the meat, and that would be part of the considerations.

Q362 Neil Parish: At the moment you do not know.

Simon Hall: No.

Q363 Neil Parish: It is not only EU, is it? It is IOE as well. You cannot even just blame the EU for this one. It is international trade rules as well, isn’t it? I am asking you.

Simon Hall: It is in the legitimate interests of our Veterinary Medicines Directorate that we do not use a vaccine in food producing animals where there is any consequent risk to public health, so these international organisations are not being in any way difficult.

Q364 Neil Parish: No, but they are the ones who lay down the legislation as to whether you can trade meat across borders.

Simon Hall: Yes.

Neil Parish: I think you will find if they did not accept the vaccine, you would not be able to trade that meat across borders. Is that your view as well?

Professor Hewinson: At the moment I do not know.

Q365 Chair: If Mr Parish wants to pursue this, the question is: will the Commission allow us to vaccinate if there is a ban on milk and meat products going to other parts of the EU?

Professor Hewinson: Part of the discussion would come out of the data that the VMD would look at in terms of the safety that has been generated, along with the Commission.

Q366 Neil Parish: But I think you accept my point that farmers are not going to rush out to offer their cattle for vaccination if they do not know whether they can sell the milk or the meat. I think you would probably accept that, would you?

Simon Hall: Yes.

Professor Hewinson: Yes.

Q367 Chair: Will it be for you to decide, or will it be for the Commission to decide how long the field trials will last?

Professor Hewinson: It will not be me.

Q368 Chair: Would it be for the UK authorities?

Professor Hewinson: It would be for the UK to come up with the designs of the field trials.

Q369 Chair: Are you able to say at the moment how long you think the field trials should last?

Professor Hewinson: No, I am not.

Q370 Chair: Is it dependent on this wonderful letter from Commissioner Borg?

Professor Hewinson: It will depend on what data we need to generate.

Q371 Chair: You see, this is what we are getting a little bit frustrated about. When are we going to know what data we need to comply with?

Professor Hewinson: I would hope fairly soon.

Q372 Chair: Within five years; 10 years; our lifetime?

Professor Hewinson: When will we know the data?

Chair: Yes. Fairly soon? Three months; three years?

Professor Hewinson: I would hope that the letters that we get from the VMD will give us a view on safety. The OIE has some very prescriptive numbers that you need to generate to validate your diagnostic test, and then I think the efficacy would be something that you would want to discuss, or that we would design and then show to the Commissioner, on what level of certainty the performance of the efficacy studies gave them.

Q373 Chair: Can I ask you again? How long do you think the field trials will have to last? We do not know.

Professor Hewinson: Not at this time.

Q374 Neil Parish: Do you know whether the Government has sought volunteers to volunteer their cattle for this idea of having a field trial? I cannot see people queuing up.

Chair: I think we will cross that bridge when we get the data.

Professor Hewinson: Yes, to get to the design you need to sort out the issues of milk and meat.

Q375 Mrs Glindon: What estimate do you have of the cost of the vaccine and DIVA test?

Professor Hewinson: Again, that will depend on the scale of use of it, but at the moment, based on the fact that the dose you use is 10 times lower than the badger vaccine, I think the price at the going rate would be about £5 or £6 per dose. However, that will depend on how much vaccine you would use. I think the DIVA test would be a similar price to the gamma interferon test, which is about £25.

Q376 Mrs Glindon: So in total it would be quite a considerable cost.

Professor Hewinson: I do not know if that is considerable, but that is what it would cost. However, there could be scales of efficiency.

Q377 Mrs Glindon: It has been estimated that 50% of the vaccinated cattle population will test positive to the tuberculin test at every routine annual test, and so DIVA testing would be necessary if it was introduced on stream.

Professor Hewinson: What we see from BCG vaccination is that the sensitisation to the skin test falls off such that, at about nine months, there are only about 10% of animals that are positive. Again, this comes to how you would use the test, how you might align testing and vaccination, and the logistics of how you might use a vaccine, but that might mean that you would only use the DIVA test on the positive animals. That is one way that you might use it-I am not saying it has been decided yet-but that would mean that you would be using the DIVA test on maybe 10% of animals.

Q378 Mrs Glindon: Trained members of public are permitted to vaccinate badgers. Could the same policy apply to the vaccination of cattle, or must the cattle vaccine be administered by a vet?

Simon Hall: In principle, farmers, who are on the whole skilled professionals, are allowed to vaccinate their own animals. It is foreseeable that one of the conditions that the Commission might put on in the early stages of the trial is that they want, probably, official vets to carry out the vaccination to make sure that the vaccinated animals are being correctly identified. Other than that, what you say is true.

Q379 Mrs Glindon: Practically, if the animal was identified, there would be no barrier to a trained person who was not a vet administering.

Simon Hall: The competence to administer a vaccine is well within a trained farmer. The level of assurance that we would have to give, quite reasonably, that vaccinated animals had been correctly identified and were properly controlled, if there were restrictions on how they could be traded, would almost certainly require official supervision, if not officials doing the vaccine during the controlled stages of the field trail.

Q380 Chair: Could I just ask: there is then going to be an administration charge as well as the vaccine and the DIVA test?

Simon Hall: There would certainly be an administrative cost, yes, which somebody would have to pay.

Q381 Iain McKenzie: On that administrative cost, I take it that is a cost for the vet? I take it these animals will have an individual passport as such, a veterinary passport, so the vet will add this to their passport. If they were administered the vaccination by a trained farmer or others, would they still be able to add this to their veterinary passport for each animal?

Simon Hall: We are getting into the realms of speculation, because these are details that would need to be sorted out, but actually the cattle traceability system now relies far more on computerised data than it does on paper passports. Paper passports are really just a back-up. In some way, vaccinated animals would have to be officially recorded as such, so that, in particular if we were not at liberty to export them alive to other countries, we could provide those guarantees.

Q382 Chair: It has not prevented horses being-

Simon Hall: If I could just digress a little bit, the Commission blamed BSE for some things, but what BSE has actually given us is a very rigorous system of individual identification and traceability in cattle, with a centralised database, which actually has been extremely valuable in implementing TB controls and would be well suited to regulation of a statutory vaccination scheme.

Q383 Iain McKenzie: Let us take it a step further and look at other vaccines. Are any of you gentlemen aware of any work being done to find vaccines that are more effective and do not interfere with the skin test?

Professor Hewinson: That is research that is ongoing. The ideal would be to have a vaccine that did not desensitise the animal to the skin test, so then you could carry on using the skin test and that would overcome the need for a DIVA test. There is some work ongoing. There are some proofs of principle that there are vaccines that do not desensitise to the skin test, but at the moment none of them have proven as effective as BCG on their own. There is ongoing work, but this is long term; this is not a short fix. Certainly what you pick up from the Commission is that, if you could carry on using the skin test, that would help give that level of assurance, as long as the vaccine did not suppress the skin test response.

Q384 Iain McKenzie: Looking at the other direction, would you say there are breeds of cattle that are possibly more susceptible to bovine TB than others and, if there are, might there be a genetic solution for the future?

Professor Hewinson: Often it is quite difficult to tease apart what is due to a breed and what is due to the management of those animals, in terms of how resistant they are, versus whether your management system is pushing infection. The studies that have been more convincing are, one, a study that showed if you put zebus and HolsteinFriesians and mixed breeds together in a situation where they are all exposed to the same force of infection, zebu animals-these are the African and Indian animals that have the hump on the back-were about twice as resistant to infection or were half as likely to get TB as the Holstein-Friesians. Again, that could be because the Holstein-Friesians may be under more stress and producing more milk, etc. There have been some studies now genetically in the UK and in Ireland that are trying to look at defining heritability of resistance to infection. There is a paper that has come out recently that suggests there is 18% heritability-whether it is resistance to infection or response to the skin test is a key question.

Q385 Iain McKenzie: It is not necessarily straightforward to look at an area of the country and say, "A low infection rate: that equals that particular breed of cattle." There are complexities involved in it.

Professor Hewinson: It is the complexity. What you would need really to do is to put the different breeds all together under the same force of infection, and see if some were more resistant than others. What they are trying to do is to look at, if there are certain bulls that have sired, by artificial insemination, whether there is any association with different lines and resistance to infection within herds, but it is not clear whether that is true resistance or whether it is a response to the skin test that you are testing. It would be wonderful to select for animals that were resistant to TB, which did not lose any of their other traits. That would be fabulous. If, on the other hand, you were selecting for animals that did not respond to the skin test, you might have a different problem on your hands. There is more work to be done yet, but it might be possible. There is no one single gene that has been found that gives you resistance; it is a combination of genes.

Q386 Dan Rogerson: Back to badgers, what benefits would an oral vaccine for badgers bring?

Professor Hewinson: As opposed to an injectable vaccine?

Dan Rogerson: Vaccination for badgers, full stop. Inevitably, I would think, an oral one is going to be preferable to trying to manhandle badgers. I will take that as read.

Professor Hewinson: It is obvious. Again, this comes back to the question of how much TB is going from badgers to cows, how much is badger to badger, etc. To quantify the advantage is difficult, but I think the lessons are that, if you do nothing about your wildlife reservoirs, when you model disease, then you will get spillback into cattle. The two control tools you have in wildlife are either culling or vaccination. If you model what happens with vaccination of cows and badgers, if you do both, you will reduce TB further than just using cattle vaccines alone, because you are creating immunity within that population.

Q387 Dan Rogerson: How much further-significantly further?

Professor Hewinson: Significantly further. Then, theoretically, could you get herd immunity? I do not know; the logistics are very difficult. However, the modelling suggests that this would take many, many years to achieve, so vaccination would not be a quick fix especially as, when you are vaccinating badgers, you are leaving infected animals, so the vaccine does not cure preexisting infection. The time it takes for a vaccine to start having an effect in a wildlife population is dependent on the infected badgers dying off and then getting more protection. Any vaccination strategy focusing on badgers would need to be, I would say, quite widescale and longterm.

Q388 Dan Rogerson: What progress has been made towards developing one?

Professor Hewinson: Oral vaccines?

Dan Rogerson: Yes.

Professor Hewinson: Progress is being made. There are a number of formulations that are under investigation. I would say that none of them are ready for use yet. Oral vaccination, I think, has its own challenges: one, that you have to protect the BCG; and two, you have to reproduce it. There are technical challenges to immunising the animal itself reproducibly. There are technical challenges in delivering the vaccine. The efficacy of a vaccination campaign with oral vaccination is not just how well it works in the individual.

Dan Rogerson: You have to get it into the badger.

Professor Hewinson: It is how much population coverage you can get. There are two challenges to get the right deployment strategy with the right bait and the right oral vaccine. Oral vaccination is harder to control the dose to get to the right place to give you protection.

Q389 Dan Rogerson: Accepting these technical challenges, the question was: how much progress are we making?

Professor Hewinson: There are some lead candidates that have given proof of principle that oral vaccination can give you similar protection to injectable vaccination. There are proofofprinciple studies.

Q390 Dan Rogerson: That is the technical side. The other challenge is getting it in the right forum for badgers.

Professor Hewinson: There are still technical challenges to getting uptake to the different populations. Cubs seem to be slightly easier, in terms of the formulations that we have at the moment, than adult uptake.

Q391 Dan Rogerson: The followon question is that, in the Republic of Ireland, they are making some progress; they are trialling something now. Are they further ahead than us and, if so, why?

Professor Hewinson: Actually it is a partnership. We are working together with the Republic of Ireland. We have been doing some of the experimental studies. They are doing a field trial that will give proof of principle that oral vaccination in the field might be possible, and this is linked in with New Zealand, because the formulations that have been used have been developed for possums in New Zealand. It is divvying up the work, working together collaboratively, to try to generate enough data to give proof or principle and to create data that might go into a licensing document.

The trial that is going on in the Republic of Ireland is not a trial of how the vaccine would be finally used, so it is not being incorporated in a bait and being up taken up as bait. What they are doing is they are trapping the badgers, anaesthetising them and then injecting the formulation down, so that they swallow the BCG in a formulation. Although it will give you proof of principle of how the vaccine in that formulation might work, it does not give you-

Q392 Neil Parish: You still have to trap them.

Dan Rogerson: You still have the method to prove.

Professor Hewinson: You have to trap them, yes. It is not telling you how effective it will be in a bait. I would say that there is progress, but it is not something that is-

Q393 Dan Rogerson: It is our progress too is what you are saying.

Professor Hewinson: These things are so different. These things take a lot of time. One of the other differences is that every TB experiment takes a year, because the disease progresses so slowly. If you have variation in one experiment, that takes you back a year. We have a very strong network of collaborators, both in the human TB vaccine side, to see if there are any advances that we can apply to badge or cattle vaccination, but also a network of people who work on M. bovis vaccination, so that, with the scarce resources around the world to do this sort of work, we are trying to optimise the information that we can all generate in a synergistic way.

Q394 Neil Parish: I want to ask a question about public expectation regarding vaccine and DIVA tests. To use your own words, Professor Hewinson, either badger or cattle vaccine is not a quick fix.

Professor Hewinson: It is not.

Q395 Neil Parish: Yet, in part of the public out there, there is an aspiration that it is a quick fix. What can Defra do to manage people’s expectations more on this matter?

Professor Hewinson: You can ask Defra. I think there might be something in public engagement around what is known and what is not known, and the challenges that are ahead.

Q396 Neil Parish: There is no doubt, Madam Chairman, that the more evidence we take on vaccination, one way or the other, one, the more confused we become and, two, the longer time it seems to be in the process. I do not think that perhaps that has got out to the public, the length of time that it is going to take to develop these vaccines. Can Defra not actually be putting more on its websites or whatever? Surely there is something Defra can do.

Chair: It is something we might wish to ask the Minister. Do you have a view?

Professor Hewinson: My view, and I have been doing some of this, is to engage with the press to try to communicate some of these issues. I have been saying it is not a silver bullet; you need to use all the different tools and some of the complexities around vaccine development.

Q397 Neil Parish: There is also the time scale, Madam Chairman. This is the point. What we are getting in evidence is that, however we do it, it is going to take some years, probably 10 years, and I just do not think that is coming out. Very few people seem to be aware of this.

Professor Hewinson: I would say the only tool you have around vaccination in the immediate term is the injectable vaccine for badgers. That is licensed and available. The challenge is how you would utilise that most effectively.

Q398 Neil Parish: As far as cattle, there is none.

Professor Hewinson: As far as cattle, there is no vaccine at the moment. As Simon says, there is an issue of rolling out and learning as you go, but it is not available yet, no. The only thing that is available is an injectable badger vaccine.

Q399 Chair: Could I just move on to the rationalisation of the veterinary laboratories, Mr Hall? We did discuss it briefly when we met last week. You will be aware of the view that the Committee took, when we took evidence on this in early 2012, and particularly the impact it would have on rural areas. Could you share with the Committee what the particular rationale behind the closure of the vet labs were, rather than just saving money?

Simon Hall: When we talk about vet labs, these are the laboratorytesting people standing at benches, working with test tubes and that to diagnose and investigate disease, carried out in what were then approximately 14 regional laboratories spread around England and Wales, and one in Scotland. Very simply, the level of work that was available for them to do had dropped dramatically and, in particular, largescale testing and the surveillance and testing campaigns that had gone on for decades-for example, brucellosis testing in the 1970s and 1980s, moving on to BSE and then scrapie testing-had all come to an end and had not been replaced. Fundamentally, we had overcapacity. We had skilled people and expensive facilities with not enough work to do. Even though the workload had dropped dramatically, in fact the costs to us, and eventually the taxpayer, were going up.

First of all, we as an agency have a responsibility to deliver efficient and costeffective public services, so that has to be a consideration. Also, if skilled people do not have enough work to do, they are unable to maintain their expertise. Also, in the way in which we work, which is qualityassured and where there is a heavy input on health and safety, the overhead cost of each team of people is considerable. That was the essence of the business case for rationalising the laboratory testing done out in the regions from 14 down into six locations, where we can have goodsized teams of staff, which are fully occupied, doing a good range of work, maintaining their expertise and being effectively managed.

Q400 Chair: It is just that Newcastle does not strike me as being a centre of livestock production. Presumably one of the reasons that these veterinary laboratories had grown up was that they were close to where the livestock were. The Committee would just like to know if you have now proceeded to a further consultation with a view to further closures, and completely closing those such as in Thirsk, in my own constituency, where you have already taken some of the scientists out. That has coincided with the rise of Schmallenberg and possibly liver fluke as well. We just wondered if you would like to comment on whether you think the labs now have the resources to cope with such an incident. [Interruption.] If I could just finish the question-I am almost there-one of the issues is a rapid response and a rapid test to limit the economic impact on that community. Clearly, the longer distances the samples have to travel do not necessarily lend themselves to that.

Simon Hall: There are quite a lot of different diseases out there. A lot of the testing that is done is fairly routine. There is no great rush and, in fact, it is commonplace for samples to be transported either by courier or even firstclass post between laboratories. It is normal that vets would submit samples to investigate their clients’ problems by post or courier. In fact, in amongst our network when there were 14 laboratories for the laboratory testing, it was set up so that certain ones specialised in certain tests. Something that was perhaps hand-delivered to the laboratory in Thirsk would then be couriered overnight to somewhere else where the test was actually done.

In the specific case of Schmallenberg, because it is new and the tests are, to some extent, under development, all that is actually done at the central laboratory in Weybridge. It is not done in the regional laboratories. For the diseases where a rapid response is important, for example foot and mouth disease, that again is already centralised where the expertise is, so Pirbright or Weybridge, and there are rapid mechanisms, including if necessary aircraft, to get the samples to the single expert lab. That is laboratory testing.

I would also note that, for many of these tests, there is a commercial market. For example for Schmallenberg, vets and farmers have the choice of private sector labs, which will provide them with a service and that is fine. That is part of the service.

The consultation, which was out a few months ago and finished on 15 February, was not about that. It was about our disease surveillance network customarily built on a network of, in fact, those same facilities, where there are expert vets there to investigate disease outbreaks or disease events, and with a postmortem facility for dealing with carcasses as part of that investigation. That is what that latest consultation has been about. It closed on 15 February. We had a lot of responses; we are analysing them. The principles that were given to us by the independent advisory group chaired by Professor Dirk Pfeiffer did point towards again concentrating the work in fewer locations, where we can maintain the expertise better. We can maintain and develop the expertise better, and make better use of expensive staff and facilities, by keeping them fully occupied.

Q401 Chair: I am pleased you mentioned that, because my understanding is that Thirsk does most post-mortems for many miles around. Are you saying that now they are going to be couriered or lifted by aircraft to be tested, when they would actually have been tested on the doorstep, as they have been at the moment? Was this all part of the master plan in September 2011, but that was just the first round and this was always planned as the second round of closures?

Simon Hall: To a reasonable approximation, these are different activities.

Q402 Chair: Those are weasel words, "a reasonable approximation".

Simon Hall: Okay, I will say the big picture and then the approximation. Samples-blood samples, faeces samples, milk samples-that need some scientific test done on them to detect disease, for example, are commonly couriered around the country, sent by post and even sent abroad if that is what is necessary to do the test. That is a perfectly satisfactory way of organising that.

Q403 Chair: Excuse me a moment, but is that deemed to be costeffective?

Simon Hall: Yes.

Q404 Chair: It is better to post it or courier it from Thirsk to Amsterdam than it is to do the original test in Thirsk.

Simon Hall: On the whole, yes, though not Amsterdam but one of our remaining locations, for example in Bury St Edmunds. In the nature of modern laboratory testing, there are economies of scale. You have expensive machines and expensive people. If you can keep them fully occupied, it is much more efficient and easier to qualitycontrol.

Q405 Chair: Do they produce many sheep in Suffolk?

Simon Hall: Sheep in Suffolk?

Chair: Yes.

Simon Hall: Yes.

Q406 Chair: As many as in North Yorkshire?

Simon Hall: I do not know, but possibly not. If I can move on to the second part, the thing that we have consulted on recently is not that; it is about having teams of vets with postmortem facilities at their disposal to investigate disease and other incidents on farm. That does generate some of the samples that require testing and that is where the overlap is, but not all of them. A lot come in by post anyway. Sorry; I will stop there.

Q407 Neil Parish: I know we got the answers on Schmallenberg, but if you have a suspected case of Schmallenberg on a farm, how long does it take to get it tested? Secondly, are you aware of how far away a vaccine for Schmallenberg is?

Simon Hall: Schmallenberg is not a regulated disease, so it is between a farmer and their private vet. They may well not even notice that they have had the infection, because often it can pass through a flock unnoticed. It is up to them now to decide what level of investigation to carry out.

Q408 Neil Parish: If they wanted to have it tested, how quickly could it be done?

Simon Hall: Firstclass post into our lab network ends up in Weybridge. I am not sure what the turnaround time is but, if you are doing serology, you are not looking at the acute situation; you are really looking at historic infection. It is not a result you are going to take immediate action on, so the timing is not critical, unlike some things like foot and mouth disease, where you need it virtually instantaneously. On the vaccine, I think you heard from VMD what they know about it and I do not have any better information than that. Unusually, information has been released to the press that there is at least one candidate vaccine under consideration by VMD. Normally this would be regarded as commercially confidential, but information has been released.

Q409 Chair: There is potentially a loss of expertise, presumably, with these vets and postmortem examinations being lost from areas like North Yorkshire, like Thirsk, where obviously Stan Done is internationally renowned for his expertise as a leading veterinary scientist. Are you not the least bit worried that this expertise is going to be lost?

Simon Hall: The point that was brought to our attention by the independent advisory group is, if we want vets with expertise, for example in pathology, pig disease, whatever, for the future, the upandcoming vets have to have a case load; they have to be able to work with colleagues. That is one good nonfinancial reason to concentrate this activity in fewer busier centres. In fact, the objective of sustaining the expertise that we need to carry out surveillance on behalf of Government is one of the main motivators behind the proposal that we consulted on.

Q410 Chair: If you are a vet and you want to work with sheep, I do not suppose you would think of going to Weybridge as the obvious place to go.

Simon Hall: Well, no.

Q411 Dan Rogerson: Something that is raised from time to time-and I represent an area that has a high incidence of TB-is concern about other species, pets for example. We have talked about the health issues around TB and how it passes along the various vectors and so on. Is this something that you are doing any work on currently, whether it is, for example, transferring increasingly into cats?

Professor Hewinson: It is statutory to report TB in different species so, yes; we do report strain type and culture, especially to our Health Protection Agency colleagues, if there is TB in cats or other domestic species where there might be a health risk.

Q412 Dan Rogerson: Is this something where there is a fairly flatline number of incidences that are reported to you or is this something that is on the increase?

Professor Hewinson: I would have to get back to you on that, I am afraid. I do not know.

Q413 Dan Rogerson: I would be interested to hear anything you have on that one or any other species that are in contact with people.

Professor Hewinson: We do publish the species.

Q414 Chair: If you could provide perhaps not a longer paper but a short note.

Professor Hewinson: We will send you a graph or something like that.

Chair: Thank you. Professor Hewinson and Mr Hall, can we thank you on behalf of the whole Committee very warmly for being with us? I am sure we will have an opportunity to meet again in the future. Thank you very much indeed for participating.

Prepared 14th March 2013