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Let's discuss the BCG vaccine



 Added by  Sally (Guest)
 21 Apr 2010, 3:44 PM


The BCG vaccine is frequently mentioned as the most common vaccine to help protect against TB. It has been used to protect people from the human form of the disease, although more recently in the UK the vaccination programme has been stopped owing to its poor cost effectiveness. An injectable form has recently been licensed for use on badgers. Could it be used for cattle? Is it a reliable vaccination and has it helped prevent the human form of TB?

Sally
According to the Flint Chronicle (www.flintshirechronicle.co.uk/flintshire-news/local-flintshire-news/2012/06/14/farmer-issues-warning-over-bovine-tb-rates- 51352-31176757/) Ivor Beech, chairman of NFU Cymru Clwyd, is concerned about bTB. He said: “It’s a worrying time. It’s not getting better, it’s getting worse.” He has a herd of 600 cattle at his farm in Rhuddlan and suffered a herd breakdown in March. He said; “We have been free of it [bovine TB] for 50 years. One of the animals tested positive and another two inconclusive. It’s creeping back into the area. We are having a second test done this week so we will know if more have come down with it. I’m hoping it was a bad reaction to the test as it’s not 100% accurate. There have been one or two cases of the same thing happening at farms locally but coming clear on the second test.”
 
Mr Beech is yet another farmer who says that more could be done to protect cattle. “It’s frustrating to see bovine TB coming into herds. I don’t understand why there is no vaccine to protect the animals and keep them healthy.”
 
becky
Some interesting comments from politicians attending the Cornwall show.
 
Shadow farm minister Huw Irranca-Davies, said: "I genuinely do not think culling is a long-term solution. We need to revisit the 1970's view of eradicating TB. We have to be realistic that there is no longer any question of eradicating it - it is too widespread now. We need to redouble our efforts on badger and cattle vaccination."
 
Cornwall MP George Eustice agreed that development and licensing of a cattle vaccine was essential. Mr Eustice, the Tory MP for Redruth and Camborne, said: "It would be unacceptable to fast-track the vaccine if the EU dragged its feet over approving it.
 
Source: http://www.fwi.co.uk/Articles/08/06/2012/133293/TB-cull-areas-prepared-for-go-ahead.htm#.T9IJdlSxU6w.twitter
 
becky
Sensible talk at the Beef Expo when a question time debate focused on bovine TB (reported today in Farmers Weekly www.fwi.co.uk/Articles/28/05/2012/133138/Beef-Expo-No-quick-fix-for-TB-control.htm).
 
Progress towards vaccination of cattle was commonly supported by the panel, which consisted of Stuart Roberts, (who sits on the Animal Health and Welfare Board for England), Adam Henson (Countryfile), Poul Christenson (Natural England) and Mike Gooding (FAI Farms).
 
However, Gooding believed progress on vaccine development would be influenced by wider political issues. "If the economy collapses in Greece, political focus will not be on a TB vaccine. Maybe we as an industry need to think how research (in to a vaccine for cattle) is funded," he said, suggesting that with the rise in the price paid for prime cattle, perhaps producers should consider contributing to funding for vaccine research.
 
Mr Henson urged farmers not to go 'to war over bovine TB' and advised farmers to work together; "Although emotions run high on both sides over possible control measures, the disease must not be allowed to dominate the wider debate on animal health issues. It must not be allowed to overshadow other important diseases, such as Johne's and BVD, that also pose a threat. It must not turn in to a badger vs cattle debate."
 
becky
Report entitled 'Farmers’ Willingness to Pay for a
Tuberculosis Cattle Vaccine' by Richard Bennett and Kelvin Balcombe (published / accepted Nov 2011). This report concludes that the results of the survey show that cattle farmers have a substantial WTP for a
bTB cattle vaccine. They also show that farmers primarily value the ability of a vaccine to prevent a breakdown (or rather to reduce the probability of a breakdown) rather than the ability of a vaccine to reduce the severity of a breakdown. This is not surprising, given that some of the most disruptive and costly consequences of bTB, such as movement restrictions and re-testing, are incurred regardless of the severity (i.e. number of reactor cattle) of a herd breakdown. However, farmers also recognise that a vaccine is unlikely to be 100% efficacious and so they value insur-
ance backing that would pay compensation to them should vaccinated cattle succumb to bTB.
 
 
Abstract
We use contingent valuation (CV) and choice experiment (CE) methods to
assess cattle farmers’ attitudes to and willingness to pay (WTP) for a bovine tuberculosis (bTB) cattle vaccine, to help inform vaccine development and policy. A survey questionnaire was administered by means of telephone interviews to a stratified sample of 300 cattle farmers in annually bTB-tested areas in England and Wales. Farmers felt that bTB was a major risk for the cattle industry and that there was a high risk of their cattle getting the disease. The CE estimate produced a mean WTP of £35 per animal per single dose for a vaccine that is 90% effective at reducing the risk of a bTB breakdown and an estimated £55
for such a vaccine backed by 100% insurance of loss if a breakdown should occur. The CV estimate produced a mean WTP of nearly £17 per dose ⁄ per animal ⁄ per year for a vaccine (including 100% insurance) which, given the average lifespan of cattle, is comparable to the CE estimate. These WTP estimates are substantially higher than the expected cost of a vaccine which suggests that farmers in high risk bTB ‘hotspot’ areas perceive a substantial net benefit from buying the vaccine.
 
becky
In the Welsh Assembly document: 'A Strategic Framework for
Bovine TB Eradication in Wales' available to download at http://wales.gov.uk/docs/drah/publications/120320tbstrategicframeworken.pdf, there are sections (reproduced below) on cattle vaccination.
 
6.3 Cattle Vaccination
In theory, vaccination of cattle against TB has the potential to reduce the frequency of transmission from infected to susceptible animals (including both other cattle and wildlife). An effective approach to vaccination should result in both a reduction in the frequency of new breakdowns and a reduction in the severity of those breakdowns. However, as with all vaccines, a cattle vaccine will not guarantee that all cattle vaccinated are fully protected and a proportion may still become infected. Recent research also indicates that to maintain sufficient levels of protection annual re-vaccination is likely to be necessary. The possible future use of cattle vaccines is the subject of national research and ongoing discussion
with the European Commission. These discussions have identified a number of legislative and technical issues and it is clear that further research and negotiations will be necessary before the vaccination of cattle becomes a viable option for delivery. It will be important to prepare for the day when cattle vaccination can become part of our TB eradication strategy.
 
7.3 Cattle Vaccination
Objective:
Develop a strategy for cattle vaccination based on evidence and experiences from the UK, and from other disease eradication programmes.
 
Future options for controlling the spread of bovine TB may include vaccination of cattle. The Science Review agreed with this approach:
”Vaccination of cattle against bTB is not currently available in the UK but it may become so in the future. Vaccinated cattle show a positive reaction to the tuberculin skin test, which currently requires
slaughter of that animal under EU regulations.”, (Science Review Report, Page 3, Para 11).
 
Actions:
• Develop a strategy for cattle vaccination and its potential implementation when more research and information becomes available.
• Encourage international collaboration between scientists, veterinarians and the farming industry to resolve the challenges of this approach.
 

 
becky
Press Release received from Rethink bTB today.
 
Welsh Badger Cull Announcement
Rethink Bovine TB Demands Cattle Vaccination
 
Rethink BTB, the research group which last year highlighted serious failings in current Bovine TB policy and cattle test accuracy, has welcomed today’s statement by John Griffiths, the Welsh Government Minister for Environment and Sustainable Development.
 
Badger vaccination may help, and importantly avoids the serious risk inherent in badger culling of further spreading disease.
 
However the main issue has again been missed. Test and slaughter of cattle is a primitive approach to disease control, made even more ineffective by the inaccurate nature of the tests used. Any long term and effective solution must include cattle vaccination.
 
The cattle vaccine, BCG, has been used on humans for decades. If the political will existed, use on cattle would have been licensed years ago. Defra admit that recent research indicates a protective effect between 56% and 68%. This vastly outperforms any other measure proposed including badger culling.(1)
 
Rethink BTB spokesman Michael Ritchie, said that: “It is not enough that the UK Government is gently “asking” the EU for permission to vaccinate cattle against BTB. They must demand it, or simply declare that we will vaccinate cattle anyway. Tens of thousands of cattle are being slaughtered unnecessarily every year so that we comply with outdated EU laws”.
 
Notes:
Copies of the second edition of the Rethink BTB report are available for download free of charge from www.rethinkbtb.org/rethink_documents/BTB_rethink_2nd_edition.pdf
 
The report proposes that Bovine TB should be handled like any other animal disease, and so farmers should be free to choose the most suitable means of control for their farm. The highest priority must be licensing of the cattle vaccine and removing European legal barriers to its use.
 
(1) Defra web site http://www.defra.gov.uk/animal-diseases/a-z/bovine-%20tb/vaccination/cattle-vaccination
 
becky
P and S, farmer in Oxford, email dated 19/3/12.
 
This is so helpful - it sounds that it is moving along on intelligent lines.
 
Today.. how amazing your letter has come today ... we have once again had the technicians ( not vets) beginning the 6 week ritual for another TB test.
 
Each time all 700 cattle have to go through this and each time only one or only two have gone down and each time there has been no lesions at slaughter.   So every 6 weeks another testing of 700 cattle. We have been able to sell a few beef animals, and been worried about the quantity of fodder/silage that will see us through the winter when we have to keep so many on the farm.
 
 
becky
Summary paper from rethink bTB:
 
Cattle vaccination against Bovine TB - is it imminent?
Defra has provided the following information, extracted from Freedom of Information requests and other correspondence. This indicates that a cattle vaccine is actually closer to deployment than the
Government is admitting.
 
Application for VMD approval has been made
“An application to the Veterinary Medicines Directorate (VMD) (the UK’s `regulatory body for veterinary medicines) for an ‘in principle’ decision on licensing was made on 20 January 2012 and we would normally expect to know the outcome in 9-12 months.”
 
Studies suggest ‘considerable protection’
“BCG has been used in numerous vaccine studies since 1911 in cattle. Although studies are sometimes difficult to compare - as a variety of vaccine strains, challenge strains, vaccination and infection routes, and ways to measure protection have been applied - the results of the majority of these studies have demonstrated considerable protection. The results of controlled field studies are more variable but the overall majority also demonstrated protection, including recent studies conducted in Mexico (Lopez-Valencia et al., 2010) and Ethiopia (Ameni et al., 2010).”
 
Now submitted for assessment
“Studies investigating the efficacy and safety of BCG Danish Strain 1331 (a commercially produced strain widely used as human vaccine) required for licensing have been completed by Defra Health and Veterinary Laboratories Agency and these data have been included in the recently submitted
licensing application (see above) to the VDM for assessment.”
 
EU legislation is still holding up field trials
“Studies to date cannot provide a definite figure for vaccine efficacy when administered to cattle under field conditions in the UK and it is currently not possible to generate these data in the field because of existing EU legislation prohibiting vaccination of cattle against TB (see below). However, small-scale field studies have been carried out recently in Ethiopia and Mexico and depending on the parameters selected the protective effect of vaccination was between 56% and 68%.”
 
Moving ahead with the DIVA test
DEFRA indicate validation and certification of DIVA test, possibly by the end of 2012.
“Vaccination of cattle with BCG results in a proportion of animals becoming tuberculin test positive (both to the intradermal tuberculin skin test and gamma interferon blood test) and can therefore lead to false positive results in BCG-vaccinated but TB-uninfected cattle. In parallel with developing cattle TB vaccines, AHVLA is also developing a test to differentiate infected from vaccinated animals (so-called DIVA test). This test, based on the gamma interferon blood test, can be used alongside the tuberculin skin test in vaccinated animals where necessary, to confirm whether a skin test positive result is caused by vaccination or TB infection. The studies to generate validation data in vaccinated cattle are expected to be completed and data analysed by Easter 2012. If it is deemed that no further studies are needed, our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the test. Providing the OIE is satisfied with the fitness for purpose of the test, the earliest we could have OIE validation and certification would be the end of 2012.”
 
Preparing for deployment
“As the science becomes clearer Defra will be in a firmer position in the coming months to begin to discuss with farmers, vets and other interested parties about how the vaccine and DIVA test can be used in the field and the likely implications on different types of farm business.”
 
Sally
Some very good points made in the last post (11 March). We would be very interested to know why the unions are so against cattle vaccination. Virtually all the farmers we have spoken to would prefer this to the current test and cull policy, in which they have so little faith.
 
lewistresinwen
An intersting issue is the stance of the farming unions.They seem to be constantly pushing for a badger cull but seem to have no enthusiasm for vaccination whatsoever.I have been told by several vets that it is the unions that are opposed to vaccinating cattle.I gave my view on this in the Welsh Assemby consultation document last year.I stated that I beleived that the current test and cull policy was designed to preserve the export of live animals.Whatever the difficulties of vaccinating cattle,surely it would be better than the horror of the current policy.I consider the current policy to be the definition of insanity,based on the economics of the madhouse.Who decides the position of the NFU and the FUW on this.Is it some minority vested interests that are having a disproportionate influence on their policies?
 
Sally
Published studies re BCG vaccination of cattle vaccination:
 
Ameni G, Vordermeier M, Aseffa A, Young DB, Hewinson RG (2010). Field evaluation of the efficacy of Mycobacterium bovis bacillus Calmette-Guerin against bovine tuberculosis in neonatal calves in Ethiopia. Clin Vaccine Immunol. 2010 Oct;17(10):1533-8. Epub 2010 Aug 18.
 
Berggren S.A. (1977). Incidence of tuberculosis in BCG vaccinated and control cattle in relation to age distribution in Malawi. British Veterinary Journal, 133, 490-494.
 
Berggren S.A. (1981). Field experiment with BCG vaccine in Malawi. British Veterinary Journal, 137, 88-96.
 
Bretscher P.A. (1994). Prospects for low dose BCG vaccination against tuberculosis. Immunobiology, 191, 548-554..
 
Buddle B.M., de Lisle G.W., Pfeffer A., Adwell F.E. (1995a). Immunological responses and protection against Mycobacterium bovis in calves vaccinated with a low dose of BCG. Vaccine, 13, 1123-1130.
 
Buddle B.M., Keen D., Thomson A., Jowett A.G., McCarthy A.R., Heslop J., de Lisle G.W., Standford J.L., Aldwell F.E. (1995b). Protection of cattle from bovine tuberculosis by vaccination with BCG by the respiratory or subcutaneous route, but not by vaccination with killed Mycobacterium vaccae. Res Vet Sci., 59, 10-16.
 
Buddle B.M. (2001). Vaccination of cattle against Mycobacterium bovis. Tuberculosis, 81, 125-132.
 
Buddle, B.M., Wards, B.J., Aldwell, F.E., Collins, D.M. and de Lisle, G.W. 2002. Influence of sensitisation to environmental mycobacteria on subsequent vaccination against bovine tuberculosis. Vaccine 20: 1126-1133.
 
Buddle B.M. Wedlock D.N., Parlane N.A., Corner L.A., De Lisle G.W., Skinner M.A. (2003). Revaccination of neonatal calves with Mycobacterium bovis BCG reduces the level of protection against bovine tuberculosis induced by a single vaccination. Infection and Immunity 71: 6411-9.
 
Buddle BM, Aldwell FE, Skinner MA, de Lisle GW, Denis M, Vordermeier HM, Hewinson RG, Wedlock DN. (2005). Effect of oral vaccination of cattle with lipid-formulated BCG on immune responses and protection against bovine tuberculosis. Vaccine, 23, 3581-3589.
 
Buddle, B.M., Denis, M., Aldwell, F.E., Vordermeier, H.M., Hewinson, R.G., Wedlock, D.N. 2008. Vaccination of cattle with Mycobacterium bovis BCG by a combination of systemic and oral routes. Tuberculosis 88: 595-600.
 
Buddle, B.M., Wilson, T., Aldwell, F.E., de Lisle, G.W., Vordermeier, H.M., Hewinson, R.G., Wedlock, D.N. 2011. Low oral BCG doses fail to protect cattle against an experimental challenge with Mycobacterium bovis. Tuberculosis 91: 400-405.
 
Buxton J.B., Glover R.E. (1939). Experiments with calves on immunity conferred by single and double injections of BCG in an oily excipient. Journal of Comparative Pathology, 52, 47-56.
 
Calmette A., Guérin C. (1911). Recherches expérimentales sur la defense del’orgganisme contre l’infection tuberculose. Annuals of the Institute of Pasteur, 25, 625-641.
 
Calmette A., Guerin C. (1914). Contribution a l’etude de l’immunite antituberculeuse chs les bovies. . Ann Inst Pasteur, 28, 329-337
Calmette A., Guérin C. (1920). Novelles recherches expérimentales sur la vaccination des bovidés contre la tuberculose. Annuals of the Institute of Pasteur, 34, 553-560.
 
Calmette A., Guérin C. (1924). Vaccination des bovidés contre la tuberculose et methode nouvelle de prophylaxie de la tuberculose bovine. Annuals of the Institute of Pasteur, 38, 371-398.
 
Cheneau Y., Blancou J. (1975). Comparative values of live or killed BCG and trypsinised Koch’s bacillus in the immunisation of zebu against tuberculosis. Rev. Elev. Méd. Vét. Pays trop. 28, 1-7.
 
Cheneau Y., Blancou J. (1975). Comparative values of live or killed BCG and trypsinised Koch’s bacillus in the immunisation of zebu against tuberculosis. Rev. Elev. Méd. Vét. Pays trop. 28, 1-7.
 
Chodnik K.S. (1965). Freeze-dried BCG for vaccinating cattle. J. Comp. Path., 75, 263-266.
 
Colditz G.A., Brewer T.F., Berkey C.S., Wilson M.E., Burdick E., Fineberg H.V., Mosteller F. (1994). Efficacy of BCG vaccine in the prevention of tuberculosis. Journal of the American Medical Association, 271, 689-702.
Colston J. (2003). BCG in wild-life and domestic livestock; virulence and efficacy. In: Development of vaccines for bovine tuberculosis. Report of the Independent Scientific Group
 
Vaccine Scoping Sub-committee. Defra Publications, London pp. 39-44.
Doyle T.M., Stuart P. (1958). Vaccination of cattle with BCG. British Veterinary Journal, 114, 3-10.
 
Ellwood D.C. (1975). First results of the field use of BCG vaccine to control bovine tuberculosis in Malawi. British Veterinary Journal, 131, 186-189.
 
Ellwood D.C., Waddington F.G. (1972). A second experiment to challenge the resistance to tuberculosis in BCG vaccinated cattle in Malawi. British Veterinary Journal, 128, 619-626.
 
Fritsche K. (1956). Weitere Ergebnisse mit der modifizierten BCG-Schutzimpfung bei Kaelbern. Zentralbl. Vet. Med. III:63-74.
Glover R.E., Ritchie J.N. (1953). Field trials with BCG for the immunisation of calves against tuberculosis. British Veterinary Journal, 109, 411-427.
 
Griffin J.F. (2000). Veterinary tuberculosis vaccine development. Clinical Infectious Diseases, 30, S3, 223-228.
 
Guérin C., Richard A., Boissiere M. (1927). Essai de prophylaxie de la tuberculose bovine par le BCG dans une exploitation rurale infectée (1921-1927). Annuals of the Institute of Pasteur, 41, 233-253.
 
Haring C.M., Traum J., Hayes F.M., Henry B.S. (1930). Vaccination of calves against tuberculosis with Calmette-Guérin culture, BCG. Hilgardia, 4, 307-394.
 
Hope, J. C., M. L. Thom, B. Villarreal-Ramos, H. M. Vordermeier, R. G. Hewinson, and C. J. Howard. (2005). Vaccination of neonatal gnotobiotic calves with Mycobacterium bovis BCG induces protection against intranasal challenge with virulent Mycobacterium bovis. Clin. Exp. Immunol. 139, 48-56.
 
Larson W.P., Evans W.A. (1929). A two-year experiment with the “Calmette” method of vaccination. Journal of the American Veterinary Medical Association, 74, 580-585.
 
Lopez-Valencia G, Renteria-Evangelista T, Williams Jde J, Licea-Navarro A, Mora-Valle Ade L, Medina-Basulto G. (2009). Field evaluation of the protective efficacy of Mycobacterium bovis BCG vaccine against bovine tuberculosis. Res Vet Sci. 2010 Feb;88(1):44-9. Epub 2009 Jun 28.
Mares R.G. (1972). Control of bovine tuberculosis in Malawi by the use of BCG vaccination. The Veterinary Record, 90, 428-429.
 
Moodie P.A. (1977). Tuberculin reactions in BCG. British Veterinary Journal, 133, 642-645.
 
Murphy D., Corner L.A.L., Gormley E. (2008). Adverse reactions to Mycobacterium bovis bacilli Calmette–Guerin (BCG) vaccination against tuberculosis in humans, veterinary animals and wildlife species. Tuberculosis (2008) 88, 344–357
 
Newell D.G., Hewinson R.G. (1995). Control of bovine tuberculosis by vaccination. The Veterinary Record, 136, 459-463.
 
Novak D.D., Suyubaeva B.P. (1986). Assessment of postvaccinal immunity to tuberculosis (in calves inoculated with BCG and BK-Khartov vaccines). The Veterinary Bulletin, 56, 361 (Abstract 27640).
 
O’Reilly L.M., Daborn C.J. (1995). The epidemiology of Mycobacterium bovis infection in animals and man: a review. Tubercle and Lung Disease, 76, S1, 1-46.
 
 
Rolle M., Wiethe H. (1956). Results of BCG vaccination in cattle in Bavaria. The Veterinary Bulletin, 27, 105 (Abstract 663).
Schellner H., Gaggermeier G. (1955). Vaccination of cattle in herds infected with TB with the ‘strain P’ tubercle baccillus described by Gräub. The Veterinary Bulletin, 26, 183 (Abstract 1117).
 
Schroeder E.C., Crawford A.B. (1929). Studies concerning the Calmatte-Guérin method of vaccinating animals against tuberculosis. Journal of the American Veterinary Medical Association, 74, 733-782.
 
Sibgatullin R.S. (1982). Eradicating tuberculosis from large cattle-breeding complexes using BCG vaccine. Veterinary Bulletin, 53, 731 (Abstract 5212).
 
Skinner M.A., Wedlock D.N., Buddle B.M. (2001) Vaccination of animals against Mycobacterium bovis. Rev.Sci. Tech. Off.Int.Epiz., 20 112-132
 
Skinner, M.A., Buddle, B.M., Wedlock, D.N., Keen, D.L., de Lisle, G.W., Tascon, R.E., Ferraz, J.C., Lowrie, D.B., Cockle, P.J., Vordermeier, H.M. and Hewinson, R.G. 2003 A DNA prime- BCG boost vaccination strategy in cattle induces protection against bovine tuberculosis. Infect. Immun. 71: 4901-4907.
 
Skinner, M. A., D. N. Wedlock, G. W. de Lisle, M. M. Cooke, R. E. Tascon, J. C. Ferraz, D. B. Lowrie, H. M. Vordermeier, R. G. Hewinson, and B. M. Buddle. (2005). The order of prime-boost vaccination of neonatal calves with Mycobacterium bovis BCG and a DNA vaccine encoding mycobacterial proteins Hsp65, Hsp70, and Apa is not critical for enhancing protection against bovine tuberculosis. Infect Immun 73: 4441-4.
 
Tzeknovitzer M. (1927). Étude de la vaccination antotuberculose par le BCG. Annuals of the Institute Pasteur, 41, 322-357.
 
Vordermeier HM, Rhodes SG, Dean G et al. (2004). Cellular immune responses induced in cattle by heterologous prime-boost vaccination using recombinant viruses and bacille Calmette-Guerin. Immunology, 112, 461-470.
 
Vordermeier HM, Huygen K, Singh M, Hewinson RG, Xing Z. (2006). Immune responses induced in cattle by vaccination with a recombinant adenovirus expressing mycobacterial antigen 85A and Mycobacterium bovis BCG. Infect. Immun., 74, 1416-1418.
 
Waddington F.G., Ellwood D.C. (1972). An experiment to challenge the resistance to tuberculosis in BCG vaccinated cattle in Malawi. British Veterinary Journal, 128, 541-552.
 
Watson E.A., MacIntosh C.N., Konst A. (1928). Research on Bacillus Calmette-Guérin and experimental vaccination against bovine tuberculosis. Journal of the American Veterinary Medical Association, 73, 799-816.
 
Wedlock D.N Vesosky B, Skinner MA, de Lisle GW, Orme IM, Buddle BM. (2000). Vaccination of cattle with Mycobacterium bovis culture filtrate proteins and interleukin-2 for protection against bovine tuberculosis. Infect Immun., 68, 5809-15.
 
Wedlock, D.N., Skinner, M.A., Parlane, N.A., Vordermeier, H.M., Hewinson, R.G., de Lisle, G.W., Buddle, B.M. 2003. Vaccination of cattle with DNA vaccines encoding the mycobacterial antigens MPB70 and MPB83: protein boosting induces antibody and does not enhance vaccine efficacy. Tuberculosis 83: 339-349.
 
Wedlock, D.N., Vordermeier H.M., Denis, M., Skinner, M.A., de Lisle, G.W., Hewinson, R.G., van Drunen Littel-van den Hurk, S., Babiuk, L.A., Buddle, B.M. 2005. Vaccination of cattle with a mycobacterial protein vaccine and BCG induces better protection against bovine tuberculosis than vaccination with BCG alone. Infect. Immun. 73: 3540-3546.
 
Wedlock D.N., Denis M., Vordermeier H.M., Hewinson R.G., Buddle B.M. (2007). Vaccination of cattle with Danish and Pasteur strains of Mycobacterium bovis BCG induce different levels of IFNgamma post-vaccination, but induce similar levels of protection against bovine tuberculosis. Vet Immunol Immunopathol. 2007 118, 50-8.
 
Wedlock, D.N., Denis, M., Painter, G.F., Ainge, G.D., Vordermeier, H.M., Hewinson, R.G., Buddle, B.M. 2008. Enhanced protection against bovine tuberculosis after coadministration Mycobacterium bovis BCG and a mycobacterial protein vaccine-adjuvant combination, but not after coadministration of adjuvant alone. Clin. Vaccine Immunol. 15: 765-772.
 
Wedlock, D.N., Aldwell, F.E., de Lisle, G.W., Vordermeier, H.M., Hewinson, R.G., Buddle, B.M. 2011. Protection against bovine tuberculosis induced by oral vaccination of cattle with Mycobacterium bovis BCG is not enhanced by co-administration of mycobacterial protein vaccines Vet. Immunol Immunopath. (in press).
 
Woodruff H.A., Gregory T.S. (1928). The prevention of tuberculosis in cattle. Further investigations to determine the value of the BCG vaccine for the prevention of tuberculosis. J. Council Scientific and Industrial Research (Australia), 1, 158-162.h
 
Young J.A., Paterson J.S. (1949). Studies on the vaccination of cattle as a measure against infection with tuberculosis with the living vole acid-fast bacillus. Journal of Hygiene (London), 4, 39-78.
 
Zuckerman O.M. (1980). Badgers, cattle and tuberculosis. Report to The Right Honourable Peter Walker, MBE, MP
 
Sally
MG has sent us the response he has received from Defra to his follow up questions (see posting on 5 Feb). The letter is dated 1 March and the ref is RFI 4564. The relevant bits are extracted below, with his consent.
 
Thank you for your follow up request asking for additional information about a cattle vaccine for bovine TB, an oral badger vaccine, DIVA test and steps the government has taken to change EU law to allow vaccination.
 
Your first issue concerns evidence. You may have already seen the latest addition to the Defra website concerning cattle vaccines. http://www.defra.gov.uk/animal-diseases/a-z/bovine-tb/vaccination/cattle-vaccination/ This briefly explains the challenges faced in licensing this vaccine and provides a small number of references suitable for web page presentation.
 
But you are of course right and BCG has been used in numerous vaccine studies since 1911 in cattle – see Annex C. Although studies are sometimes difficult to compare - as a variety of vaccine strains, challenge strains, vaccination and infection routes, and ways to measure protection have been applied – the results of the majority of these studies have demonstrated considerable protection. The results of controlled field studies are more variable but the overall majority also demonstrated protection including recent studies conducted in Mexico (Lopez-Valencia et al., 2010) and Ethiopia (Ameni et al., 2010).
 
Studies investigating the efficacy and safety of BCG Danish Strain 1331 (a commercially produced strain widely used as human vaccine) required for licensing have been completed by Defra’s Animal Health and Veterinary Laboratories Agency and these data have been included in the recently submitted licensing application to the Veterinary Medicines Directorate (the UK’s regulatory body for veterinary medicines) for assessment. Provided it is satisfied with the safety, quality and efficacy data, VMD would be able to confirm that requirements to obtain a marketing authorisation have been met/fulfilled. If circumstances remain unchanged and the EU prohibition of the vaccination of cattle against TB is then lifted, the Secretary of State would be able to grant the marketing authorisation for the product. The safety, efficacy and quality data in the marketing authorisation dossier is commercial in confidence and cannot be released at the present time.
 
Studies to date cannot provide a definite figure for vaccine efficacy when administered to cattle under field conditions in the UK and it is currently not possible to generate these data in the field because of existing EU legislation prohibiting vaccination of cattle against TB (see below). However, small-scale field studies have been carried out recently in Ethiopia and Mexico and depending on the parameters selected the protective effect of vaccination was between 56% and 68%.
However, to put BCG in cattle into context: as with BCG in other species it is not 100% effective in preventing TB. Rather, it provides a spectrum of protection:
• Some cattle will be fully protected;
• Some cattle will benefit from reduced disease;
• Some cattle will get no protection from vaccination; and
• As far as we know BCG does not have a therapeutic effect in already infected animals.
 
BCG vaccination of cattle could be a valuable tool when used alongside other TB control measures in the UK.
 
Vaccination of cattle with BCG results in a proportion of animals becoming tuberculin test positive (both to the intradermal tuberculin skin test and gamma interferon blood test) and can therefore lead to false positive results in BCG-vaccinated but TB-uninfected cattle. In parallel with developing cattle TB vaccines, AHVLA is also developing a test to differentiate infected from vaccinated animals (so-called DIVA test. This test, based on the gamma interferon blood test, can be used alongside the tuberculin skin test in vaccinated animals where necessary, to confirm whether a skin test positive result is caused by vaccination or TB infection. The studies to generate validation data in vaccinated cattle are expected to be completed and data analysed by Easter 2012. If it is deemed that no further studies are needed, our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the test. Providing the OIE is satisfied with the fitness for purpose of the test, the earliest we could have OIE validation and certification would be the end of 2012.
Your second group of questions concerned the licensing process to which the answers are as follows: We already knew that the ban on vaccination would have to be lifted before vaccination could go ahead and that was clear in the consultation document. A license can only be granted because there is a statutory power to do so. In the case of a cattle vaccine against TB the EU ban on vaccinate precludes the issue of such a license. A license application has been made and if there is an agreement in principle that will be announced.
 
Thirdly, you ask about the regulatory and technical challenges. These include lifting the EU ban on cattle vaccination, see above and; the amount and quality of evidence required by VMD and the European Commission and other Member States before lifting the ban. These challenges were discussed in the original cattle vaccines policy paper published by Defra in 2008 see http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb/documents/vaccine_cattle.pdf As you say, the vaccine and DIVA test cannot be licensed until the legal ban is lifted. We hope that the period between the lifting of the legal ban on use of vaccine and the granting of a licence for its use can be kept very short. But the first is a pre-requisite of the second.
 
Fourthly you ask when matters related to the date will be clarified, when the application to VMD was made and when we expect to hear back. An application to VMD for an ‘in principle’ decision on licensing was made on 20 January and we would normally expect to know the outcome in 9-12 months. Indications from the European Commission are that their proposal for an EU Animal Health Law will be put to the European Parliament and Council of Ministers later this year. It is unclear how long it will take before these can be adopted, or what their final form will be. In the meantime we will be doing all we can to ensure the evidence produced in support of the cattle vaccine and DIVA test is sufficient to persuade the European Commission and Member States to lift the present ban. The pathway to what we hope will be a licensed and effective vaccine is clear. It is just the timing that remains unclear, since it depends on the actions of a number of institutions, including the European Commission, Parliament and Council of Ministers.
Finally, you asked in connection with the international ban on vaccination what was ‘sufficient evidence for lifting the ban’ and the timescales involved. Sufficient evidence will involve at least an agreement in principle on the part of the VMD to license the vaccine; international certification by the OIE of the evidence regarding the DIVA test; and validation by the European Food Standards Agency (EFSA) of vaccinating cattle against TB. On the basis of this the EC and Member States may seek further evidence. As far as timescale is concerned, the process has started and will be subject to discussions that have yet to take place with OIE and EFSA. These are planned for later this year. However, it would be wrong to guess at a completion date, but we’re doing all we can to influence others to move things on as soon as possible. The Commission has not given a timescale because the necessary legal framework is not yet in place. The Commission has however indicated that they plan to put their proposal on a new AH Law to the European Council and Parliament in the autumn but it is unclear how long this process will take to achieve completion.
 
 
Yours sincerely
 
 
Defra TB Programme
 
Email: ccu@correspondence@defra.gsi.gov.uk
 
becky
Bovine Tuberculosis
 
Question asked by Baroness Smith of Basildon
 
To ask Her Majesty's Government what representations they have made to the European Union regarding the vaccination of cattle against tuberculosis; on what dates; and what response was received.[HL15462]
 
The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Taylor of Holbeach): The Secretary of State met Commissioner Dalli on 14 March 2011 to discuss bovine TB generally and in particular the development and use of a cattle vaccine and a test to differentiate infected from vaccinated animals. The Minister of State met Commissioner Dalli on 6 February 2012, when they spoke about cattle vaccination; this time to support the Commission's draft proposals for a new EU animal health law, which would allow the Commission, with the support of member states, to lift the ban on cattle vaccination when the evidence and appropriate certifications are in place. We continue to lobby hard for a change to EU legislation, but realistically this is still several years away and we cannot be confident other member states will agree to it.
 
becky
Here is the updated situation re cattle vaccination on the Defra website: www.defra.gov.uk/animal-diseases/a-z/bovine-tb/vaccination/cattle-vaccination/
 
Vaccination of cattle against bovine TB, used in conjunction with existing TB control measures, could have benefits in reducing the prevalence, incidence and spread of TB in the cattle population and could also reduce the severity of a herd breakdown regardless of whether infection is introduced by wildlife or cattle.
 
Developing effective cattle TB vaccines is a high priority for Defra. We have invested more than £23 million in cattle vaccine and associated diagnostics R&D since 1998, and over the next 4 years have budgeted to spend a further £9.3 million.
 
The science about vaccination and the use of BCG
BCG (Mycobacterium bovis Bacille Calmette-Guérin) is the most suitable cattle TB vaccine candidate in the short term. Experimental studies show that BCG vaccination reduces the progression, severity and excretion of TB in cattle (1-5) and field studies show that it can reduce transmission of disease between animals (6-7).
 
How efficacious is BCG in cattle?
Studies to date cannot provide a definite figure for vaccine efficacy when administered to cattle under field conditions in the UK and it is currently not possible to generate these data in the field because of existing EU legislation prohibiting vaccination of cattle against TB (see below). However, small-scale field studies have been carried out recently in Ethiopia(6) and Mexico(7) and depending on the parameters selected the protective effect of vaccination was between 56% and 68%.
 
BCG in cattle, as with BCG in other species, is not 100% effective in preventing TB. Rather, it provides a spectrum of protection:
 
Some cattle will be fully protected;
Some cattle will benefit from reduced disease;
Some cattle will get no protection from vaccination; and
As far as we know BCG does not have a therapeutic effect in already infected animals.
BCG vaccination of cattle could be a valuable tool when used alongside other TB control measures in the UK.
 
Licensing studies demonstrating the safety and efficacy of BCG have now been completed by Defra’s Animal Health and Veterinary Laboratories Agency (AHVLA) and in January 2012 an application for marketing authorisation (required to place a veterinary medicinal product on the market) was submitted to the UK’s Veterinary Medicines Directorate (VMD) for assessment. The assessment process may take up to a year to complete and providing it is satisfied with the safety, efficacy and quality data, VMD will be able to confirm that requirements to obtain a marketing authorisation have been met. However, VMD will only be able to grant a marketing authorisation for BCG once the existing EU prohibition on vaccination of cattle against TB is lifted.
 
Legal barriers to vaccination of cattle against TB and what is being done to change the law
Vaccination of cattle against TB is currently prohibited by EU legislation, in place principally because BCG vaccination of cattle can interfere with the tuberculin skin test which is the recognised primary diagnostic test for TB in cattle.
 
Relevant legislative barriers include:
 
TB vaccination of cattle is prohibited under EU national eradication plans (Directive 78/52/EEC);
OTF (Officially TB Free) testing requires tuberculin skin test for trade in live cattle (Directive 64/432/EEC) and BCG vaccinated cattle could give false positives to the prescribed tuberculin skin test; and
Trade in cattle products is tightly controlled by Reg (EC) 853/2004 and BCG vaccinated cattle could give false positives.
Defra is working with the EU to change the current legislation which would allow TB vaccination of cattle and use of a test to differentiate infected from vaccinated animals (so-called “DIVA” test – see below) to be used as a trade test.
 
Particular attention is being given by Defra to:
 
Providing evidence that the vaccine is safe and effective in the vaccine MA application which was submitted to the VMD in January 2012;
Seeking an internationally validated DIVA test, which must be as good as the current tuberculin skin test. Evidence for certification of a DIVA test will be submitted to the OIE (World Organisation for Animal Health) by the AHVLA later this year;
Acceptance of vaccination and the DIVA test by other Member States which have OTF status but whose interests may lie in other diseases such as Johne’s disease. In addition, by the end of 2012, Defra expects, perhaps in collaboration with the EC, to submit the issue of TB cattle vaccination to the European Food Safety Authority (EFSA) for its opinion.
An opportunity to lift the EU prohibition on vaccination of cattle against TB has been created by the drafting of the new European Animal Health Law which is currently under consideration, but we must not underestimate the difficulties involved.
 
Differential diagnosis of BCG-vaccinated animals from TB-infected animals
Vaccination of cattle with BCG results in a proportion of animals becoming tuberculin test positive (both to the intradermal tuberculin skin test and gamma interferon blood test) and can therefore lead to false positive results in BCG-vaccinated but TB-uninfected cattle (8). In parallel with developing cattle TB vaccines, AHVLA is also developing a test to differentiate infected from vaccinated animals (so-called DIVA test (8-10). This test, based on the gamma interferon blood test, can be used alongside the tuberculin skin test in vaccinated animals where necessary, to confirm whether a skin test positive result is caused by vaccination or TB infection. The studies to generate validation data in vaccinated cattle are expected to be completed and data analysed by Easter 2012. If it is deemed that no further studies are needed, our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the test. Providing the OIE is satisfied with the fitness for purpose of the test, the earliest we could have OIE validation and certification would be the end of 2012.
 
Further cattle TB vaccine and DIVA research and development
Further research in progress includes: continued vaccine development improving BCG and development of vaccines that do not sensitise cattle to the single intradermal comparative cervical tuberculin test (non-sensitising vaccines); development and further validation of new DIVA reagents; development and validation of a DIVA skin test; computer modelling to assess how efficient a vaccine for TB will have to be to provide protection to herds and the benefit of vaccination in different types of farm businesses, to assess the likely interaction of vaccination with routine surveillance and to recommend optimal schedules for vaccine delivery.
 
Effective cattle vaccines against TB that do not require a DIVA test, i.e. do not sensitise cattle to the tuberculin skin test, are a long-term research goal.
 
Preparing for deployment
As the science becomes clearer Defra will be in a firmer position in the coming months to begin to discuss with farmers, vets and other interested parties about how the vaccine and DIVA test can be used in the field and the likely implications on different types of farm business.
 
References
(1) Wedlock D.N., Denis M., Vordermeier H.M., Hewinson R.G., Buddle B.M. (2007). Vaccination of cattle with Danish and Pasteur strains of Mycobacterium bovis BCG induce different levels of IFN gamma post-vaccination, but induce similar levels of protection against bovine tuberculosis. Vet Immunol Immunopathol. 118, 50-8.
 
(2) Wedlock D.N., Aldwell F.E., Vordermeier H.M., Hewinson R.G., Buddle B.M. 2011. Protection against bovine tuberculosis induced by oral vaccination of cattle with Mycobacterium bovis BCG is not enhanced by co-administration of mycobacterial protein vaccines. Vet Immunol Immunopathol.144(3-4):220-7. Epub 2011 Sep 29.
 
(3) Buddle, B.M.,Wilson, T., Aldwell, F.E., de Lisle, G.W., Vordermeier, H.M., Hewinson, R.G., Wedlock, D.N. 2011. Low oral BCG doses fail to protect cattle against an experimental challenge with Mycobacterium bovis. Tuberculosis 91: 400-405.
 
(4) Vordermeier H.M., Villarreal-Ramos B., Cockle P.J., McAulay M., Rhodes S.G., Thacker T., Gilbert S.C., McShane H., Hill A.V., Xing Z., Hewinson R.G. 2009. Viral booster vaccines improve Mycobacterium bovis BCG-induced protection against bovine tuberculosis. Infect Immun. .Aug;77(8):3364-73. Epub 2009 Jun 1. Erratum in: Infect Immun. 2011 May;79(5):2134.
 
(5) Hope J.C., Thom M.L., McAulay M., Mead E., Vordermeier H.M., Clifford D., Hewinson R.G., Villarreal-Ramos B. 2011. Identification of surrogates and correlates of protection in protective immunity against Mycobacterium bovis infection induced in neonatal calves by vaccination with M. bovis BCG Pasteur and M. bovis BCG Danish. Clin Vaccine Immunol. 2011 Mar;18(3):373-9. Epub 2011 Jan 12.
 
(6) Ameni, G., Vordermeier, M., Aseffa, A., Young, D.B., Hewinson, R.G. 2010. Field evaluation of the efficacy of Mycobacterium bovis Bacillus Calmette-Guérin against bovine tuberculosis in neonatal calves in Ethiopia. Clin. Vaccine Immunol. 17: 1533-1538
 
(7) Lopez-Valencia G., Renteria-Evangelista T., Williams Jde J., Licea-Navarro A., Mora-Valle Ade L., Medina-Basulto G. (2009). Field evaluation of the protective efficacy of Mycobacterium bovis BCG vaccine against bovine tuberculosis. Res Vet Sci. 2010 Feb;88(1):44-9. Epub 2009 Jun 28.
 
(8) Whelan A.O., Clifford D., Upadhyay B., Breadon E.L., McNair J., Hewinson G.R., Vordermeier H.M. 2010. Development of a skin test for bovine tuberculosis for differentiating infected from vaccinated animals. J. Clin. Micro. 48, 3716-3181.
 
(9) Vordermeier M., Gordon S.V., Hewinson R.G. 2011a. Mycobacterium bovis antigens for the differential diagnosis of vaccinated and infected cattle. Vet Microbiol 151(1-2):8-13.
 
(10) Vordermeier M., Jones G.J., Whelan A.O. 2011b. DIVA reagents for bovine tuberculosis vaccines in cattle. 2011b. Expert Rev Vaccines. 10(7):1083-91.
 
Sally
More comments from MR 8/2/12:
 
“....Once a licensed cattle vaccine and effective DIVA test are available, the basis for declaring herds tuberculosis-free will need to change. As part of the ongoing consultation on the new EU Animal Health Law, we will ..."
 
Why are they waiting - “we will” implies they have done nothing to date.
 
Defra says they will "be using the strong scientific and technical evidence on the efficacy and safety of the cattle vaccine" - “the strong evidence” - a term that indicates such evidence exists and is of a robust and substantial nature.
 
Why a 3 year delay between the vaccine and DIVA test being ready in 2012 and changes to legislation? Before the European Communities Act 1972 we could have in a matter of days changed legislation to allow vaccination and hence stop or reduce the seizure and slaughter of cattle/ Is Defra saying that as a result of EU membership we have to wait not days, not a time of our choosing but an uncertain time, a time exceeding three years?
 
"By the time we came to publish the TB Eradication Programme in July 2011 we were aware that a TB cattle licence could not be issued by the Veterinary Medicines Directorate until the ban on vaccination had been lifted…and we said this in the Eradication Programme. " What measure or authority stops licensing preceding legislation? Why was this not known before, and when the badger cull consultation was published? Even if a license cannot be issued until the ban is lifted, why can the licensing process not be otherwise completed and an announcement to that effect made?
 
"As I have explained above, we had already said in the consultation that deployment for use in the field could not be before 2015 at the earliest. When we came to publish the Eradication Programme it was clear that significant technical and regulatory challenges remained and this led us to conclude that the 2015 date should be dropped until matters had been clarified."
 
What were the
a) regulatory
b) technical
challenges
and why were they only now apparent?
 
It would appear from this response that Defra claim:
A vaccine and DIVA test cannot be licensed unless and until the ban is lifted.
The ban cannot be lifted until, from para 86 of http://www.defra.gov.uk/publications/files/pb13601-bovinetb-eradication-programme-110719.pdf
Vaccine is available i.e. licensing has occurred.
Which means nothing can ever happen.
 
Or arguably until information on efficacy is available, which Defra imply above (see “the strong evidence”) is now available This means the ban can be lifted NOW.
 
Lifting of the ban and licensing can be simultaneous, if the preparation for legislating is carried out simultaneously with preparation for licensing.
 
If matters are so confused and uncertain that no date can be deduced or estimated or even set as a target, a full disclosure of the problem needs to be made, inter alia so that interested and expert parties can propose solutions. If no one outside Defra understands the problem, only Defra can solve it, which is manifestly not happening.
 
"We still do not have a fixed date by which we expect cattle vaccine to be deployed in the field. However, the details underpinning these uncertainties as requested in your freedom of information request are withheld under exemptions 27 (international relations) and 35 (formulation of government policy) of the Freedom of Information Act".
 
This seems to extend the meaning of S 27 and 35. It is hard to see how it relates to formulation of Government policy when there is no question of formulating such policy - the Government has already declared the relevant policy specifically to “request” a specific change in EU legislation. The exemption therefore expires under S35 (2) a of the Act.
 
Alternatively there is an overriding public interest in disclosure as the information relates to a consultation (badger cull) which while now closed was conducted on false information.
 
Notwithstanding the above the full reasons for arguing that S27 and 35 apply must be advanced and appealed.
 
"You also asked what steps the government has taken to change EU law to allow vaccination in anticipation of licensing. In brief we are continuing with the work described in paragraphs 83-88 of the TB Eradication Programme for England see http://www.defra.gov.uk/publications/files/pb13601-bovinetb-eradication-programme-110719.pdf".
 
This states at 88 that the EU Commission WAS asked and sent the UK away until “sufficient evidence” is available. It does answer the question, by clearly implying that nothing further has been done by the Government.
 
If the EU institutions include a functioning legislature, as appears to be the case, then it must be possible to pass or amend legislation rapidly to meet emerging circumstances, exploit opportunities or deal with emergencies.
 
Why can the EU not be prevailed upon to graciously grant a derogation or by other means provide relief (vaccination) to hard pressed UK farmers suffering under a failed BTB policy?
 
Furthermore there is no adequate reason the EU cannot pass the required legislation and make it conditional on relevant licensing of vaccines and the DIVA test.
 
VMD must have a set of parameters for efficacy to be established - they are set before not after doing tests.
 
At 84 the same document states: The necessary regulatory studies are nearing completion and we intend to submit an application for a marketing authorisation for a BCG cattle vaccine later this year. While the Veterinary Medicines Directorate (VMD) will be able to confirm whether it is satisfied with the safety, quality and efficacy data provided, it will not be able to grant a marketing authorisation for the product while cattle TB vaccination is prohibited in EU legislation.
 
Sally
Email from MR with his comments on the content of the Defra response above.
 
My overall assessment is that the EU cares little about the problem and has said so to our well lunched diplomats, but it would upset the vested interests in government to admit that we are killing our cattle purely because the EU says we should. Then someone might discover BCG and the DIVA test could have been licensed years ago.
 
He has given the following comments re the Defra response above.
 
Re 3 in the posting above:
 
Quoted paragraph in 3, so, THE evidence. Tested already? May even be ready and waiting for a rubber stamp. Bu 2015 - this is scandalous. Parliament could change it overnight. But we have to REQUEST that our laws are changed.
 
Re 4 in the posting above:
 
So Defra did not understand the process when they published the badger cull consultation. Tell the Badger Trust - additional evidence for a judicial review. Causality is not needed to establish a failure of due process - only failure to follow the due process. How can technical difficulties be covered by 27 and 35?
 
Re 5 in the posting above:
 
Which says at 84 that 'Defra has invested around £18 million in the development of cattle vaccines and associated diagnostic tools. The necessary regulatory studies are nearing completion and we intend to submit an application for a marketing authorisation for a BCG cattle vaccine later this year. While the Veterinary Medicines Directorate (VMD) will be able to confirm whether it is satisfied with the safety, quality and efficacy data provided, it will not be able to grant a marketing authorisation for the product while cattle TB vaccination is prohibited in EU legislation.'
 
All the questions we asked DEFRA can then be applied to the VMD being satisfied etc (i.e what stage are they at and what problems if any exist etc etc.
 
Then follows a simple proposition - VMD must know what the parameters are for licencing. They test and establish they are met. They do not wait to set the parameters until after seeing the test results.
 
Why can the EU not apply the same process - agreement at least in principle that a licensed vaccine and DIVA test can be used but only when licensed? There is no impediment to a legislature passing legislation that says: “Thou shalt not do it UNLESS the following conditions are met.”
 
It is very common - typically you may not sell this that and the other, change the use of land, own a firearm, practise as doctor, say you are an architect etc etc unless you have a license or consent to do it. In many such cases a body, other than the state, sets the conditions - architects for instance. So simple to draft amendments to legislation allowing BCG/DIVA test to be used if and only if they are licensed at the time of use.

 
Sally
MG has also sent us this Freedom of Information response from Defra relating to cattle vaccine for Bovine TB (Ref: RFI4469). Please note paragraphs are numbered for ease of reference - see next posting.
 
1. Thank you for your request received on 4 January 2012 asking for documents relating to the way Defra describes the availability of cattle vaccine for bovine TB. As you know we have handled your request under the Freedom of Information Act 2000 (FOIA).
 
2. In the September 2010 consultation on badger control we said:
 
“Defra had invested £18 million by the end of the last financial year on the development of cattle vaccines and associated diagnostic tools. We aim to have a licensed cattle vaccine by 2012. This vaccine is BCG (Bacille Calmette-Guérin, the human TB vaccine) which sensitizes cattle to the mandatory tuberculin skin test for some time after vaccination and can lead to a positive result when an animal is not infected with M. bovis (a “false positive‟). Therefore Defra is also developing a diagnostic test to differentiate infected from vaccinated animals (known as a “DIVA‟ test) that could be used alongside the tuberculin skin test, where necessary, to confirm whether the animal is indeed infected. Our aim is also to have the DIVA test approved by 2012.
 
3. But we also made clear in paragraph 63 of the same documents that...
“....Once a licensed cattle vaccine and effective DIVA test are available, the basis for declaring herds tuberculosis-free will need to change. As part of the ongoing consultation on the new EU Animal Health Law, we will be using the strong scientific and technical evidence on the efficacy and safety of the cattle vaccine and the role of a DIVA test to request the necessary changes to EU legislation to lift the requirement for the skin test to be the only test to confer OTF herd status. Due to the need to change EU legislation, which is a lengthy process, we anticipate that a cattle vaccine and DIVA test could not be used in the field before 2015 at the earliest....
 
4. By the time we came to publish the TB Eradication Programme in July 2011 we were aware that a TB cattle licence could not be issued by the Veterinary Medicines Directorate until the ban on vaccination had been lifted…and we said this in the Eradication Programme. As I have explained above, we had already said in the consultation that deployment for use in the field could not be before 2015 at the earliest. When we came to publish the Eradication Programme it was clear that significant technical and regulatory challenges remained and this led us to conclude that the 2015 date should be dropped until matters had been clarified. We still do not have a fixed date by which we expect cattle vaccine to be deployed in the field. However, the details underpinning these uncertainties as requested in your freedom of information request are withheld under exemptions 27 (international relations) and 35 (formulation of government policy) of the Freedom of Information Act.
 
5. You also asked what steps the government has taken to change EU law to allow vaccination in anticipation of licensing. In brief we are continuing with the work described in paragraphs 83-88 of the TB Eradication Programme for England see http://www.defra.gov.uk/publications/files/pb13601-bovinetb-eradication-programme-110719.pdf
 
6. In keeping with the spirit and effect of the Freedom of Information Act 2000, all information is assumed to be releasable to the public unless exempt.
 
 
Yours sincerely
 
Defra TB Programme

 
Sally
We have been sent copies of correspondence between MG, his MP and the current Minister of State for Agriculture and Food (J Paice). He has given us permission to reproduce below.
 
Letter from MG to his MP:
 
During the English consultation on badger culling in September last year Defra stated that they “aim to have a licensed cattle vaccine by 2012” along with the accompanying ‘DIVA’ test capable of distinguishing infected from vaccinated cattle.
 
The vaccine is BCG which has been used on humans for decades and has been trialed in Ethiopia by a team including UK scientists.Martin Vordermeier and Glyn Hewinson from TB Research Group VLA and Doug Young from Imperial College(see attached report)
 
This year Defra are saying that they are “continuing to invest heavily in developing a cattle vaccine and an oral badger vaccine but both are still many years away and we simply can’t say with any certainty when they might be ready to deploy.”
 
This is hardly progress. From an estimate of two years there is now an indefinite delay.
 
There must be a reason for the delay and there must have been an announcement of the change with full reasons.
 
Can you please ask the Minister for a full explanation.
 
Can you also find out what steps the government has taken to change EU law to allow vaccination in anticipation of licensing.
 
Response from Paice, via MG's MP:
 
Thank you for your letter of 17 January on behalf of your constituent about bovine TB cattle vaccines.
 
Cattle vaccination can reduce the risk of infection and onward transmission, and, alongside other control measures, has the potential to make a significant contribution to the control and eventual eradication of bovine TB. Vaccination cannot guarantee that all cattle will be fully protected against TB and is therefore unlikely ever to be suitable for use as a sole eradication strategy.
 
Developing affordable and usable vaccines for cattle and badgers is our ultimate goal and the Secretary of State has announced that Defra will make available up to £250,000 a year over the next three years to support and encourage badger vaccination. An injectable badger vaccine is already available but there are practical difficulties with this, which means that it is not a realistic option for dealing with the problem in the short term. Developing an oral badger vaccine and a cattle vaccine remains a top priority for the Government, and Defra will be investing a further £20m in vaccines research and development over the next five years, but we cannot say with any certainty when these vaccines might be ready to deploy.
 
Additionally, cattle vaccines are currently prohibited by EU legislation as the lead candidates are based on BCG, which can interfere with the tuberculin skin test. Some vaccinated cattle could therefore react positively to tuberculin as if infected by TB, and herds could not be declared officially TB-free.
 
Government continues to invest in vaccine development and are working with the EU to lift the current ban on TB vaccination of cattle and allow the DIVA test to be used as a trade test.
 
We therefore anticipate that the deployment of a cattle TB vaccine is still several years away and we simply cannot say with any certainty when it might happen.
 
Full details of the package of measures announced on 14 December can be found on the Defra website at www.defra.gov.uk.
 
RT HON JIM PAICE MP
 
Further letter sent by MG to his MP:
 
Thank you for forwarding the letter from Jim Paice.
Unfortunately he has not answered either of my questions.
I repeat:
 
What is the reasons for the change from “aim to have a licensed cattle vaccine by 2012 to “continuing to invest heavily in developing a cattle vaccine and an oral badger vaccine but both are still many years away and we simply can’t say with any certainty when they might be ready to deploy
 
and
 
What steps have the government taken to change EU law to allow vaccination in anticipation of licensing.
 
Would you please ask the Minister for direct answers to both these questions.

 
Sally
http://www.gloucestershirewildlifetrust.co.uk/what-we-do/bovine-tb/science/vaccine-cattle
 
It would seem that the Glos WT has achieved/divulged more in the last few weeks re cattle vaccine than any other body. Here is their latest update - well worth reading. It reveals that a cattle vaccination should be imminent. The stumbling block --- the EU.
 
Gordon McGlone CEO of Glos Wildlife Trust has got back from his Brussels trip discussing vaccination. On the BFF twitter he said: "Good vist yesterday to Brussels to discuss #bTb #cattle #vaccine with EC officials and MEP Mairead McGuiness; why? bit.ly/s9HPKS".
 
becky
The Archers, the popular farming soap on Radio 4, is promoting badger vaccination. The local farmers recently voted to embark on a vaccination programme for their badgers. They apparently took advice from the Gloucestershire Wildlife Report on Vaccine Deploymet Programme (see www.gloucestershirewildlifetrust.co.uk/sites/wt-main.live.drupal.precedenthost.co.uk/files/GWT-Badger-Vaccination-Deployment- Programme-2011.pdf).
 
becky
Research carried out by the Countryside and Community Research Institute (CCRI) and Cardiff University reveals that 48% of farmers thinkt vaccination is a good thing. 341 farmers were surveyed during the autumn of 2010 in five areas of England (in Devon, Gloucestershire and Cheshire), including the Gloucestershire area of the Badger Vaccine Deployment Project (BVDP). Whilst 48% thought that vaccination was a good thing to do, only a quarter believed it would help prevent the spread of bTB.
 
"Less than a quarter of farmers thought Defra could manage vaccination competently, while a third thought that the Government’s scientific case for badger vaccination lacked credibility.
 
The vast majority (89%) believed that it was not their responsibility to pay for vaccination.
 
Interestingly 52%) of those suveyed did not think the Government were doing a good job in relation to bTB policy.
 
Most farmers were pessimistic about their ability to do anything to avoid bTB restrictions - 79%t said that it was simply a ‘matter of luck’ if their cattle became infected."
 
becky
We are told that the information about the new test mentioned in the post above came from http://www.gloucestershirewildlifetrust.co.uk/what-we-do/bovine-tb/science/vaccine-cattle and has apparently been checked with Weybridge before they wrote it.
 
becky
Interesting comments from Phil Hoskins, President of Small Farms Association at http://www.thisisnorthdevon.co.uk/pilot-badger-cull-trials-really-worth-effort/story-14456527-detail/story.html
 
Of great interest is this extract from article; 'I have been following the development of the test to differentiate infected from vaccinated cattle. Evidence to support international validation of the test will be submitted to the international animal health standards organisation in the summer. This is an independent certification that should be acceptable as evidence of the efficacy of the test. Surely now we should be asking that the EU amends the relevant directives and regulations to enable the development and use of a TB vaccine in cattle?'
 
We agree!
 
becky
Blog post at Rethinkbtb (http://www.rethinkbtb.org/blog.html#home)
 
So far all Stephen Crabb has managed to extract from Jim Paice (see "Vanishing Vaccine” below) is confirmation of all sorts of things that everyone knew already, such as “research takes time” and “changes will be required to EU legislation”.
 
The questions remain:
 
Defra stated in 2010 that they aimed to have a cattle vaccine licensed by 2012.
 
Why and on what evidence was this statement issued?
 
What has changed since?
 
Why is no estimated or target date available?
 
We do have an assurance from Stephen Crabb (but not from the Minister) that “my colleagues will take all necessary steps to ensure that the vaccinations can be deployed as soon as they are available”. That is reassuring but hardly a full answer to the final question:
 
Will steps to amend EU law (which prohibits cattle vaccination against TB) be taken when a cattle vaccine is licensed, or are they being taken now in anticipation of licensing?
 
There is a certain skill to answering questions in a helpful manner. Greater skill is needed to avoid answering while leaving your interrogator convinced you have answered. Jim Paice has exhibited neither.
 
Farmers and taxpayers deserve complete and open answers. We will now try the Freedom of Information Act.
 
becky
Email from BH dated 5/1/12
 
Mr Paice revealed that cattle vaccine for TB could be in laboratories in “a year or two”.
 
Then it would be a question of negotiating with the EU Commission to get beef from vaccinated cattle accepted in European law, which would not be easy because only the UK and the Irish Republic would want the concession.
 
“Realistically we think a cattle vaccine is still six years away,” he said.
 
http://www.thisisdevon.co.uk/Badger-cull-trial-details-t-stay-secret-Minister/story-14333149-detail/story.html
 

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