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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
Dave Purser owns a 48ha pasture farm in Glos. He comes from a local farming family and has kept his own cattle since the 1980′s in a TB ‘hot-spot’. The business has included a commercial beef and calf rearing unit but the herd has never been under TB2 restrictions. Here he gives his views on the bovine TB problems.
 
I've kept cattle in a Gloucestershire 'TB hot-spot' since the 80's so I'm no stranger to the rigmarole of annual bTB testing. But the dread I feel at testing time comes from the threat posed by Defra's 'test and cull' policy rather than concern about the disease itself.
 
In every other instance where disease threatens our cattle, we have vaccination in our armoury. We know that vaccines reduce the incidence of disease in our cattle and this gives us scope to use our own skills to manage the health and welfare of our herds to suit our particular circumstances.
 
We are only denied this essential approach with bTB because of an outdated EU directive governing export which insists on 'accelarated eradication' of the disease and simultaneously bans the use of cattle vaccine, which predictably leads to carnage in all directions.
 
We are a well informed society, especially since the advent of the internet, so even the casual observer can see that the answer to this issue is to challenge the EU and get the rules changed to allow cattle vaccine - hence the huge and justifiable public outcry in opposition to a massacre of our badgers.
 
It's not good enough these days for those in favour of the cull to use sensational headlines and hope the public will simply accept what they read.
 
"26000 cattle were slaughtered in 2011 for TB control" - yes, but Defra's own figures tell you that there were 5.4million cattle in England in 2011*. This is a loss of less than half a percent of the national herd which is easily outnumbered by those cattle routinely slaughtered every year because of ailments such as lameness, mastitis etc.
 
"11.5% of herds were restricted in 2011" - yes, in other words, 88.5% of herds were NOT restricted in 2011 demonstrating that only a small proportion of herds are affected by bTB.
 
And restricted herds can carry on trading despite TB restrictions, as described in detail on the website of the TB Farm Advisory Service at http://www.southwest-tbadvice.co.uk/ which includes case studies showing the many options available.
 
So facts, figures and science show that bTB is not "the main threat to the cattle industry" but is actually a problem for a minority of herds, mostly in the West country. Cases of bTB have not risen dramatically, there is no epidemic, there is nothing different about 2012 to explain any hysteria so there is simply no justification for the rush to shoot badgers now.
 
The NFU, NBA and other farming bodies should avoid a PR disaster by abandoning the badger cull and start putting their weight behind forming an accreditation scheme under which UK farmers can be given the option of vaccinating their cattle and each animal's passport can be stamped to show that they are then excluded from export.
 
Members of the scheme could be exempted from the 'test and cull' policy which would give the pedigree and dairy herds an opportunity to avoid the needless slaughter of their breeding stock and protect their gene pools by using vaccination and accreditation instead.
 
The scheme wouldn't have to include all counties because we can't expect farmers in the two, three and four year testing areas, who form the the vast majority of herds in the country, to share the burden with those of us in the 'hot-spots'.
 
But before the doom merchants say it can't be done, let's remember that this approach isn't new. It's exactly how we eradicated brucellosis, another infectious cattle disease, some twenty odd years ago**. Aren't we meant to get wiser with age?
 
 * for cattle numbers in England in 2011 see http://www.defra.gov.uk/statistics/files/defra-stats-foodfarm-landuselivestock-june-statsrelease-englandcropslivestocklabour-111... , page 2.
 
** for Brucellosis see Defra publication: "Options for vaccinating cattle against bovine tuberculosis", Annex 1- 'Examples of vaccination policies for other diseases, Brucellosis Vaccination' http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb/documents/vaccine_cattle.pdf
 
becky
As the badger culling start date looms the media have carried many reports, mainly about the massive public opposition to the proposed shooting and evident strength of feeling among those who are opposed to the policy. Of course many of us believe that the best way forward is cattle vaccination.
 
Ardent opposer of the cull, Brian May, is currently in Brussels to campaign for cattle vaccinations as a humane alternative to the slaughter. He is campaigning hard for a change in the law to allow the use of the BCG vaccination, due to be licensed soon for cattle. He is joined by Gavin Grant, RSPCA Chief Executive. Brian established Teambadger which brings together all the leading UK animal charities opposing the cull.
Brian and Gavin are meeting a range of European officials and parliamentarians, including figures from the European Environment and Agriculture directorates general. Brian May said: “What is absolutely clear from the available scientific evidence is that vaccination of cattle and badgers, along with bio-security and movement controls in the farming industry, is the only way to make meaningful progress.”
 
In the meantime prominent scientists question the cull. Lord John Krebs at the University of Oxford (he headed the team that carried out the original trials), calls the cull 'crazy' and says: "The pilot cull is flawed because it aims to remove 70% of badgers without an accurate estimate of the starting number". He has accused ministers of 'cherry picking' from his results to justify the programme. "I'm certainly not impressed with the current policy," he said.
 
Christl Donnelly, an epidemiologist at Imperial College London, who was also a member of the team that performed the original trials has reservations too; 'Is it worth culling so many animals for 16% fewer infected herds? There, you get very different answers depending who you ask.'
 
Responding, Farm Minister, David Heath said it was a 'little disrespectful' of those scientists who followed up previous trials to 'simply say that their work is not effective'. A pretty pathetic response.
 
Many campaigners apparently suspect the reasons for the culls going ahead as being partly due a caving in by the Coalition government to blood-sport enthusiasts - who like nothing more than running around at night shooting helpless wild animals. We should remember that badgers were tormented for generations in England by blood sports enthusiasts until the Cruelty to Animals Act 1835 made badger baiting illegal. UK animal welfare charities report a resurgence of this illegal barbaric practice in recent years, along with an increase of animal cruelty in general.
 
Information from:
 
www.newscientist.com/article/dn22375-uk-badger-cull-tentatively-supported-by-science.html
www.telegraph. co.uk/earth/earthnews/9603758/Cull-of-little-black-and-white-creatures-not-political-minister-claims.html
http://news.uk.msn.com/badger-cull-will-hit-bovine-tb-1
www.xperedon.com/news_1795
 
Sally
In an interview in the Independent today ( www.independent.co.uk/environment/nature/vital-cull-or-heartless-slaughter-the-great-badger-debate-8202970.html) between NFU leader, Peter Kendall, and Chris Packham, Chris had the last word - and it made good sense.
 
Dear Peter,
I am a pragmatist and realist. I couldn't say that I'm not motivated emotionally by this issue but for me, and many others, the science, the economics and the support of a sustainable future for British farmers comes first. We just don't want to slaughter wildlife if it serves no purpose.
Vaccination is the way to go. There are both oral and injectable badger vaccines but applying these over large areas will always be both difficult and expensive. Badgers are shy, nocturnal and live underground, they are thus inaccessible. Cattle are not. Ear-tagged, monitored and manageable – they could be easily vaccinated so why aren't they, when a vaccine is available? Well, although cattle are regularly vaccinated for other diseases, there is an EU ban on TB vaccines. This is because the bovine BCG vaccine interferes with the mandatory tuberculin skin test. Cattle that had been vaccinated would technically fail the test, meaning they couldn't be declared TB free and that farmers couldn't sell them overseas. We urgently need a modified cattle vaccine and then the guts to get the EU ban lifted – both difficult objectives. So instead let's blame it on the badgers and kill a few – much easier.
Our government's most respected scientific advisors have been queuing up to point out the fallacy of this cull... Lord Krebs has said that it is "crazy" and that vaccination and biosecurity are central to controlling TB. Professor Sir Robert Watson has said that "culling won't solve the problem". But I think it's appropriate that Professor John Bourne, chair of the ISG, have the last word. He has said: "I think the most interesting observation was made to me by a senior politician who said, 'Fine John, we accept your science, but we have to offer the farmers a carrot. And the only carrot we can possibly give them is culling badgers'."
Q. How could a badger possibly be a carrot? A. When it's a scapegoat.
Chris
 
becky
A meeting at a Chedworth farm on 29/08/12 gave rise to the letter below which was sent to media contacts in September.
 
Bovine TB and Cattle Vaccination
 
While vaccination is the response to most infectious diseases, with cattle and Bovine TB it is the one weapon in the disease management armoury which has yet to be deployed.
 
A vaccine against Bovine TB for cattle (along with the associated DIVA test which differentiates between infected and vaccinated animals) has been developed and is ready to licence, but is held up by regulatory and European legal obstacles. Meanwhile farmers are being misled into believing that cattle vaccination is many years away.
Following a meeting of interested organisations and individuals the following Declaration has been put to Owen Patterson the new DEFRA Minister:
 
"Now that a cattle vaccine is ready for licensing, we are convinced that the only way to control bovine TB and hence avoid the devastating and costly current Bovine TB policy is to vaccinate all bovine animals and where necessary wildlife.
 
We therefore call on the Government to take immediate action to eliminate all legal and political obstacles preventing farmers from vaccinating their cattle against Bovine TB.
 
We represent a cross section of scientists, veterinarians, farmers and conservationists concerned about the impact of bovine TB on the farming industry and countryside."
 
We await his response with interest.
 
Yours faithfully
 
Nigel Finch, farmer, Gloucestershire
Kate McNeil, farmer, Yorkshire
Jean and Keith Morgan, farmers, Carmarthenshire
Steve Jones, farmer, stockman and lecturer on ethical farming, Glos
Peter Pennington Legh, farmer, Wiltshire
Cliff and Maureen Carnell Farmers, Carmarthenshire
Chris and Mary Wheeler Farmers, Pembrokeshire
Rebecca Hosking Farms for the Future
Dr Mark Jones, vet and Executive Director of Humane Society International
Brian Davies, Founder, Network for Animals
Sally Hall, Bovinetb.co.uk campainging for the right to vaccinate cattle
Lorraine Platt, Founder, Blue Badger
Dr. Chris Cheeseman, Ecologist
Dr. Gordon McGlone, Chief Executive, Gloucestershire Wildlife Trust
Celia Thomas, Farmer and Chair of Pembrokeshire Against the Cull
Jeff Hayden, Finance Director for the Badger Trust
Michael Ritchie, Rethink Bovine TB
Lucy Borde, Brock Vaccination
Chris Skinner, Norfolk farmer, conservationist and broadcaster
Carole Youngs, Smallholder Series
Wenda Shehata, cattle owners, East Sussex
Jean and Keith Morgan, farmers, Carmarthenshire

 
becky
I wonder how this story can be justified? It is clear from all the farmers who have contacted us that they are very supportive of a cattle vaccine and would like to see vaccination introduced as soon as possible. One wonders who is really behind the procrastination?
 
 
www.thisissomerset.co.uk/Farmers-question-reliability-vaccine-curb-bovine/story- 17055860-detail/story.html
 
'Farmers question reliability of vaccine to curb bovine TB ahead of badger cull. Farmers have dismissed claims that a vaccine against bovine TB could be rolled out within months, negating any need to cull badgers to stop the disease.'

 
Sally
RETHINK BTB CATTLE VACCINATION LATEST:
Email (via MG) from Defra re. Cattle Vaccination and DIVA test.
"As things currently stand the UK would need a derogation to undertake field trials in England or any field studies would need to be carried out in non-EU countries."
 
If the Government had the political will it could seek a derogation and start Cattle Vaccination trails next year.
 
Full email from DEFRA 31 July 2012.
 
Dear
Thank you for your email.
 
The studies described to generate validation data from AHVLA’s prototype DIVA test in BCG-vaccinated experimentally-challenged cattle were completed and analysed by Easter 2012.
 
The OIE was asked to evaluate the test but because there were no data from the field (since TB vaccination of cattle in the field is prohibited by EU law) but rather (by necessity) the test performance had been evaluated in a limited number of experimentally vaccinated cattle they could not accept this validation. We have subsequently put the dossier to experts at a number of international reference laboratories seeking their views on our results and our approach to validation and are awaiting their advice. This will be used to inform what other experimental and field studies would be needed for the OIE to accept validation of the test.
As things currently stand the UK would need a derogation to undertake field trials in England or any field studies would need to be carried out in non-EU countries.
 
The latter would not be ideal for validation of the DIVA test since ordinarily these studies would be carried out under the field and environmental conditions of the intended country of use.
 
I hope this answers your questions.
 
Regards,
 
Defra TB Programme
 
Sally
Could DEFRA be pushing harder?
 
Michael Ritchie, spokesman, Rethink Bovine TB writes:
 
"The only significant obstacle to a cattle TB vaccine is EU law, which forbids vaccination against BTB because it may interfere with the (woefully inaccurate) skin test. For this reason DEFRA has developed a test able to differentiate between vaccinated and infected cattle, the DIVA test.
 
"In 2010 DEFRA stated that it aimed to have BCG and the DIVA test licensed by 2012 but that "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".
 
"It is now 2012 and both BCG and the DIVA test are ready to licence, but DEFRA is vaguely stating that use is "many years away". Why the change from 2015? It is because DEFRA is hoping that proposed new EU animal health legislation will allow vaccination.
 
"It is not clear what steps, if any, DEFRA has taken to change the law or get a derogation during the years it has been developing the vaccine. It is equally perplexing that DEFRA is just hoping that a major redraft of EU law will provide the solution, rather than demanding that existing law is changed and changed urgently to allow cattle farmers to protect their stock.
 
"Earlier this year DEFRA asked the World Organisation for Animal Health (OIE) to licence the DIVA test. DEFRA was caught unawares when the OIE demanded UK field trials, trials that DEFRA claims it cannot do because use of the vaccine in the UK is illegal.
 
"There the matter is stuck - the vaccine is ready to licence but illegal to use. The DIVA test removes the reason vaccination is illegal, making the law pointless. But the DIVA test cannot be licensed until the vaccine is legal.
 
"What is now needed is nothing more than a strong DEFRA minister who will put an end to this farce and order officials to find solutions - not create more bureaucratic muddles - so as to deploy cattle vaccination without delay."
 
becky
The following are extracts are from an email from a farmer (SC) who makes some very interesting and relevant comments
 
The Farmers Weekly article said 'that the BCG vaccine was tested in Ethiopia where all the cattle had BTb. It still was 60% efficient in protecting against infection. This raises two questions.......why on earth haven't we made a vaccine for Ethiopian Farmers and their cattle instead of giving aid to despotic rulers.......and what would the efficacy be in herds where the infection rate is more like 5-10%?
 
I don't think that vets are against vaccination, especially if they were entrusted to do it. I am assuming that the 4 year testing areas are much bigger than the intensive testing areas and that most progressive practises see their future in working with farmers to promote herd health under the various herd health initiatives........mine is Herdsure backed by DEFRA.
 
Also the great plan for DEFRA vets to take testing back in house only lasted a few months, as it proved to be hard, dirty and dangerous work!! All cattle have passports, so it is easy to record the vaccination.
 
Since I wrote, I have heard of two farms that have had BTb diagnosed in the abattoir despite having clear skin tests. One farm never having a reactor before.
 
Another friend has lost nearly half his herd this year and this is not attributable to badgers.
 
In the Foot and Mouth crisis, a vaccination zone around an outbreak was proposed, with the furthest areas being done first, then working to the centre. I would cynically say that we had a practise vaccination exercise with the blue tongue "crisis", which seemed to work ok.
 
Both F&M and bluetongue show how poor DEFRA are at calculating the risk of diseases, even in these modern times. So if it is so essential to have a pilot cull, it is equally essential to have a pilot vaccination area?
 
None of my cattle that were incubating Johnes ever reacted to the skin test, although you can get false positives to Johnes if you take bloods at the same time as BTb testing. It is best to double check the diagnosis with a dung sample.I am recording all my TB tests now and so could look back at an animal's bumps history eventually. The one bull came from a 4 year testing area.
 
I did find the bovinetb and rethinktb web sites some time ago, and I have shared them as they have helped shape my thinking.
 
I find farmers in 4 year testing areas are just thankful that they don't have a problem whilst those in hot spots are desperate for any solution.
 
So I will see how high up the NFU I can get to speak about vaccination and also plant some acorns in the various organisations I belong to.
 
As I have a closed herd of Pedigree cattle, I have been researching import/export of genetics and also undertaking a programme to make my herd more healthy. I am thwarted buying semen from most of the world because the bulls were vaccinated against BVD and IBR and thus show up as having the disease. I can't easily buy bulls from Britain that haven't been vaccinated for the above, due to the rules governing the health of my herd! So if you are a UK breeder, you have to compromise the health of your herd by omitting IBR and BVD vaccinations, in the hope that you may get a sale to Europe. This could be driven by vanity! The only way I can get around this impasse is to use embryos which then cause problems with organic rules!!
 
So I see absolutely no reason why vaccination of cattle for BTb should not be a personal decision for individual farmers.... thus allowing for healthier herds and less sleepless nights at testing time!
 
Those that choose not to vaccinate run the risk of having cattle slaughtered and no compensation, but I'm sure most in hot spots would vaccinate. If I find an animal with say Johnes in my herd health programme, I have to slaughter it without compensation.
I'm sure potential importers from Europe would avoid buying from hotspots anyway.
 
And if the worst came to the worst, it is pretty easy and relatively cheap to export embyos.
 
No Brainer what!!??
 
What is clear is that the higher echelons of the NFU and Defra maintain rules that are decades behind reality!
 
becky
 
becky
McGill I, Menache A, Knight A, Allen C, Hill S & Eastwood B.
Simultaneous vaccination ‘best way’ to tackle bTB. Letter to Vet Times [UK]
2012; 42(38): 35.
 
 
Dear Editor,
 
We are all veterinary surgeons - either clinicians or scientists - and are dismayed that there is a very real prospect that this government will pursue a cull of badgers.
 
The report of DEFRA’s own Independent Scientific Group (ISG)1 which was set up to look at the issue, states in the conclusions of its £50 million research project: "Careful evaluation of our own and others' data indicates that badger culling can make no meaningful contribution to cattle TB control in Britain."
 
Despite this weighty opinion to the contrary, the Coalition has chosen to cherry pick data that supports the need to cull badgers - a policy that, in our opinion, is flawed on many levels.
 
The cull would cause untold suffering to the unfortunate badgers targeted in this massacre, and would result in additional suffering due to resultant ecosystem imbalances. Bovine TB reduction is likely to be very small at best, and in some areas may actually increase1. Attempting to remove the major carnivore from a local ecosystem by shooting, not only encourages badger movements into neighbouring areas and then back again1, it would also disturb the population numbers and increase
movement of other species such as foxes, deer, rats, voles, mice and birds, which potentially also carry TB2,3 thus furthering its spread.
 
We do have to question as to whether a thorough Disease Risk Analysis has been properly carried out on shooting large numbers of potentially TB infected animals in the same vicinity. Far from removing the threat of TB, it is entirely possible that the contamination of the land with TB bacteria will simply further its spread into other wildlife, and ultimately, dairy cows.
 
We are dismayed that the heads of veterinary organisations such as the BVA and BCVA have made statements supportive of the cull, and feel that this gives a misleading impression as to the views of the veterinary profession as a whole. The veterinary profession is almost entirely composed of individuals who care a great deal about animal welfare, and who, in general, respect wild animals and their right to live
wherever possible unabused by humans.
 
Solving the problem of TB in the UK will require study of the mode of transmission to naturally infected cows. In particular the genetics of resistance to TB in the dairy herd needs to be further elucidated. Breeding preferentially for milk yield via artificial insemination (AI) has undoubtedly had some adverse impacts on the genotype of the
cow in other respects4,5,6, as natural selection is no longer operant. The susceptibility of most of the dairy herd to BSE, for example, was largely due to the paucity of genetic variation in the PrP gene, which controls susceptibility to BSE7,8. Indeed, evidence suggests that the BSE agent actually arose de novo from mutated PrP genes in the dairy herd9. When this BSE agent was delivered into the food supply by the recycling of cattle offal back into cattle food, the catastrophic results were all too
predictable - for cows, for farmers, for consumers, and for the UK. Have we learned nothing from that debacle?
 
Infectious agents and their hosts tend to adapt or co-evolve together such that a balance is formed between infection, immunity and survival, and this is demonstrably true for TB10,11. In badgers, this balance with TB has happened across millennia. Dairy cows stopped co-evolving with TB more than 50 years ago, due to AI. The only thing dairy cows have co-evolved with, is human will, industrial economic policy - and money.
 
We need to start implementing the outbreeding of dairy cows to introduce some heterozygosity, or hybrid vigour, back into these unfortunate creatures, before they become the ticking bio time bomb that intensification, and a breeding programme based on AI, could result in.
 
It is a disgrace that the veterinary profession would even consider a cull of badgers when there are alternative strategies for the long term, such as vaccination, which haven't been tried on any large scale. This, rather than slaughter, is the preferred method for the control of TB in humans. Perish the thought that the medical profession would choose to follow the same medieval control methods as the veterinary profession. Both cattle and badgers should be vaccinated, in our view, to give such a trial the best chance of success. The ISG recommended that a vaccine for
cattle should be a priority1.
 
For the long term, putting a sticking plaster over one running sore, when there are metaphorical sores breaking out all over the dairy industry, will not, in our view, resolve the problem. The problems need to be tackled at their fundamental root - and that is the way that the dairy industry has evolved during the past 60 years. Since the 1950s, AI has been used to selectively breed mutant cows which produce large quantities of milk, but which evidently have little resistance to diseases such as TB and BSE. The fact that any herds with cattle showing detectable immunity to TB (TB
reactors) are summarily slaughtered, further increases the immunological naivety of the herd.
 
 
The economic pressures brought to bear have recently brought the value of milk down below the cost of production, further pressuring farmers and cows, and compounding the problem. Intervention by the Government to protect small-scale milk producers financially, would alleviate many welfare issues in cattle brought on by sheer poverty - of both small farmers and cattle. TB is often a disease of poverty, in humans as well
as animals, and many of our dairy cattle live in poverty equivalent to that of a workhouse during the industrial revolution. Most importantly, there is poverty in the lack of any normal relationships around breeding and calf rearing. The only long-term solution is a paradigm shift in favour of cattle welfare, small farmers and wildlife - not mega-dairies and money. We need to start looking, right now, at the economic and genetic background to the dairy industry, and fix it, before it's too late.
 
We support the long term restructuring and de-intensification of the dairy industry to better support the health and welfare of cattle, as well as that of small farmers and consumers. This would go some way to help to ensure a more natural, less pressured life for the dairy cow.
 
 
We wish to register a view that we believe represents the majority of our profession. We the undersigned do not support a badger cull. The widespread shooting of a protected indigenous species like the badger would be brutal, misguided, foolish, disgraceful, expensive and potentially counter-productive.
 
We believe that a simultaneous vaccination programme, for both cattle and badgers, would be the best solution to protect animal and human health.
 
Yours faithfully,
 
Iain McGill BSc(Hons), BVetMed, MRCVS
Andre Menache BSc(Hons), BVSc, MRCVS
Andrew Knight BSc(Vet Biol), BVMS, CertAW, DipECAWBM(WSEL), PhD,
MRCVS, FOCAE
Caroline Allen MA, VetMB, CertSAM, MRCVS
Sophie Hill BA(Open), MA (Cantab), VetMB, PGCE, MRCVS
Bronwen Eastwood BSc(Hons), BVetMed, MRCVS
 
 
 
References
 
1. DEFRA. Bovine TB: The Scientific Evidence. Final Report of the Independent
Scientific Group on Cattle TB. June 2007.
 
2. Hardstaff JL, Bulling MT, Marion G, Hutchings MR, White PC. Impact of external
sources of infection on the dynamics of bovine tuberculosis in modelled badger
populations. BMC Vet Res 2012 Jun 27;8(1):92.
 
3.Chambers MA. Review of the diagnosis and study of tuberculosis in non-bovine
wildlife species using immunological methods. Transbound Emerg Dis 2009
Aug;56(6-7):215-27.
 
4. Stachowicz K, Sargolzaei M, Miglior F, Schenkel FS. Rates of inbreeding and
genetic diversity in Canadian Holstein and Jersey cattle. J Dairy Sci 2011
Oct;94(10):5160-75.
 
5. Hinrichs D, Thaller G. Pedigree analysis and inbreeding effects on calving traits in
large dairy herds in Germany. J Dairy Sci 2011 Sep;94(9):4726-33.
 
6. Nino-Soto MI, Heriazón A, Quinton M, Miglior F, Thompson K, Mallard BA.
Differential gene expression of high and low immune responder Canadian Holstein
dairy cows. Dev Biol 2008;132:315-20.
7. Goldmann W, Hunter N, Martin KN, Dawson M and Hope J. Different forms of the
bovine PrP gene have five or six copies of a short, G-C-rich element within the
protein-coding exon. J General Virology 1991; 72: 201-204.
 
8. Juling K, Schwarzenbacher H, Williams JL, Fries R. A major genetic component of
BSE susceptibility. BMC Biol 2006 Oct 2;4:33.
9. Nicholson EM, Brunelle BW, Richt JA, Kehrli ME, Greenlee JJ. Identification of a
Heritable Polymorphism in Bovine PRNP Associated with Genetic Transmissible
Spongiform Encephalopathy: Evidence of Heritable BSE. PLoS ONE 2008; 3(8):
e2912.
 
10. Dorhoi A, Reece ST, Kaufmann SH. For better or for worse: the immune response
against Mycobacterium tuberculosis balances pathology and protection. Immunol Rev
2011 Mar;240(1):235-51.
 
11. Gagneux S. Host-pathogen coevolution in human tuberculosis. Philos Trans R Soc
Lond B Biol Sci 2012 Mar 19;367(1590):850-9.
 
Sally
Farmers Weekly have done an in-depth article (http://www.fwi.co.uk/Articles/03/10/2012/135507/EU-laws-stifle-progress-on-cattle-vaccination.htm) about cattle vaccination. The main article makes rather depressing reading. I think it clearly reveals the influences of vested interest groups (scientists and vets) - again a sledgehammer to crack a nut approach. This is where change is needed. There needs to be an assessment of the true risks of bovine TB - vaccination alone should suffice. One does wonder how £20 a dose for the BCG can be justified?
 
At the end of the article the following comments from Michael Ritchie of Rethink bTB clearly revel where the real problems lie.
 
"The only significant obstacle to a cattle TB vaccine is EU law, which forbids vaccination against BTB because it may interfere with the (woefully inaccurate) skin test. For this reason DEFRA has developed a test able to differentiate between vaccinated and infected cattle, the DIVA test.
 
"In 2010 DEFRA stated that it aimed to have BCG and the DIVA test licensed by 2012 but that "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".
 
"It is now 2012 and both BCG and the DIVA test are ready to licence, but DEFRA is vaguely stating that use is "many years away". Why the change from 2015? It is because DEFRA is hoping that proposed new EU animal health legislation will allow vaccination.
 
"It is not clear what steps, if any, DEFRA has taken to change the law or get a derogation during the years it has been developing the vaccine. It is equally perplexing that DEFRA is just hoping that a major redraft of EU law will provide the solution, rather than demanding that existing law is changed and changed urgently to allow cattle farmers to protect their stock.
 
"Earlier this year DEFRA asked the World Organisation for Animal Health (OIE) to licence the DIVA test. DEFRA was caught unawares when the OIE demanded UK field trials, trials that DEFRA claims it cannot do because use of the vaccine in the UK is illegal.
 
"There the matter is stuck - the vaccine is ready to licence but illegal to use. The DIVA test removes the reason vaccination is illegal, making the law pointless. But the DIVA test cannot be licensed until the vaccine is legal.
 
"What is now needed is nothing more than a strong DEFRA minister who will put an end to this farce and order officials to find solutions - not create more bureaucratic muddles - so as to deploy cattle vaccination without delay."
 
lewistresinwen
The new farming minister,David Heath,was recently
quoted as saying,"there is no cattle vaccine in the pipeline either,because among other reasons,it would require a test to distinguish between vaccinated and infected cattle (and significant changes to EU legislation)".
Never heard of the DIVA test then!To be fair,he hasnt been
in the job long,give him time.

 
becky
Vice-president of the National Farmers Union, Adam Quinney and cattle farmer near Stratford on Avon has suffered from bTB breakdowns on his farm. Le lost 18 of his 70 cattle a year ago. In an article in the Guardian (www.guardian.co.uk/environment/2012/sep/30/badger-cull-bovine-tb-farmers?newsfeed=true) he blames the lack of an organised plan to tackle bovine TB is what the majority of farmers are fed up with. Interestingly he says:
 
"We need a complete programme, not a pick and mix. Farmers were promised a vaccine. Each year for 20 years we have been told there is a vaccine just a few years away and have been sold a pup. We shouldn't have got to this point. Bovine TB is hardly a new disease."
 
So why is the NFU not pushing harder for a cattle vaccination - held up only because of EU bureaucracy ...?
 
Sally
Interesting comments David and I agree with many of them. Have you seen the paper by the Torgerson 'Public Health and Bovine TB, what's all the fuss about?'. It can be read at http://www.zora.uzh.ch/47412/
 
You mention Johnnes disease, also caused by Mycobacteria and VERY widespread in UK cattle herds. It can also affect the result of the skin test. We do discuss this on this website - see the thread at http://www.bovinetb.co.uk/forum_topic.php?thread_id=54
 
David_J_Slater
Do Ruth and Sally realise that the BCG vaccine for humans is a live vaccine of Bovine Tuberculosis (M. bovis)?
http://en.wikipedia.org/wiki/Bacillus_Calmette%E2%80%93Gu%C3%A9rin
 
Is this why humans don't succumb to TB from cattle? Are we vaccinated against it - and are we the carriers and spreaders?
 
Well, I agree with Ruth. The BCG vaccine for humans has no proof of effectiveness - it is likely to be hygiene improvements and lowered stress factors in western living http://www.whale.to/m/gunn.html
 
The human BCG vaccine has never been used in the USA and the declining rate of deaths and incidences of TB is exactly the same for countries who do use the BCG (Canada and UK for example).
 
The whole area of vaccine efficiency is flawed and largely promoted by the vaccine companies themselves.
 
Furthermore, dairy cows may not pose a risk to humans with regard to TB, but they do in so many other ways. So much so that dairy farming is now a toxic industry that desperately needs cleaning up.
 
Cows carry Johnes Disease - Mycobacterium avium para-TUBERCULOSIS. http://www.johnes.org/general/faqs.html This is never mentioned in any website I have read regarding this issue, yet this bacterium gives cows an IBS. It is passed into humans via milk and meat, and is almost certainly responsible for human IBS and other digestive disorders including TB of the gut. Crohn's Disease is prominent in this connection.
 
In the wake of Mad Cow Disease then Foot and Mouth, it is high time the dairy herd was culled. The first disease still exists, although the second one was an invention to help cull the cows with BSE. It didn't work, as the cure was simply to kill cows at 30 months old - or before the symptoms of BSE become observable. CJD was rediagnosed as various other neurological disorders in humans such as dementia (in the same way disease diagnoses like polio, meningitis, and AIDS were changed to give the impression that vaccines and drugs work). BSE did not go away and cows are still truly toxic.
 
The ONLY way to clean it up is by widespread culling of the dairy herd. In areas of the world who are defined as TB free (ie 99%) they will cull entire herds with positive reactors. But of course, how can we trust a test that is based upon an antibody theory of infection that is laughable at best http://www.whale.to/vaccines/antibody.html
 
So we should as a society stop blaming wildlife for the spread of TB but firmly put the blame on humans. Firstly we need to reduce stress and biosecurity in dairy herds. Second we need to cull all herds with any sign of TB. Thirdly we need to stop giving the BCG vaccine to humans. Fourthly, we need to get out of the EU.

 
Farmer
According to today's Independent Lord Krebs, says the plan to cull badgers is 'crazy'. How odd because the Government's culling plans are allegedly based on the Krebs' report! He has said that the Department of Environment, Food and Rural Affairs' plan was misguided because they could have no way of knowing the badger population in the trial areas:
 
"I would go down the vaccination and biosecurity route rather than this crazy scheme that may deliver very small advantage," he said.
 
Sally
Following a meeting organised by Rethink bTB last week those attending have sent the following statement to Owen Paterson. It is good to see groups working together towards a common aim at last.
 
'Now that a cattle vaccine is ready for licensing, we are convinced that the only way to control bovine TB and hence avoid the devastating and costly current bovine TB policy is to vaccinate all bovine animals and where necessary wildlife. We therefore call on the Government to take immediate action to eliminate all legal and political obstacles preventing farmers from vaccinating their cattle against bovine TB. We represent a cross section of scientists, veterinarians, farmers and conservationists concerned about the impact of bovine TB on the farming industry and countryside.'
 
Sally
'Bovine tuberculosis vaccine research: Historical perspectives and recent advances', by W. Ray Waters, Mitchell V.Palmera, Bryce M. Buddleb and H. Martin Vordermeierc. Published March 30, 2012.
 
Interpretive Summary:
Despite highly successful eradication efforts in several countries, tuberculosis of cattle remains a serious health concern worldwide. In addition, an outbreak of tuberculosis in white-tailed deer in Michigan and continued importation of tuberculous cattle from Mexico have seriously hindered eradication efforts within the United States. Elsewhere, wildlife reservoirs including Eurasian badgers in the UK, brushtailed possums in New Zealand, wild boar in Spain, and cape buffalo in southern Africa seriously hinder control efforts. Without new strategies, eradication and control of bovine tuberculosis will be impossible. Thus, improved techniques such as vaccination are needed for prevention of tuberculosis in cattle. In this article, historical perspectives on bovine tuberculosis vaccine research are reviewed as well as recent advances. This article provides a summary on the current knowledge of bovine tuberculosis research.
 
Technical Abstract: The emergence of wildlife reservoirs of Mycobacterium bovis infection in cattle as well as increased inter-regional trade with associated spread of M. bovis has led to renewed interest in the use of vaccines for the control of bovine tuberculosis (TB). Field efficacy trials performed in the early 20th century demonstrated the partial effectiveness of bacilli Calmette Guerin (BCG) for the control of bovine TB. Recent experimental trials with cattle have demonstrated that: (1) subunit vaccines may boost immunity elicited by BCG in cattle, (2) T cell central memory immune responses evoked by protective vaccines correlate to protection upon subsequent M. bovis challenge, (3) BCG is particularly protective when administered to neonates, and (4) differentiation of infected from vaccinated animals (DIVA) is feasible in cattle using in vitro or in vivo methods. In regards to wildlife reservoirs, the efficacy of BCG has been demonstrated for brushtailed possums (in field trials) as well as Eurasian badgers, wild boar, and white-tailed deer (each in experimental challenge studies). Vaccine delivery to wildlife reservoirs is primarily oral, although a parenteral route is being deployed for badgers in England. Vaccine efficacy trials, both experimental challenge and field studies, with cattle and their wildlife reservoirs represent a primary example of the one health approach, with outcomes relevant for both veterinary and medical applications.
 
Full report available to purchase from: www.sciencedirect.com/science/journal/0264410X/30/16
 
Sally
DEFRA research project - we have asked what progress is re following.
 
Evaluation of the protection efficacy of vaccines against bovine TB in a natural transmission setting. - SE3227
 
Description
 
Bovine tuberculosis remains an economically important problem in Great Britain with potential zoonotic consequences. As such, Defra continues to have a statutory obligation to control tuberculosis in farm animals in Great Britain under the Animal Health Act of 1981, the Tuberculosis Orders, and various EC directives. Despite implementation of a test and slaughter strategy using the tuberculin skin test to detect infected animals, the incidence of bovine tuberculosis in cattle has been increasing exponentially since 1988. In 1996, an independent scientific commission chaired by Professor John Krebs to review the situation of bovine TB in GB concluded that the development of a cattle vaccine and associated diagnostic test had the best prospect of controlling the disease in the National Herd. This conclusion has been re-affirmed in the House of Commons Environment, Food and Rural Affairs Committee’s report on Bovine TB (2004) and by the findings of the Independent Scientific Group Vaccine Scoping Sub-committee, which highlighted that work on development and testing of vaccines should be maintained in order to produce a vaccine that is more effective than BCG in cattle. Significant scientific advances have been made towards this goal by VLA and our collaborators (especially AgResearch, NZ) as a result of Defra-funded projects. These advances have meant that Defra’s TB vaccine programme is broadly on track with the timeline outlined by the Krebs’ Report for the development of cattle TB vaccines.
 
However, as highlighted by Defra’s Vaccine Programme Advisory Group (VPAG) at their inaugural meeting, a major barrier to progress in cattle vaccine research is the absence of experimental systems to measure vaccine efficacy in a natural transmission setting. Without this information, it is difficult to assess whether “laboratory” advances will have any significant impact in the field. The need to assess the ability of promising TB vaccine candidates to protect cattle against natural transmission of M. bovis was announced by the Animal Health Minister Ben Bradshaw to the House of Commons on 9 June 2005 and by Defra in an accompanying press release. In the press release it was stated that Defra would contract ‘further work looking at new vaccine candidates and delivery protocols in a natural transmission study in cattle at the Veterinary Laboratories Agency. A naturally infected herd will be used to compare the effectiveness of several vaccines’.
 
The aim of this proposal is to establish a facility for generating natural transmission of M. bovis between cattle by assembling reactor cattle in a contained setting. This facility will then be used to determine the efficacy of promising vaccine candidates under conditions of natural transmission. This will be done by introducing sentinel vaccinated and control animals into the reactor herd and leaving them in-contact with reactor animals for 10-12 months. The protective efficacy of vaccine candidates will be determined by comparing disease rates between vaccinated and unvaccinated cattle. The first vaccine to be tested will be BCG given to neonates. Subsequent vaccines to be tested in this way will be prioritised on the basis that they have been shown to induce better protection against experimental challenge in cattle than BCG. This design was presented to and approved by VPAG, which includes a representative from the ISG, at its meeting on 12 May 2005.
Objective
 
01. To develop logistical framework for project
 
02. To perform proof of concept experiment
 
03. To determine protective efficacies of cattle TB vaccines under conditions of natural transmission
 
04. To evaluate reagents for differential diagnosis
Time-Scale and Cost
 
From: 2005
 
To: 2012
 
Cost: £6,945,146
 
Contractor / Funded Organisations: Veterinary Laboratories Agency
 
Sally
DEFRA research project - we have asked what progress is re following.
 
Continuation of the development for vaccines against bovine TB in cattle - SE3224
Description
 
In 1996, Government tasked an independent scientific committee chaired by Professor John Krebs, to review the problem of bovine tuberculosis (TB) in GB. The recommendations of this committee were published in the Krebs’ Report to the Minister of Agriculture Food and Fisheries in 1997. Government subsequently adopted many of the recommendations put forward by this report including the recommendation that vaccination of cattle offered the best long-term solution for controlling the disease in the National Herd and that priority should be given to the development of a cattle vaccine against bovine TB together with an associated diagnostic test suitable for use in vaccinated animals. This view has been re-affirmed recently in the House of Commons Environment, Food and Rural Affairs Committee’s report on Bovine TB (2004) and by the findings of the Independent Scientific Group Vaccine Scoping Sub-committee. During previous DEFRA-funded projects, we and our collaborators have made significant progress in developing TB vaccines for cattle such that we are on track with the time-scale for vaccine development outlined in the Krebs Report. Specifically: (i) we have shown that DNA or protein subunit vaccines used in combination with BCG gives superior protection against experimental challenge in cattle than BCG (heterologous prime-boost) and highlighted the need for better adjuvants for these sub-unit vaccines, (ii) we have developed prototype reagents that allow discrimination between vaccinated and infected animals; (iii) we have identified correlates of disease severity that can predict the success or failure of vaccination and (iv) we have developed an extensive network of collaborators involved in the Global effort to develop vaccines against human tuberculosis. This current proposal will build on these recent advances. It addresses Defra’s current TB research requirements identified in the AHWR research requirements document (September 2004) under heading R1. Specifically, we will concentrate on optimising heterologous prime-boost approaches to improve BCG by (i) identifying vaccine subunit candidates that boost BCG-induced immunity in cattle using antigen mining techniques that we have developed in previous research contracts, and comparing the efficacy of these vaccines in mice and cattle (objectives 1,3,4); (ii) testing new adjuvant systems in combination with promising subunit vaccines in cattle (objective 2); (iii) testing TB vaccines in cattle that are in phase I clinical trials in humans (objective 6), and (iv) continuing to utilise the close and effective network of collaborations that we have developed with the human TB vaccine community (objective 5,6). We have also engaged in a private/public partnership with a pharmaceutical company (Pfizer Animal Health), and this relationship will be developed over the life of this proposal (objective 7). In addition, this proposal will support the continued development of reagents for differential diagnosis that are suitable for use in vaccinated animals.
 
Objective
 
Objective 1: Evaluation of antigens identified in antigen mining project as subunit vaccine candidates.
 
Objective 2: Selection of most potent adjuvant for protein delivery.
Objective 3: Determination of protective efficacy of subunit vaccine candidates in mice.
 
Objective 4: Establish and validate immune correlates of protection and pathology.
 
Objective 5: Compare vaccine efficacy of protein/adjuvant subunit vaccines developed in 02 and 03 with proteins delivered by viral vectors in cattle
Objective 6: Assess the immunogenicity and protective efficacy in cattle of vaccines developed for the human TB vaccine effort now entering human clinical trials.
 
Objective 7: Develop private/public partnership (PPP) with Pfizer Animal Health
Time-Scale and Cost
 
From: 2005
 
To: 2012
 
Cost: £8,129,312
 
Contractor / Funded Organisations: Veterinary Laboratories Agency
 

 
Sally
Why, if Defra wanted to do field trials and deploy BCG, did they did not start getting permission from Brussels when they started the work?
 
Sally
MR sent DEFRA further questions.
 
Your response to RFI 4564 attached stated:
 
"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"
 
 
Can you please advise:
if work was completed by Easter 2012 or if not when is completion expected
and
if the application has been made to the OIE or if not , when it is expected to be made.
 
The DEFRA reply was as follows:
 
The studies described to generate validation data from AHVLA’s prototype DIVA test in BCG-vaccinated experimentally-challenged cattle were completed and analysed by Easter 2012. The OIE was asked to evaluate the test but because there were no data from the field (since TB vaccination of cattle in the field is prohibited by EU law) but rather (by necessity) the test performance had been evaluated in a limited number of experimentally vaccinated cattle they could not accept this validation. We have subsequently put the dossier to experts at a number of international reference laboratories seeking their views on our results and our approach to validation and are awaiting their advice. This will be used to inform what other experimental and field studies would be needed for the OIE to accept validation of the test. As things currently stand the UK would need a derogation to undertake field trials in England or any field studies would need to be carried out in non-EU countries. The latter would not be ideal for validation of the DIVA test since ordinarily these studies would be carried out under the field and environmental conditions of the intended country of use.
 
Sally
MR sent us this response from DEFRA to a Freedom of Information request for information.
 
Cattle Vaccine for Bovine TB Freedom of Information Request
 
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.
 
You have challenged the use of exemptions set out in the original correspondence for why documents are not being released to you. As referred to in Annex A of our previous letter, if you are unhappy with the service you have received in relation to an FOI request and you wish to make a complaint or appeal against our decision you should write to Brendan Walsh, Head of Defra’s Information Rights Team at Area1B, Ergon House, Horseferry Road, London, SW1P 2AL, (email: informationrights@defra.gsi.gov.uk) who will arrange for an internal review of your case. Details of Defra’s complaints procedure are on our website.
 
The remainder of the points you’ve raised are not FoI matters.
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.
 
A list of published studies re BCG cattle vaccination and the DIVA test was produced.
 
becky
Will Wales lead the way regarding bTB cattle vaccination? 'Vaccinating cattle against TB - what does the future hold' is an article in Gwlad Summer 12 Bovine TB Special Edition. It can be read in full at: http://gwladonline.org/bovinetb/120723vaccinatingcattleagainsttb/;jsessionid=LCXRQhLVLdpDQWX316hV86TJN13cWmzPrFGTVgnQhpnHVQ5nLnfL!-1988510053?lang=en
 
Used alongside existing measures, vaccinating cattle against bovine TB has the potential to make a significant contribution to the eradication of TB in the future.
 
Developing an effective vaccine has been high priority in Great Britain. More than £23 million has been invested since 1998 in research and development into an effective vaccine. BCG (Mycobacterium bovis Bacille Calmette-Guérin) is currently the most suitable vaccine candidate having been shown to reduce the effects of TB in cattle, and the spread of TB between animals.
 
Vaccinating cattle against TB is currently illegal under EU law. This is because BCG vaccine causes cattle to test positive to the TB test used to establish herd TB freedom (i.e. the skin test). Herd TB freedom is needed for herds to trade cattle, so vaccine use would lead to a ban in the UK trade in live cattle. Whilst the EU trade in live cattle is limited, EU law also prohibits the sale of milk for human consumption from skin test positive cattle and requires these animals to be slaughtered.
 
In an attempt to resolve these issues and clear the way for use of the BCG vaccine Animal Health Veterinary Laboratories Agency (AHVLA) research has led to the development of a new blood test, the DIVA test, to distinguish between infected and vaccinated animals. It is hoped that the DIVA test will gain international recognition from the World Organisation for Animal Health in due course.
 
In the longer term the UK aims to work with the European Commission to develop changes to EU legislation allowing the DIVA test to be used in place of, or alongside the tuberculin skin test to establish herd official freedom from TB in BCG vaccinated cattle.
 
In preparation for any changes in EU legislation the Welsh Government along with vets, other experts and the cattle industry have started to consider a cattle vaccination strategy for farmers in Wales.
 
becky
Pembrokeshire Against the Cull (PAC) representatives met with John Griffiths, Minister for Environment and Sustainable Development, and Christiane Glossop, Chief Veterinary Officer for Wales earlier this week.
 
One of the main topics covered in the meeting was an update on the progress of the badger vaccination programme. They learned that the rates of capture and vaccination in the IAA are on a par with those of FERA with 438 badgers vaccinated already. However, further key areas discussed were cattle vaccination. From what was said at the meeting it looks as though Wales may be a front runner in championing cattle vaccination - and biosecurity, TB statistics and testing.
 

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