Rethink Bovine TB

Badger cull trials failBovine TB

Posted by Susan Hooper Tue, December 03, 2013 09:41:54

W Gloucestershire and W Somerset Pilot Cull Results 2013

It is widely accepted that for the pilots to be effective, a minimum of 70% of
the badger population must be culled within a maximum period of 6 weeks.

Failure to meet these targets risks worsening the spread of bTB through
perturbation.

The population estimates - which are critical to calculating the 70% minimum -
have been altered so substantially in the past 12 months that they cannot
reasonably be relied upon.

But on any measure, the results show that 2013 pilots have fallen
woefully short of targets. This will most likely worsen rather than reduce bTB.

Vaccination in the Control of Bovine TBBovine TB

Posted by Susan Hooper Wed, September 11, 2013 16:24:26

The Institute of Zoology has organised a workshop for 3 Oct 2013 – 10:00 am - 5:00 pm to discuss cattle vaccination for bovine TB.

Programmes for controlling Bovine TB in the UK and abroad have inevitably led to increased interest in vaccines for cattle and wildlife. The renewed interest has been accompanied by myths and misunderstanding about the efficacy and practical application of vaccination at a population level.

This one-day event, with speakers who are leading experts from academic, government and charitable organisations, will explore the principles behind vaccination and practical use in the field.

Principal topics will include:

How vaccines work at the individual and population levels.
Recent uses of vaccination for disease control and elimination in wild and domestic animals.
Practical low cost deployment of injected badger vaccination.
Development of oral badger vaccines.
Current status and prospects for cattle vaccination against Bovine TB.

Followed by discussion and debate with a panel drawn from the main speakers and other experts.


Who should attend:

Politicians, policy advisers, farming and food industry representatives, conservationists, vets, and academics involved or interested in the control of Bovine TB in livestock and wildlife.

Registration:

Full rate £40
ZSL Fellows and students £20
(Please bring your ZSL membership card or student card to the event)

Buffet lunch and refreshments are included in the registration fee.

Registration deadline 26 September 2013

For more information about this event, to download the full programme and to register visit http://www.zsl.org/science/events/vaccination-in-the-control-of-bovine-tb,773,EV.html

Blatant propaganda?Bovine TB

Posted by Susan Hooper Thu, June 13, 2013 18:38:20

Our attention was drawn to a posting at http://bovinetb.blogspot.co.uk dated Friday 07 June, 2013 and headed 'Not cattle ....' It related to a debate on bovine TB that had been held in Cheltenham. Included within the piece was the following statement: 

'But in questions or points from the floor, one speaker announced that in her professional capacity and at the present time, she was treating 8 people in the county of Gloucestershire for Zoonotic tuberculosis - which they had contracted during an up close and personal relationship with the family cat'.

For some reason the author(s) of this site is determined to remain anonymous so we have been unable to make contact with them but we did contact Public Health England and were told by Louise Dirks, the Public Health Practitioner of the Glos, Avon and Wiltshire area that the above statement is, in fact, erroneous. 

In view of the sensitivity of the subject, we wonder why the authors chose to publish such blatant propaganda without first checking for accuracy? It certainly makes us skeptical regarding the credibility of the rest of the information set out on their blog pages.

EU influences progress of cattle vaccinationBovine TB

Posted by Susan Hooper Sun, May 12, 2013 18:54:53

Earlier this year the current Secretary of State for Enviornment, Food and Rural Affairs received a letter from Tonio Borg, EU. It referred to the UK bTB eradication programme to be implemented in 2013 which has been approved by Commission Implementing Decision 2012/761/EU. The letter summarised a number of commitments made. 

The EU has a good deal of interest in bTB policy in England and Wales. It has allocated considerable funds to support the UK bTB programmes (EUR 116,3 Mio in total). The EU therefore expects significant improvements in the epidemiological situation in 2013 to show efficient use of these EU funds; 'absolutely necessary in view of a further renewal of the EU financial support to this programme.' This then is the main reason for its direct influence.

Of greatest interest to us was the attachment which related to the future possible use of a vaccine for cattle. The text is set out below. However, we believe that with a strong political will and the support of the farming industry  there is no good reason why cattle vaccination can't be a viable option in the near future.

Vaccination against bTB is explicitly forbidden in the EU legislation on disease control (Council Directive 78/52/EEC) and implicitly also in intra-Union trade legislation, as vaccination is not compatible with the provisions for testing and herd qualification (Council Directive 64/432/EEC). EU legislation is fully in line with OIE standards on international 

trade and can be changed only by the European Parliament and the Council. 

The main reason for the current vaccination ban is due to the possibility that vaccinated animals are not fully protected against bTB infection. Due to the suboptimal protection induced by the available vaccines (live BCG vaccine), vaccinated animals may become infected if exposed to the disease agent and then they cannot be distinguished from the non-infected vaccinated animals, due to the interference of vaccination with existing diagnostic methods (PPD-tuberculin skin test). This would jeopardise current bTB control and eradication policy. 

UK has invested considerable resources to develop a candidate vaccine accompanied with diagnostic test(s) that would be compatible with the vaccine (DIVA1 tests). Apparently only Ireland and New Zealand have shown some interest in this development. 

Scientific knowledge on bTB vaccination was reviewed during a recent technical workshop held in Cardiff. The outcome of the workshop clearly indicates that the hypothetical use of the only candidate vaccine (live BCG vaccine) presents still many knowledge gaps, in particular concerning the performance of the vaccine (level and duration of protection, 

protection from disease or infection), safety (possible shedding of the attenuated live pathogen by vaccinated animals), conditions for use (age of animals, type of herd) and suitability of candidate DIVA test(s). 

Fundamental scientific information is not yet available on the reliability and feasibility of cattle vaccination accompanied by use of DIVA test(s) that is fundamental for a possible change in the current EU policy on the control and eradication of bTB. Future studies should also address food safety concerns (shedding of vaccine strain in milk), human health 

concerns (BCG is the only vaccine available for humans and its use in cattle may lead to the selection of BCG-resistant strains of bTB that may affect also humans) and animal health and trade concerns (proper discrimination between vaccinated and infected animals, costs/benefits of vaccination policy, current policy, acceptability of vaccinated animals in 

international trade). 

However, you can find attached a tentative time line for bTB vaccination of cattle in UK and the EU, showing the series of steps/milestones that will be needed. I would like to underline that under the current circumstances the timeline provided is to be considered as purely indicative. 

In the Annex attached a tentative time line for possible use of a vaccine against bovine tuberculosis in the EU was set out. 

The letter and attachments can be read in full at:https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/183229/bovinetb-letter-paterson.pdf

Health and Safety of Bovine TB Skin TestBovine TB

Posted by Susan Hooper Wed, April 24, 2013 18:58:06

Testing cattle using the existing, archaic and imperfect skin test, necessitating penning/testing on two different days each time, can be a significant health risk to those farmers and testers involved. In January of this year a dairy farmer (just 55 years old) was crushed by a bull as he tested cattle for TB on his Carmarthenshire farm. There was another similar incident in Ireland in April 2010. 

Following a Freedom of Information request to the Health & Safety Executive (HSE), over the last 4 years there have been seven reported incidents involving serious injury during bTB testing. However, the HSE, in its response, warns that there may be more as it relies on the mention of the term 'TB' in the report searches. 

We know too that there are many more accidents and injuries, involving both farmers and testers. However, many of these do not come under the jurisdiction of the HSE as this body does not deal with the self employed. The self employed are apparently responsible for their own safety. In many areas testing is now done annually and for those with herd breakdowns it can be as frequent as every 60 days. Penning and testing cattle, particularly those not used to being handled regularly, is known to pose significant health and safety risks but these are currently ignored. The situation would not be tolerated in any other sector.

Bovine TB is not a public health risk because milk is pasteurised. A control, rather than eradication policy could be devised, based instead on cattle vaccination which would necessitate minimal handling. Testing could then be utilised for high risk herds only, eg raw milk herds.

FARMERS' RESPONSE TO EFRA INQUIRYBovine TB

Posted by Susan Hooper Wed, March 20, 2013 19:32:24

This is an excellent response from a Rethink bTB farmer supporter. Other submissions can be viewed at:www.publications.parliament.uk/pa/cm201213/cmselect/cmenvfru/writev/bovine/contents.htm

We own a 48ha farm in Gloucestershire and have kept beef 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. 

Summary 
1) Concern that Defra has distorted the extent of bovine TB infection in England and Wales 
2) BCG cattle vaccine and the Diva test are available 
3) A trial of cattle vaccine should be rolled out in areas with repeated outbreaks of bTB 
4) An earlier Defra report models cattle vaccination policies in great detail 
5) History gives us the example of Brucellosis which was successfully eradicated via a cattle vaccination program 
6) Defra must ensure that the EU prioritises work on the New Single Regulatory Framework for Animal Health 
7) Role of the EU 
8) Conclusions 
9) References/links 


1) Concern that Defra has distorted the extent of bovine TB infection in England and Wales 

The object of the exercise when addressing the issue of bovine TB should be to adopt an approach which is not detrimental to the business of cattle farming and which takes account of good public relations. But the more that Defra has become fixated on the idea of a badger shoot, the more the department appears to have ignored public opinion and distorted the extent of bTB infection in this country. 

For example, Defra Minister Owen Paterson recently made a statement in the House of Commons on the badger cull - widely reported in the press - which included the claim that "bovine TB is the most pressing animal health problem facing the UK today" and he described the incidence of bovine TB as an 'epidemic'. ¹ 

But Defra's own statistics simply do not justify these alarmist claims. 

According to Defra's latest figures published on 12th December 2012, the number of cattle slaughtered each year for bTB control has remained stable for the last ten years at a figure averaging just half of one percent of the national herd, year on year ². This figure is easily outnumbered by fallen stock and cattle slaughtered annually due to lameness, infertility, mastitis etc. 

Defra present their bTB ‘Key Facts & Figures’ for 2011 negatively but we can still see from these figures that 88.5% of herds in England and 76.4% of herds in the hot-spots went about their business completely unaffected by bTB for the whole of that year and most of the remaining herds were only restricted for a short time ³ 

There are ‘TB maps’ on the Defra website with areas shaded red but they contain far too many red dots to correspond with half a percent of the national herd slaughtered for bTB control annually and there is nothing on the web page to explain what each of the red dots represent. If each dot is a bTB incident then each dot must be removed when the incident is cleared otherwise the map is nothing but a misrepresentation of the true extent of infection 4. 

Clearly it is Defra’s ‘test and cull’ policy which causes the most grief to the cattle industry so it is vital that the incidence of bTB infection is properly presented and that the minority of herds affected are precisely identified in order to ensure that any future plan for control is proportionate. 

2) Cattle vaccine and the Diva test are available 

Cattle vaccination is the only long-term solution to bovine TB and this approach could be pushed through with the right political will. 

Cattle vaccine and the Diva test are available as reported on the Defra website as follows: a) "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) "

b) "Our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the [diva] 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" 

NB. This page on the Defra website was referred to during the Commons debate on the badger cull on 25th October but the reference to the 'diva' test was subsequently removed from the web page on 5th Nov 2012. However, a cached version of the original web page from the Defra web site on 29th Oct 2012 is attached for reference 5. 

3) A trial of cattle vaccine should be rolled out in areas with repeated outbreaks of bTB Defra need to apply to the EU for a derogation to allow UK field trials of the cattle vaccination and the Diva test to begin. A trial of BCG cattle vaccine could be rolled out to individual herds which are identified as having repeated outbreaks of bTB along with 'ring fence' vaccination of surrounding herds. In addition, a cattle vaccine trial could be offered as an option to all farmers/keepers with pedigree, single-suckled or dairy herds who currently have to trust to luck to avoid having their breeding and foundation stock wiped out by Defra's test and cull policy.

None of the vaccines we use for our livestock gives 100% protection but, as it states on the Defra website 7, a vaccine against bTB can reduce the prevalence, incidence and spread of TB in the cattle population and also reduce the severity of a herd breakdown, regardless of whether infection is introduced by wildlife or cattle. The status of vaccinated cattle could be certified by stamping the animal's individual passport.

4) An earlier Defra report models cattle vaccination policies in great detail 

A Defra report entitled "Options for Vaccinating Cattle Against Bovine Tuberculosis" produced in 2008 and endorsed by numerous prominent stakeholders, including the NFU, set about modelling various vaccination programs, including the lead option of compulsory vaccination of high risk herds in annual testing parishes 6. 

The model showed that this option, funded by the govt, would save up to one fifth of the costs of the current 'test and cull' policy, as follows: 

"The model predicts vaccinating cattle in yearly tested parishes would cost around £170 million to £180 million over the period from introduction in 2012 to the end of the modelled period in 2026. It predicts benefits from fewer breakdowns and less routine testing of between £150 million and £250 million, potentially saving up to one fifth of the costs of the current policy measures. The benefits from vaccinating cattle in yearly tested parishes are likely to justify its costs over this period." (Para 1.2 'Economic Assessment of Lead Option'). 

The report also suggests that certifying vaccinated cattle would save on resources in terms of the Diva test (Para E14, E15). Cattle now have individual cattle passports so these can be stamped to show the animal has been vaccinated. 

5) History gives us the example of Brucellosis which was successfully eradicated via a cattle vaccination program 

The Defra report "Options for Vaccinating Cattle Against Bovine Tuberculosis" 6 includes a detailed section on the vaccination policy which led to the successful eradication of Brucellosis (Annex 6.1.1). 

This involved a combination of voluntary and mandatory vaccination, in line with the geographical incidence of disease, administered by Defra Local Veterinary Inspectors or Local Veterinary Practices and a herd accreditation scheme was established to monitor disease status. 

This system could be adapted for use with bTB. Cattle now have individual cattle passports so these could be stamped to show the animal has been vaccinated saving on resources in terms of the Diva test. 

6) Defra must ensure that the EU prioritises work on the New Single Regulatory Framework for Animal Health 

Defra say on their website "An opportunity to provide a future legal basis for vaccination of cattle against TB is likely to be created by the proposed new European Animal Health Law, which is currently under consideration by the European Commission" 7 

The EU describes the New Single Regulatory Framework for Animal Health, the so-called EU Animal Health Law, as follows: "Current legislation does not fully support prevention. It is more reactive than proactive and doesn't provide real incentives for stakeholders (animal keepers, traders, business operators) to use mechanisms to prevent, on one hand, the introduction of the diseases to their holdings and, on the other hand, their spread to other holdings, regions and countries." 8

The AHWBE (Animal Health and Welfare Board for England) were due to publish their review of these EU proposals in 2012 but we have not received a reply to our request for a copy of their conclusions to date 9. 

7) Role of the EU In a recent statement, the European Commission confirmed that the EU Health Commissioner would advise on the exact process and timing required to implement cattle vaccination in the UK 10. The Commission also points out in this statement that substantial financial support is provided for the UK bovine TB eradication programme adding "For 2012, EUR 31.2 million were allocated to implement a rapid eradication strategy. There is no EU financial support provided for the culling of badgers." 

8) Conclusions

• Defra are using the badger shoot as a distraction and obfuscating the facts around the incidence of infection of bovine TB seemingly to avoid addressing the necessary option of cattle vaccination. The generous funding provided by the EU may be acting as an incentive to continue with the current 'test and cull' policy. • The current Defra administration must not sideline the valuable research and information contained in the earlier Defra report entitled "Options for Vaccinating Cattle Against Bovine Tuberculosis" 6 . • Defra should apply to the EU Health Commissioner for a derogation to allow UK field trials of the cattle vaccination and the Diva test to begin.

• Defra officials must shift their focus away from badger shooting and concentrate on the proposals from the EU for a New Single Regulatory Framework for Animal Health, the so-called EU Animal Health Law, which will pave the way for proactive and preventative cattle vaccination for the benefit of the cattle farming industry long term. 

9) References/links
1 http://www.defra.gov.uk/news/2012/10/23/badger-cull/ 2 http://www.defra.gov.uk/statistics/files/defra-stats-foodfarm-landuselivestock-tb-statsnotice-121212a.pdf page 6
3 http://www.defra.gov.uk/animal-diseases/a-z/bovine-tb/ , Key Facts & Figures
4 http://www.defra.gov.uk/animal-diseases/a-z/bovine-tb/about-bovine-tb/ 
5 Defra cattle vaccination Google cache 29 Oct 12.mht (NB This is a cached version of the original web page from the Defra web site on 29th Oct 2012 and is an mhtml file which opens as a web page). 
6 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb/documents/vaccine_cattle.pdf 
7 http://www.defra.gov.uk/animal-diseases/a-z/bovine-tb/vaccination/cattle-vaccination/ 
8 http://ec.europa.eu/governance/impact/planned_ia/docs/45_sanco_animal_health_law_en.pdf 
9 http://www.defra.gov.uk/ahwbe/files/ahwbe-forwardplan2012.pdf , page 2, Action Plan
10 http://ec.europa.eu/unitedkingdom/press/press_releases/2012/pr1245_en.htm

Bovine TB VaccinationBovine TB

Posted by Susan Hooper Wed, March 20, 2013 19:28:19

RETHINK BOVINE TB's SUBMISSION TO EFRA 
Submission to the Environment, Food and Rural Affairs Committee 
Inquiry examining the vaccination of badgers and cattle in relation to Bovine TB 

1. Introduction. 
1.1 Rethink Bovine TB is an independent group with an interest in agriculture, animal diseases, animal welfare and the financial viability of farming. 
1.2 We confine our submission to vaccination of cattle against Bovine TB and Defra’s recent handling of associated regulatory issues. 

2. Summary. 
2.1 Paradoxically vaccination against Bovine TB was banned so that Bovine TB could be detected. 
2.2 Defra’s claims for vaccine efficacy are misleading as they ignore the way vaccines work in a herd to stop the spread of disease. Defra have not modelled the effect of vaccination on herd breakdowns. 
2.3 Defra had scheduled all regulatory work except changing EU law for completion in 2012. The vaccine and DIVA test are ready but not licensed or approved because Defra had not appreciated the requirements. 
2.4 Little has been done to change EU law to enable vaccine use. 
2.5 Enquiries into the delays and reasons for delays have been evaded by a Defra Minister and by civil servants. 
2.6 Defra only realised around 2011 that a vaccine could not be licensed until the EU ban on use had been lifted. 
2.7 Defra were taken by surprise when the OIE demanded field trials which would involve vaccination in the field which is illegal. Defra have still not decided whether to try to perform the trials, putting the whole programmer in doubt. 

3. Cattle Vaccination 
3.1 The principal means of preventing epidemics and protecting against infectious diseases is almost always vaccination. Bovine TB in cattle is an exception only because vaccination was made illegal as the readily available vaccine, BCG, interferes with the test used to detect the infection. In other words the leading solution to BTB, vaccination, was banned so BTB could be detected. 
3.2 However a “DIVA” test which distinguishes between vaccinated and infected cattle is now awaiting approval, and work to enable licensing of BCG (a vaccine used on humans for many decades) as a cattle vaccine is complete. 
3.3 Although modelling data is scarce it would be reasonable to expect vaccination to produce a dramatic reduction in the number of herd incidents and individual cattle slaughtered, even at the lower estimates of vaccine efficacy. 

4. Efficacy of cattle vaccination 
4.1 The results of the majority of studies of BCG use on cattle have demonstrated considerable protection with field studies in Mexico and Ethiopia indicating 56 – 68% protection of individuals. (Note that this is often incorrectly rounded down to 50 - 60%. Correctly rounded it becomes 60 – 70%). 
4.2 Defra repeatedly caution that BCG will not provide complete protection. As for any vaccine this is correct, but very misleading because of the way vaccines work in a herd. 
4.3 There are two reasons for vaccinating against infectious disease: 
a. To protect an individual. Any protection helps but as near 100% as possible is preferable. 
b. To protect a population. It is only necessary to achieve a level of immunity at which that the disease cannot spread through the population, and goes into decline – the herd immunity threshold. Less than full protection of each individual is generally sufficient, and not every individual need be vaccinated. 
4.4 For cattle the aim is to protect the herd so the disease goes into decline, not to protect any one individual animal. 
4.5 Any level of efficacy will help reduce incidence, even if herd immunity is not achieved. 
4.6 Defra claim that “It is not clear what effect BCG vaccination of cattle would have in reducing the incidence of TB herd breakdowns.” 
4.7 Why has no modelling of this critically important aspect been carried out for Defra? 
4.8 Further unanswered questions include: 
4.9 What efficacy would be needed to achieve herd immunity? 
4.10 What would be the equivalent efficacy if vaccination was combined with other measures, such as properly designed and enforced cattle movement protocols? 
4.11 What efficacy, using cattle vaccination alone, would be needed to achieve the same effect as the current policy? 
4.12 If vaccination was used alongside the existing test and cull policy (obviously with use of the DIVA test) what reduction in the number of cattle slaughtered could be expected? 

5. Progress 
5.1 Defra included the following statements in their September 2010 Consultation ; 
5.2 “We aim to have a licensed cattle vaccine by 2012” 
5.3 “Our aim is also to have the DIVA test approved by 2012” 
5.4 “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.” 
5.5 From this, Defra had scheduled a 2012 completion for all scientific and regulatory work. 
5.6 The remaining obstacle would be EU legislation. 

6. Current Status under EU law 
6.1 The ban on cattle vaccination was introduced because the BCG vaccine can interfere with the Tuberculin skin test. This is no longer a problem because of the DIVA test. Yet we cannot repeal the obsolete law ourselves, but must go cap in hand to the European Commission. 
6.2 It is not clear why Defra thought 2015 marked a watershed in changing EU law. They were hoping that proposed new animal health legislation might allow vaccination of cattle against BTB but they admit they have no control and limited influence. 
6.3 If changing EU legislation is as Defra claim “a lengthy process” Defra should have started the “lengthy process” at the same time as work on the vaccine and DIVA test. 
6.4 In Defra’s September 2010 consultation they stated at Para 63: “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........”. 
6.5 In the “Bovine TB Eradication Programme for England July 2011” Defra state at Para 87: “We will be using the scientific and technical evidence on the efficacy and safety of the cattle vaccine and the role of a DIVA test to press the case in Europe.........”. 
6.6 The use of the definite article in “The strong ............. evidence” and “The ............ evidence” implies such evidence already existed. The repeated term “We will be” clearly means we have not yet. 
6.7 From Para 88 of the same 2011 document: “Changing EU legislation is a lengthy and uncertain process and preliminary discussions with the EU Commission have indicated that a change to the legal framework on vaccination and DIVA testing cannot be considered until sufficient evidence of their effectiveness is available. This is likely to take some time and as a result we anticipate that a cattle vaccine and DIVA test will not be available for use in the field for many years.” 
6.8 Does “cannot be considered” mean cannot be lobbied and prepared for, or cannot be implemented? The former meaning seems to be the one accepted by Defra. The latter is the likely reality. We note that “...until sufficient evidence of their effectiveness is available” contradicts “the strong scientific and technical evidence” in the 2010 consultation quoted above. 
6.9 The 2015 target has become an indeterminate delay of “many years”. The vaccine and DIVA test are ready for licensing, but little or nothing has been done to change the law to allow approval and use. 

7. Correspondence with the Minister of State 
7.1 Letters from Jim Paice, (when Minister of State) in reply to correspondence with Mark Williams MP failed completely to explain what steps have already been taken to change EU law. After ignoring the EU aspects the then Minister finally (letter 19 March 2012) discusses procedure for changing EU law, still ignoring the question. 
7.2 If the Minister ignores the question, one would assume no action has been taken. 

8. FoI Requests 
8.1 Requests under FoI 2000 were fielded with a more direct and honest form of evasion – simple refusal to answer difficult questions. 
8.2 “When we came to publish the [TB] Eradication Programme [July 2011] 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.” 
8.3 We have been unable to establish what the “significant technical and regulatory challenges” are, nor how they might affect international relations and formulation of government policy. 

9. Licensing and Approvals 
Vaccine 
9.1 In RFI 4469 Defra admitted “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” 
9.2 Why were Defra not aware of this crucial information from the outset? 
DIVA Test 
9.3 Before (and if) the EU lifts the ban on vaccinating cattle against BTB, the DIVA test must be approved by the OIE. Defra submitted an application following Easter 2012. This was rejected by the OIE as no UK field trial data was submitted. Field trials cannot be conducted in the UK without a derogation from the EU because vaccination of cattle is illegal under EU law. 
9.4 Why did the demand for field trials take Defra by surprise? It should not have done. They were aware of the potential requirement long ago when the Vaccine Advisory Group highlighted the absence of experimental systems to measure vaccine efficacy in a natural transmission setting. In 2005 Defra announced the necessary research, albeit to be done in contained facilities not as field research. 
9.5 In any properly organised development programme, approval and licensing is discussed with the regulators at every stage in development. Any element that would not be approved is altered or dropped and all trials the regulator requires are designed into the programme at every stage. In most cases licenses or derogations can be obtained for necessary veterinary research which would otherwise involve illegal acts. 
9.6 Why did Defra not discover in advance the OIE requirement for field trials and corresponding need for an EU derogation? 
9.7 It appears that the vaccine licence cannot be issued unless the vaccination ban is lifted; The vaccination ban cannot be lifted; Until the DIVA test is approved; Which cannot happen until field trials are conducted; Field trials cannot be conducted until the vaccination ban is lifted. 
9.8 The matter was further confused by FoI 5189 of 19 December 2012 , in which Defra stated: “But as yet no decisions have been taken on whether or not to undertake experimental or field trials.” 
9.9 This is a shambles, and one which Defra must have foreseen yet failed to prevent. 

10. Conclusions and Recommendations 
10.1 The test and cull strategy has failed to achieve OTF status and arguably has worse effect than the disease itself. The only proportionate solution likely to achieve better results is cattle vaccination. 
10.2 Defra’s attempts to achieve regulatory and legal approvals for vaccine use have descended into farce. 
10.3 Defra Ministers must put an end to this and order officials to find solutions - not create more bureaucratic muddles - so as to deploy cattle vaccination without delay." 

11. Postscript The 2010 Rethink Bovine TB report “Bovine TB: Time for a Rethink” concluded that: 

Bovine TB is not a significant human health risk in the UK. Hardly anyone catches Bovine TB from cattle or cattle products in the UK. 
The effect on animal welfare, and on farmers, of cattle testing and culling is worse than the disease itself. Farmers should be free (or required) to vaccinate cattle.
Milk pasteurization and meat inspection should continue. 
The tuberculin skin test is woefully inaccurate, even worse than generally believed.
Some 60 years from introduction the test and cull policy has failed. 
www.rethinkbtb.org 10 January 2013

Ministers must stand up to EU after Badger Cull VoteBovine TB

Posted by Susan Hooper Thu, October 25, 2012 21:01:19

The Commons motion passed today by an overwhelming majority of 119 does not just condemn the badger cull, it clearly calls for the only realistic solution; “a vaccination programme for badgers and cattle”.

It is clear from statements by Defra that the cattle vaccine and the DIVA test to distinguish between infected and vaccinated cattle are ready to license.   Cattle vaccination against Bovine TB, on Defra’s own figures, would give 56 – 68% efficacy, far more effective than any other proposed action.

Only two obstacles stand in the way.   EU law currently forbids vaccination of cattle against Bovine TB, and because of this Defra have failed to carry out field trials to complete the licensing process.

Michael Ritchie, spokesman for Rethink Bovine TB said that “Defra seem to have got completely bogged down in a deadly mixture of their own and the EU’s bureaucratic inertia”.   “The new Defra Ministers have a unique opportunity to make a real difference to farmers and to cattle welfare by standing up to Brussels.   With the political will, which the e-petition and today’s Commons vote has shown exists, we could be vaccinating cattle and reducing Bovine TB within months”

Notes:

The cattle vaccine (BCG) has been used for many decades on humans against the human strain of TB.   It is ready for licensing for cattle, along with the “DIVA” test able to distinguish between infected and vaccinated cattle.

Defra admit that recent research indicates a protective effect for BCG of between 56% and 68%.   This vastly outperforms the most optimistic estimates for badger culling.  

No vaccine is perfect – the object when vaccinating herds is to give the herd a level of combined immunity which slows the spread of the disease until it reaches zero.   Cattle vaccination could be used alongside almost any other policies, including the vaccination of badgers which is underway in Pembrokeshire after the Welsh Government abandoned plans for a badger cull.

Defra figures are at:

www.defra.gov.uk/animal-diseases/a-z/bovine-%20tb/vaccination/cattle-vaccination/