April 2002











An affiliation of organisations affected by 2001 UK epidemic


Co-ordinating Office:              3 The Common, Siddington, Cirencester, Glos  GL7 6EY

Tel: 01285 644319 / 01285 656812

















1            INTRODUCTION
















5.1            Modern Vaccines and Tests

            The issues of efficacy, potency and availability




5.2       The Role of the OIE,  Sale of Meat and Animal Products Post Vaccination, Carriers, Disease Free Status and Export Markets

















An affiliation of organisations affected by 2001 UK epidemic


Co-ordinating Office:              3 The Common, Siddington, Cirencester, Glos  GL7 6EY

Tel: 01285 644319 / 01285 656812








1            INTRODUCTION


1.1       The UK 2001 FMD epidemic caused widespread damage and loss to many people, their businesses and their communities.   The impact of the control of the disease on animal welfare, farming, tourism, the wider rural economy, individuals and the social fabric of rural Britain was massive and far reaching. 


1.2       In financial terms, the control of the epidemic created a fiscal cost of circa £3billion, a loss to the tourism sector of between £4-5 billion and an overall cost to the general economy of circa £20 billion*.   The control measures also resulted in the slaughter of over 10 million animals, the vast majority of which were healthy.   The measures also created unacceptable welfare problems for animals that could not be moved and faced starvation, adverse weather conditions and totally inappropriate circumstances for lambing and calving.  In many instances the provisions for humane slaughter were totally ignored and animals were subject to unacceptable suffering and cruelty.


1.3       The impact on communities and individuals faced with the vast extent of slaughter and culling, the loss of livelihoods and often their life’s work generated distress and despair.  The despoilment of the countryside due to the construction of the funeral pyres and burial pits needed for the disposal of such huge numbers of animals was untenable.   The psychological impact to many involved is still manifest and will take many years to recover from – some may never do so.


1.4       Both NFMG and Vets for Vaccination witnessed at first hand the effects and impacts of the adopted control policies on individuals, communities, animal welfare and on the economy and social infrastructure of rural UK.  The inter-dependent and inter-related nature of this economy and its society directs that control measures must minimise the effects of FMD control and seek to restore normality in the swiftest time scale.


1.5       We have therefore sought to prepare a programme for the containment and control of  FMD which does not create such major and widespread impact to all concerned and enables a modern, scientific and socially responsible approach to FMD control. 


*           Source of data: HM Govt, English & Welsh Tourism Council and IOD






2.1       The ability to differentiate between animals which have responded to vaccination and those that have responded to infection is key to the utilisation of an emergency, protective vaccination policy.


This differential ability enables the presence or circulation of virus to be monitored, and thus can in turn lead to the eradication of potential carrier animals.  It can also be used to determine freedom from infection and subsequently a rapid return to disease free status.


2.2       In recent years vaccines for FMD have become greatly refined.   Modern, state of the art vaccines can be produced with highly purified antigens, which are free from Non-Structural Proteins (NSP) of the FMD virus.


2.3            Animals, vaccinated with highly purified, NSP-free vaccines, produce antibodies against the Structural Proteins (SP) but not against NSP.


However, FMD virus infection induces antibodies against both Structural Proteins as well as Non Structural Proteins.


2.4       Marker tests have now been developed which can differentiate between antibodies due to vaccination as opposed to antibodies due to infection.


2.5       NSP-free vaccines used in combination with an NSP-test enables differentiation between animals that have responded to infection (antibodies for both NSP and SP present) and those that have solely responded to vaccination (only antibodies for SP present).


            NSP free vaccination stimulates an antibody response only to structural (capsid) proteins, whereas infection also stimulates an antibody response to non structural proteins.


2.6       The conventional tests – Virus neutralisation (VN), VP1-ELISA, demonstrate antibodies against FMD without differentiation between infection and vaccination.  The VN test has to be carried out in high containment, because it is carried out with FMD virus.  The test will only give a positive result if the field strain is of the same serotype as the test strain.


2.7       The marker test principle which we are advocating – for example – the Intervet Chekit-FMD-3ABC - demonstrates antibodies only after infection and not after vaccination.


              Furthermore, the Chekit-FMD-3ABC is not serotype specific and will be positive for all FMD viruses, irrespective of the serotype.


            We understand that both Merial and United Bio-Medical are in the process of  developing similar vaccines and tests.  However we base our programme on the Intervet Checkit FMD 3ABC system as this system has been advanced in the technical papers presented to the 22nd  Conference of the Office International Epizooties (OIE) Regional Commission.



            Any commercial NSP free vaccine could be used with the appropriate test, subject to validation by the OIE and the Veterinary Laboratories Agency based at Weybridge.



  2.8     As the NSP free vaccine and marker test enables animals to be screened to determine which animals have responded solely to vaccination, as opposed to those that have responded to viral challenge, this process overcomes two of the key objections to the use of vaccination, namely:


1          that vaccination can mask carrier animals resulting from viral  challenge, pre or post vaccination – and thus pose a risk to the rest of the national population


2          that vaccination would hinder or compromise a national eradication programme.




2.9       Our proposal is to screen herds and flocks with the 3ABC marker test, post vaccination with NSP free vaccines,  and to cull those herds and flocks where tests detect any animals with antibodies against the 3ABC protein – thus indicating a response to viral challenge by field infection. 


We have followed the precautionary principle, since the sensitivity of the anti-NSP tests is not 100% and therefore does not allow unambiguous classification of each tested animal.   By applying the test on a herd or flock basis greatly reduces the probability of non-detection of previously exposed animals which might harbour virus.


In culling these herds and flocks this then eliminates any possible carriers among the positive animals, and among false negative animals which might also be present in the same herd.


            Herds and flocks in which no animals test positive to 3ABC protein are found can be allowed to live out the rest of their economic life and continue into the food chain as this demonstrates that these herds/flocks have not been exposed to the virus.


Although the  sensitivity of the test is reported to be more than 99% (ie less than a 1 in 100 chance of failing to detect a previously exposed animal -see attached paper from Intervet), until quantitative assessment of the risk of non-detection of individual animals which have been exposed to virus is available, we propose that the test should be applied on a herd/flock  basis to reduce any risk that individual animals may be missed.


This can be considered, therefore, to be a highly precautionary measure which may in future be able to be modified; following experience in countries where post-vaccination surveillance is conducted.








3.1       The implementation of an emergency, protective vaccination programme enables herds and flocks to gain immunity from FMD infection and thus prevent further spread and dissemination of the virus.  FMD cases rapidly cease in well-vaccinated populations.


3.2       If animals are protected from viral challenge by vaccination and thus cannot contract the infection, then these animals cannot then pass on the disease.


3.3            Furthermore, vaccination not only prevents further hosts of infection being created, but also means that such animals do not have to be culled, nor do they then need any provision for disposal processes.


3.4       Also the need for compensation for the slaughtered animals does not arise.


3.5       During the UK 2001 FMD epidemic the disease was only brought under control with a ‘stamping out’ policy after seven months.   The first case was confirmed on the 20 February and the last case on the 30 September 2001.


3.6       Under an emergency vaccination regime, cases would not be expected to occur in the vaccination zone more than 30 days after the start of a vaccination campaign that takes no longer than 10 days to complete. Experience in other countries indicates the last case often occurs well before this if stamping-out of infected premises also occurs


3.7       In our proposals, the use of emergency protective vaccination, applied in conjunction with other measures, seeks to ensure that the disease is brought under control in a far shorter time period.  In addition, and of great benefit to the wider rural economy and its communities, the need for the countryside to remain ‘closed’ for an indeterminate time period would not be necessary. 


            The paramount need for a swift return to normality and the minimisation of impact of FMD is therefore greatly enhanced by the use of a vaccination protocol.


3.8       In essence the draft programme proposes a containment of the virus by isolating the outbreak and surrounding the infected area with vaccinated animals that will have developed herd and flock immunity.  This prevents the virus from spreading and replicating and thus enables the disease to be brought under control.


            In the 2001 outbreak in the Netherlands the disease was brought under control and further outbreaks ceased 8 days after the completion of the vaccination programme.


We submit the following programme for consideration by interested parties and

stakeholders in the FMD debate.  Its purpose is to prepare a deliverable, practical

programme that can be proposed in due course to UK Government, the EU and the






1          Although we acknowledge that there are statutory procedures that must be followed, once clinical symptoms have been identified and the presence of the disease is suspected,  there is also a need for the subsequent process to be clear and easily understood by all those involved.


2          Given the implications of the extensive animal movements now occurring daily in the UK and Europe, the length of time taken to confirm the suspect case is critical.   An explicit Contingency Plan must set out and determine precisely how, when and where the laboratory confirmation of the first suspect case is to be undertaken.  Most importantly it must define the time scale for these actions.


3          An agreed course of action, also specified and detailed in an adopted Contingency Plan, must then be followed. 



4          Such actions, which are crucially time dependent, must involve:


a            Rapid and accurate laboratory diagnostic tests, if possible in regional facilities (or if developed – cow side/ farm gate) using PCR viral assay. – to ascertain definite confirmation, or otherwise,  of the infection in the shortest possible time.


A pen-side test for virus antigen has been recently described with excellent sensitivity and detection of virus in 10 minutes. RT-PCR  will detect virus during the latter part of the incubation period and sub-clinical infection, in addition to clinical cases.


b            Immediate isolation of suspect premise(s), imposition of movement restrictions and effective farm quarantine, involving full bio-security, bio-sanitary arrangements to the premise.


c            Notification of potential outbreak and temporary ‘holding’ position to neighbouring farms and small holdings.


d            A placing on alert of the relevant authorities and agencies



5          If laboratory confirmation is negative then it may be sensible to consider compensation for any losses to the farmer incurred through the imposition of restrictions and bio-security arrangements.  The purpose being to inculcate a culture of responsibility and incentive for farmers to swiftly report suspect cases without loss of earnings, even if the case subsequently proves to be a false alarm.


6          In the event of positive confirmation then the following procedures should be implemented: 


Again a pre-agreed, adopted contingency plan must detail operations and involve:           


                        a            Immediate imposition of nation wide movement restrictions


                        b            Immediate slaughter of index premise


                        c            Immediate effective farm quarantine


                        d            Tracing of dangerous contacts


                        e            Surveillance and laboratory testing of contiguous premises,



7          Should it be found that the disease has not been contained, but that it has already been dispersed and seeded before movement restrictions have been imposed, as happened in the current outbreak, then an emergency, protective, vaccination to live policy should be applied.  


8          The vaccination to live procedures should be effected without the need for a pre-determined and pre-agreed threshold of confirmed cases, but should be introduced as the primary method for control for the high risk area surrounding the location of confirmed IPs.



9          This vaccination procedure should be introduced in conjunction with the following provisions:


a            Immediate, enforced, effective farm quarantine – with a pre agreed protocol, including safe animal separation distances from neighbouring farms


b            Immediate, enforced bio-security - with pre agreed protocol, measures etc –these plans should cover all animal, vehicle, personnel, feed and milk tanker movements – (milk should not be collected from Form D farms without strict adherence to air filter maintenance.)


10        Monitoring and surveillance - Any clinically identified infected stock – preferably supported by PCR viral assay confirmation, would be slaughtered.


11        Immediate implementation of ring, or zonal, or defined administrative area for application of protective, emergency, vaccination programme - around IP(s), dependent on geographical dispersal, local conditions - extent and scale of vaccination zone to be determined via  pre-detailed criteria, and current assessment of on the ground situation and circumstances.


Vaccination should be applied from edge of zone or area towards centre of outbreak(s), and simultaneously with different teams on contiguous premises at the highest risk of receiving and amplifying infection at the heart of the zone, and to all susceptible livestock.


            (Responses to initial consultations with Intervet have suggested that  surveillance zone radii of 10 km may be applied by the EU.  However, for administrative purposes and depending on the scale of the outbreak, we consider that the extent of the vaccination zone will need to be determined as above – but with regard for the need to establish a sufficient area of immunity to enable infection to be contained.)


            The principle consideration is to rapidly achieve a protected zone around the area with high herd immunity 5 days or more ahead of anticipated first virus challenge, together with vaccination at the “heart” of the area to reduce potential virus amplification at the centre, and protect farms at highest risk.


The vaccination programme should aim for completion in less than10 days, so that response to vaccination is seen from about 5 -7 days post-commencement and cases should cease by day 24 post-commencement.


12        All tracings back from index premise should be traced, and animals inspected, and dependant on the period elapsed since the contact, tested for evidence of exposure on a probability basis.


If within the vaccination zones, these farms should be vaccinated if no evidence of infection is clinically detected.  If outside an existing vaccination zone, the decision to keep under surveillance, to vaccinate or to slaughter will depend on a number of factors.  A thorough risk assessment to determine the probability or likelihood of exposure to infection should form part of this process.


13        Standstill period to allow response to vaccine, or response to viral challenge pre or post vaccination.  (this time scale should be a minimum of 14 days, preferably 21 days)


14        Regular Monitoring and surveillance for clinical signs


15        30 days post vaccination commence screening with 3ABC marker test to differentiate and determine which animals have responded to vaccine and those who have responded to viral challenge, either pre or post vaccination – if not previously identified by clinical means during monitoring.  


These animals which have responded to viral challenge will then be slaughtered.  We propose that herds and flocks with 3ABC positive animals be culled.  Those with herds and flocks with 3ABC negative animals do not need to be culled and can be allowed to live. 


The prevalence of animals with antibodies to viral challenge may be highest close to the index IP, but the majority of herds and flocks would not be infected.


16        Those animals which have not shown any response to viral challenge and are 3 ABC negative should be subject to the provisions detailed in the Strategy for Emergency Vaccination against FMD – which was adopted by the EU in March 1999.


            Section 7 of this document sets out “Guidelines for the movement of animals and animal products within and out of an area which has been subject to emergency vaccination” .


            This paper acknowledges that the OIE rules do not take into account  the new serological tests for FMDV-NSP, able to discriminate between vaccinated and infected herds.  See page 17.


            The authors of the report, the Scientific Committee on Animal Health and Welfare, recommend that not less than 30 days from the completion of vaccination, an adequate surveillance system must be established.


            Restrictions can be lifted when the surveillance has been completed with negative results.  (This surveillance is detailed in paras 7.2.1 to 7.2.3 of the Strategy.)   Copy attached


17        We submit that the provisions contained within Paras 7.2.1 to 7.2.3 must be followed to determine FMD free herds and flocks.  However, given that the process we proscribe should not result in any carriers or false negative cases of FMD, we submit that the requirement for separation and treatment of vaccinated meat and meat products must now be re-assessed.


18        In the following sections we contend that the programme we are advocating, using NSP free vaccines and marker tests, directs:


1            that the separation and treatment processes for vaccinated meat, meat and milk products do not need to be applied.


2            that the surveillance regime can be utilised to demonstrate freedom from FMD infection.


As a consequence there should be no distinction between;


1            the end use of meat, and meat and milk products of vaccinated animals, and


2            the length of time to return to disease free status,


regardless of whether vaccination or stamping out is applied to control

the disease.


* PCR – polymerase chain reaction


* 3ABC Marker test – papers available on request












5.1            Modern Vaccines and Tests


5.1.1    The issues of efficacy, potency and availability of vaccines and tests are key to the acceptance of the incorporation of vaccination as part of a control programme.


We have considered the published documents of Merial, Intervet and United BioMedical*, consulted with vets and virologists and raised this issue with the Chief Veterinary Officer regarding vaccination of the hefted flocks (Aug 2001).


*All these papers are available and we can forward them if required.



5.1.2    Modern vaccines can be produced in a highly purified and inactivated form.  If administered in the appropriate form and in the right conditions they can provide effective immunity when used as part of a programme to control the disease with subsequent surveillance and testing.  Ref Drs Sutmoller, Barteling, Watkins, Merial publication, etc



5.1.3    The main opposition that we have encountered to the use of vaccination is that the non structural protein test, used to distinguish between response to vaccine as opposed to response to infection, has not yet been fully validated to the guidelines of the OIE.


Intervet have now introduced a 3ABC marker test which is capable of differentiating between response to vaccination and response to viral challenge.  This has been extensively tested and trialled and provides a definitive tool to differentiate between those animals that have responded to vaccination or viral challenge, for use at herd level.  We understand that this test is now ready for submission to the OIE for validation.


Merial have also produced a similar test and had the test independently assessed although the test is a ‘described’ test, but it is not yet ‘proscribed’, as it has not yet been validated.


United Bio-Medical (UBI) have also developed a range of similar tests and state:  “The complete UBI NS test system has a specificity approaching 100% on vaccinated livestock.  We believe that our system has sufficient sensitivity and specificity to detect evidence of infection in vaccinated herds (eg, potentially infectious carrier animals if they truly exist) while distinguishing the antibody response to infection from the response to vaccination.”


UBI is currently going through a licensure process with the US Dept of Agriculture for the UBI FMDV NS EIA.


5.1.4    The benefits of such tests is that they provide the key tool to screen herds to determine the presence, or otherwise, of animals which have met FMDV infection.  Herds with a low proportion of reactors on a primary screen could then be re-tested by serology in a complete herd test,  with possible addition of a second test to determine if virus or viral RNA, or anti-FMDV IgA was present in a pharyngeal sample of positive animals. 


Such a system was used in Korea in 2000 following emergency vaccination with results presented to OIE as part of the process of regaining FMD freedom.  This means that rapid surveillance methods can be used as a means of demonstrating freedom from infection, which is paramount in regaining disease free status. 


We refer to attached paper from Dr Sutmoller and Dr Barteling presented to the Royal Society Inquiry.


In our discussions regarding the vaccination of the hefted flocks in Wales, the subsequent surveillance and testing, using the NSP test to differentiate between response to vaccination as opposed to challenge pre or post vaccination, was to have provided an effective method of establishing the extent of disease spread, response to vaccination and in determining disease free status.



5.1.5            Availability of Vaccines


We raised the following questions with Intervet and enclose below their response:


1   Are NSP free, highly purified, inactivated, oil-adjuvanted vaccines

available in sufficient quantity to enable them to be used as part of           

the Programme?


and following from this, do Intervet produce them, or any other commercial company?


The product, which is produced in The Netherlands, is being sold in the

Middle East and the Far East.  This product is free from NSP.  We deliver

millions of doses to the market.  Availability depends on the quantities,

which are required.  Antigen-banks ensure availability of sufficient

quantities of vaccine within days in case of emergency.



2    Also, is it known what rate of production could be achieved and in   

      what time scale?


From an antigen-bank we can deliver 500,000 doses within 4 days and

subsequent quantities, depending on availability of antigen within days. The

critical factor really is the availability of antigen and that can be ( and in

the UK is) arranged by contract.  Normally the first quantity would be

produced even before the definite decision to vaccinate is taken.  




5.2       The Role of the OIE,  Sale of Meat and Animal Products Post Vaccination, Carriers, Disease Free Status and Export Markets


5.2.1    The Office International Epizooties (OIE) based in Paris is the international body responsible for conferring disease free status (DFS).   Currently, return to DFS post vaccination requires 12 months, while only 3 months is required following a ‘stamping out’ method of control.


5.2.2            However “These trade regulations are not based on risk assessments, but rather:

* on the notion that vaccination might perpetuate carriers in the population and that those carriers may pose a risk for FMD free countries that do not practice vaccination.

* that there are no methods available for the detection of carriers in vaccinated populations”


“Normal export should be resumed, when after any outbreak, the veterinary services would show the absence of FMD.

*This should be independent of whether stamping-out plus ring vaccination or vaccination only was used to control the outbreak.

*There should not be a set time limit.

*The sooner the country or region shows the absence of viral activity the earlier normal trade can be resumed.”


See attached paper of Dr Sutmoller’s presentation to the Royal Society.


5.2.3            Because the tests now exist to determine between antibody response to infection and antibody response to vaccination those animals which have responded to infection can now be identified and slaughtered.  Such infection may have arisen as a result of pre or post vaccination viral challenge before the vaccinated animal has responded to the vaccine.


Those animals which have responded only to vaccination can thus be identified.


5.2.4            Animals which have been vaccinated and not responded with anti-NSP antibodies to infection might not be detected if tests of low sensitivity are used.  Therefore tests should be used on herd basis where the probability of non-detection can be estimated and would be extremely low with a well designed screening program.  Further, there has been no scientific evidence to show that such animals have ever infected other animals, so non-detection carries exceptionally low risk.


            Carriers or persistently infected animals

            *The fear that vaccination causes FMD carriers and interferes with the eradication effort is completely hypothetical and scientifically unfounded.

            *There is much more chance of getting FMD carriers among cattle and sheep with clinical or sub-clinical FMD.”


            See attached paper from Dr Sutmoller’s presentation to the Royal Society.



5.2.5    It is therefore necessary to move to a science based risk assessment to determine absence of disease, rather than rely on an arbitrary time scale.


5.2.6    Post vaccination surveillance and serology, with the use of the 3ABC marker tests, provide the definitive tools to determine disease free status and can thus be used to restore DFS possibly sooner than with stamping out.   There is certainly no justification to apply a penalty of a longer time period with vaccination.


5.2.7    Our programme proposes only to utilise NSP free vaccine in conjunction with the 3 ABC marker test to enable a swifter return to Disease Free Status, by  demonstrating freedom from FMD.


5.2.8    We now understand that a proposal has been put to the OIE, to allow a return to the status of ‘FMD-free without vaccination’  at 6 months after the last vaccination, provided that absence of infection has been demonstrated with a NSP test. This proposal includes the condition that a NSP-free vaccine is used.


5.2.9            Similarly the restraints placed upon the use of vaccinated meat, meat products and milk are not required as it can be clearly demonstrated that the animals have not been exposed to infection, and herds proven to be clear of past exposure present no risk.


5.2.10  It is therefore fundamentally important that the criteria governing return to DFS and export markets are based on science based risk assessment.   If this basis is established then the current penalties incurred with the use of vaccination are no longer applicable.  Vaccination as a modern, humane approach to FMD control can be used without the need for any pre-determined or pre-agreed thresholds, but as the preferred and primary means of control for at-risk farms, together with immediate slaughter of animals where acute infection is confirmed.







6.1       The Adoption of Process and Procedures to deal with future outbreaks       


6.1.1    May we respectfully ask the Committee to consider:


1          Agreeing a process and procedure with farmers, livestock owners, local veterinary practitioners and the State Veterinary Service to establish surveillance regimes.


2          The drawing up of national, regional and local contingency plans which are in the public domain and produced in consultation with local communities representing all sectors and stakeholders.


3          That the Contingency Plans should include clear protocols detailing diagnostic facilities, effective farm quarantine, safe animal separation details, and bio-security arrangements for farms, personnel, vehicles and animals.


4          The Contingency Plan should make provision for vaccine banks and determine how, and who should deliver the vaccine and how this is to be regulated, recorded and monitored.


5          The Contingency Plan should make proper provision for humane slaughter and disposal of infected stock.


6          The Contingency Plan should also define a regime and protocol for post vaccination surveillance, monitoring and testing programmes.


7          Discussions should be undertaken now with the OIE and EU to agree such protocols and define all procedures.  Particular regard should be had to the process to be adopted to demonstrate freedom from FMD.





April 2002




The National Foot & Mouth Group and Vets for Vaccination are very grateful for the assistance and advice from various vets and scientists in the preparation of this paper. 


In particular we would like to thank Dr Keith Sumption, of Edinburgh University, for his extensive assistance and guidance throughout the preparation of the Programme. 


Also we thank Dr Paul Sutmoller and Dr Simon Barteling of the Netherlands for their various papers, presentations and advice on vaccination, its applications in various control protocols and on carriers and science based risk assessment.


We are also grateful to Dr Sheila Crispin and Dr Sarah Binns of Bristol University for their constructive comments and advice on the proposal.


Finally we thank Dr Paul van Aarle of Intervet for providing further information on the availability,  uses and application of vaccines and tests.





1          Strategy for Emergency Vaccination Against FMD – Report of the Scientific Committee on Animal Health & Animal Welfare

Adopted by the EU 10 March 1999



            2            Intervet Technical Paper – The use of a 3ABC marker-test for FMD

Presented to the 22nd Conference of the OIE Regional Commission for Asia, the Far East and Oceania


3          Dr Paul Sutmoller’s power point presentation to the Royal Society of London – January 2002


4          Dr Paul Sutmoller & Dr Simon Barteling paper to the Brussels Conference on FMD of December 2001


5          OIE – International Animal Health Code 2001 – Chapter 2.1.1 Foot and Mouth Disease