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FOOT AND MOUTH DISEASE EMERGENCY VACCINATION

QUESTION AND ANSWER BRIEF

Contents:

FUTURE DISEASE CONTROL POLICY

  1. In the event of a future outbreak of FMD, what would be the disease control policy?
  2. Why don’t we routinely vaccinate livestock against FMD?
  3. In the event of a future outbreak of FMD, how would the Government determine its disease control strategy?
  4. How will the Decision Tree help in the decision making process on disease control strategy?
  5. Why can’t the Government decide now how it would control a future FMD outbreak?
  6. Can the EU force a Member State to vaccinate?
  7. How quickly would a decision to vaccinate be made?
  8. How can stakeholders be sure that vaccination is properly considered by the Government as a disease control option in the event of a future outbreak?
  9. What vaccination strategy would be used?
  10. So when would Suppressive vaccination (to kill) be considered?
  11. How would the size of the vaccination zone and species to be vaccinated be determined?
  12. If vaccination was restricted to one or two localities, how would this be justified to farmers elsewhere?
  13. When will the new EU Directive become domestic legislation?

WHAT HAS CHANGED SINCE 2002?

  1. Was emergency vaccination considered as a disease control measure during the 2001 FMD outbreak?
  2. Why didn’t we vaccinate in 2001?
  3. So what has changed since 2001 with regard to the use of emergency vaccination?

VACCINE SUPPLIES

  1. Does the UK hold supplies of vaccines?
  2. Will the UK have sufficient stocks of vaccines?
  3. How do we know whether we are holding stocks of the right strains of vaccine?
  4. What strains of FMD vaccine do we currently hold?

OPERATIONAL ARRANGEMENTS

  1. Which animals would be vaccinated?
  2. Over what period of time would the vaccination programme be expected to be completed?
  3. What is the line of command for managing a vaccination programme?
  4. How will farmers be informed when their animals will be vaccinated?
  5. Why use a commercial contractor to vaccinate?
  6. How will the vaccination contractor work alongside the LDCC?
  7. What level of resource is the vaccination contractor able to provide?
  8. What capability is there to increase the level of resource needed?
  9. Once the vaccination zone has been determined, how will the contractor implement a vaccination programme?
  10. What happens if a member of a vaccination team suspects that FMD is present on a farm?
  11. What biosecurity arrangements will apply to the contractor?
  12. What arrangements are in place for on farm biosecurity?
  13. What happens to clinical waste?
  14. Why use lay vaccinators?
  15. What controls are in place to safeguard the vaccine’s safety efficacy and efficiency?
  16. What training will be provided to lay vaccinators?
  17. What role will farmers play in the vaccination process?
  18. What if farmers refuse to assist/co-operate?
  19. Will farmers be paid if they assist in the vaccination process?
  20. How will vaccinated animals be identified?
  21. What data/records will be kept of vaccinated animals?
  22. Will teams have mobile crushes?
  23. What equipment is available to implement a vaccination programme?
  24. Who would take the decision to vaccinate if there is a case of FMD on the English/ Scottish or English/ Welsh border?
  25. What arrangements are in place to test contingency plans for vaccination?

EFFECTIVENESS OF VACCINATION

  1. Are the current vaccines good enough to control the disease?
  2. Can FMD mutate in response to the vaccine?
  3. Can vaccinated animals develop and spread the disease?
  4. What is the risk of spread from infected animals to those already vaccinated?
  5. What is the vaccine effectiveness/disease risk when animal are stressed e.g. at weaning?

POST VACCINATION TESTING

  1. How quickly after vaccination could the country regain its “FMD freedom” status?
  2. What sort of tests would be used to demonstrate absence of infection in animals that have been vaccinated?
  3. Are existing NSP tests internationally recognised?
  4. So, if there are no internationally recognised tests, would this stop us from using emergency vaccination as a disease control measure in the event of a future outbreak?

STAKEHOLDER ISSUES

  1. Do stakeholders still have reservations about the possible use of emergency vaccination in the event of a future outbreak?
  2. What assessment has been made of the likely economic implications if a decision is taken to vaccinate?
  3. Are stakeholders aware of the Government’s Vaccination policy?

WHAT HAPPENS TO ANIMALS AND THEIR PRODUCTS AFTER THEY HAVE BEEN VACCINATED?

  1. What are the various Phases of a vaccination campaign?
  2. Are there any movement controls on vaccinated animals?
  3. What happens to the products from vaccinated animals?
  4. Why do products from vaccinated animals have to be treated before being placed on the market?
  5. What is the required treatment for milk from vaccinated animals?
  6. What is the required treatment for meat from vaccinated animals?
  7. Can we export any products from vaccinated animals to the EU?
  8. Can we export products from vaccinated animals to third countries?
  9. Is compensation paid for animals which are vaccinated?
  10. After vaccination, when could farmers safely restock with other cattle/sheep/pigs?
  11. Would vaccination have any implications for the feeding and management of treated animals? Would there be any husbandry or behavioural characteristics farmers should expect to which they need to respond?
  12. What assurances would HMG have over the re-opening of the UK export market and to third countries following an outbreak of FMD?

TREATMENT OF PRODUCTS FROM ANIMALS WHICH HAVE NOT BEEN VACCINATED

  1. Do products from unvaccinated animals have to be treated?
  2. Why do products from unvaccinated animals have to be treated?
  3. So what are the required treatments for products from the Infected Area?
  4. How long would these treatments be required?

VACCINATION SURVEILLANCE AREA

  1. What is the Vaccination Surveillance Area?
  2. What controls would be placed on the Vaccination Surveillance Area?

SPECIAL MEASURES

  1. What arrangements are in place for the conservation of “rare breeds”?
  2. Which groups of animals will be eligible to be registered as “rare breeds”?
  3. What are the special measures which may be applied to “rare breeds”?
  4. Are zookeepers also required to pre-register their animals for special measures?

FUTURE DISEASE CONTROL POLICY

1. In the event of a future outbreak of FMD, what would be the disease control policy?

As in 2001, the basic disease control policy in the event of a future outbreak would be the slaughter of susceptible animals on infected premises and those identified as dangerous contacts. This is the requirement of the new EU FMD Directive. But greater prominence would be given to the use of emergency vaccination if measures additional to the basic slaughter policy were required to control the disease.

  1. Why don’t we routinely vaccinate livestock against FMD? There has been a ban on routine (prophylactic) vaccination across the EU since 1992 and this ban is maintained in the new EU FMD Directive. This allows EU Member States to maintain the highest FMD international trading status under (OIE) rules of “countries free from foot-and-mouth disease without vaccination”.
  2. In the event of a future outbreak of FMD, how would the Government determine its disease control strategy?

The “Decision Tree” which forms part of FMD Contingency Plan (see Annex b to the Contingency Plan) sets out the factors that the Government would take into account in deciding disease control strategy.

4. How will the Decision Tree help in the decision making process on disease control strategy?

The Decision Tree seeks to aid transparency about the future policy decision making process so that all those concerned will understand how the decisions were arrived at. In addition to the “Decision Tree”, a “Vaccination Protocol” has been developed to clarify what factors need to be taken into consideration. This has been published on Defra’s website at http://defraweb/footandmouth/pdf/vacprotocol.pdf. A “Vaccination Scenarios” document has also been published at http://defraweb/footandmouth/pdf/vaccinationscenarios.pdf . This document illustrates, through the use of scenarios, the potential role for the possible use of emergency vaccination in tackling a future outbreak of FMD.

5. Why can’t the Government decide now how it would control a future FMD outbreak?

As circumstances can vary widely, it is not possible to prescribe a detailed response in advance of an outbreak. The decision to adopt a particular control strategy will depend on a wide range of factors as indicated in the “Decision Tree”, many of which cannot be determined until we have knowledge of the nature and extent of the outbreak. Veterinary and scientific advice and judgement remain vital in determining disease control strategy.

6. Can the EU force a Member State to vaccinate? The Directive places a duty on Member States to prepare all arrangements necessary for emergency vaccination in an area at least the size of the Surveillance Zone as soon as the first case of FMD is confirmed.

An EU Decision to introduce emergency vaccination may be made when outbreaks threaten to become widespread or when other Member States are at risk. This can be either at the request of the Member State at risk or initiated by the Commission itself.

The affected Member State would, of course, be consulted in the decision-making process.

  1. How quickly would a decision to vaccinate be made? It is not possible to place timescales on when decisions on disease control policy would be taken. Decisions would be made as quickly as possible given the particular set of circumstances and would be reviewed repeatedly as circumstances changed and more information became available.
  2. How can stakeholders be sure that vaccination is properly considered by the Government as a disease control option in the event of a future outbreak?

There is a duty upon the Secretary of State, contained within the Animal Health Act, to consider the most appropriate means of preventing the spread of foot-and-mouth disease, particularly the use of emergency vaccination.

If measures additional to the slaughter of animals on infected premises and those identified as dangerous contacts are required, and the Secretary of State decides to use preventive slaughter powers, she has to publish the reasons for using these powers and explain why emergency vaccination is not being used.

  1. What vaccination strategy would be used? The Government’s preference, if emergency vaccination is used, is for (protective) vaccination to live.
  2. So when would Suppressive vaccination (to kill) be considered? Suppressive vaccination (to kill) might be considered where the number of animals to be culled is likely to exceed the immediately available disposal capacity. In those instances, animals in defined areas would be vaccinated first and slaughtered only as disposal capacity became available. It could also be used where there is an urgent need to reduce the amount of virus circulating in an area and reduce the risk of spread beyond that area.
  3. How would the size of the vaccination zone and species to be vaccinated be determined?

The decision on which species would be vaccinated and the size and shape of the vaccination zone would be determined by veterinary/epidemiological judgement. Other factors such as the availability of vaccine; the virulence of the strain; its tendency to airborne transmission; and how long the disease had been undetected, facilitating its spread, would all need to be taken into account. Seasonal farm management factors may also need to be taken into account.

12. If vaccination was restricted to one or two localities, how would this be justified to farmers elsewhere?

If the Government decided to go ahead with vaccination it would make clear the criteria for any vaccination campaign.

13. When will the new EU Directive become domestic legislation? We will be consulting on a new Statutory Instrument to replace the FMD Order 1983 and its numerous subsequent amendments later this year. In the meantime, if there was an outbreak of FMD we would have sufficient domestic legislative powers to control it.

WHAT HAS CHANGED SINCE 2002?

14. Was emergency vaccination considered as a disease control measure during the 2001 FMD outbreak?

During the 2001 outbreak, vaccination was considered on 10 occasions, but not adopted.

15. Why didn’t we vaccinate in 2001? Scientific and veterinary advice was that we would eradicate the disease quickest and most effectively through culling and tight biosecurity.

The Chief Veterinary Officer and Chief Scientific Adviser did recommend vaccination in North Cumbria to protect cattle before they were turned out from their winter sheds, providing such a policy was supported by a substantial proportion of farmers, vets, consumers and the wider food trade. Such support was not forthcoming. As the epidemic waned, the arguments for vaccination became less compelling.

16. So what has changed since 2001 with regard to the use of emergency vaccination?

The Royal Society’s Report on Infectious Diseases in Livestock and the Lessons Learned Inquiry Report, published in response to the 2001 outbreak, recommended that emergency vaccination should considered as part of the control strategy from the start of any future outbreak, in addition to culling of animals on infected premises and those identified as dangerous contacts. However, the Royal Society Report recognised that there were a number of issues to be overcome before emergency vaccination could be considered as a fully viable disease control option. This included logistical and scientific issues and gaining stakeholder buy-in to such a policy. Much progress has been made towards resolving these issues since the 2001 outbreak of FMD.

In addition, the new EU FMD Directive, adopted in September 2003, gives greater prominence to the potential use of emergency vaccination as a disease control measure in the event of a future outbreak. Article 14 of the Directive places a duty on Member States “to prepare all arrangements necessary for emergency vaccination in an area at least the size of the Surveillance Zone” as soon as the first case of FMD is confirmed.

VACCINE SUPPLIES

  1. Does the UK hold supplies of vaccines? The UK has its own stocks of FMD antigens held on its behalf by a commercial supplier. These supplies are suitable for use in an emergency vaccinate - to -live strategy, the Governments preferred vaccination policy.
  2. Will the UK have sufficient stocks of vaccines? In addition to its own stocks of FMD antigens, the UK has access to a wider range of strains in the EU Vaccine Bank for emergency use.
  3. How do we know whether we are holding stocks of the right strains of vaccine?

The number of doses and the strains available are reviewed annually based on advice from the Institute of Animal Health at Pirbright on those strains of FMD which present the greatest risk to the UK.

20. What strains of FMD vaccine do we currently hold? This information is classified.

OPERATIONAL ARRANGEMENTS:

21. Which animals would be vaccinated?

The species of animals to be vaccinated would be subject to veterinary/epidemiological assessment. Then only those over 2 weeks old in the case of ruminants and over 8 weeks old in the case of pigs, within the Vaccination Zone would be vaccinated. Exceptions would be Dangerous Contacts, Infected Premises, premises where disease is confirmed following discovery by the vaccination team of suspected clinical signs of FMD, and (unless and until the presence of FMD is ruled out there) any premises where clinical signs are suspected.

Breeds considered to be ‘Breeds at Risk’ may also be considered for vaccination if they were within the Vaccination Zone. See below.

22. Over what period of time would the vaccination programme be expected to be completed?

The programme will be completed as soon as is practicable.

  1. What is the line of command for managing a vaccination programme? The strategic direction behind any vaccination programme would ultimately be provided by the CVO and Ministers through to the NDCC. The NDCC would house a vaccination cell which would manage an appointed vaccination contractor from the centre to ensure it could be used to best effect on a national basis.
    1. How will farmers be informed when their animals will be vaccinated? The vaccination contractor will contact farmers to arrange for pre-vaccination inquiry visits to be carried out by veterinary surgeons to check animals for any signs of disease and to assess animal handling facilities.
    2. Where FMD is not found, vaccination team(s) will be dispatched to the farm/holding to vaccinate, tag and record details of each animal. Each vaccination team will consist of a lay vaccinator (acting under veterinary direction), an animal handler/ear tagger and a data recorder.
  2. Why use a commercial contractor to vaccinate? Veterinary and other staff resource within DEFRA/SVS is likely to severely stretched in an FMD outbreak situation and the appointment of an external contractor to provide the vaccination resource ensures that we have a sufficient number of teams trained and on standby to be used in the event of an outbreak.
    1. How will the vaccination contractor work alongside the LDCC? Given the fact that the vaccination contractor will be managed on a national basis, effective communications at a local level will be essential to ensure smooth
    2. implementation. This will be addressed as part of the development of operational instructions – yet to be developed - where it is envisaged some form of local coordination cell will be created within the LDCC which will act as a liaison point between the LDCC and the contractor/vaccination teams.
  3. What level of resource is the vaccination contractor able to provide? Our current arrangements provide for our external contractor to provide 50 fully trained and equipped vaccination teams to be put into the field by day 5 of an outbreak (each team consists of a vaccinator, an ear tagger and a recorder).
  4. What capability is there to increase the level of resource needed? Our vaccination contractor is committed to ramping up our initial response of 50 vaccination teams, to meet any reasonable disease scenario, within four to five days - at whatever stage this notice is given.
  5. Once the vaccination zone has been determined, how will the contractor implement a vaccination programme?

The vaccination contractor will contact farmers to arrange for pre-vaccination inquiry visits to be carried out by veterinary surgeons to check animals for any signs of disease and to assess animal handling facilities.

Where FMD is not found, vaccination team(s) will be dispatched to the farm/holding to vaccinate, tag and record details of each animal. Each vaccination team will consist of a lay vaccinator (acting under veterinary direction), an animal handler/ear tagger and a data recorder.

30. What happens if a member of a vaccination team suspects that FMD is present on a farm?

Teams will be withdrawn from farms where clinical signs of FMD are suspected. In doing so, biosecurity protocols must be followed and all relevant items for disposal placed into a clinical waste bag which should then be sealed for disposal. Teams would be redeployed after suitable biosecurity protocols have been followed and a 72 hour break.

    1. What biosecurity arrangements will apply to the contractor? The contractor is required to ensure that its veterinary surgeons and vaccination teams are fully aware of the bio-security measures which must be followed and ensure these are enforced. Relevant training will be provided to vaccination teams based on the biosecurity guidance issued by Defra and Scotland.
    2. The Contractor’s staff must not have come into contact with susceptible animal species for 72 hours prior to vaccinating animals in a vaccination zone and for 72 hours post completion of work in a vaccination zone. Staff who come into contact with stock infected with FMD are required to withdraw from the vaccination programme for a period of 72 hours and must not come into contact with susceptible livestock.
    1. What arrangements are in place for on farm biosecurity? There is strict guidance in place for the handling and disposal of vaccine and clinical waste. Vaccination team members will be required to adhere to strict biosecurity protocols and guidance when entering and leaving a farm. Call off contracts are in place for the collection and disposal of clinical waste.
    2. The State Veterinary Service has also issued VIPER (Veterinary Insets, Procedures, and Emergency Routines) Instructions which outline the arrangements for on farm biosecurity during an outbreak.
  1. What happens to clinical waste? The contractor is responsible for ensuring clinical waste is put into secured plastic bags, cleansing and disinfection of the bags and their delivery to a secure site at the vaccination centres for regular collection and incineration.
  2. Why use lay vaccinators? To relieve pressure on veterinary surgeons during future outbreaks of FMD, when it is likely that they would be fully occupied on other essential control duties.

Current legislation prevents anyone other than a qualified Veterinary Surgeon from receiving and administering vaccine to animals. Depending on the scale and nature of the outbreak there may not be enough veterinary resource to implement a vaccination programme and for this reason we have recently been out to consultation on proposed amendments to the Veterinary Surgeons Act and the Medicines Act to allow for the sale, supply, and distribution of vaccine by lay personnel, under veterinary direction. This would enable a vaccination programme to be carried out more quickly and would leave qualified veterinary staff free to carry out other essential tasks during an outbreak. We are currently considering responses received. Details of the consultation can be found on Defra’s website.

35. What controls are in place to safeguard the vaccine’s safety efficacy and efficiency?

Whoever (i.e. Defra officer or contractor) takes receipt of vaccine will still need to comply with the provisions contained in the “Rules and Guidance for Pharmaceutical Manufacturers and Distributors” and this requirement has been embodied into the contract with the vaccination contractor.

36. What training will be provided to lay vaccinators? As a minimum, vaccination teams’ training will cover:

  • Health and Safety issues including, but not limited to the dangers of receiving an injection of oil based vaccine and the need for immediate medical attention, relevant HSE guidance.
  • A course leading to a certificate of competence, valid for one year signed by a veterinary surgeon for vaccination team members required to act as lay vaccinators.
  • The use of equipment including applicators and ear tags, vaccination kits and handling facilities such as crushes
  • Cleansing and disinfection procedures to be used.
  • Biosecurity
  • Animal handling
  • Organisation and exchange of information between vaccination teams/directing veterinary surgeons/vaccination centres.

37. What role will farmers play in the vaccination process? Given their knowledge and familiarity with their animals, farmers will be encouraged to assist with the vaccination process and, in an emergency situation, this will be a valuable option that may help us reduce the size of the vaccination teams and complete the task more quickly, and hence the speed at which the vaccination programme as a whole can be completed.

While assistance may be sought with the gathering and handling of animals, tasks such as the identification and recording of vaccinated animals (as required by the EU Directive on FMD – see below ), and the handling and administration of vaccine, is subject to strict control and audit requirements. All vaccine used, returned to the vaccination centre or “wasted” must be accurately recorded centrally. The vaccination contractor will ensure all necessary legislative and professional guidance is adhered to in this respect.

  1. What if farmers refuse to assist/co-operate? There is a duty placed upon farmers to assist with the vaccination process in the Animal Health Act 1981, as amended in 2002. This Act also gives powers for the issue of a warrant authorising an inspector to enter premises, using reasonable force if necessary, for the purpose of vaccination.
  2. Will farmers be paid if they assist in the vaccination process? No.
  3. How will vaccinated animals be identified? The EU Directive on FMD requires Member States to take measures for additional identification or permanent and indelible marking of animals in the case of vaccination. It does not require animals to be uniquely identified. To meet this requirement we will use plastic orange button tags, (which will be available only to the SVS to reduce the risk of fraud) which have been deemed preferable to metal tags as they pose fewer welfare issues.
  4. What data/records will be kept of vaccinated animals? In addition to this, we will be required to record the Official Animal Identification (OAI) numbers of cattle. This is required for any future tracing of vaccinated bovines. The cattle passports system administered by the British Cattle Movement Service (BCMS) and their associated database the Cattle Tracing System (CTS) would be used to record vaccinated animals.
  5. Will teams have mobile crushes? An initial assessment of additional facilities required on farm/holding will be undertaken as part of the pre-vaccination visit and Defra has a call of contract in place to provide mobile animal crushes should the need arise.
  6. What equipment is available to implement a vaccination programme? DEFRA currently hold vaccination equipment on two sites, one based at Aston Down in Gloucestershire and the other at the Central Science Laboratory (CSL) in York. We are responsible for the purchase and maintenance of equipment in usual circumstances. However, in the event of an outbreak this responsibility will transfer to the vaccination contractor.

With present stocks of disposable equipment vaccination teams will be able to vaccinate one farm per day for a period of 13 days. However the number of animals that a team will be able to vaccinate will vary depending of weather conditions and the number of daylight hours. However, call off contracts are in place for the supply of further items of essential equipment. Call off contracts are in place to purchase additional equipment and these are triggered immediately upon suspicion of disease to ensure sufficient equipment is available.

44. Who would take the decision to vaccinate if there is a case of FMD on the English/ Scottish or English/ Welsh border?

In the event of a reported case of FMD on the English/ Welsh or English/ Scottish border, devolved administrations will have a important role in the decision making process on whether to vaccinate. However, the ultimate decision will need to be made by the Secretary of State on the advice of the CVO.

45. What arrangements are in place to test contingency plans for vaccination? Vaccination plans were tested in an HQ exercise in November 2003 and there are ongoing plans for further exercises to be carried out and a national scale exercise is taking place during June.

EFFECTIVENESS OF VACCINATION

  1. Are the current vaccines good enough to control the disease? Yes, however no vaccine is 100% effective. It is possible that in a small number of cases there would be a failure of the vaccination to provide protection, not because the vaccine itself is ineffective, but either because of inadequate administration of the vaccine or because a small number of animals are likely to respond atypically and develop only a low level of immunity.
  2. Can FMD mutate in response to the vaccine? There is no evidence that it can.
  3. Can vaccinated animals develop and spread the disease? Once vaccinated, animals are considered fully protected and should not develop disease. However, the virus can replicate even in animals immune against the development of clinical disease if they are exposed to infection. A proportion of such animals can become persistently infected while never developing clinical disease. These are so-called “carriers”. Expert scientific advice is that spread from vaccinated carrier animals is a rare event: the amount of virus excreted is many orders of magnitude less than that excreted by animals during the acute phase of disease or during sub-clinical infection. Excretion from carriers is intermittent and at a diminishing level over time, occasionally up to three years.
  4. What is the risk of spread from infected animals to those already vaccinated? There is such a risk for an initial period of 3-5 days following use of high potency vaccine while immunity takes effect (10-12 days for lower potency vaccines).
  5. What is the vaccine effectiveness/disease risk when animals are stressed e.g. at weaning?

Stress should not normally inactivate the vaccine.

POST VACCINATION TESTING

51. How quickly after vaccination could the country regain its “FMD freedom” status?

The OIE (Organisation International des Epizooties – the international animal health standard setting body) sets down rules for recovery of FMD free status. Disease free status can be recovered:

  • three months after the last case where culling of animals on infected premises and dangerous contacts (“stamping out”) and surveillance are applied;
  • three months after the slaughter of the last vaccinated animal where stamping out, serological surveillance and emergency (“suppressive”) vaccination is used.
  • six months after the last case or the last vaccination where stamping out and “protective” vaccination to live is used, provided that serological surveillance based on the detection of FMD non-structural proteins demonstrates the absence of infection in the remaining vaccinated population.

52. What sort of tests would be used to demonstrate absence of infection in animals that have been vaccinated?

Antibody tests – Non Structural Protein (NSP) tests - exist which can differentiate between animals, on a herd basis, which have been vaccinated and those which have been vaccinated and subsequently exposed to the FMD virus, or may still be infected.

  1. Are existing NSP tests internationally recognised? As yet there are no internationally recognised NSP tests for use in any species of livestock. The OIE (the international animal health standard setting body) has agreed the principle of using NSP tests for serosurveillance to distinguish herds that have been vaccinated against FMD from those that have been infected but the sampling level to demonstrate this is still under consideration. There are currently two NSP tests for FMD described in the OIE manual but as these are not sufficiently reliable on an individual animal basis, they cannot be accepted as prescribed tests for the purposes of international trade. Nevertheless, the OIE FMD and Exotic Diseases Commission and the OIE Code Commission have accepted the principle of herd based NSP serosurveillance as a basis for countries regaining FMD free status.
  2. So, if there are no internationally recognised tests, would this stop us from using emergency vaccination as a disease control measure in the event of a future outbreak?

The absence of an internationally validated test would not prevent the use of vaccination in the event of a future outbreak. We would use a herd based NSP test on a statistical basis and, where positive results were found, we would use a higher discriminatory test (Probang). However, this may result in a delay in demonstrating freedom from disease.

STAKEHOLDER ISSUES

55. Do stakeholders still have reservations about the possible use of emergency vaccination in the event of a future outbreak?

Since January 2003, we have been engaged in a series of meetings with stakeholders to discuss the implications of disease control strategies, including emergency vaccination. Smaller sub-group meetings have also been held, amongst others, with the meat, milk and retail sectors. This work is continuing to gain stakeholder acceptance of products from vaccinated animals entering the food chain as normal.

56. What assessment has been made of the likely economic implications if a decision is taken to vaccinate?

As recommended in the Lessons Learned Report, Defra has commissioned a Cost Benefit Analysis on Disease Control Strategies which will consider a number of core scenarios and provide additional evidence for future decision making on disease control strategy. Results from the Cost Benefit Analysis are expected towards the end of 2004.

57. Are stakeholders aware of the Government’s Vaccination policy? DEFRA is communicating with stakeholders to ensure that they are aware of issues relating to the Government’s vaccination policy. We are liasing with farming, food and consumer groups to ensure that the views of all interested parties are appropriately represented in the policy making process. We are undertaking a programme of regional communications to reach a wide section of the rural economy. There has also been stakeholder involvement in the development of the FMD Directive and the Contingency Plan.

WHAT HAPPENS TO ANIMALS AND THEIR PRODUCTS AFTER THEY HAVE BEEN VACCINATED?

58. What are the various Phases of a vaccination campaign? There are three Phases to a vaccination campaign:

Phase 1: During this phase the geographical area for vaccination and the species to be vaccinated are identified. This phase lasts until 30 days after completion of vaccination in the zone.

Phase 2: This phase is after vaccination is completed and prior to the completion of the classification of holdings by carrying out a clinical and serological (NSP) survey.

Phase 3: This after completion of the survey to check for infected animals amongst the vaccinated population, but before FMD free status has been regained.

59. Are there any movement controls on vaccinated animals? During Phase 1, movement of live animals of susceptible species is prohibited between holdings and out of the vaccination zone, except for immediate slaughter.

In Phase 2, movement of live animals of susceptible species is prohibited between holdings and out of the vaccination zone, except for immediate slaughter.

During Phase 3, movement of live animals of susceptible species out of the vaccination zone is prohibited, except for immediate slaughter. Movement of susceptible animals between holdings can be authorised. Unvaccinated animals can move outside the vaccination zone.

Vaccinated animals cannot be exported even after FMD free status is regained.

  1. What happens to the products from vaccinated animals? The products from vaccinated animals have to be treated and the treatments vary according to the phase of the vaccination campaign (see below).
  2. Why do products from vaccinated animals have to be treated before being placed on the market?

This is done for animal health reasons – to prevent the virus accidentally being spread. There are no implications for human health.

62. What is the required treatment for milk from vaccinated animals?

During all 3 phases of a vaccination campaign, milk from vaccinated animals has to be heat treated (pasteurised) at a dairy within the vaccination zone or transported outside the zone for treatment, subject to strict biosecurity rules.

63. What is the required treatment for meat from vaccinated animals? During Phase 1, all meat from vaccinated animals has to be heat-treated or naturally fermented and matured before it is placed on the market.

During Phase 2, fresh meat from vaccinated pigs would still be subject to heat treatment. Meat from vaccinated cattle and sheep would have to be deboned and matured before being placed on the market.

During Phase 3, meat from vaccinated animals would have to be treated as in Phase 2. However, during this Phase untreated meat from vaccinated cattle and sheep can be placed on the domestic market only. Untreated meat from vaccinated pigs can be placed on the domestic market and can also be exported to another Member State if requested by them.

  1. Can we export any products from vaccinated animals to the EU? Provided products from vaccinated animals have been treated in line with requirements, they can be exported to the EU. During Phase 3, untreated meat from vaccinated pigs can be exported, to other Member States, at their request. Such meat would have to bear a special mark.
  2. Can we export products from vaccinated animals to third countries? Provided products from vaccinated animals have been treated in line with requirements, they can be exported to third countries. Once FMD free status is regained, no treatment is required.
  3. Is compensation paid for animals which are vaccinated? If a policy of emergency vaccination to live is adopted, no compensation will be payable as the animals will live out their normal economic lives. Compensation is however, paid for animals slaughtered under a suppressive vaccinate to kill policy.
  4. After vaccination, when could farmers safely restock with other cattle/sheep/pigs?

Vaccination in itself does not prevent re-stocking. This will depend upon other restrictions in force at the time and the veterinary judgement taken about when it is safe to re-stock.

68. Would vaccination have any implications for the feeding and management of treated animals? Would there be any husbandry or behavioural characteristics farmers should expect to which they need to respond?

There are no implications.

69. What assurances would HMG have over the re-opening of the UK export market and to third countries following an outbreak of FMD?

There can be no certainty in this area. There are OIE recommendations but these do not have legal force. We can expect that other countries (EU and other) would want to be satisfied that the disease had been fully stamped out. This would involve serological testing on a large scale. This would be the position whether we vaccinated or not.

The EU Directive lays down the rules for marketing meat and milk and their products (see answer to question 32). Vaccinated live animals will not be eligible for intra-Community trade.

TREATMENT OF PRODUCTS FROM ANIMALS WHICH HAVE NOT BEEN VACCINATED

  1. Do products from unvaccinated animals have to be treated? If the animals are from the infected area (Protection or Surveillance Zone), their products also have to be treated. This is unlike the situation in 2001.
  2. Why do products from unvaccinated animals have to be treated?

This is done for animal health reasons – to prevent the virus from being accidentally spread. There are no implications for human health.

72. So what are the required treatments for products from animals from the Infected Area?

The requirements for meat are complicated – this is why we have produced 2 papers: one for the meat industry and one for farmers – to explain these in detail. These papers will be published on our website in due course.

But the requirements can be summarised as follows:

Meat produced from animals from the Protection Zone has to be heat-treated. In practice, however, as animals are only allowed to move from the Protection Zone for emergency slaughter, it is unlikely that there would be any meat produced from these animals.

Meat from sheep and cattle from the Surveillance Zone has to be either heat treated or deboned and matured; meat from pigs has to be heat-treated.

Milk from animals in the Infected Area has to be pasteurised.

73. How long would these treatments be required?

Treatment of products from animals from the Infected Area would be required for at least the first 30 days after the Protection and Surveillance Zones were declared. After this, it may be possible to gain derogation to sell these products without treatment.

VACCINATION SURVEILLANCE AREA

  1. What is the Vaccination Surveillance Area? Once a decision to vaccinate has been taken, the EU FMD Directive requires a Vaccination Surveillance Area not less than 10 kilometres wide surrounding the vaccination zone to be established.
  2. What controls would be placed on the Vaccination Surveillance Area? Within this zone, movement restrictions would apply, animals could not be vaccinated and there would be enhanced disease surveillance.

SPECIAL MEASURES

    1. What arrangements are in place for the conservation of “rare breeds”? One of the accepted recommendations in the Government response to the FMD Inquiries was that Defra should draw up arrangements for the prior registration of zoo and rare breed collections to facilitate a possible emergency vaccination strategy. In addition, Articles 15 and 77 of the new EU FMD Directive (2003/85/EC) provide a legal basis for the conservation of “farm animal genetic resources”.
    2. We are currently developing a database to meet this requirement.
  1. Which groups of animals will be eligible to be registered as “rare breeds”? Definitions of ‘breeding nuclei’ and ‘farm animal genetic resources’ (as termed in the Directive) have been agreed following a consultation exercise and the criteria have been announced.

In order to be eligible for the special measures detailed in the Directive, premises must be pre-registered and appropriate levels of bio-security must be applied.

Details of how to register will be announced later this summer.

  1. What are the special measures which may be applied to “rare breeds”? Special measures may include an option to derogate from the requirement to slaughter all animals on infected premises and an option to vaccinate.
  2. Are zookeepers also required to pre-register their animals for special measures?

No. There is no requirement in the Directive for zoo animals to be pre-registered. However, the Royal Society Report recommended that a list of zoos be drawn up so that they can easily be located in the event of a future outbreak. Defra’s Global Wildlife Division are working on this in conjunction with the Local Authorities.

25 June 2004