Epidemiological questions

1. Why is vaccination being mooted now?

There are two factors. One is the imminence of cattle turn out and the concern that in areas with dense sheep populations in which there may be undisclosed infection this could lead to a surge in new cases in cattle. The suggestion from farming leaders that farmers might keep cattle housed for longer than normal is welcome and has already been reflected in advice to farmers. But it only offers cattle partial protection. Many of the recent new cases in Cumbria have been in housed cattle (linked to movements of people and equipment). The second factor is recent advice from the Government's Chief Scientific Adviser which suggests that although current policies are containing the epidemic, in northern Cumbria - and possibly Devon - this would only be achieved at the cost of losing a high proportion of the livestock.

Vaccination of cattle and allowing them to complete their normal working lives also subsequently reduces pressures on disposal (particularly of older cattle) and minimises the risk of further spread of disease from slaughtered animals not yet disposed of.

2. What factors make vaccination a possibility in Cumbria and Devon but not elsewhere?

Vaccination is not ruled out in other areas. What presently makes northern Cumbria and possibly Devon prime cases is the high level of infection overall in the area and the prospect of large numbers of cattle being turned out, after winter housing, among sheep still carrying undetected infection. The objective of vaccinating cattle would essentially be to ensure that these areas come out of the epidemic with significant numbers of cattle still alive. Protecting the cattle by vaccination would allow more time to address the problem in the sheep population by a mixture of culling and serological testing, which will be a lengthy process.| top |

3. How does the situation now differ from when previous advice was issued (eg on 3 April by the Chief Scientist's Group) or when the epidemiologists recently visited the regional control centres?

See answer to question 1.

4. What is the present estimate of the progress of FMD on the basis of current control programme?

The current outbreak of FMD in the UK is a heterogeneous group of epidemics. Overall the number of cases and the dissemination rate (as at 11 April) are declining, although this hides increases or plateaus in some areas. The Estimated Dissemination Rate for the epidemic as a whole is 0.8 in the most recent full week. The epidemic is continuing in Durham, North Yorkshire, Lancashire and the Lake District. The numbers of cases may be increasing in the Severn Valley. Case numbers in Devon have levelled off but this may take no account of hidden disease in sheep. The epidemic appears to be decreasing in Powys, Northumberland and Cumbria (though Cumbria is still giving rise to more than half the new cases). The epidemic is controlled in Essex & Kent and Anglesey & Gwynedd. Cases continue to occur outside the defined geographic clusters, but the majority have a clear link to existing cases.

5. How does achieving 24/48 hr affect the prognosis?

Achievement of the 24 hour and, so far as possible, 48 hour targets remains the key policy objective for disease control. Vaccination is a supplement to help reduce the amount of virus in circulation, not a substitute for the overall policy of stamping out the disease.

6. What difference does movement of cattle out of housing at the end of this month make?

See answer to question 1. The scientific advice is that keeping cattle housed reduces their risk of exposure to infection, compared to a situation where they would be in contact with sheep, but is not of itself any guarantee against infection, as has been demonstrated by the recent new cases in housed cattle.

7. Can keeping cattle housed provide an alternative to vaccination?

See answers to question 1 and question 6. It is apparent that some cattle are already being turned out.

8. What is the reduction in numbers of cattle, sheep and pigs expected to be slaughtered if we start to vaccinate?

The epidemiologists' projections suggest that on current policies, without vaccination, between 70% and 99% of livestock in northern Cumbria could be lost. With vaccination, the aim would be to protect all the cattle which remain at the point when vaccination would start (currently estimated at up to 240,000 cattle in Cumbria and up to 180,000 in Devon). Vaccinating cattle should also contribute indirectly to keeping more sheep alive, as with the cattle protected there would be less of a risk in letting breeding ewes and special flocks live and gradually serologically testing them over time. The risk of infecting pigs would also be lower.

9. Will vaccination prolong the course of FMD?

This outbreak is likely to have a long 'tail' because of the extent of infection in the sheep population, which may continue to circulate unrecognised. This means that we can expect isolated individual new cases to keep occurring from time to time for many months after the bulk of the epidemic has been stamped out. This is likely to be the case regardless of whether we vaccinate or not. There is no reason why vaccination of cattle of itself should prolong the epidemic as the scientific evidence is that the chances of vaccinated carrier animals infecting other non-vaccinated livestock are low. Vaccination would only be renewed if the state of disease control in sheep justified further protection for cattle; in these circumstances the long tail of the disease would already be extended, without vaccination.| top |

The Science of Vaccination

10. Are the current vaccines good enough to control the disease?

Yes, but see answers to question 14 and question 19.

11. Can FMD mutate in response to the vaccine?

There is no evidence that it can.

12. Serological test - vaccine and anti bodies v disease

We would not plan to serologically test vaccinated cattle (which will all be individually identified). We might, however, need to serologically test the progeny of vaccinated animals. Vaccination of breeding animals will result in the presence of maternal antibodies in their young. These antibodies provide effective initial protection but they decrease during the first few months of life at a rate which depends on the immunity of the dam and are likely to be lost by 3-4 months of age.

13. How do we prove that FMD is eliminated from a vaccinated area?

By serologically testing non-vaccinated stock in the vaccination area.

14. What spread from vaccinated animals?

Once vaccinated animals are fully protected they 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.

15. Need to separate vaccinated cattle from sheep?

There is no need for a physical barrier. There would be enhanced veterinary surveillance in the area around the vaccination zone. Vaccination would enable the situation where sheep subsequently come into contact with cattle, eg at shearing or tupping, to be properly managed.

16. What risk of spread from infected sheep to vaccinated cattle?

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) and MAFF would therefore recommend keeping cattle housed for a week after vaccination. Thereafter there should be no danger of vaccinated animals becoming infected for at least 6 months. The vaccine will continue to give some protection for up to 12 months, but not necessarily enough to protect against a high level of exposure to infection towards the end of that period. If it was thought necessary to maintain immunity for longer than 6 months a booster dose might be required. See also Question 9.

17. How reliable are the later serological tests in distinguishing vaccinated and exposed stock?

There is a blood test for distinguishing vaccinated from infected animals, but it is not at present suitable for general use. It is not our intention at this time to serologically test vaccinated cattle, as they are unlikely to play a significant role in transmitting disease. Rather, we expect to be targeting serological testing on sheep and unvaccinated cattle (including calves), and there are effective tests that could be used for this.

18. What is the vaccine effectiveness/disease risk when animal are stressed eg at weaning?

See answer to question 16. Stress should not normally inactivate the vaccine.

19. What proportion of cattle will the vaccine fail to protect?

No vaccine is 100% effective. It is possible that in a small number of cases there will be a failure of the vaccination to protect vaccinated cattle, 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.| top |

Practical issues arising from vaccination

20. Which areas are to be vaccinated?

Depending on the course of the disease and final veterinary judgements, around 132 parishes, which contain the 3km zone around infected premises in the heavily infected area, would be covered in Cumbria and around 110 in Devon.

21. Which animals are to be vaccinated?

All cattle over 7 days old, with the exception of 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. Note that vaccination would be carried out on Contiguous Premises where eligible cattle are still alive.

22. Will hefted sheep be exempted from a cull or vaccination?

There is no intention to vaccinate any sheep. Unless they become infected, the presumption is that hefted sheep would not be culled but would be left on the fells. At a later stage when they would normally be brought down for management purposes such as shearing or tupping, breeding ewes could be serologically tested before being returned to the fells.

23. Does MAFF have sufficient resources to operate a vaccination programme without detracting from the 24 hour cull?

Yes. Planning and operating the vaccination campaign has been contracted out to ADAS. ADAS has recruited and trained people with experience of handling stock locally in Cumbria and Devon to form vaccination teams, assisted in Cumbria by members of the army. Veterinary supervision will be provided by 50 TVI's, some of whom will have to be temporarily taken off other lower priority duties, not the 24 hour cull.

24. Would vaccination release resources which can be used to improve the welfare disposal and movement schemes?

Vaccination of cattle will release resources currently going into culling and disposing of cattle. This should help speed up the culling and disposal of sheep. It may make a contribution in relation to the welfare disposal scheme, but this is unlikely to be significant. The effort on this scheme is in any case being intensified.

25. How will farmers be informed when their cattle will be vaccinated and about what they are required to do (eg collect cattle together, have passports to hand etc)? What notice period for a visit will the farmer receive?

If and when a decision is made to proceed with a vaccination programme, full information will be posted to farmers. Once the programme begins each farmer will be contacted by phone by ADAS to arrange appointments for first the vet and then the vaccination team to visit. The ADAS phone call could be anything from 3-13 days after the initial contact. As well as making the appointments the ADAS phone call will seek the farmer's co-operation in planning the vaccination, including asking him to have the cattle gathered in one place (if they are not housed) and having passports available. Normally ADAS will seek to arrange for the vet to visit the following day and the vaccination team the day after, but they will take account of individual farmers' wishes as far as possible.

26. What if a farmer resists vaccination?

The statutory instrument will provide for powers of entry, but MAFF and ADAS will be looking to achieve the maximum degree of farmer co-operation by full information and careful explanation rather than proceeding by force.

27. Over what period of time is the vaccination programme in Cumbria and/or Devon expected to be completed?

The Commission's Decision giving us clearance to vaccinate requires us to complete the programme within a 14-day period, though we will try to work faster than this if practicable.

28. What are the precise vaccination plans, including the use of further boosters?

In Cumbria and Devon, if vaccination goes ahead in either or both, the plan would be to use high potency vaccine from the International Vaccine Bank at Pirbright. A single dose would achieve immunity for 6 months so no booster injection would be required during that period. See also Question 9.

29. Are all cattle vaccinated? Why has advice changed about vaccinating pregnant cows? Do new-born cattle have to be vaccinated - if so what is the exit programme?

All cattle over 7 days old. There is no contra-indication of the vaccine for pregnant cows. Calves under 7 days old will not be vaccinated and so will be in the same position as progeny born after the vaccination campaign. There is no intention of returning at a later date to vaccinate calves which are have not been vaccinated (through being unborn or under 7 days of age at the time of the vaccination exercise).

30. How is the 10km surveillance zone to be managed, both in England and Scotland?

The surveillance zone is an area which is closely monitored for signs of infection (given that infection could be present in the vaccination zone but not apparent because the majority of cattle will be immune). This surveillance is normally achieved through a combination of controls on the movements of susceptible livestock and enhanced veterinary surveillance. These measures are already in place throughout Great Britain as part of the GB Control Area introduced on 23 February. The surveillance zone (where in most cases the required controls would already be applicable under the wider restrictions being imposed in Great Britain) would be lifted 30 days after completion of the vaccination programme.

31. What role is NFU nationally or on the ground asked to play during this exercise?

We would be looking to the NFU for help both nationally and locally in explaining to farmers the reasons for resorting to vaccination and in seeking individual farmers' full co-operation with the programme.| top |

Post Vaccination Farm Management

32. How will farmers in vaccinated areas run their businesses including sales of meat and milk, sales of calves and rearing stock, sales of breeding animals and purchase of herd replacements?

Sales of milk from vaccinated animals will be subject only to the requirement that it must be pasteurised (NB: this requirement applies equally to milk to be used for feeding to farm animals, not just to milk for the human food chain). In the first 30 days following vaccination, treatment has to be carried out in an establishment within the vaccination zone or, in exceptional circumstances to be authorised on a case by case basis by the competent authorities, outside the zone. After the first 30 days there is no restriction on where treatment may be carried out. During the first 30 days following vaccination any movement of vaccinated animals to slaughter would have to be licensed and meat would have to be heat-treated. After 30 days, movement of vaccinated animals to slaughter will still have to be licensed but meat will have to be deboned and matured for 24 hours at 2:C. Meat from vaccinated animals will carry the same round GB stamp as other meat.

Vaccinated animals cannot be moved outside the vaccination zone for 12 months following vaccination or following the last confirmed outbreak in the zone, whichever is later, except direct to a slaughterhouse for immediate slaughter. But progeny of vaccinated animals will be able to move freely out of the zone, subject to being clear on serological testing, from 3 months after completion of vaccination. Purchase of herd replacements will be permitted when it is considered that the risk of infection has ceased.

33. What arrangements will be in place for the marketing of milk and meat during the 30 day restricted period?

See answer to question 32. It is recognised that the requirement for milk to be pasteurised within the vaccination zone in the first 30 days would present practical problems. Our starting point is the presumption that unavailability of sufficient processing capacity within the vaccination zone should constitute an "exceptional circumstance" within the terms of the Standing Veterinary Committee decision (see Question 32).

34. After vaccination, are farmers free to turn cattle out of winter housing?

It is recommended that cattle are kept indoors for about a week after vaccination to ensure full immunity, after which they are free to turn them out.

35. After vaccination, when can 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 (ie removing of Infected Areas and the veterinary judgement taken about when it is safe to re-stock).

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

There are no implications other than the advice to keep cattle housed for a week after vaccination while full immunity is achieved.

37. What can farmers do after vaccination, especially previously slaughtered farms? Can reintroduced stock be kept next to vaccinated stock?

See answers to question 34 and question 35.

38 How are vaccinated carriers to be detected and managed?

See answer to question 14. All vaccinated animals will have their ear tag numbers recorded and their cattle passports stamped. Those without such tags will be tagged at the time of vaccination with a vaccination tag and the cattle passport would subsequently need to be endorsed with the vaccination tag number.

39. Does stress make any such animals more likely to shed virus?

As with other infections, this is possible in a small number of cases.

40. What will be your slaughter policy in the event that FMD is confirmed on premises where vaccination has taken place?

We propose that this would be based on the premise that for this purpose vaccinated cattle can be regarded as having developed immunity 10 days after vaccination. This takes account of the fact that immunity takes up to 4/5 days to develop, and of the fact that whether or when the cattle have been exposed to disease, as well as whether they may be incubating it, is unknown. After that 10-day period, we envisage that vaccinated cattle could be dealt with in a different way, in the event of an outbreak on the premises, from unvaccinated animals, including cattle.

So, during the 10 days following vaccination, any confirmed outbreak of FMD on the premises, whether or not affecting vaccinated cattle, would lead to ALL cattle (including vaccinated cattle), sheep, pigs and goats on the premises having to be killed.

After the tenth day following vaccination, the position would be as follows:-

FMD confirmed in pigs, sheep or goats: kill all sheep, pigs and goats. Do NOT kill vaccinated cattle, but kill UNvaccinated cattle unless there are good epidemiological reasons for keeping them alive.

FMD confirmed in unvaccinated cattle: kill all unvaccinated cattle, sheep, pigs and goats, keeping vaccinated cattle alive.

FMD confirmed in vaccinated cattle: kill all vaccinated and unvaccinated cattle, as well as sheep, pigs and goats. {FMD in vaccinated cattle suggests that in some way vaccination has failed, so it can no longer be assumed that vaccinated cattle on the premises are not susceptible.}| top |

Market Implications

41. Will processors and retailers buy product from vaccinated animals now, and in the future?

High level discussions are under way with the processing and retail trades to obtain reassurance on this.

42. If products aren't marketable, will Government act as the purchaser of last resort?

We are aiming to ensure that products will be marketable. For meat, the decision on the new round GB stamp will help. For milk, there is no sign of retailer or consumer resistance to pasteurised milk from infected areas. There is no provision under EU law for national Governments to act as a purchaser of last resort of agricultural produce beyond the existing market support provisions under certain CAP market organisations.

43. Some farms will have breeding stock as an output, will their losses be compensated as vaccinated animals cannot leave the zone?

At the moment we have no basis for compensating for the inability of this category of animal to be moved out of the vaccination zone, but we recognise that this is a legitimate concern which will need to be addressed on its merits.

44. Will the Government compensate sellers of vaccinated animals if they receive lower prices because of reduced demand or have no market?

We will aim to ensure that there is a market for their produce. The Government will not compensate for lower market prices beyond the market support mechanisms already in place under the relevant CAP regimes.| top |

European and World Trade implications

45. What assurances does HMG have over the re-opening of the UK export market to EU and to third countries?

The Government has no assurances and there can be no certainty in this area. There are OIE recommendations (see answer to question 46) but these do not have legal force. Given the scale of the outbreak we have suffered and the fact that it has been predominantly in the sheep population, we can expect that other countries (EU and other) will want to be satisfied that the disease in sheep has been fully stamped out. This is likely to involve serological testing of sheep on a large scale. This will be the position whether we vaccinate or not.

The Commission decision 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 (but live cattle cannot currently be exported in any case because of BSE-related restrictions).

46. What are the mechanics of re-establishing exports? Will the UK be zoned?

It is possible to seek agreement for zoning from the EU and OIE (internationally). The latter may take longer for recognition. FMD-free status for a vaccinating zone where vaccinated animals are not slaughtered will not be recognised for at least 12 months after the end of vaccination and 12 months after the last confirmed case in the zone. These are minimum periods, and given the level of infection we have experienced in the sheep population we can expect other countries to be risk-averse in their attitude to accepting re-establishment of our former FMD-free status.

Products which can be exported at present provided they meet the requirements of the Commission decision will continue to be eligible, including products from the vaccination zone.

47. What are the implications for internal trade of animals, meat and milk within the UK?

Vaccinated animals will not be eligible to leave the zone other than for slaughter. Their progeny will be eligible subject to a negative blood test. See answer to question 32. Other species will be eligible to leave the zone when the disease risk is considered to be acceptable (ie when the Infected Area is removed).

48. How do we know the EU will not take a different view against vaccinated countries in month's time?

EU Member States' are likely to be guided in their attitude to vaccinated countries by the OIE recommendations (but see answers to question 9, question 45 and question 46).

49. Will normal trading rules and relationships take longer to achieve if we have used vaccination, even in a restricted area, than if we proceed with slaughter alone?

This is difficult to predict given that we cannot accurately estimate when the last case will occur with or without vaccination (but see answers to question 9, question 45 and question 46).| top |

Other Areas

50. How will the restriction of vaccination to one or two localities be justified to farmers elsewhere, especially those involved in a contiguous cull?

If the Government decides to go ahead with vaccination it will make clear the criteria for any vaccination campaign. These would be likely to include the level of infection in the sheep population and projections for the survival of the cattle population on current policies in particular areas, as well as a logistical criterion (disposal problems and resource implications in areas where on current policies significant numbers of cattle look likely to be condemned).| top |

Decisions

51. How will the Government consult, arrive at a decision and publicise that decision and the reasons for it?

The Government is in the process of publicly explaining why it believes that a limited vaccination programme is now the correct approach. Our aim is to establish whether such a programme would command the support of the farming community. We will not proceed with vaccination unless we have that support. Publishing these answers to questions that farmers have asked is an important part of that process.