Emergency vaccination sectionfrom government response to Enquiries document (pdf file of 48 pages)
4.3.13 The Royal Society accepts, as does the Government, the need for validation of tests to distinguish vaccinated from infected animals. The Government is aware of a variety of NSP (non-structural protein) tests that are at differing levels of validation. There are currently a number of research projects in the UK, Europe and America and many of the European groups are partners in a European Union Concerted Action project on FMD diagnosis. The main limiting factor for the validation of such tests is the availability of suitable panels of sera, especially from vaccinated and then challenged animals. Defra is supporting research into this area. In addition, the Government also accepts that there is a need to develop accepted strategies for surveillance after vaccination. Indeed, this is something that the OIE has under consideration.
4.3.14 Constraints on environmentally safe disposal methods, which would need the active involvement of the Environment Agency at the earliest possible stage, will be one of the factors in decisions on whether to adopt emergency vaccination, whether to live or to kill.
4.3.15 The acceptability and hence the saleability of products from vaccinated animals is a key issue. The apparent lack of support last year from the food and farming sectors was a key factor in the Government deciding not to vaccinate cattle in Cumbria and Devon. The Lessons Learned report highlights this issue.
4.3.16 The Government is completely satisfied that meat and meat products from vaccinated animals can enter the food chain. The Food Standards Agency advise that the health implications from eating meat, milk or other produce from animals that have been treated with authorised FMD vaccines are negligible. The Government is committed to tackling these issues, in consultation with all interested parties, so that it is in a position to trigger an emergency vaccination campaign should the need arise. This process of consultation will take some time to complete. In the meantime, the Government needs to retain its full armoury of weapons against the disease. Operational issues relating to emergency vaccination are in Annex III.
4.3.17 Emergency vaccination can only take place as the subject of EU decision. In order for a vaccination strategy to be fully effective there would need to be a concerted EU approach and a new legislative framework at EU level. The Government will actively pursue with the Commission the need for a new framework for the use of vaccination and for the research effort on FMD and animal disease across the EU.
4.3.18 Last year the EU Decision authorising use of emergency vaccination in the UK laid down a number of post-vaccination controls. It is possible that the new draft FMD Directive will include similar provisions. If so, these would require meat from vaccinated animals to be heat treated until at least 30 days have elapsed following vaccination and further restrictions for a period of 12 months. Meat would have to be de-boned and matured. There are known to be problems in achieving the required maturation (to get the meat down to the required pH level) in pork and lamb, which is why countries which vaccinate tend to only export beef. The taking of semen, ova and embryos from vaccinated animals would also be prohibited. Vaccinated animals would not be permitted to move out of the vaccination zone for 12 months (except under licence to slaughter).
4.3.19 The FMD status of all countries is ultimately determined by the OIE. Should emergency vaccination be used, it would be necessary to satisfy all concerned that FMD virus has been eradicated, that all controls relevant to vaccination had been followed, and that vaccinated animals did not harbour FMD. So the Government will also develop with stakeholders an exit strategy designed to permit an early return to disease-free without vaccination status for the UK..
4.3.20 The Royal Society recommends that Defra should explore with the EU and OIE what improvements to vaccines and surveillance tests are required to allow restoration of disease free status to be based entirely on surveillance results without the requirement for a minimum waiting period. Changes to the OIE code in May 2002 reduced the minimum waiting period from 12 to 6 months following emergency vaccination, provided a stamping out policy had been deployed and a serological survey had adequately demonstrated the absence of infection. The Government believes that this will allow emergency vaccination to be more readily used as a disease control strategy in the future.
4.3.21 The UK is an importing country as well as an exporting country. The Government therefore is unable to agree that a minimum waiting period following an outbreak should be entirely abolished. Such conditions are intended to protect importing countries - including the UK itself - from FMD.
Routine (prophylactic) vaccination
4.3.22 The inquiry reports acknowledge that because of the EUs declared policy of stamping out the disease and maintaining its "FMD free without vaccination" status, existing EU law only provides for the use of vaccination in an emergency and then only as an aid to disease control.
4.3.23 The Royal Society proposes that the Government should take the lead in developing an international research programme aimed at an improved vaccine that would permit routine and global vaccination of livestock against FMD and other diseases of animals on List A maintained by the OIE. The Royal Society report underlines the complications associated with routine vaccination - including the variety of FMD strains and serotypes, the short immunity period conferred by current vaccines, the need for all susceptible animals to be vaccinated, and the severe trade restrictions that would be imposed.
4.3.24 The Government agrees that an improved vaccine that would permit routine and global vaccination of livestock against all strains of FMD is a desirable long-term goal. This is an issue of international rather than national scope and would be most effectively led by an international organisation such as the FAO or possibly as an EU initiative. The Government intends to raise this issue with its EU partners in discussions on future research priorities.