Bluetongue: Vaccination
- Vaccine order
- Size of vaccine bank
- Voluntary vaccination
- Purchasing vaccine
- Administering vaccine
- Vaccination planning
- Commission co-funding
- Ordering with Intervet
- Cost of vaccine
- Use against other serotypes
- Use of live vaccines
- Vaccination in other Member States
- Effect of vaccination on exports
- Effect on organic status?
- Food safety
Vaccine order
The UK was the first Member State dealing with the current outbreak in northern Europe to make an order for vaccine.
Defra has placed an order with Intervet for 22.5 million doses of Bluetongue serotype 8 (BTV-8) vaccine. 20 million doses are reserved for use in England and 2.5 million doses are reserved for potential use in Wales. In keeping with the principles set out in the Bluetongue Control Strategy, livestock keepers in the Protection Zone will be able to purchase vaccine from the bank through their private vets. Intervet has indicated that vaccine will begin to be available from May.
Size of vaccine bank
At this stage it is difficult to tell the extent to where Bluetongue will be found by the time vaccine is delivered, or what demand for vaccine will be. However, following some estimates of likely take-up of vaccine from industry and expert recommendation on where we could expect the disease to be present next year, we decided to order 20 million doses for use in England. We will consider with industry how best to secure future supplies of vaccine.
Vaccination policy in Scotland, Wales and Northern Ireland is a devolved matter.
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Voluntary vaccination
We believe that mass vaccination can be best achieved through a voluntary approach. Farming representatives have said that take-up of vaccine is likely to be high in a voluntary scheme, especially with an industry-led campaign promoting the benefits of vaccination. A voluntary programme will:
- allow vaccination to be rolled out as quickly as possible, as vaccine is delivered;
- reduce the cost of vaccination to a minimum by reducing regulatory burdens; and
- give farmers the freedom to take business decisions.
The option of a compulsory programme has been fully considered with industry. However, the UK will continue to be at risk of introduction of disease through potential cross-Channel vector spread from northern Europe and the legitimate trade in animals from other Member States; there is no scientific evidence to suggest an immediate prospect of eradication through vaccination. Moreover, a compulsory programme would involve increased regulatory burdens, cost at least 50% more than voluntary vaccination and slow down the speed of delivery.
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Purchasing vaccine
The vaccination plan sets out how livestock keepers in the Protection Zone will be able to purchase vaccine from the bank through their private vets. It is expected that purchasing vaccine will make economic sense for livestock keepers as the cost of purchasing and delivering vaccine is significantly outweighed by the potential costs of the impact of the disease.
Under EU law, vaccination cannot be carried out outside of a Protection Zone. Depending on vaccine availability and the disease situation, once vaccination is progressing broadly across the Zone the intention is to extend or modify the Zone in order to permit further vaccination, allowing a phased approach as vaccine is delivered.
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Administering vaccine
The vaccine we have ordered has not yet been granted a marketing authorisation but it is expected that it will be issued with a prescription only medicine (POMv) licence. Vets will therefore be responsible for prescribing vaccine to animals under their care following a clinical assessment. However, vets will not necessarily have to administer the vaccine themselves - if appropriate, keepers will be allowed to administer the vaccine to their animals under the authority of private vets with an appropriate level of advice or supervision where necessary.
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Vaccination planning
The vaccination plan was developed in close conjunction with the Core Group, representatives from farming and veterinary organisations, devolved administrations and scientific experts on Bluetongue. A summarised version of the plan was submitted to the Commission on Friday 15 February.
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Commission co-funding
The Commission has announced that some funds will be available to reimburse certain costs associated with Member States’ vaccination programmes. This can include up to 100% of the cost of the vaccine and up to 50% of the costs of delivery, subject to certain ceilings. However, any funding would only be available for 2008 and is likely to require high levels of official supervision, increasing costs and reducing speed of delivery. We will seek any co-funding available, provided it is not tied to conditions that are inconsistent with the aims for controlling disease or would increase the overall costs of vaccination to farmers.
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Ordering with Intervet
We issued a tender for vaccine in November. After careful consideration of the three bids submitted, we chose Intervet as the preferred bidder on the basis of technical specification, delivery schedule and price. Livestock keepers will be able to purchase vaccine from the bank and we believe that the Intervet vaccine will offer them the best value and most effective option. Intervet has been developing a Bluetongue serotype 8 (BTV-8) vaccine for over a year, has an established track record in producing vaccines for other diseases and supplies vaccine for Defra’s avian influenza vaccine bank.
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Cost of vaccine
The vaccine will be available in 50ml and 20ml bottles, and will be available through private vets via veterinary wholesalers. The wholesale “list” price will be £22.02 for the 50ml bottles and £13.10 for the 20ml bottles.
The final on-farm price is likely to be around £27.50 - £33.00 for the 50ml bottles (i.e. 55-66p per ml) and around £16.35 - £19.65 for the 20ml bottles (i.e. 82-98p per ml), plus VAT in order to cover the overhead, handling and administration charges throughout the distribution process.
Use against other serotypes
There are 24 serotypes of Bluetongue and the vaccines in development for use against Bluetongue serotype 8 (BTV-8) do not offer any cross-protection against the other 23. If another serotype of Bluetongue enters the UK then the vaccine that we are ordering will have no effect and a new vaccine would have to be purchased or developed.
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Use of live vaccines
There are significant, potential risks associated with live Bluetongue vaccines:
- Live vaccines strains can become more virulent than the field strain, produce new strains through re-assortment with the field strain and circulate in the midge vector.
- Live vaccines can also cause disease in some breeds of sheep (and potentially cattle), cannot be given to pregnant ewes (as they can cause foetal deformities) and can be a potential source of infection on mating and artificial insemination as the vaccine can be found in the semen of bulls and rams.
The use of live vaccines would therefore not normally be considered as a disease control measure.
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Vaccination in other Member States
Discussions are on-going with the European Commission and Member States affected by Bluetongue on the relative merits of possible approaches to vaccination, including the possibility of establishing a harmonised approach.
Effect of vaccination on exports
Bluetongue vaccination is accepted by both the EU and OIE (the World Organisation for Animal Health) as a valid form of controlling Bluetongue. Within the EU, vaccinated animals should be able to be moved between restricted zones (along the same lines as domestic trade) and we would expect the impact on exports to third countries to be minimal.
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Effect on organic status?
The Soil Association has indicated that there is no risk to the organic status of livestock vaccinated with an inactivated Bluetongue vaccine.
Food safety
The Food Standards Agency have advised that provided authorisation is based on the usual criteria and any necessary interval for elimination of residues is observed, there would be no food safety implications attached to use of an inactivated Bluetongue vaccine. Our contract with Intervet will require the vaccine to have at least a provisional marketing authorisation before it is delivered, which will confirm that the vaccine is safe.
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Page last modified: 29 April, 2008
