Bluetongue Vaccination Campaign

Bluetongue Stakeholders Meeting attended by Douglas Scott
Best Western Edinburgh Capital Hotel

THE SCOTTISH BLUETONGUE VACCINATION CAMPAIGN PLAN

1. INTRODUCTION

This document sets out the aim of the vaccination campaign against bluetongue virus serotype 8 (BTV8) in Scotland, and the arrangements for the delivery of the campaign.

During 2008, the Scottish Government/Industry Stakeholder Group (the Group) has considered at length how bluetongue can best be kept out of Scotland, and how vaccination can be used to achieve this. Under EC rules bluetongue vaccine can only be used in a bluetongue Protection Zone (PZ). The Group has taken into account both veterinary and scientific advice and UK trade issues. They have considered the input of the Scottish Government's Centre of Excellence in Epidemiology (EPIC), who have analysed potential incursion and control scenarios, and the veterinary advice that declaring a PZ during a period of vector (midge) activity presents a high level of disease risk by allowing the free movement of potentially infected animals to Scotland.

1.1. Description of current disease situation

Scotland currently remains free from BTV8. To date* 1381 infected premises have been identified in south of England. No new cases have been reported so far as a result of virus circulating in 2008. However, it is expected that disease will re-emerge in the south of England later in summer 2008.

Modelling work carried out within the UK suggests that Scotland is likely to remain at a low but increasing risk of a BTV8 incursion via midge-borne spread from England, or from the movement of infected animals, until the end of the vector period in the autumn of 2008. The research also suggests that the risk would be reduced by an adequate coverage of vaccination in England, where vaccination is voluntary. Controls are in place to minimise the risk of incursion through animal movements.

Defra have been rolling out vaccination from the area of highest risk in England (the original PZ) and across the rest of England as vaccine becomes available. By early September the PZ will be expanded to cover the whole of England and Wales. Potentially infected animals will then be able to move up to the border with Scotland. The particular risk that this represents to Scotland will depend on the effectiveness of the English and Welsh voluntary campaigns in achieving high levels of vaccine uptake.
* 20 Aug 2008

1.2. Aim of vaccination campaign

The Group has decided that the best approach to protect Scotland's livestock industry is to continue to keep disease from establishing in the midge and animal populations in Scotland, and hence keep disease and associated restrictions out of the country for as long as possible. This is the aim of the vaccination campaign. Mass vaccination will create a sufficient level of protective immunity in our susceptible animal populations so that the virus cannot circulate and therefore cannot establish. The Group have decided to delay undertaking any vaccination campaign until the vector-free (i.e. midge-free) period of winter 2008/09. This will allow animals in Scotland to gain immunity before midge activity resumes in the spring, when there is a risk that midges will spread disease from any infected animals moved to Scotland once it becomes a PZ.

1.3. Final factors to consider before launch

Bluetongue vaccination will not be a one off requirement for this year only. The campaign will continue for a number of years, and vaccination of new livestock and the administration of boosters will be required until an exit strategy is put in place. In addition, under EU rules, it is not possible to remove Restricted Zone status without at least two years disease freedom from bluetongue and this has long-term trade implications. The final decision on whether, and when, to launch a vaccination campaign in Scotland must take these factors into consideration. The Group has decided that if disease spread is seen in England and Wales this summer, vaccination of animals in Scotland is necessary to protect the livestock industry. However if there is no emergence of disease elsewhere in GB this summer, it is possible that a vaccination campaign this winter would not be in the best interests of the Scottish livestock industry.

1.4. Contingency plan

Whilst the preferred approach is to commence vaccination in winter 2008/09, there is a risk that a disease incursion may occur earlier. A contingency stock of vaccine has been obtained in case of an outbreak in Scotland during the summer or autumn of 2008. If vaccination is required to control an outbreak, the precise arrangements will be determined at the time, taking into account the specific circumstances such as timing, epidemiological situation and geography. The most likely response would be a localised vaccination campaign with the objective of reducing the risk of further disease spread. The main campaign across the rest of the country would then be conducted during the vector-free period as planned.

1.5. Key Facts of the Scottish Vaccination Campaign

1.5.1. Timing of start of campaign
It is envisaged that vaccination will commence at the start of the vector-free period of winter 2008/09, in November or December. All susceptible animals of appropriate age in Scotland should be vaccinated. Precise timing will be based on veterinary and entomological advice supported by meteorological assessments.

1.5.2. Compulsory and Voluntary Species
The Group decided that vaccination should be compulsory for cattle and sheep. Vaccination will be voluntary (but strongly encouraged) for other susceptible species, including goats, deer, and camelids (for which the vaccine is not currently licensed). For more details see section 2.2.

1.5.3. Vaccine administration
Where animals are intended to remain within the PZ, the Group agreed that vaccination by animal keepers was appropriate. This will help achieve good compliance by keeping costs to a minimum and allowing vaccination to be undertaken at the most suitable time for individual enterprises and their management practices.

Animals leaving the Scottish PZ and going to a free area will require vaccination by a vet and an accompanying certificate. For more details see section 2.1.

1.5.4. Monitoring and Enforcement
In discussion with veterinarians and wholesalers it was agreed that the vaccine order form through which keepers order vaccine from their veterinarian will be submitted to the Scottish Government for monitoring uptake. For more information on monitoring and enforcement see section 3.6.

1.5.5. Funding
Any mass vaccination campaign is associated with significant costs for both industry and Government. The Scottish Government has provided support of £2.6 million towards the cost of the vaccine secured for use during the first vector-free period (50% of the total manufacturer's price). Industry will bear the remainder of the vaccine cost plus other delivery costs such as veterinary administration, etc.

The Scottish Government will meet the costs of activities such as surveillance, monitoring and enforcement.

2. VACCINE DELIVERY

2.1. Vaccine facts

The Scottish Government has secured 12 million doses of vaccine against BTV8, from Merial Animal Health Limited. For further information about the Merial vaccine, see the dataset attached as Annex 1, and the Merial website at:
http://uk.merial.com/producers/bluetongue.asp

The following information applies to the Merial vaccine, but it should be noted that vaccines available from other companies in the future may have different dosage requirements, etc.

2.1.1. Dosage and booster requirements
Sheep require one 1ml dose of vaccine, and cattle require two 1ml doses of vaccine given four weeks apart. In other species, such as goats, deer and camelids, veterinary advice is that two doses of vaccine should be given four weeks apart. Vaccination of these species should be discussed with your veterinary surgeon.

In order to maintain immunity, one annual booster is required for all species. The booster should be given within 12 months of the initial vaccination. For ease of management, it is recommended that all livestock are given boosters during the vector-free period each year, as long as the booster is given no later than 12 months after the initial vaccination. Failure to give a booster within 12 months will lead to a drop in immunity and mean that cattle will require two doses again.

2.1.2. Vaccine administration
Vaccination of animals by keepers will be permitted for all eligible animals remaining within, or moving directly between, PZs. However, any move to a free area will require veterinary administration (for both doses where required) and certification.

2.1.3. Supply
BTV8 vaccine is a prescription only medicine. Livestock keepers will obtain vaccine from their veterinary surgeons, who will receive it through normal veterinary medicine wholesale arrangements.

Under the terms of bluetongue legislation, livestock keepers will be allowed to order vaccine from only one veterinary practice, and must only order the amount needed for immediate use. Keepers are advised not to stockpile bottles for future use.

Vaccine can only be held by livestock keepers when the Declaration to start the vaccination campaign comes into effect. Illegal holding, use or onward sale of bluetongue vaccine is subject to a penalty of up to £5,000 and six months in prison.

2.1.4. Bottle size
The vaccine will be supplied mainly in 100 ml bottles. A smaller supply of 50ml bottles is also expected to be available in December.

It is recognised that these bottle sizes will not necessarily be appropriate for all keepers, particularly those with smaller herds/ flocks. To accommodate this it may be possible for your veterinary surgeon to dispense vaccine into smaller quantities for sale. This should be discussed with your vet.

2.1.5. Price
Throughout the first vector free period of 2008/09 the price of the Merial vaccine secured will be subsidized by the Scottish Government. Based on recent experience on bluetongue vaccine sales it is anticipated that the bottle prices from vet practices will be in the range of £?? – £?? for the 100ml bottles.

2.1.6. Storage
The vaccine must be stored at between 2 and 8°C to maintain efficacy. Vaccine must be stored by wholesalers and veterinary surgeons under appropriate cold chain arrangements.

Once the sale of vaccine begins, animal keepers are advised to use the vaccine on the day of purchase. Once a bottle is opened it must be used within 8 hours.

2.2. Species

Vaccination will be compulsory for all cattle and sheep. The only exemptions will relate to age or if the animals are going to be slaughtered before the end of the vector-free period or before they become immune. Exemptions are detailed in section 3.

Vaccination of deer, goats, camelids and other susceptible species will be voluntary, as no BTV8 vaccine currently has marketing authorisation for species other than cattle and sheep. Vaccine can be prescribed for these species by vets under the prescribing 'cascade' principle, which sets out rules for the provision of veterinary medicines where no authorised product exists for a particular species. Vaccination of these species is strongly encouraged. All keepers of all susceptible animals will be eligible to receive vaccine secured by the Scottish Government at the subsidised cost.

3. CAMPAIGN REQUIREMENTS

3.1. Geographical coverage

Advice from veterinary advisors, epidemiologists and entomologists suggest that no part of Scotland is guaranteed to remain free of infection indefinitely. Therefore, as a minimum the whole of mainland Scotland will be declared a PZ and vaccination of all cattle and sheep required. It is anticipated that this will also apply to all of the islands. The need for vaccination or a possible exemption from the PZ on the Scottish islands is under review by the Group and will be decided in the next few weeks.

3.2. Requirements during vector free period (VFP)

It is envisaged that vaccination will commence at the start of the vector-free period of winter 2008/09. The campaign will be launched in November or December. All cattle and sheep of 3 months of age and older should be vaccinated before the end of the vector-free period in March 2009.

3.3 Requirements during vector period (VP)

When we move from the vector-free period into the vector period of spring – autumn 2009, in March 2009, the following additional requirements will apply:

• animals too young to have been vaccinated by the end of March must be vaccinated by the time they are 6 months old,
• animals too young to have been vaccinated by the end of March must be vaccinated at least 21 days before being moved off their holding of origin

These requirements will remain in place on an ongoing basis for the next few years.

3.4. Exemptions

From the start of the campaign, the following categories of cattle and sheep will be exempt:

• animals of less than 3 months of age,
• animals destined for slaughter before the date at which vaccination would provide them with immunity (i.e. 21 days after vaccination in sheep, and 21 days after the second vaccination in cattle)
• animals destined for slaughter before the end of the vector-free period of winter 2008/09 (likely to be the end of March 2009)

When we move from the vector-free period into the vector period of spring-autumn 2009 (likely to be in March 2009), the following additional exemption will apply:

• animals that will be going straight to slaughter from their holding of origin at less than 6 months of age;
• unsold sheep or cattle that were intended for slaughter should be vaccinated at the first opportunity after arriving back on the.

3.5. Livestock movements and trade

The EC regulations allow all vaccinated animals to move freely within and between PZs where the same serotypes are circulating. This means that once Scotland declares a PZ, many previous restrictions on domestic and EU trade from a PZ to Scotland will be removed. Animals are permitted to move out of a PZ or Surveillance Zone (SZ) if they fulfil at least one of the conditions set out in Annex III of the Commission Regulation (EC) No. 1266/2007. These conditions include that in order to move into an area free of bluetongue, animals must have been vaccinated, individually identified and certified by a veterinarian and be currently immune and must also meet one of the following conditions:
(i) They were vaccinated more than 60 days before the movement; or
(ii) They were vaccinated with an inactivated vaccine in time for immunity to be established (which depends on the vaccine used) and were found negative to a virus test carried out at least 14 days after the onset of immunity; or
(iii) They were previously vaccinated and have been re-vaccinated with an inactivated vaccine within the immunity period; or
(iv) They were kept in a bluetongue seasonally free zone from birth or at least 60 days before vaccination and were vaccinated with an inactivated vaccine in sufficient time for immunity to develop.
Other EU Member States must accept animals that meet these legally required conditions. Although trade with third countries is subject to the same legal controls for leaving a PZ, there is no guarantee that such animals will be accepted by individual countries.

3.6. Monitoring and enforcement

When keepers receive vaccine from their vet, the vet will pass their order form to Scottish Government to record the premises that have undertaken vaccination. The Scottish Government will monitor uptake and holdings with cattle and sheep that have not been vaccinated will be identified and follow up action taken to ensure compliance.

These checks will also be supported by on farm document checks by Scottish Government and Animal Health staff during cross compliance visits. As part of wider enforcement measures, random blood samples will be also be taken from animals on a spot-check basis to ensure that animals have been vaccinated.

4. FUTURE YEARS

Vaccination will be required for a number of years until an exit strategy has been developed. The terms of the exit strategy, which will focus heavily on surveillance, will be set out in EU legislation. Until the exit strategy has been delivered annual booster shots will be required, plus full treatment of naïve stock. The vaccination strategy will be kept under regular review by the Group.

5. LEGISLATION

European Commission rules in relation to bluetongue, including those on vaccination, are contained in the Bluetongue Directive (Council Directive 2000/75/EC) and Bluetongue Regulation (Commission Regulation 1266/2007). These have been transposed into Scottish legislation by the Bluetongue (Scotland) Order 2008 (SSI 2008/11) and the Bluetongue (Scotland) Amendment Order 2008. A Declaration under this Order will set out the legal requirements for the campaign; including the geographic area over which vaccination will be conducted, the time window for the initial mass campaign, and classes of sheep and cattle exempted from vaccination as outlined in this document.