The Scottish Government

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THE SCOTTISH BLUETONGUE VACCINATION CAMPAIGN PLAN

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

Since early 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 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.

1.1. Description of current disease situation

Scotland currently remains free from BTV8. To date 149 ¹ infected premises have been identified in south of England and Wales since the disease first appeared in the south of England in Autumn 2007. No new cases were reported as a result of virus circulating in 2008. However, a number of infected imported animals have been identified in Scotland, England and Wales.

Modelling work suggested that Scotland was 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-active (i.e. midge-active) period in the autumn of 2008. The research also suggested that the risk would be reduced by an adequate coverage of vaccination in England, where vaccination is voluntary. During the summer of 2008, controls were put in place to minimise the risk of incursion through animal movements.

Vaccination was rolled out from the area of highest risk in England (the original PZ) across the rest of England and Wales as vaccine became available. Since 01 September 2008, the PZ has covered the whole of England and Wales. Although vaccine uptake in East Anglia and south west England has been high, in Cumbria, Northumberland and Wales it has been lower. Low levels of vaccine uptake, and the cases of imported infected animals south of the border over the last year or so, suggest that imported infection continues to pose a risk of disease introduction into areas of GB that are currently free from disease.

¹2 February 2009

1.2. Aim of vaccination campaign

In April 2008, the Group decided that the best approach to protect Scotland's livestock industry was 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. In September 2008, the Group agreed that the continuing risk to Scotland and economic costs merited acceptance of PZ restrictions in order to launch a vaccination campaign. The aim of the vaccination campaign is to keep Scotland free from the disease and to prevent disease becoming established in the event of an incursion.

The Group decided to delay undertaking a vaccination campaign until the vector-free (i.e. midge-free) period of winter 2008/09. This minimised the immediate risk of declaring a PZ (which opened Scotland up to imports of potentially infected animals from other BTV8 Restricted Zones), while allowing susceptible 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 into Scotland.

1.3. The Campaign Launch

The final decision on whether to launch a vaccination campaign in Scotland was taken on Tuesday 16th September, when the Group convened to discuss the significance of imported infected animals being detected in the north of England. The Group decided that a compulsory vaccination campaign would commence on 03 November 2008. A Declaration under the Bluetongue (Scotland) Order 2008 designated the whole of Scotland a PZ and a second Declaration designated the whole of Scotland a Vaccination Zone. Vaccination can now take place in all parts of Scotland. First year vaccination is to be completed during the specified window which ends on 30 April 2009. The Declaration detailing the terms of the Vaccination Zone can be seen in Annex 1.

It was recognised that bluetongue vaccination will not be a one-off requirement. The campaign will potentially continue for a number of years, and vaccination of livestock and the administration of boosters are required until an exit strategy is agreed with the EC. Under current EU rules, it is not possible to remove Restricted Zone status until at least two years of proven disease freedom from clinical cases of bluetongue have passed. These conditions mean that the commencement of the vaccination campaign has long-term implications.

1.4. Key Facts of the Scottish Vaccination Campaign

1.4.1. Timing of start of campaign

Vaccination commenced at the start of the vector-free period of winter 2008/09, on 03 November. The timing of this start date was based on veterinary and entomological advice supported by meteorological assessments, and consideration of the practicalities of vaccine administration given the timings of conventional husbandry practices.

1.4.2. Compulsory and voluntary species

The Group decided that vaccination is compulsory for cattle and sheep. Vaccination is voluntary (but strongly encouraged) for other susceptible species, including goats,

deer, camelids and susceptible zoo species (for which the vaccine is not currently licensed). All susceptible animals of appropriate age in Scotland should be vaccinated. For more details on species see section 2.2 and on vaccination requirements see section 3.

1.4.3. Vaccine administration

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

Animals leaving the Scottish PZ and moving to a BTV8SZ, a non- BTV8RZ or a disease free area will require vaccination by a vet. For more details see section 2.1.

1.4.4. 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 by vets to the Scottish Government for the monitoring of uptake. For more information on monitoring and enforcement see section 3.7.

1.4.5. Funding

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

The Scottish Government will continue to meet the costs of other bluetongue-related activities such as research, surveillance, monitoring and enforcement.

2.1. Vaccine facts

2.1.1. Bluetongue strain 8 vaccines

In 2008 the Scottish Government, on the request of the Group, secured 12 million doses of BTVPUR AlSap 8 vaccine from Merial Animal Health Limited. This order was placed to make sure that vaccine would be available to Scottish keepers when needed, as at that time vaccine was in short supply across Europe. Since then vaccines developed by other companies have been launched, and there is now a choice of product on the market. Other BTV8 vaccines are the Zulvac 8 Bovis vaccine from Fort Dodge Animal Health, and the Bovilis BTV8 vaccine from Intervet/Schering-Plough Animal Health. These are also available for order through veterinarians.

Any of the vaccines may be used in the Scottish campaign. The vaccines have different minimum age requirements, dosage requirements, prices etc. Keepers may use whichever vaccine suits their circumstances best, however only the price of the Merial vaccine is supported by the Scottish Government.

Animals can be vaccinated with the Merial vaccine at the age of three months. 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. Keepers should discuss vaccination of these species with their veterinary surgeon. For further information about the Merial vaccine, see the datasheet in Annex 2, and the Merial website at: http://uk.merial.com/producers/bluetongue.asp.

For further information about the Fort Dodge vaccine, see the datasheet in Annex 2 and the Fort Dodge website at:

http://www.noahcompendium.co.uk/Fort_Dodge_Animal_Health/Zulvac_8_Bovis/-47851.html

For further information about the Intervet vaccine, see the datasheet in Annex 2 and the Intervet website at: http://www.intervet.co.uk/news/2008-04-01_-_bluetongue_vaccination_guidelines.asp.

2.1.2. Vaccine administration

Vaccination of animals by keepers is permitted for all eligible animals remaining within, or moving directly between, BTV8PZs. However, any move to a BTV8SZ, a non- BTV8RZ or a free area will require the animals to have been vaccinated and certified by a vet.

2.1.3. Supply

BTV8 vaccines are prescription-only medicines. Livestock keepers can obtain vaccine from their veterinary surgeons, who receive it through normal veterinary

medicine wholesale arrangements. It has been available from vets since the Campaign began at the start of November.

Livestock keepers must order vaccine from only one veterinary practice, and must only order the amount needed for immediate use. Keepers must not place duplicate orders with different veterinary practices, or stockpile bottles for future use. Under the terms of the Declaration of the Vaccination Zone, all vaccine must be used within 35 days of receipt by the keeper, or be disposed of.

2.1.4. Bottle size

The vaccine produced by Merial is being supplied mainly in 100 ml bottles. A smaller number of 50ml bottles is also now available.

It is recognised that these bottle sizes are not necessarily appropriate for all keepers, particularly those with smaller herds/flocks. To accommodate this, veterinary practitioners may be able to dispense vaccine into smaller quantities for sale. Keepers should discuss this with their vet. Alternatively, keepers may co-ordinate and order vaccine together, and are encouraged to discuss their plans with their neighbours and discuss ordering for multiple holdings with their vet.

The vaccines manufactured by Fort Dodge and Intervet come in a range of bottle sizes. For further information see above websites detailed on p. 4.

2.1.5. Price

The Scottish Government is providing support of half of the manufacturer's price towards the cost of the Merial vaccine secured for use during the first vector-free period of 2008/2009. The vaccine is available from veterinary practices at approximately £44 - £58 (+VAT) per 100ml bottle. The price per dose may be higher for smaller amounts where a vet has to split a bottle.

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.

Household fridges are only suitable for relatively short periods of storage and animal keepers are advised to use the vaccine on the day of purchase. It must be used within 35 days of receipt or be disposed of. Once a bottle is opened it must be used within 8 hours.

2.1.7. Revaccination

In order to maintain immunity, an annual revaccination is required for all species. It is recommended that all livestock are given this during the vector-free period each year. Ideally animals should be revaccinated at least two weeks prior to the end of the vector-free period, so that the animals develop a strong level of immunity prior to the period of greatest risk during the vector-active period.

Revaccination must be administered within 12 months of the last dose. However, it is possible to revaccinate earlier, for example, keepers may wish to revaccinate animals less than a year after the first vaccination in order to synchronise revaccinations, and to ensure they can be planned to fit in with other management practices in the future without compromising the effectiveness of vaccinal protection.

Revaccination of animals can be carried out with a vaccine from a different manufacturer than that used for the primary course (but the full primary course should be given using the same vaccine, e.g. the two initial does in cattle).

2.1.8. Reporting adverse reactions

Both the manufacturers and the British Veterinary Association ( BVA) have stated that there is no evidence of adverse reactions (harmful and unintended consequences) caused by administration of the bluetongue vaccine. The BVA has also confirmed that a very low level of reports of suspected adverse effects has been reported through the Suspected Adverse Reaction Surveillance Scheme ( SARSS).

If keepers do experience adverse reactions in their animals which appear to be due to administration of the bluetongue vaccine, this should be reported through SARSS by their vet. More information is available from the Veterinary Medicines Directorate ( VMD) on their website:

http://www.vmd.gov.uk/General/Adverse/animal2.pdf

The licensing conditions of the vaccine state that the vaccine should not be co-administered with other products, but advice from the manufacturers is that no specific issues of co-administration with other treatments have arisen. If keepers are considering co-administering the vaccine with other treatments for management reasons they should discuss this with their vet.

2.2. Species

2.2.1. Compulsory and voluntary species

Vaccination is compulsory for all cattle (including farmed buffalo) and sheep. The only exemptions relate to age or if the animals are going to be slaughtered within certain time periods. Exemptions are detailed in section 3.4.

Vaccination of deer, goats, camelids and other susceptible species is 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, and should be discussed between the keeper and their vet. All keepers of all susceptible animals are eligible to purchase vaccine secured by the Scottish Government at the supported price.

2.2.2. Coverage

The objective of the campaign is to vaccinate all cattle and sheep, and the majority of the other susceptible domestic species. Wild deer will not be vaccinated. By focussing on domestic species, vaccination of at least 80% of the total Scottish susceptible animal population should be achieved. Experience in other countries has shown that bluetongue can be successfully eradicated by vaccination of 80% of the total susceptible population.

3.1. Geographical coverage

Advice from veterinary advisors, epidemiologists and entomologists suggests that no part of Scotland is guaranteed to remain free of infection indefinitely. The whole of Scotland has been declared a PZ and vaccination of all cattle and sheep is required.

As the Scottish islands are separate epidemiological units in disease terms, consideration was given to allowing them to opt out of participation in the compulsory programme. Shetland keepers requested a voluntary approach for animals staying within the islands. This request was granted due to the unique circumstances of Shetland. These include the large distance from the mainland, the relatively small number of animal movements, the local bye-law which allows enforced testing of all imported animals, and the significantly lower temperatures experienced further north. The combination of these factors significantly reduces the risk of disease being imported to Shetland, and of it becoming established and spreading should it be introduced. However, after 30 April, all store animals being moved from the Shetland Islands to the mainland must be vaccinated before movement.

Keepers on the Orkney Islands and Western Isles also requested derogations from compulsory vaccination for animals not intended to leave the islands. They have been told that the Scottish Government will consider a request for a similar approach to Shetland, but to do so would require the putting in place of arrangements which reduce the risk of disease entering and becoming established on the islands, such as testing all susceptible animals coming on to the islands.

3.2. Requirements during vector-free period

All cattle and sheep in the compulsory areas, of 3 months of age and older, must be vaccinated before the end of the vector-free period on 30 April 2009.

3.3. Requirements during vector-active period

When we get into the vector-active period of spring, after 30 April 2009, ongoing requirements will apply in the compulsory areas:

1. Animals which are too young to have been vaccinated by the end of April 2009, or are born after the end of April 2009, must be fully vaccinated before they reach the age of 6 months.
2. Animals which are too young to have been vaccinated by the end of April 2009, or are born after the end of April 2009, must be vaccinated in advance of moving off the holding if over 3 months of age. (Note that calves between 3-4 months of age that have received the primary injection of vaccine are permitted to move).
3. Animals which are moved into the compulsory areas of Scotland from an area not subject to compulsory BTV8 vaccination (such as England & Wales), must be vaccinated as soon as possible and not later than 14 days after entering the compulsory areas, unless the new keeper has documentary evidence that the animals were vaccinated before arrival.
4. Unvaccinated animals which are moved into the compulsory vaccination areas of Scotland from Shetland must be vaccinated before leaving the Shetland Islands.

These requirements will remain in place for the duration of the vaccination campaign. Exemptions are permitted as listed below.

3.4. Exemptions

The following categories of cattle and sheep are exempt:

1. animals of less than 3 months of age.

2. animals destined for slaughter before 30th April 2009.

3. animals destined for slaughter after 30th April but before the date at which vaccination would provide them with immunity (i.e. 21st May).

4. animals that will be going from their holding of origin straight to slaughter, or to slaughter via a market, at less than 6 months of age.

5. animals remaining on Shetland.

6. animals moved from Shetland to the mainland going straight to slaughter, or to slaughter via a market.

(NB - Unsold sheep or cattle that were intended for slaughter and are unvaccinated under these exemptions should be vaccinated at the first opportunity and not later than 14 days after arriving back on the holding of origin. Unvaccinated animals originally intended for slaughter but purchased for further finishing or breeding must be vaccinated as soon as possible and not later than 14 days on arrival at their new farm of destination).

3.5. Extensions

Following feedback from industry groups, and from farmer meetings it was recognised that difficulties are faced by some keepers in vaccinating their animals under the terms of the programme. There are a relatively small number of remote hill flocks which were turned out before the start of the Campaign last November and which are not normally gathered until after the end of April. There are also a number of cases where animals are kept on uninhabited islands which are not normally visited until later in the year.

After consideration of these issues, it was agreed that keepers of such animals could apply for an extension of the deadline for vaccinating these animals.

3.5.1. Keepers of remote hill flocks

• Keepers of hill sheep in remote areas who are unable vaccinate their flocks by 30 April 2009 due to animal welfare issues related to gathering heavily pregnant ewes and ewes with newborn lambs at foot, may apply for permission to implement an extended deadline for vaccination of 30 June 2009.
• Applications can only be considered for sheep flocks in remote areas north and west of the Great Glen (the Caledonian Canal). The area eligible for consideration covers the mainland and islands and includes the Isle of Mull.
• Case-by-case applications must be made to the local Animal Health Office, with the animals' vet confirming the negative welfare impact of vaccinating by the end of April. Further guidance and the application form is attached in Annex 1.

3.5.2. Keepers of animals on remote islands

• Keepers of sheep or cattle which reside on uninhabited islands, who are unable to gain access to vaccinate these animals by 30 April 2009, may apply for permission to implement an extended deadline for vaccination of 30 June 2009.
• Keepers affected must sign a declaration committing them to vaccinating by the end of June, and have the declaration signed off at their local Animal Health Office. The form to be used is attached in Annex 1.

The extended deadlines for these two groups of animals are one-off measures for 2009 only. In future years, keepers must ensure that vaccination of all animals is planned to fit in with normal husbandry practices, and that revaccination of all adult animals is carried out in time to maintain full immunity.

3.6. Livestock movements and trade

3.6.1. Movements within Scotland

• Prior to 30 April, animals are permitted to move between holdings as normal, whether vaccinated or not.

• After 30 April, animals over 3 months of age are allowed to be moved only if they have been vaccinated (or are exempt). (Note that animals younger than 3 months of age can be moved unvaccinated, and that calves between 3-4 months of age that have only received the primary injection of vaccine are permitted to move).
• Animals on Shetland, where vaccination is voluntary, are allowed to be moved unvaccinated after 30th of April. However animals moving from Shetland to the mainland have to be vaccinated prior to movement, unless specifically exempt (see Section 3.4).
• Keepers are encouraged to use the voluntary self-declaration form to provide evidence of vaccination when selling animals. The form can be downloaded from the Scottish Government website at www.scotland.gov.uk/bluetongue.

3.6.2. Movements between Scotland and the rest of the UK

• Movements of vaccinated or unvaccinated animals into Scotland from the rest of GB and Northern Ireland are permitted. Animals brought into Scotland must be vaccinated within 14 days of arrival unless the new keeper has documentary evidence that the animals were vaccinated before arrival.
• Movements of vaccinated or unvaccinated animals from Scotland to the rest of GB are permitted as all of GB is part of the BTV8PZ.
• Northern Ireland is a BTV8-free area, and will only accept animals from Scotland if they have been vaccinated against BTV8 by a vet and fulfil at least one of the conditions set out in Annex III of the European Commission Regulation (EC) No. 1266/2007 (see the following section for further details).

3.6.3. Movements between Scotland and continental Europe

• EC regulations allow all animals to move freely within and betweenBTV8PZs.
• Animals are only permitted to move out of a BTV8PZ 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 vaccination by a vet. Further information can be found in the 'movement' section on the Scottish Government bluetongue website, at: www.scotland.gov.uk/bluetongue.
• EU Member States must accept animals that meet these legally required conditions, however, we would encourage all keepers in Scotland to avoid sourcing imports from high risk areas. Animals brought in to Scotland must be vaccinated within 14 days of arrival unless the keeper has documentary evidence that they were vaccinated before arrival.

Note that EC rules are subject to change. Keepers should check the BTV movements section on the Scottish Government website for up-to-date and more detailed information.

3.6.4. Movements between Scotland and Third Countries

• Although trade with third countries is subject to the same legal controls for leaving a PZ as those laid out for EC countries above, there is no guarantee that such animals will be accepted by individual countries.

3.6.5. Shows and sales in Scotland held after 30 April

• Animals in Scotland are permitted to move to shows and sales in Scotland as normal provided they follow the vaccination requirements set out in Section 3.3. and 3.6.1.
• Animals arriving in Scotland from other countries are permitted as described in Sections 3.3, 3.6.2 and Section 3.6.3.
• Note that unvaccinated animals arriving in Scotland for shows or sales and which remain in Scotland for 14 days or longer must commence the vaccination course no later then 14 days after arrival.
• Potential exhibitors should be aware that organisers of some shows may choose to accept only vaccinated animals. Keepers considering showing animals in Scotland this year should contact the show organisers in advance to check their requirements.

3.7. Monitoring and enforcement

When keepers receive vaccine from their vet, the vet passes their order form to Scottish Government to record the premises that have received vaccine. The Scottish Government are monitoring uptake and holdings with cattle and sheep that have not received vaccine 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 help to ensure that animals have been vaccinated.

Vaccination will be required for a number of years. The terms of the exit strategy, which focuses heavily on surveillance, is set out in EU legislation, and includes sufficient evidence from surveillance using sentinel animals to prove absence of disease for at least two years. Until the exit strategy conditions have been met, it is likely that annual revaccination will be required, plus full vaccination of naïve stock. The vaccination strategy will be kept under regular review by the Group.

An amendment to the EC regulations on bluetongue was published in February 2009 and allows areas without disease to vaccinate while also maintaining strict import conditions. This is subject to rigorous surveillance requirements which are still under discussion with the EC. When more details become available the Group will meet to consider whether this is a desirable option for Scotland.

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, as amended). These have been transposed into Scottish legislation by the Bluetongue (Scotland) Order 2008 (SSI 2008/11, as amended). The Declaration of a Vaccination Zone under this Order sets 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.

Further information for keepers and vets can be found on the Scottish Government's website at www.scotland.gov.uk/BTVvaccination. This website includes a Q&A, copies of the vaccine order form and self-declaration form and a video of the Chief Veterinary Officer Prof Charles Milne answering questions about the campaign. Information can also be obtained from vets and local Animal Health Divisional Offices.

Animal Health & Welfare Division

Scottish Government

on behalf of the Scottish Government & Industry Stakeholder Group

Version 1.3

24 February 2009

Note that the details in this document are continuously updated in light of developments. The most recent version can be seen on the Scottish Government Bluetongue website.