Bluetongue: Vaccination
Operational guidance
Key points
- Defra has placed an order with Intervet for 22.5m doses of BTV-8 vaccine, and a further order with Merial for 13m doses.
- Livestock keepers will be allowed to administer the vaccine to their animals
- If the animals are vaccinated in order to be moved out of a Protection Zone for the purposes of intra-community trade, livestock keepers should consider the movement requirements.
- The vaccine will only be authorised for use inside Protection Zones, and in line with the published vaccination roll-out plan.
- You must order vaccine responsibly – obtainment of vaccine is only allowed under licence and it is illegal to stockpile vaccine or use outside of the Protection Zone.
Vaccination plan
- The aim has been to develop a vaccination programme which will:
- allow vaccination to be rolled out as quickly as possible, as vaccine is delivered; and
- reduce the cost of vaccination to a minimum by using existing delivery chains and reducing regulatory burdens.
- Under EU law, vaccination can only be carried out in a Protection Zone. Once vaccination is progressing broadly across the Protection Zone, the intention is to extend or modify the Zone in order to permit further vaccination, allowing a phased approach as vaccine comes on-stream.
- However, when vaccine first becomes available from May, it may initially be necessary to limit vaccine availability within the Protection Zone in accordance with the supply of vaccine and the epidemiological situation.
- Defra’s published roll-out plan sets out the priorities for vaccination, and the order in which it is anticipated that vaccination will be rolled out. Known infected premises will take priority in this regard.
Distribution of vaccine and licensing powers
- The distribution chain for vaccine will be as follows:
- Manufacturer; to
- Wholesaler; to
- Private vet or pharmacy; to
- Livestock keeper.
- From the private vet or pharmacy onwards, possession of vaccine will be strictly licensed and can only be obtained if it is for immediate use; we have developed a system to monitor the distribution of vaccine.
- The use of vaccine will also be strictly licensed and will only be able to be used in a specific zone which equates to an area in a Protection Zone or a specific area within a Protection Zone. .
- There is therefore a responsibility on everyone to ensure that vaccine is ordered, obtained and used responsibly.
Vaccine properties
- The Intervet vaccine has been licensed for sheep and cattle. The primary course of vaccination will consist of one 1ml dose in sheep and two 1ml doses in cattle, given approximately 3 weeks apart. Full protection is established 3 weeks after the primary course. Thereafter, single booster vaccinations would be required 2 weeks before the period of risk.
- The Merial vaccine is expected to be licensed for sheep and cattle. The primary course of vaccination is expected to consist of one 1ml dose in sheep and two 1ml doses in cattle, given approximately 4 weeks apart.
- If used in other ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle.
- Vaccination in these species would have to be undertaken under the cascade system under the direct personal responsibility of a veterinarian. There will be no withdrawal periods if the vaccine is used in goats. Guidance on the use of cascade (PDF 138 KB - Link to the Veterinary Medicines Directorate website)
- It is essential that the data sheet requirements with regard to storage temperature are strictly adhered to at all times.
Key considerations for vets
- Vets should be able to satisfy themselves to a reasonable level of confidence that the amount of vaccine ordered and supplied is appropriate for needs and stock numbers.
- Vets should satisfy themselves of the competency of the client to administer vaccine, if appropriate.
- Vets should be aware of the state of health of the animals to be treated.
- As a POM-V the vaccine can only be prescribed by veterinarians to animals under their care.
- The prescribing veterinary surgeon will therefore have to:
- satisfy themselves of the competency of the client to administer vaccine, if appropriate;
- arrange any necessary visit(s) to check the livestock and premises if the practice has not been on the unit in previous six months or any other suitable period of time in order to satisfy the condition “under our care”; and
- ensure correct numbers of doses for numbers of stock.
- It may also be useful for practices to establish a list of clients and the number of doses they need or require in advance recording those farms electronically or in hard copy preferably by County so that they can ensure a fair and rapid delivery of vaccine as it becomes available.
- This vaccine has not previously been used in the field and a clear line of communication between veterinary surgeon and farmer would be vital to report suspected lack of efficacy or any other suspected adverse reactions through the VMD’s SARSS scheme.
- Vets must order vaccine responsibly. It is suggested that ordering vaccine from two or more wholesalers at the same time against individual client orders is likely to jeopardise Defra’s strategic aim to allow a controlled vaccination programme in the face of limited stocks of vaccine.
- The adequacy of suitable refrigerated storage space should be addressed
- The obtainment of vaccine will be licensed and distribution of vaccine will be monitored.
- Vets may be asked to provide ordering and sales information in respect of Bluetongue vaccine to Defra at any time.
Key considerations for farmers
- Farmers must order vaccine responsibly. The obtainment of vaccine will be strictly licensed.
- Farmers can vaccinate their own animals. However should certification for movement out of a Protection Zone be required then you may need a supporting certificate from a vet, or for the vet to administer the vaccine. See movement requirements on the Defra website.
- In all cases, vaccination must be recorded on each premises (i.e. in medicine books). However, when animals are vaccinated with a view to certification for movement (either for domestic or intra-community trade) their individual numbers must be accurately recorded. There will be no requirement for vaccinated animals to be given a specific individual identification (e.g. specific ear tag).
- Vaccine must be used, or disposed of, within 8 hours of opening a bottle.
- Farmers should ensure that they have adequate and sufficient refrigerated storage facilities for vaccine.
- Advice on how vaccinated animals can be moved out of the Protection Zone will be published shortly on the Defra website.
- It is the responsibility of the farmer to have access to adequate handling facilities and to ensure the safety and knowledge of those allowed to vaccinate.
- Reporting of clinical cases of Bluetongue (even in vaccinated animals) is mandatory as it is a notifiable disease. Any adverse reactions to vaccination must be reported to the manufacturer via your private vet.
Key considerations for wholesalers
- Wholesalers will be allocated vaccine based on the market share in the area of consideration, either the whole Protection Zone or an area within the Protection Zone.
- Refreshing of stocks to wholesalers from Intervet to maintain requirements together with potential re-distribution between wholesalers will be facilitated by:
- Wholesalers submitting data back to Intervet at a frequency defined by Intervet to enable information on sales and current stocks to be monitored.
- Wholesalers submitting information to Intervet with regard to orders (or pre-orders) to hand.
- Wholesalers will be asked to supply vaccine to veterinary surgeons and pharmacists based on the published vaccination rollout strategy, in accordance with the legislation and timely instruction from Defra, and knowledge of supply levels held by Intervet.
- Wholesalers will be supplying vaccines in accordance with the MHRA cold chain distribution legislation. Due to the potential large volumes of cold chain material orders may not be fulfilled by the normal supply chain routes.
- As the supply of the vaccine will be only against a firm order and the vaccine will be for immediate use there will be no returns to the wholesalers.
- Wholesalers may be asked to provide sales information in respect of Bluetongue vaccine to Defra at any time.
Key considerations for pharmacists
- Pharmacists should follow the relevant guidelines for vets.
- Pharmacists should only supply vaccine to farmers who have submitted a prescription in hard copy from a veterinary surgeon, where the prescription defines that the destination farm is inside the Protection Zone.
- Pharmacists will be unable to hold stock of vaccine pending the potential arrival of such prescriptions.
- Pharmacists may be asked to provide sales information in respect of Bluetongue vaccine to Defra at any time.
Page last modified: 27 June, 2008