All emergency vaccines have to be manufactured according to a specific emergency product licence for which standard information is required:

Orders must be confirmed in writing, including the number of doses, and the date required. The annual throughput of the farm must also be indicated, so that the maximum volume of vaccine possibly required during the 1 year life-time of the licence can be estimated.

You are required to supply the name, address and postcode of all farms involved. If animals are to be vaccinated at a different site to where they will be reared, the VMD will require a letter from the responsible veterinarian stating that vaccinated animals will only be moved between the named farms.

The VMD require to be satisfied that the isolate(s) to be included in the vaccine are actually responsible for the disease outbreak and that the disease is a significant welfare problem. You will need to supply as much information as possible about how the strain(s) was isolated, the symptoms of disease, the morbidity or mortality rate, etc. If Ridgeway Biologicals did not isolate the strain, you will need to confirm that the method of isolation complies with our TSE risk assessment.

The VMD require that the use of an emergency vaccine is fully justified, particularly if there are other commercially available vaccines or treatments. You will need to provide details of the outcome of all intervention strategies tried to date. If there is a commercial vaccine available, you will need to explain why this is not being considered.

Before we can release the vaccine, and in addition to laboratory safety tests, it is required that the vaccine be tested in the target species on site (termed the On Farm Safety Test). You must ensure that the farmer is aware of this requirement and indicate if the vaccine sample for this test is to be sent to your practice or the farm.