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.