|
|
|
The best known safety test is that used for cattle as described in the European Pharmacopoeia.
The tongue of each of 3 healthy, susceptible cattle is injected with 2 ml of vaccine, followed 4 days later by three times the dose indicated on the label using the prescribed route. The animals are observed for a total period of 10 days. No lesions or clinical signs of FMD should occur on the feet or tongues.
The OIE Manual of Recommended Diagnostic Techniques and Requirements for Biological Products describes an alternative test for other species in which each animal is vaccinated with a double dose of vaccine by the prescribed route and checked daily for a minimum of seven days for evidence of signs of FMD or toxicity.
The statistical validity of the FMD safety test in animals is controversial
when it is recognised that only 4 doses (approximately) of vaccine is
tested in each animal, three of which are administered by the least sensitive
route. This may be contrasted with the in vitro test, in which at least
200 doses can be tested with ease.
|
