Page 833 - Veterinary Immunology, 10th Edition

VetBooks.ir Adverse Effect Principles

In determining whether a vaccine causes an adverse effect, the
following three principles should apply. First, is the effect

consistent? The clinical responses should be the same if the vaccine
is given to a different group of animals, by different investigators,
and irrespective of the method of investigation. Second, is the effect
specific? The association should be distinctive and the adverse
event linked specifically to the vaccine concerned. It is important to

remember that an adverse event may be caused by vaccine
adjuvants and components other than the major antigens. Finally,
there must be a temporal relationship. Administration of the

vaccine should precede the earliest manifestations of the event or a
clear exacerbation of a continuing condition.

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