The standardization of viral vaccines

Abstract

Extract

The production of any new vaccine on a mass basis must necessarily be accompanied by a certain amount of risk that the product may not be entirely safe. The necessity for including adequate control tests for some specific factor associated with either safety or potency may not be foreseen initially and, as in the case of an early batch of Salk-type poliomyelitis vaccine, this deficiency may have tragic consequences. With such products, therefore, the degree of risk which may be tolerated must obviously depend upon the incidence of the disease in question and the amount of benefit which it is hoped that the vaccine will offer. On the other hand, experience derived from continued manufacture and use of a product enables the gradual accumulation and application of selected control tests, until a point is reached where there is no measurable risk associated with its use. However, to achieve acceptance, a vaccine must possess more general attributes than those relating specifically to the personal safety and welfare of the recipient, and it is with the laboratory evaluation of a number of these factors that the present discussion is concerned.