REVIEWS OF INFECTIOUS DISEASES • VOL. 6, SUPPLEMENT 2 • MAY-JUNE 1984 Standardization of Safety and Potency Tests of Vaccines Against Poliomyelitis


Two of the most important test procedures involved in the production of oral poliovirus vaccine (OPV) and inactivated poliovirus vaccine (IPV) are those for safety and potency. An improved method has been developed for neurovirulence testing of monovalent com-ponents of the trivalent OPV that is more reproducible and quantitative than previous procedures and requires fewer monkeys. A more reproducible method for assaying the potency of OPV has also been developed. Both standardized procedures have been incorporated into the, World Health Organization's International Requirements for this vaccine. Although recent data comparing the sensitivity of monkeys and tissue culture for the detection of residual infectious virus in IPV indicate the latter is significantly better, the results have not been confirmed. Recently developed new in vivo and in vitro tests for assaying IPV potency have not been sufficiently evaluated to indicate which may serve as a standardized procedure. Experience has taught us that standardization is essential to achieve the assurance that successive lots of vaccine from the same or a different manu

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