Improved, standardized methods for testing the safety and potency of oral poliovirus vaccines have been developed and incorporated into WHO requirements.
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Supports refined OPV safety standards; leaves open need for prospective validation in current manufacturing.
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 components 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.
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Bennett L. Elisberg (1984) studied this question.
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