Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated), Annex 2

Overview

WHO Requirements for oral poliomyelitis vaccine (OPV) were first formulated in 1962 (1) and then revised in 1966 (2) and 1972 (3) when an appendix describing the production of OPV in human diploid cells was added. The Requirements were further updated in 1982 (4) to reflect an accumulation of data, particularly on the performance and evaluation of the monkey neurovirulence test (MNVT) and tests on the karyology of human diploid cells. The Requirements were then updated in full in 1989 (5) to take account of the WHO Requirements for continuous cell lines used for biologicals production, which had been adopted in 1985 (6) – with a WHO Study Group concluding that, in principle, such cell lines were acceptable for use as substrates for the production of biologicals (7).