Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated), Annex 2, TRS No 980

Overview

WHO Requirements for oral poliomyelitis vaccine (OPV) were first formulated in 1962 (1), and revised in 1965 (2), and then again in 1971 (3), when an appendix describing the production of OPV in human diploid cells was added. The Requirements were further updated in 1982 (4) following 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 for poliomyelitis vaccine (oral) were updated in full in 1989 (5) to take account of the general requirements for the characterization of continuous cell lines for the preparation of biologicals, which were adopted in 1985 (6), and after a WHO study group concluded that, in principle, such cell lines are acceptable as substrates for the production of biologicals (7). An addendum was subsequently adopted (8) that introduced changes in the tests used to confirm freedom from detectable DNA sequences of simian virus 40 (SV40); introduced the mutant analysis by polymerase chain reaction (PCR) and restriction enzyme cleavage (MAPREC) assay as an optional additional in vitro test for poliovirus type 3; increased levels of laboratory containment for wild polioviruses (WPVs) (9); and provided guidance on additional antibody screening tests (for foamy viruses) for animals from closed primate colonies used as a source for primary monkey kidney cells.

The scope of the present Recommendations encompasses poliomyelitis vaccines (oral, live, attenuated) derived from the original Sabin strains, some by simple passage and others by more complex routes, including plaque purification. This document is intended to apply to all Sabin poliovirus strains regardless of their history. It does not necessarily apply to other strains that may be developed. This document should be read in conjunction with other relevant WHO Guidelines, such as those on the nonclinical (34) and clinical evaluation (35) of vaccines.

Full version of the WHO Technical Report Series N° 980