Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 993

Overview

The Requirements for inactivated poliomyelitis vaccine (IPV) were first formulated in 1959 (1) and revised in 1965 (2). Following several advances in vaccine production technology, the Requirements were further updated in 1981 (3) and amended in 1985 (4). At that time, the introduction of continuous cells for the manufacture of IPV was a novel development. Therefore, when the regulatory control of products manufactured in continuous cells had been standardized, the Requirements were again updated in 2000 (5). An addendum was then developed in 2003 (6), specifying the measures to be taken to minimize the accidental risk of reintroducing wild-type poliovirus from a vaccine manufacturing facility into the community after global certification of polio eradication.

Since the Recommendations for the production and control of poliomyelitis vaccine (inactivated) were last revised in 2000 (5) and 2003 (6), there have been several changes in vaccine production, including the use of seed viruses derived from Sabin strains, which make further revision of the Recommendations necessary.

These WHO Recommendations provide guidance to NRAs and manufacturers on the quality and nonclinical and clinical aspects of IPV in order to ensure the quality, safety and efficacy of the vaccines. The scope of the present document encompasses IPV derived from: (a) the wild-type strains that have been used in the manufacture of IPV for many years; (b) the attenuated Sabin strains that have been used in the manufacture of oral poliomyelitis vaccine (OPV); and (c)  new alternative poliovirus strains currently under development, including those derived by recombinant DNA technology. This document does not cover vaccines which are based on virus-like particles (VLPs) and replicons. However, some of the aspects discussed may be relevant to these types of seeds and should be taken into consideration during vaccine development using such seeds. The document should be read in conjunction with other relevant WHO guidelines such as those on the nonclinical (8) and clinical (9) evaluation of vaccines.

Full version of the WHO Technical Report Series N° 993