Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 1024

Overview

At its sixty-fifth meeting in 2014, the WHO Expert Committee on Biological Standardization adopted the latest WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated). These WHO Recommendations provide guidance on the manufacture and control, nonclinical and clinical evaluation, and lot release of inactivated poliomyelitis vaccines (IPV).

The Recommendations include guidance on the use of several assays requiring the handling of live poliovirus and were produced at a time when only limited data and experience with Sabin-based IPV (sIPV) were available, and when no specific biocontainment requirements for IPV manufacturing had been adopted. Since then, the third revision of the WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use (GAPIII) was adopted by the World Health Assembly in 2015 to provide guidance on the implementation of biosafety and biosecurity measures at facilities handling poliovirus in the post-eradication era. In addition, WHO Guidelines for the safe production and quality control of poliomyelitis vaccines were adopted by the Committee in 2018. These Guidelines further align the biocontainment requirements for the production of both sIPV and IPV derived from wild-type strains (wIPV) with good manufacturing practices (GMP) and GAPIII requirements. Currently, a step-wise implementation of GAPIII is taking place according to the WHO GAPIII Containment Certification Scheme. As few laboratories have the highcontainment facilities required by GAPIII, global capacity for performing assays using live poliovirus, particularly type-2, is limited.

Full version of the WHO Technical Report Series N° 1024