WHO/BS/2019.2359 WHO collaborative study to investigate the utility of next generation sequencing (NGS) as a molecular test of virus stocks used in the manufacture of Poliovirus vaccine (Oral)

Overview

Batches of live-attenuated oral polio vaccine (OPV) are tested for molecular consistency as part of the batch release process using the mutational analysis by PCR and restriction enzyme cleavage (MAPREC) test. This test targets nucleotide 472 located in the 5’ non-coding region in type 3 OPV measuring the level of reversion from nucleotide uracil (U) to cytosine (C), which is directly associated with an increase in neurovirulence in animal models. The MAPREC test requires specific reagents, is technically demanding and expertise in the assay is difficult to acquire and maintain. For this reason, the availability of high throughput next generation sequencing technology allowing quantification of nucleotide polymorphisms in viral genomes is being explored as an alternative to MAPREC. A collaborative study was conducted for this purpose.