Roadmap for assessment of nOPV2manufactured by PT Biofarma under the EUL procedure

Overview

To address more efficiently the outbreaks of polio resulting from mutations in mOPV2, a novel OPV2 (nOPV2) vaccine has been developed and designed to be less likely to mutate into a form that can cause cVDPVs and vaccine-associated paralytic polio (VAPP). The goal of the nOPV2 project is to develop an oral polio vaccine that is more genetically stable than the current mOPV2 and to replace mOPV2 as the stockpile vaccine.