GACVS sub-committee on novel OPV2 safety

Public notice

Overview

On Friday 13th November,2020, the type 2 novel oral polio vaccine (nOPV2) became the first vaccine authorized by WHO for use under Emergency Use Listing (EUL)[i]. This will allow its rollout for limited initial use in countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. The role of nOPV2 is to protect against type 2 poliovirus - to rapidly prevent and minimize outbreaks, prevent infection and paralysis, save lives, and ultimately, to contribute to polio eradication.

 

The GACVS Sub-Committee was established in time with nOPV2 initial use under EUL, to ensure that an independent group of experts provides a systematic, timely and coordinated ongoing review of safety data and outcomes related to nOPV2 use in the field. The GACVS Sub-Committee on nOPV2 Safety will advise WHO and its Member States on safety outcomes following the use of initially pre-licensed type 2 novel oral poliovirus vaccine, during the EUL period, prior to the availability of Phase III clinical trial results.[ii] This will ensure that the overall decision to accelerate the timeline to roll out nOPV2 from its initial to wider use under EUL and beyond, will be informed and based on sound evidence.

WHO Team
Pharmacovigilance (PVG)