nOPV2

To better address the evolving risk of type 2 circulating vaccine-derived poliovirus (cVDPV2), GPEI partners are working to deploy an additional innovative tool – novel oral polio vaccine type 2 (nOPV2). The vaccine is a modified version of the existing type 2 monovalent OPV (mOPV2), which clinical trials have shown provides comparable protection against poliovirus while being more genetically stable and less likely to revert into a form which can cause paralysis in low immunity settings. The vaccine’s increased genetic stability means there is also a reduced risk of seeding new cVDPV2 outbreaks, compared to mOPV2.

nOPV2 is being considered for deployment under WHO’s Emergency Use Listing procedure (EUL) to enable rapid field availability. Even after meeting rigorous EUL criteria for safety and immunogenicity, nOPV2’s performance in the field will continue to be monitored in line with EUL standards and data collection will continue, with the ultimate goal of WHO prequalification.

General information

Resources for Countries

WHO Executive Board decision urging Member States to expedite processes for authorizing the importation and use of nOPV2 on the basis of its emergency use listing – February 2020

The WHO Executive Board serves to implement the decisions and policies of the World Health Assembly, and to advise and facilitate its work. Meeting in Geneva, the Board noted both the evolving public health emergency associated with circulating vaccine derived poliovirus type 2 (cVDPV2) and the new GPEI strategy to control these outbreaks, and made a decision which urges Member States to accelerate processes to enable importation and use of nOPV2, on the basis of its emergency use listing.

WHO Emergency Use Listing (EUL) procedure

nOPV2 is being considered for deployment under WHO’s Emergency Use Listing procedure (EUL) to enable rapid field availability. The EUL procedure involves careful and rigorous analysis of existing data to enable early, targeted use of unlicensed vaccines, therapeutics and in-vitro diagnostic products for a Public Health Emergency of International Concern – which polio has been since 2014. The EUL procedure document defines the steps that WHO follows to establish eligibility of unlicensed products for assessment under this procedure, the essential information required, and the process used to determine eligibility for the time-limited listing of products.

Latest SAGE conclusions and recommendations – April 2020

The Strategic Advisory Group of Experts (SAGE) on Immunization is an independent group of scientific experts which advises WHO on vaccines and immunization. At its April 2020 virtual meeting, SAGE endorsed in principle the criteria for initial nOPV2 use under emergency use listing (EUL) for cVDPV2 outbreak response.

 

Framework for Initial Use of nOPV2 – April 1, 2020

Endorsed by the SAGE, this framework provides guidance for the initial use of nOPV2 under the EUL.

Roadmap for assessment of nOPV2 under the EUL

This document outlines the steps, activities and timelines for WHO’s assessment of nOPV2 under the EUL, and post-recommendation activities

Clinical summary for novel oral polio vaccine type 2 (nOPV2)

This document provides a summary of nOPV2 clinical development data.

This document is also available in: French

Implementation of nOPV2 for cVDPV2 outbreak response: Technical guidance for countries 

This is the official WHO technical guidance document for the implementation of nOPV2 at the country level under WHO EUL. It contextualizes nOPV2 rollout and describes the implementation readiness checklist, which is contained in the nOPV2 vaccine deployment readiness checklist Excel tool.

This document is also available in: French

nOPV2 vaccine deployment readiness checklist

This tool summarizes the requirements for country-level implementation of nOPV2 under WHO EUL and the additional requirements that will apply during the nOPV2 initial use period. More information on the Readiness Reporting and the GPEI’s assessment of country readiness is featured in the document Implementation of nOPV2 for cVDPV2 outbreak response: Technical guidance for countries, which serves as a companion document for this tool.

This document is also available in: French| Arabic |

nOPV2 technical guidance PowerPoint 

The PowerPoint serves as a complementary document to the technical guidance PDF and the vaccine deployment readiness checklist. It is meant to communicate and help facilitate country-level discussions about the readiness process for nOPV2 implementation under WHO EUL.

This document is also available in: |French| Arabic|

nOPV2 Technical Brief

This document provides a quick summary (only) of the key operational considerations for the use of nOPV2 in outbreak response as a quick reference for EPI managers, immunization focal points, and field staff.

This document is also available in: French| Arabic |

 

Coordination and Management

The GPEI has established an nOPV2 Working Group to manage and coordinate the rapid and effective rollout of nOPV2. The group includes representatives from each of the GPEI partner organizations and focuses on research, regulatory, supply, communications, policy, and implementation readiness activities.

Learn more about the nOPV2 Working Group.