Real-world performance of nOPV2 reinforces strong safety profile

October 11, 2021 by PATH

Experts endorse successful completion of initial use period

The Strategic Advisory Group of Experts on Immunization (SAGE) – an independent group of scientific experts that advises the World Health Organization (WHO) on vaccines and immunization – has endorsed the strong safety performance of nOPV2 use in real-world settings. SAGE reviewed data from the initial use period for nOPV2, which began in November 2020.

Since 2015, PATH has helped advance the development of nOPV2 by serving as the convener of the product development consortium; providing technical input into manufacturing and clinical trials; overseeing the development and execution of novel tests to assess the vaccine’s genetic stability; and facilitating data-sharing among partners.

In November 2020, the vaccine received a recommendation for initial use under WHO’s Emergency Use Listing (EUL) procedure, based on the urgent need to contain outbreaks and on promising clinical data from Phase 1 and Phase 2 nOPV2 trials.

Since the beginning of the initial use period initiated by the EUL approval, seven countries have delivered approximately 100 million doses of nOPV2 in response to type 2 polio outbreaks. SAGE experts endorsed nOPV2’s graduation from initial use status after a thorough review of safety and genetic stability data gathered from passive and active surveillance activities. The endorsement allows for loosened verification restrictions for countries that wish to apply for use of nOPV2 while still requiring robust vaccine performance monitoring.

WHO’s EUL procedure also requires clinical research on nOPV2 to continue with the aim of achieving licensure and WHO prequalification, which will ensure long-term accessibility for use of nOPV2 to curb outbreaks in the years ahead. To that end, PATH is currently sponsoring a Phase 3 trial of nOPV2 to build the needed evidence base. PATH is also advancing early clinical research for novel oral polio vaccines to protect against polio type 1 and type 3 (nOPV1 and nOPV3).

For more information about nOPV2:

Fact sheet

Polio eradication and beyond: a long-term vaccine strategy

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