A novel vaccine to hasten the end of polio
Anticipating the global risk posed by outbreaks of vaccine-derived polio, researchers accelerated the development of a novel oral polio vaccine (nOPV2) more genetically stable than its predecessor. Today, nOPV2 is driving down the number of outbreaks.
Clinical research
Technical assistance
Partnership management
Regulatory strategy
Vaccine manufacturing and supply
Data analysis
Our approach
- Developed shared templates, tools, and processes for partner communication.
- Provided clinical trial technical support, including statistical analysis and the development of a novel genetic stability assay.
- Created and updated risk management strategies.
- Advised on regulatory strategies and provided inputs into WHO applications.
- Facilitated data-sharing agreements among partners.
- Sponsored clinical research to support WHO prequalification.
- Evaluated surveillance data.
Our partners
The Bill & Melinda Gates Foundation
Bio Farma
US Centers for Disease Control and Prevention
Fighting Infectious Diseases in Emerging Countries
Global Polio Eradication Initiative
icddr,b
Intravacc
Medicines and Healthcare Products Regulatory Agency
MRC Unit The Gambia
University of Antwerp
University of California, San Francisco
Why PATH was chosen to do this work
Scientific technology is only as impactful as its ability to reach its intended recipients. Taking technology to scale involves numerous skillsets across the entire vaccine development and delivery spectrum. PATH has amassed expertise at every stage, several of which applied to the nOPV2 project, from clinical trial guidance to regulatory strategy.
Our work is done through partnerships, building on our deep experience facilitating complex collaborations. Bringing together diverse stakeholders under shared vision, assumptions, and tools, and providing technical support to fill the needed gaps, ensured a streamlined, focused approach in a dynamic environment to accelerate access to nOPV2.
Novel science
The success of nOPV2 hinged upon its ability to retain a safe genetic profile. To test this feature during clinical studies, PATH developed a next-generation sequencing (NGS) assay to detect any concerning genetic changes to the weakened virus post-vaccination. This method is also now part of the standard testing protocols for nOPV2 manufacturing at Bio Farma.
The successive implementation of this novel method also helped inspire changes to the WHO’s guidelines for oral poliovirus vaccine manufacturing, paving the way for NGS analysis to replace the use of animals for routine vaccine release testing.
PATH also sponsored an nOPV2 Phase 3 study in The Gambia, the first to assess the vaccine on the African Continent and in a population at high risk of polio outbreaks. This data allowed nOPV2 to be considered for WHO prequalification, a mechanism for ensuring long-term access to the vaccine.
A novel milestone
WHO prequalified nOPV2 in December 2023. Three years earlier, despite the challenges posed during the COVID-19 pandemic, nOPV2 became the first vaccine to achieve an Emergency Use Listing (EUL) from WHO. (COVID-19 vaccines would follow the EUL approval pathway shortly thereafter.)
As with COVID-19, nOPV2 received EUL based on strong clinical data and on the urgent need to control worsening vaccine-derived outbreaks. Our team helped evaluate the EUL surveillance data, which confirmed the results of our clinical analysis and that the vaccine design worked as intended in real-world settings.
Next steps
nOPV2 has ushered in a new era for polio eradication efforts. Next, PATH and partners are turning attention to nOPVs that address polio types 1 and 3. If successful and warranted, these vaccines may also become available under EUL, and eventually be WHO-prequalified.