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WHO Prequalifies New Novel Oral Polio Vaccine (nOPV2)

by Olivia Martinez
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mesvaccins.net

Patrick GEROME, le 13/02/2026

The World Health Organization (WHO) has prequalified a new oral polio vaccine type 2 (nOPV2), bolstering the global supply of this critical vaccine needed to halt outbreaks of type 2 poliovirus and accelerate progress toward polio eradication. This development is particularly important as global health organizations continue to work towards eliminating this debilitating disease worldwide.

The prequalification confirms the vaccine meets international standards for quality, safety, and efficacy required for global vaccination programs. This allows for its procurement and distribution through United Nations agencies, including UNICEF, and promotes its use in numerous countries for polio prevention and control.

The newly prequalified vaccine is manufactured by Biological E. Limited (BioE) in India, following a technology transfer from PT Bio Farma in Indonesia. This prequalification builds upon previous WHO approvals of the nOPV2 vaccine produced by PT Bio Farma, as well as vaccines formulated and packaged by BioE using raw materials from PT Bio Farma. This latest endorsement expands BioE’s role, transitioning the company from filling and finishing bulk vaccine supplied by PT Bio Farma to full vaccine production.

By adding another qualified manufacturer, the WHO is diversifying and strengthening the production base for nOPV2, ensuring a more resilient, reliable, and sustainable vaccine supply for countries facing outbreaks.

The nOPV2 was developed to combat outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2), which can emerge in populations with low vaccination rates. Compared to the traditional monovalent oral polio vaccine type 2, nOPV2 is genetically more stable, reducing the risk of sparking new outbreaks while maintaining its effectiveness in quickly stopping virus transmission.

The nOPV2 vaccine is indicated for active immunization in all age groups and its emergency use is authorized during outbreaks caused by type 2 poliovirus, when required by the Global Polio Eradication Initiative (GPEI) or the WHO. Since its initial deployment, the vaccine has been used in numerous outbreak responses, reaching hundreds of millions of children and contributing to the reduction of circulating vaccine-derived poliovirus type 2 (cVDPV2) transmission in several affected countries.

Expanding the stock of prequalified nOPV2 vaccines is a crucial step in enabling countries to respond quickly and effectively to outbreaks, protecting populations, and moving closer to a polio-free world.

Source: World Health Organization

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