WHO Prequalifies Additional Novel Oral Polio Vaccine, Boosting Global Outbreak Response

The World Health Organization (WHO) has announced the prequalification of an additional novel oral polio vaccine type 2 (nOPV2), a major step forward in strengthening the global vaccine supply and accelerating progress toward polio eradication.

The decision expands access to one of the most critical tools in the fight against poliovirus type 2 outbreaks, supporting more sustainable outbreak control and reinforcing global immunization efforts.

Strengthening Vaccine Supply for Global Immunization

WHO prequalification confirms that the vaccine meets international standards of quality, safety, and efficacy, enabling it to be procured and distributed through United Nations agencies, including UNICEF.

This designation is essential for ensuring that countries affected by poliovirus outbreaks can access quality-assured vaccines quickly and reliably.

"With this latest addition, WHO continues to diversify and strengthen the manufacturing base for quality-assured nOPV2," the Organization said, helping to build a more resilient and sustainable vaccine supply chain.

New Manufacturer Added Through International Collaboration

The newly prequalified vaccine is manufactured by Biological E. Limited (BioE) in India, using in-house bulk vaccine production following a technology transfer from PT Bio Farma (Persero) in Indonesia.

This builds on earlier WHO listings of nOPV2 produced by PT Bio Farma, as well as formulations previously filled by BioE using bulk supplied from Indonesia.

The expanded manufacturing network represents an important innovation in global vaccine production, ensuring multiple sources of supply for countries responding to outbreaks.

A Key Innovation Against Vaccine-Derived Poliovirus

The nOPV2 was developed specifically to address outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2), which can emerge in under-immunized communities.

Unlike the traditional monovalent oral polio vaccine type 2, nOPV2 is designed to be more genetically stable, reducing the risk of seeding new outbreaks while maintaining strong effectiveness in rapidly interrupting virus transmission.

This innovation makes nOPV2 central to sustainable outbreak response strategies worldwide.

Vaccination Efforts Driving Progress Toward Eradication

Progress in vaccine development and access is translating into measurable gains in the global polio eradication campaign.

In remarks to the 158th session of the WHO Executive Board, WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted the impact of immunization:

"Vaccines are also bringing us closer to the eradication of polio, with 41 cases of wild polio reported last year from just 24 districts in Pakistan and Afghanistan, down from 99 cases in 49 districts in 2024," he said.

Emergency Use Tool for Outbreak Response

nOPV2 is authorized for emergency use across all age groups in outbreak settings when required by WHO or the Global Polio Eradication Initiative (GPEI).

Since its first deployment, the vaccine has been used in numerous outbreak responses, reaching hundreds of millions of children and contributing to reductions in cVDPV2 transmission in multiple affected countries.

Moving Closer to a Polio-Free World

WHO emphasized that expanding the pool of prequalified nOPV2 vaccines is a crucial step in ensuring that countries can respond rapidly to outbreaks, protect vulnerable communities, and move closer to achieving a world free of polio.