The prequalification designation indicates that the vaccine meets international standards of quality, safety, and efficacy for global immunization programmes. It enables the vaccine to be purchased and supplied through United Nations procurement agencies, including UNICEF, supporting its use across multiple country settings for the prevention and control of poliovirus transmission.
The newly prequalified product is manufactured by Biological E. Limited (BioE), India, using in-house bulk vaccine following a technology transfer from PT Bio Farma (Persero), Indonesia. This prequalification builds on earlier WHO listings of nOPV2 manufactured by PT Bio Farma, as well as the vaccine formulated and filled by BioE using bulk supplied by PT Bio Farma.
With this latest addition, WHO continues to diversify and strengthen the manufacturing base for quality-assured nOPV2, helping to ensure a more resilient, reliable and sustainable vaccine supply for countries responding to outbreaks.
The nOPV2 was developed to address outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2), which can emerge in under-immunized populations. Compared with the traditional monovalent oral polio vaccine type 2, nOPV2 is designed to be more genetically stable, reducing the risk of seeding new outbreaks while retaining its effectiveness in rapidly interrupting virus transmission.
Progress in vaccine development and timely availability continues to translate into gains on the ground. In his opening remarks at the 158th session of the WHO Executive Board, WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted the impact of vaccination efforts on global polio eradication. “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.
nOPV2 is indicated for active immunization in all age groups and is authorized for emergency use in response to outbreaks caused by poliovirus type 2, when and where required by the Global Polio Eradication Initiative (GPEI) or WHO. 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 several affected countries.
Expanding the pool of prequalified nOPV2 is a key step toward ensuring that countries can respond rapidly and effectively to outbreaks, protect communities, and move closer to a world free of polio.
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