The World Health Organization (WHO) has prequalified an additional novel oral polio vaccine type 2 (nOPV2), strengthening the global supply of a critical tool in combating poliovirus type 2 outbreaks and accelerating progress toward polio eradication. This prequalification confirms that the vaccine meets international standards of quality, safety, and efficacy, enabling its procurement through UN agencies, including UNICEF, for use in multiple countries to prevent and control poliovirus transmission.
The newly prequalified nOPV2 is manufactured by Biological E. Limited (BioE) in India, using in-house bulk vaccine produced following a technology transfer from PT Bio Farma in Indonesia. This follows earlier WHO listings of nOPV2 produced by PT Bio Farma, as well as formulations by BioE using Bio Farma-supplied bulk, further diversifying and strengthening the manufacturing base to ensure a resilient, reliable, and sustainable supply for outbreak response.
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 more genetically stable, reducing the risk of triggering new outbreaks while remaining effective in rapidly interrupting virus transmission. Its development and deployment have already translated into measurable gains, with vaccination efforts contributing to a reduction in wild polio cases—from 99 cases in 49 districts in 2024 to 41 cases in 24 districts in 2025, mainly in Pakistan and Afghanistan, according to WHO Director-General Dr. Tedros Adhanom Ghebreyesus.
nOPV2 is authorized for active immunization in all age groups and for emergency use during outbreaks, as guided by the Global Polio Eradication Initiative or WHO. Since its initial deployment, the vaccine has been used in numerous outbreak responses, reaching hundreds of millions of children and contributing to reductions in cVDPV2 transmission in affected countries. Expanding the pool of prequalified nOPV2 vaccines ensures countries can respond quickly and effectively, protecting communities and advancing toward a polio-free world.
The Biological E. Limited nOPV2 is supplied in 20-dose and 50-dose vials, with a shelf-life of 24 months at –20 °C and up to six months at +2 °C to +8 °C, allowing flexibility for immunization programs in diverse operational settings. Opened vials may be used for up to 28 days under the WHO Multi-dose Vial Policy, supporting efficient vaccine use during outbreak campaigns.
At the 158th session of the WHO Executive Board in February 2026, delegates emphasized the importance of maintaining high-quality surveillance, vaccination, and outbreak response, particularly in remaining endemic areas. Sustaining political commitment, predictable financing, cross-border coordination, and timely access to vaccines like nOPV2 will be decisive in translating recent gains into lasting polio eradication and safeguarding a polio-free world.
