WHO Prequalifies New Type 2 Oral Polio Vaccine

The World Health Organization (WHO) has prequalified a new oral polio vaccine type 2 (nOPV2), strengthening the global supply of this essential vaccine to sustainably stem poliovirus type 2 outbreaks and accelerate progress toward polio eradication.

This prequalification certifies that the vaccine meets international standards of quality, safety and effectiveness required for global immunization programs. It enables its purchase and distribution through United Nations procurement agencies, including UNICEF, and promotes its use in many countries for the prevention and control of poliovirus transmission.

This newly prequalified vaccine is manufactured by Biological E. Limited (BioE), India, following a technology transfer from PT Bio Farma, Indonesia. This prequalification builds on previous WHO registrations for the nOPV2 vaccine manufactured by PT Bio Farma, as well as the vaccine formulated and packaged by BioE from raw materials supplied by PT Bio Farma. This new recommendation expands BioE’s role from filling and packaging bulk vaccines supplied by PT Bio Farma (PTB) to full vaccine manufacturing.

With this new listing, WHO continues to diversify and strengthen its quality-assured nOPV2 production base, helping to ensure a more resilient, reliable and sustainable vaccine supply for countries facing outbreaks.

nOPV2 was developed to combat outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2), which can emerge in insufficiently vaccinated populations. Compared to traditional monovalent oral polio vaccine type 2, nOPV2 is designed to be more genetically stable, reducing the risk of triggering new outbreaks while retaining its effectiveness in rapidly interrupting virus transmission.

The nOPV2 vaccine is indicated for active vaccination in all age groups and its Emergency use is permitted in outbreaks caused by poliovirus type 2when required by the Global Polio Eradication Initiative (GPEI) or WHO. Since its first deployment, this vaccine has been used in numerous outbreak responses, reaching hundreds of millions of children and helping to reduce the transmission of vaccine-derived poliovirus type 2 (cVDPV2) in several affected countries.

Expanding the stockpile of prequalified nOPV2 vaccines is an essential step to enable countries to respond quickly and effectively to outbreaks, protect populations and move closer to a polio-free world.

Source : World Health Organization