WHO Prequalifies Additional Novel Polio Vaccine, Boosting Global Supply
The World Health Organization (WHO) has prequalified a fresh novel oral polio vaccine type 2 (nOPV2), significantly strengthening the global supply of this critical vaccine. This development is a major step forward in sustainably controlling type 2 poliovirus outbreaks and accelerating progress toward global polio eradication.
A New Era in Polio Vaccine Production
Biological E. Limited (BioE), based in India, is now a fully qualified manufacturer of nOPV2, joining PT Bio Farma of Indonesia. This diversification of production sources is crucial for ensuring a resilient, reliable, and sustainable vaccine supply for countries battling polio outbreaks. BioE’s expanded role, transitioning from fill-and-finish operations to complete vaccine manufacturing, is a direct result of technology transfer from PT Bio Farma.
What Makes nOPV2 Different?
The nOPV2 vaccine is specifically designed to combat outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2). These outbreaks can occur in populations with low immunization coverage. Unlike the traditional oral polio vaccine, nOPV2 is genetically more stable, reducing the risk of triggering new outbreaks even as maintaining its effectiveness in halting virus transmission.
Reducing the Risk of Vaccine-Derived Poliovirus
Data from the Global Advisory Committee on Vaccine Safety (GACVS) indicates that nOPV2 significantly reduces the emergence of vaccine-derived poliovirus. Specifically, the emergence rate is 75-80% lower compared to the Sabin OPV2 vaccine with similar usage levels. Since 2021, approximately 1.3 billion doses of nOPV2 have been administered in 41 countries during nearly 250 outbreak response campaigns.
Global Impact and Emergency Use
nOPV2 is authorized for emergency use in response to type 2 poliovirus outbreaks, as determined by the Global Polio Eradication Initiative (GPEI) or the WHO. The vaccine is suitable for active immunization across all age groups. The WHO’s prequalification ensures the vaccine meets international standards for quality, safety, and efficacy, facilitating procurement and distribution through UN agencies like UNICEF.
Safety and Ongoing Monitoring
Extensive safety monitoring has been conducted since the nOPV2’s initial use in March 2021. Analysis of data from over 1 billion administered doses across 35 countries has revealed no evidence of unexpected safety concerns or adverse event clusters. The GACVS recommends continued strong surveillance and reporting of adverse events following immunization (AEFIs), including cVPDP2 emergencies, with findings reported to the Strategic Advisory Group of Experts on Immunization (SAGE).
Future Trends in Polio Eradication
The diversification of nOPV2 production signals a commitment to a more robust and responsive global polio eradication strategy. Continued investment in vaccine development, manufacturing capacity, and surveillance systems will be essential to overcome remaining challenges. The focus will likely remain on outbreak response with nOPV2, alongside efforts to increase routine immunization coverage with inactivated polio vaccine (IPV) to achieve lasting protection.
Did you grasp? Polio remains a Public Health Emergency of International Concern, highlighting the ongoing need for vigilance and coordinated global action.
FAQ
- What is nOPV2? A novel oral polio vaccine type 2 designed to combat outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2).
- Why is nOPV2 important? It’s genetically more stable than previous oral polio vaccines, reducing the risk of triggering new outbreaks.
- Who manufactures nOPV2? Currently, PT Bio Farma (Indonesia) and Biological E. Limited (India).
- Is nOPV2 safe? Extensive safety monitoring has shown no unexpected safety concerns.
Pro Tip: Staying informed about polio eradication efforts and supporting vaccination programs are crucial steps in protecting communities worldwide.
Learn more about the Global Polio Eradication Initiative: https://polioeradication.org/
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