Biological E Receives WHO Phase II Pre-Qualification for Novel Oral Polio Vaccine Type 2
Key Insights
The World Health Organization has granted Phase II pre-qualification to Biological E Limited's Novel Oral Polio Vaccine type 2 (search), enabling complete end-to-end manufacturing at a single integrated facility.
This milestone expands beyond the company's June 2024 Phase I qualification and allows for more resilient global vaccine supply for outbreak control efforts.
Biological E has already manufactured and supplied 700 million doses of nOPV2 to the global stockpile, with the vaccine deployed in over a billion doses worldwide.
Biological E Limited achieved a significant regulatory milestone as the World Health Organization granted Phase II pre-qualification for its Novel Oral Polio Vaccine type 2 (search) (nOPV2), marking a crucial advancement in global polio (search) eradication efforts. The Hyderabad-based biopharmaceutical company announced the approval covers both drug substance and drug product manufacturing at its facilities, completing the full manufacturing chain for nOPV2 at a single integrated site.
Expanded Manufacturing Capabilities
The Phase II pre-qualification represents a substantial expansion of Biological E's WHO-qualified manufacturing scope beyond Phase I, which the company received in June 2024 for drug product manufacturing using externally supplied drug substance. This progression enables the company to conduct complete end-to-end manufacturing operations, significantly enhancing global supply chain resilience for polio (search) outbreak response.
"When polio (search) outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped," said Mahima Datla, Managing Director of Biological E Limited. "With Phase II WHO Pre-Qualification enabling full end-to-end manufacturing at our facilities, global supply becomes more resilient and more responsive. That matters because every delay in outbreak response carries real risk for children and communities."
Global Supply and Deployment
Biological E has already demonstrated substantial manufacturing capacity, having produced and supplied 700 million doses of nOPV2 to the global stockpile. These vaccines have been shipped to multiple countries where immunization campaigns are actively underway to control circulating vaccine-derived poliovirus type 2 (search) (cVDPV2 (search)) outbreaks. The nOPV2 has been deployed in over a billion doses globally, specifically designed for outbreak control with improved genetic stability.
Strategic Partnerships and Support
The development reflects critical contributions from key international partners, including PT Bio Farma of Indonesia, PATH, and the Gates Foundation (search), which provided technical and programmatic support throughout the qualification process. This collaborative approach underscores the global commitment to polio (search) eradication efforts.
Enhanced Outbreak Response Readiness
With integrated manufacturing infrastructure, validated processes, and export regulatory approvals already in place, Biological E is positioned to support evolving global program requirements. The Phase II qualification significantly strengthens global outbreak response readiness by adding integrated, WHO-qualified production capacity for nOPV2, a critical vaccine used specifically for controlling cVDPV2 (search) outbreaks.
The Novel Oral Polio Vaccine type 2 (search) represents an improved formulation designed specifically to control outbreaks of circulating vaccine-derived poliovirus type 2 (search). The enhanced manufacturing capability highlights India's leadership in delivering innovative, high-impact solutions that support global polio (search) eradication initiatives, ensuring continuous, flexible, and rapid vaccine supply for international outbreak control programs.