WHO Grants Phase II Pre-Qualification to Biological E's Oral Polio Vaccine
HYDERABAD: The World Health Organization (WHO) has awarded Phase II pre-qualification (PQ) to Biological E (BE) for its novel oral polio vaccine type 2 (nOPV2), a critical tool in controlling outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2). This announcement was made by the Hyderabad-based biopharmaceutical company on Thursday, marking a significant advancement in global polio eradication efforts.
Enhanced Manufacturing and Supply Chain
The Phase II PQ certification covers both the drug substance and drug product manufactured at BE's integrated facility in Hyderabad. This achievement completes the entire manufacturing chain for nOPV2 at a single site, significantly enhancing the company's capability to ensure a continuous, flexible, and rapid supply of vaccines for international outbreak control initiatives. Previously, in June 2024, BE received Phase I PQ for drug product manufacturing using externally sourced drug substance, but the new qualification expands its WHO-approved scope to include full end-to-end production.
Biological E has already produced and supplied an impressive 700 million doses of nOPV2 to the global product stockpile. These doses have been shipped to multiple countries where immunization campaigns are actively underway to combat cVDPV2 outbreaks. With its integrated manufacturing infrastructure, validated processes, and existing export regulatory approvals, BE is well-positioned to meet evolving global demands and support worldwide polio eradication programs.
Strengthening Global Outbreak Response
The expanded WHO qualification substantially strengthens global readiness for polio outbreak responses by adding integrated, WHO-qualified production capacity for nOPV2. This vaccine is specifically designed for outbreak control with improved genetic stability, having been deployed in over a billion doses globally. Mahima Datla, Managing Director of Biological E, emphasized the importance of this development, stating, "When polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped. 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."
Collaborative Support and Future Implications
The development and qualification of the nOPV2 vaccine benefited from technical and programmatic support provided by PT Bio Farma of Indonesia, PATH, and the Gates Foundation. This collaboration underscores the global effort to eradicate polio, a disease that continues to pose threats in various regions. The Phase II PQ not only bolsters Biological E's role in the pharmaceutical industry but also contributes to public health by ensuring faster and more reliable vaccine access during emergencies, ultimately protecting vulnerable populations worldwide from polio outbreaks.
