WHO Awards Phase II Pre-Qualification to Biological E's Novel Oral Polio Vaccine
In a significant development for global health, the World Health Organization (WHO) has granted Phase II pre-qualification (PQ) to Biological E's novel oral polio vaccine type 2 (nOPV2). This Hyderabad-based biopharmaceutical company announced the achievement on Thursday, marking a crucial step in efforts to control circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks worldwide.
Enhanced Manufacturing Capabilities for Global Supply
The Phase II PQ certification covers both the drug substance and drug product manufactured at Biological E's facilities. This completes the full manufacturing chain for nOPV2 at a single integrated site in Hyderabad, significantly boosting the company's ability to ensure continuous, flexible, and rapid vaccine supply. Such capabilities are vital for international outbreak control initiatives aimed at eradicating polio, as emphasized by the company in its statement.
This new qualification expands Biological E's WHO-qualified manufacturing scope beyond Phase I. In June 2024, the company received PQ for drug product manufacturing using externally supplied drug substance. With Phase II, Biological E now manages the entire production process internally, enhancing efficiency and reliability. To date, the company has already manufactured and supplied an impressive 700 million doses of nOPV2, demonstrating its robust production capacity.
Critical Role in Polio Outbreak Response
Mahima Datla, Managing Director of Biological E, highlighted the importance of timely vaccine availability in combating polio outbreaks. "When polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped," she stated. "nOPV2 was already deployed in over 1 billion doses globally because it is designed specifically for outbreak control with improved genetic stability."
She further explained the impact of the Phase II PQ: "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." This advancement is expected to strengthen global health systems by providing a more dependable vaccine source during emergencies.
Broader Implications for Public Health
The achievement underscores Hyderabad's growing prominence as a hub for biopharmaceutical innovation and manufacturing. Biological E's success with nOPV2 not only contributes to polio eradication efforts but also sets a precedent for other vaccine producers in India and beyond. The integration of manufacturing processes at a single site reduces logistical complexities and potential supply chain disruptions, which are critical factors in pandemic and outbreak scenarios.
As the world continues to grapple with infectious diseases, such milestones highlight the importance of collaborative efforts between international organizations like the WHO and private sector companies. Biological E's Phase II PQ is a testament to the advancements in vaccine technology and manufacturing excellence, paving the way for more effective public health interventions globally.
