Hyderabad, Feb 12 (TNT): Biological E. Limited (BE) on Thursday announced it has achieved a significant milestone in global vaccine manufacturing after receiving Phase II World Health Organization (WHO) Pre-Qualification (PQ) for its Novel Oral Polio Vaccine type 2 (nOPV2), strengthening India’s role in global polio eradication efforts.
The Phase II PQ covers both drug substance and drug product manufacturing, enabling BE to complete the entire nOPV2 manufacturing value chain at a single integrated facility in Hyderabad, Hyderabad-based pharmaceutical said in a release here..
This expands the company’s WHO-qualified scope beyond Phase I PQ, granted in June 2024, which was limited to drug product manufacturing using externally sourced drug substance.
With this expanded qualification, BE enhances global outbreak preparedness by adding integrated, WHO-approved production capacity for nOPV2, a critical vaccine used to control outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2).
To date, BE has already manufactured and supplied over 700 million doses of nOPV2 to the global stockpile, with shipments to multiple countries conducting immunization campaigns to contain cVDPV2 outbreaks.
The new qualification is expected to improve supply resilience, reduce response timelines, and support rapid scale-up as global demand evolves.
Commenting on the development, Mahima Datla, Managing Director, said nOPV2 is specifically designed for outbreak control with improved genetic stability, making it safer and more effective for large-scale immunisation campaigns.
Health experts say the milestone enhances global preparedness, shortens response times during emergencies, and reinforces India’s role as a key supplier of life-saving vaccines, contributing decisively to the goal of global polio eradication.
TNT KS
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