Biological E. Limited (BE) has reached a significant milestone in the global fight against polio. The World Health Organization (WHO) has granted Phase II Pre-Qualification (PQ) for BE’s Novel Oral Polio Vaccine type 2 (nOPV2).
This approval marks a critical advancement in strengthening global outbreak response capacity.
Full End-to-End Manufacturing Now WHO-Qualified
Phase II Pre-Qualification covers both the drug substance and the drug product manufactured at Biological E.’s integrated facility. As a result, BE now completes the entire nOPV2 manufacturing chain at a single site.
Previously, in June 2024, WHO granted Phase I PQ to BE for manufacturing the drug product using externally supplied drug substance. However, with Phase II approval, the company now operates a fully integrated, WHO-qualified production process.
This transition significantly enhances manufacturing efficiency, quality assurance, and supply reliability.
700 Million Doses Already Supplied Globally
Biological E. has already produced and supplied 700 million doses of nOPV2 to the global stockpile. Moreover, the company has shipped doses to multiple countries conducting immunization campaigns to control circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.
With integrated manufacturing capabilities, BE can now respond more quickly and flexibly to global demand.
Strengthening Global Outbreak Preparedness
The expanded WHO qualification substantially improves global outbreak readiness. By adding integrated, WHO-approved production capacity, BE supports faster deployment of nOPV2 — a vaccine specifically designed to control cVDPV2 outbreaks through improved genetic stability.
This achievement reflects years of coordinated international collaboration. Partners including PT Bio Farma (Indonesia), PATH, and the Gates Foundation contributed through technology transfer, product comparability assessments, specialized testing, and manufacturing readiness programs.
As per The Press Release, this milestone demonstrates India’s growing capability to produce life-saving vaccines at scale while supporting rapid and reliable global supply chains.
Leadership Perspective on the Milestone
Commenting on the achievement, Mahima Datla, Managing Director of Biological E. Limited, emphasized the urgency of outbreak response:
“When polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped. nOPV2 has already been deployed in over a billion doses globally because it is designed specifically for outbreak control with improved genetic stability.”
She further added:
“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.”
India’s Expanding Role in Global Polio Eradication
With validated processes, export regulatory approvals, and integrated infrastructure already in place, Biological E. stands well positioned to meet evolving global program needs.
Ultimately, Phase II WHO Pre-Qualification enhances BE’s ability to deliver continuous, flexible, and rapid vaccine supply for international outbreak control programs. At the same time, it reinforces India’s leadership in developing innovative, high-impact health solutions that accelerate global polio eradication and protect children worldwide.