WHO Grants Phase II Pre-Qualification for Biological E's Oral Polio Vaccine
WHO has granted Phase II pre-qualification for Biological E Limited's novel Oral Polio Vaccine type 2, enabling full end-to-end manufacturing at a single integrated site in Hyderabad.
Biological E Limited announced that the WHO has granted Phase II pre-qualification for its Novel Oral Polio Vaccine type 2 (nOPV2). Phase II pre-qualification covers both the drug substance and the drug product manufactured at Biological E, completing the full manufacturing chain for nOPV2 at a single integrated site.
The development expands Biological E's WHO-qualified manufacturing scope beyond Phase I, under which the company received pre-qualification in June 2024 for drug product manufacturing using externally supplied drug substance. The upgrade from Phase I approval allows the Hyderabad-based firm to conduct the entire manufacturing process, from drug substance to final product, in-house at a single site.
Biological E has already manufactured and supplied 700 million doses of nOPV2 to the global stockpile, shipping them to multiple countries where immunisation campaigns are underway to control circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. The nOPV2 vaccine has been deployed in more than a billion doses globally, as it is specifically designed for outbreak control with improved genetic stability.
The managing director stated that 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 the company's facilities, global supply becomes more resilient and more responsive. Every delay in outbreak response carries real risk for children and communities.
The progress reflects the critical contributions of PT Bio Farma (Indonesia), PATH, and the Gates Foundation in providing technical and programmatic support. With integrated manufacturing infrastructure, validated processes, and export regulatory approvals already in place, Biological E is well positioned to support global programme requirements as demand evolves.
The Phase II qualification further enhances Biological E's ability to ensure continuous, flexible, and rapid vaccine supply for international outbreak control programmes, highlighting India's leadership in delivering innovative, high-impact solutions that support global polio eradication. The Novel Oral Polio Vaccine type 2 is an improved vaccine designed to control outbreaks of circulating vaccine-derived poliovirus type 2.
The company reported revenues of ₹5,050 crore for the financial year ending March 31, 2025. The nOPV2 vaccine is only accessible from a WHO-controlled global stockpile, requiring stringent readiness assessments and WHO authorization for deployment.