WHO Grants Phase II PQ to Biological E's Novel Oral Polio Vaccine Type 2
The development expands BE's WHO-qualified manufacturing scope beyond phase I, under which the company received PQ in June 2024 for drug product manufacturing using externally supplied drug substance.
Hyderabad: Biological E Limited on Thursday announced that the WHO has granted phase II pre-qualification for its Novel Oral Polio Vaccine type 2.
Phase II pre-qualification covers both the drug substance and the drug product manufactured at BE, completing the full manufacturing chain for nOPV2 at a single integrated site, the vaccine maker said in a press release.
The development expands BE's WHO-qualified manufacturing scope beyond phase I, under which the company received PQ in June 2024 for drug product manufacturing using externally supplied drug substance.
BE 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.
Commenting on the milestone, Mahima Datla, Managing Director of Biological E Limited, said that when polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped.
She noted that nOPV2 has already been deployed in more than a billion doses globally, as it is specifically designed for outbreak control with improved genetic stability.
"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," she said.
The progress reflects the critical contributions of PT Bio Farma (Indonesia), PATH, and the Gates Foundation in providing technical and programmatic support, the release added.
With integrated manufacturing infrastructure, validated processes, and export regulatory approvals already in place, BE is well positioned to support global programme requirements as demand evolves.
The phase II qualification further enhances BE'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, it added.
