Hyderabad: The World Health Organisation (WHO) granted Phase II Pre-Qualification to Biological E. Limited for its Novel Oral Polio Vaccine type 2, clearing full-scale Biological E nOPV2 production at a single integrated facility.
The approval covered both drug substance and drug product manufacturing. It expanded on the Phase I Pre-Qualification that WHO had granted in June 2024. With this clearance, the Hyderabad-based vaccine maker can now undertake end-to-end Biological E nOPV2 production under WHO standards.
The company had already supplied 700 million doses of nOPV2 to global stockpiles. These doses supported vaccination campaigns against circulating vaccine-derived poliovirus type 2 (cVDPV2). The latest approval is expected to strengthen outbreak response capacity by improving supply resilience and enabling faster deployment during emergencies.
Biological E. Managing Director Mahima Datla said rapid response and assured supply remain critical in controlling outbreaks. She stressed that delays in vaccine availability can heighten risks for children and communities.
Phase II nod boosts Biological E nOPV2 production capacity
“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. 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,” Mahima Datla said.
The milestone followed years of global collaboration involving PT Bio Farma of Indonesia, PATH, and the Gates Foundation. Moreover, with validated processes and export approvals in place, the company aims to meet evolving global demand. It also plans to support accelerated efforts toward polio eradication.