Biological E’s novel oral type 2 polio vax gets WHO phase II PQ

HYDERABAD: The World Health Organization (WHO) has granted Phase II pre-qualification (PQ) to Biological E (BE)’s novel oral polio vaccine type 2 (nOPV2), which is used for controlling cVDPV2 outbreaks, the Hyderabad-based biopharma company said on Thursday.The Phase II PQ covers both the drug substance and drug product manufactured at BE, which completes the full manufacturing chain for nOPV2 at a single integrated site and enhances the company’s ability to ensure continuous, flexible and rapid vaccine supply for international outbreak control efforts for polio eradication, Biological E said.The PQ 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.The company has already manufactured and supplied 700 million doses of nOPV2 to the product stockpile and shipped to multiple countries where nOPV2 immunization campaigns are underway to control circulating vaccine-derived poliovirus type 2 (cVDPV2 ) outbreaks.With integrated manufacturing infrastructure, validated processes, and export regulatory approvals already in place, BE said it is well positioned to support global requirements as the demand evolves.The expanded qualification significantly strengthens global outbreak response readiness by adding integrated, WHO-qualified production capacity for nOPV2, which is a critical vaccine that is used for controlling cVDPV2 outbreaks.“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,” Biological E managing director Mahima Datla said.“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 added.PT Bio Farma of Indonesia, PATH, and the Gates Foundation provided technical and programmatic support for the vaccine.