Biological E. gets WHO phase II nod for novel oral polio vaccine

Biological E. has received phase II pre-qualification of the World Health Organisation for its novel oral polio vaccine type 2 (nOPV2).

The phase II PQ covers both drug substance and drug product manufactured at BE, completing the full manufacturing chain for nOPV2 at a single integrated site. It 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 Hyderabad-based vaccine maker said on Thursday.

BE said it has already manufactured and supplied 700 million doses of nOPV2 to the product stockpile and shipped to multiple countries where the immunisation campaigns are under way to control circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.

“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 our facilities, global supply becomes more resilient and more responsive,” BE managing director Mahima Datla said.

nOPV2 has already been deployed over a billion doses globally because it is designed specifically for outbreak control with improved genetic stability, she said.

The expanded qualification significantly strengthens global outbreak response readiness by adding integrated, WHO-qualified production capacity for nOPV2 — a critical vaccine used in controlling cVDPV2 outbreaks.

The achievement reflects a multi-year, multi-partner global collaboration involving technology transfer, product comparability assessment, specialised testing and manufacturing readiness programmes across institutions. “The progress reflects the critical contributions of PT Bio Farma (Indonesia), PATH and the Gates Foundation in technical and programmatic support,” Ms.Datla said.