Biological E Limited has secured Phase II pre-qualification from the World Health Organization for its novel oral polio vaccine type 2 (nOPV2), a key milestone in international polio eradication efforts.
The Phase II designation expands the vaccine’s WHO pre-qualification to cover both the drug substance and the finished vaccine product produced at Biological E’s integrated manufacturing site. This means the company can now complete the entire production process—from bulk formulation to final formulation—under WHO-qualified standards at a single facility, enhancing flexibility and responsiveness in global vaccine supply.
This latest step builds on the company’s earlier Phase I pre-qualification in June 2024, which only permitted preparation of the finished vaccine using externally sourced drug substance. With the new approval, Biological E’s manufacturing scope is broadened, enabling more resilient and rapid production of the vaccine, which is used to control circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.
Biological E has already manufactured and supplied hundreds of millions of doses of nOPV2 to global stockpiles, with the vaccine deployed in immunisation campaigns across multiple countries. The expanded WHO pre-qualification is expected to bolster international outbreak response capabilities by strengthening integrated, WHO-qualified production capacity for this essential public-health tool.
nOPV2 was developed as a next-generation oral vaccine aimed at reducing the risk of new poliovirus outbreaks caused by circulating vaccine-derived strains, with improved genetic stability compared to earlier vaccine forms.
Its broader deployment has been central to efforts to sustainably interrupt transmission of type 2 poliovirus variants in regions with immunisation gaps.
