Biological E Secures WHO Clearance for Polio Vaccine

India’s Biological E Limited has secured Phase II prequalification from the World Health Organization (WHO) for its Novel Oral Polio Vaccine type 2 (nOPV2), marking a major step in the global push to eliminate polio.

The recent approval enables the firm to produce the drug substance and the final vaccine product at its combined plant in Hyderabad, which reinforces supply towards the worldwide immunization initiatives.

This Phase II prequalification has allowed Biological E Limited to master the entire production chain of the Novel Oral Polio Vaccine type 2 (nOPV2) by the WHO standards.

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Previously the firm had received Phase I approval in June 2024, which was limited to the fill-and- finish phase with externally sourced bulk vaccine. The new approval increases its role, and enhances the flexibility of production in cases of outbreaks.

It is an oral polio vaccine that is aimed to fight a circulating vaccine-derived poliovirus type 2 (cVDPV2) and is genetically more stable than older oral polio vaccines. By the time of writing, Biological E had provided close to 700 million doses to the stockpiles around the world. NOPV2 was used to contain outbreaks in several countries in which its more than one billion doses have been administered globally.

The vaccine was developed and introduced with the help of the global health partners, among which there were WHO, PT Bio Farma, PATH, and Gates Foundation. The nod further solidifies the role of India as a polio vaccine powerhouse and further boosts global endeavours to stamp out polio permanently.