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India’s Biological E Novel Oral Polio Vaccine Type 2 Achieves WHO Prequalification

Feb. 12, 2026: India’s Biological E Limited (BE) has achieved a major milestone in the global fight against polio after the World Health Organization (WHO) granted prequalification (PQ) status to its novel oral polio vaccine type 2 (nOPV2).

The Global Polio Eradication Initiative (GPEI) welcomed the decision, describing it as a significant step toward strengthening global supply capacity and accelerating efforts to eliminate outbreaks caused by type 2 variant poliovirus.

Expanded Manufacturing Role for Biological E

With WHO prequalification, Biological E transitions from a fill-finish role to becoming a full manufacturer of nOPV2. Previously, the company handled fill-finish activities using bulk vaccine supplied by Indonesia’s PT Bio Farma (PTB).

Since March 2024, Biological E has contributed approximately 700 million doses of nOPV2 to the global stockpile. Under its expanded manufacturing status, the company is expected to produce 600 million doses annually.

This development makes Biological E the second full manufacturer of nOPV2 worldwide, joining PT Bio Farma. The addition of another full production site diversifies supply and strengthens global preparedness against poliovirus outbreaks.

Strengthening Global Outbreak Response

Health officials say expanding manufacturing capacity is critical to ensuring rapid response when variant poliovirus outbreaks occur.

“Expanding nOPV2 manufacturing is essential to ensuring countries can respond quickly to variant poliovirus outbreaks,” said Mike McGovern, Chair of the International PolioPlus Committee at Rotary International and Chair of the Polio Oversight Board at GPEI.

He noted that Biological E’s prequalification status strengthens global vaccine availability and brings the international community closer to ending variant outbreaks permanently.

By increasing stable production capacity, WHO’s approval ensures that countries can access vaccines quickly during emergency immunization campaigns.

A Key Scientific Advancement

The novel oral polio vaccine type 2 represents a next-generation vaccine developed to address challenges associated with traditional oral polio vaccines.

Since its introduction in 2021, more than 2 billion doses of nOPV2 have been administered globally. According to GPEI, extensive field use has demonstrated that the vaccine is highly effective in stopping variant poliovirus outbreaks.

Studies indicate that the estimated risk of new variant polio outbreaks is nearly 80% lower compared to what would be expected if monovalent oral poliovirus vaccine type 2 were used at the same scale.

This improved genetic stability significantly reduces the likelihood of vaccine-derived outbreaks — a key concern in polio eradication efforts.

Dr. Kathleen Neuzil, Director for Polio at the Gates Foundation, described nOPV2 as a major scientific advancement.

“As a next-generation vaccine, nOPV2 is a major scientific advance for polio outbreak response,” she said. “Having Biological E as a full manufacturer expands the dependable supply countries need to protect children and sustain progress toward eradication.”

India’s Role in Global Vaccine Leadership

The milestone further reinforces India’s position as a global leader in vaccine manufacturing. The country has played a crucial role in expanding access to affordable vaccines across low- and middle-income nations, particularly in the Global South.

Biological E’s expanded production capacity not only strengthens outbreak response but also enhances global equity in vaccine access.

With diversified manufacturing across India and Indonesia, supply chains are expected to become more resilient against disruptions.

Global Eradication Efforts Continue

The Global Polio Eradication Initiative is a public-private partnership led by national governments and supported by six core partners:

• World Health Organization (WHO)

• Rotary International

• US Centers for Disease Control and Prevention (CDC)

• UNICEF

• Gates Foundation

• Gavi, the Vaccine Alliance

The initiative’s mission is to eradicate polio worldwide. While tremendous progress has been made over the past decades, variant poliovirus outbreaks remain a challenge in certain regions.

High-quality immunization campaigns, strong surveillance systems, and reliable vaccine supply are considered essential pillars of eradication strategy.

The addition of Biological E as a full manufacturer of nOPV2 is expected to significantly strengthen those efforts.

Looking Ahead

As countries continue to respond to variant poliovirus outbreaks, stable vaccine supply will remain critical.

Health officials emphasize that the fight against polio is at a decisive stage. Expanding production capacity ensures that vaccination campaigns can be launched swiftly and at scale whenever outbreaks occur.

With WHO’s prequalification now granted, Biological E’s full manufacturing role marks a major advancement in global polio eradication efforts — bringing the world closer to a polio-free future.