India’s Biological E Gains WHO Approval for Novel Polio Vaccine, Boosting Global Eradication Efforts
In a significant step forward in the global fight against polio, the World Health Organization (WHO) has granted prequalification (PQ) status to India’s Biological E. Limited (BE) for its novel oral polio vaccine type 2 (nOPV2). This milestone, announced on February 12, 2026, expands BE’s manufacturing capabilities and strengthens the world’s ability to respond to outbreaks of this debilitating disease.
From Fill-Finish to Full Manufacturing: A Game Changer
Previously, Biological E was involved in the “fill-finish” stage, utilizing bulk vaccine supplied by PT Bio Farma (PTB) of Indonesia. The recent WHO recommendation allows BE to undertake full vaccine manufacturing, dramatically increasing global supply. Since March 2024, BE has already contributed 700 million doses of nOPV2 to the global stockpile, and is now expected to produce 600 million doses annually.
This development is particularly crucial as it establishes BE as the second full manufacturer of nOPV2, alongside PTB. Having two independent manufacturers ensures a diversified and stable global production capacity, vital for swiftly addressing variant poliovirus outbreaks.
nOPV2: A Next-Generation Vaccine
More than 2 billion doses of nOPV2 have been administered globally since its introduction in 2021. Evidence demonstrates its effectiveness in halting outbreaks of type 2 variant poliovirus. Studies indicate that the risk of new variant polio outbreaks is nearly 80% lower when using nOPV2 compared to the older monovalent oral poliovirus vaccine type 2.
Dr. Kathleen Neuzil, Director for Polio at the Gates Foundation, highlighted nOPV2 as a “major scientific advance for polio outbreak response,” emphasizing that Biological E’s expanded manufacturing capacity will provide countries with the dependable supply needed to protect children and sustain progress toward eradication.
India’s Growing Role in Global Vaccine Manufacturing
This achievement underscores India’s increasing prominence as a global leader in vaccine manufacturing and its commitment to expanding access to affordable, life-saving vaccines, particularly in the Global South. The country’s capabilities are becoming increasingly important in ensuring equitable access to essential medicines worldwide.
The Global Polio Eradication Initiative: A Collaborative Effort
The effort to eradicate polio is spearheaded by the Global Polio Eradication Initiative (GPEI), a public-private partnership involving national governments and six core partners: the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC), the United Nations Children’s Fund (UNICEF), the Gates Foundation, and Gavi, the Vaccine Alliance.
“Expanding nOPV2 manufacturing is essential to ensuring countries can respond quickly to variant poliovirus outbreaks,” stated Mike McGovern, Chair of the International PolioPlus Committee, Rotary International, and Chair of the Polio Oversight Board, GPEI. “Biological E’s prequalification status strengthens the global supply and brings us closer to ending these outbreaks for good.”
Future Trends in Polio Eradication
While significant progress has been made, the final stages of polio eradication present unique challenges. The focus is now on interrupting all poliovirus transmission in Afghanistan and Pakistan, the two remaining countries where wild poliovirus persists, and preventing outbreaks of circulating vaccine-derived poliovirus (cVDPV) in other regions.
Several key trends are shaping the future of polio eradication:
- Enhanced Surveillance: Strengthening disease surveillance systems is crucial for rapidly detecting and responding to outbreaks.
- Innovative Vaccine Strategies: Continued research and development of new vaccines, like nOPV2, are essential to address the evolving challenges posed by poliovirus.
- Community Engagement: Building trust and engaging local communities are vital for ensuring high vaccination coverage.
- Integrated Health Systems: Integrating polio eradication efforts with broader health programs can improve efficiency and sustainability.
The WHO’s 2022-2026 strategy emphasizes a transformative approach, focusing on regional and country-specific strategies to achieve and sustain a polio-free world.
FAQ
Q: What is nOPV2?
A: nOPV2 is a novel oral polio vaccine type 2 designed to be more stable and effective in stopping outbreaks of type 2 variant poliovirus.
Q: Who are the key players in the GPEI?
A: The GPEI is led by national governments and includes the WHO, Rotary International, CDC, UNICEF, Gates Foundation, and Gavi, the Vaccine Alliance.
Q: What is the current status of polio eradication?
A: Wild poliovirus types 2 and 3 have been eradicated. Efforts are now focused on eliminating wild poliovirus in Afghanistan and Pakistan and preventing outbreaks of vaccine-derived poliovirus.
Q: Why is Biological E’s prequalification important?
A: It expands the global supply of nOPV2, ensuring countries can respond quickly to outbreaks and strengthening the overall effort to eradicate polio.
Did you know? Polio cases have decreased by more than 99% since the launch of the Global Polio Eradication Initiative in 1988.
Learn more about the Global Polio Eradication Initiative here.
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