In a significant step toward global polio eradication, the World Health Organization (WHO) has granted prequalification (PQ) status to a novel oral polio vaccine type 2 (nOPV2) manufactured by India’s Biological E. Limited (BE). This milestone, announced on February 12, 2026, expands BE’s role in the global fight against poliovirus, bolstering the supply chain for this critical vaccine and offering renewed hope for regions still battling outbreaks. The development underscores India’s growing leadership in vaccine production and its commitment to global health security. This India’s polio vaccine achievement is poised to strengthen outbreak response capacity worldwide.
For decades, the oral polio vaccine (OPV) has been instrumental in reducing polio cases globally. However, in rare instances, the vaccine virus itself can mutate and cause paralysis, known as vaccine-derived poliovirus (VDPV). The nOPV2 addresses this concern by incorporating genetic modifications that develop the virus more stable and less likely to revert to a form that can cause paralysis. This next-generation vaccine modifies the Sabin type 2 strain with genetic “locks” to enhance stability, reducing the risk of reversion to neurovirulence although maintaining immunogenicity and ease of administration.
Expanding Global Supply and Manufacturing Capacity
The WHO’s prequalification of BE’s nOPV2 is particularly important because it diversifies the global supply. Previously, PT Bio Farma (PTB) in Indonesia was the sole full manufacturer of nOPV2. With BE now fully qualified, the world has a more reliable and stable production capacity to respond to outbreaks of type 2 variant poliovirus (cVDPV2). Since March 2024, Biological E has already contributed 700 million doses of nOPV2 to the global stockpile, and is expected to produce an additional 600 million doses annually, according to the GPEI.
This increased capacity is crucial, as nOPV2 is considered indispensable for rapid outbreak response, complementing inactivated polio vaccine (IPV) in routine immunization schedules. According to the Global Polio Eradication Initiative (GPEI), nOPV2 provides both individual protection and community immunity, helping to interrupt the transmission of the virus. The GPEI’s 2022-2026 strategy emphasizes the vaccine’s role in achieving this goal.
A History of Innovation and Collaboration
The journey to this point has involved years of research, development, and collaboration. Field rollout of nOPV2 began in March 2021, initially under strict monitoring to confirm its genetic stability. PTB received full WHO prequalification in December 2023, paving the way for broader access. By 2026, over 2 billion doses of nOPV2 have been administered across more than 35 countries, primarily in Africa and Asia, where cVDPV2 outbreaks remain a threat.
While rare instances of reversion to a neurovirulent strain have been detected – such as a case in Uganda in 2025 – these have not led to widespread outbreaks, largely due to high vaccination coverage. This demonstrates the overall stability and effectiveness of the nOPV2 vaccine.
India’s Role in Global Vaccine Equity
The WHO’s approval of Biological E as a full nOPV2 manufacturer highlights India’s growing prominence as a global vaccine hub. “As a next-generation vaccine, nOPV2 is a major scientific advance for polio outbreak response,” said Dr. Kathleen Neuzil, Director for Polio at the Gates Foundation, in a press release. “Having Biological E as a full manufacturer expands the dependable supply countries need to protect children and sustain progress toward eradication.” This milestone adds to India’s record of global leadership in vaccine manufacturing and its contributions to expanding access to affordable, life-saving vaccines across the Global South.
Currently, the U.S. Government identifies approximately 30 countries where poliovirus remains a health risk. As of February 20, 2026, the nOPV2 vaccine is not available in the United States, where the inactivated polio vaccine (IPV) has been the standard since 2000.
Experts caution that prematurely withdrawing from OPV vaccination programs could reverse decades of progress and potentially lead to millions of cases of paralysis. The GPEI emphasizes the continued importance of both nOPV2 and IPV in achieving complete polio eradication.
The next key step in the global polio eradication effort will be continued monitoring of nOPV2’s performance and ensuring equitable access to the vaccine in all at-risk regions. The GPEI will continue to provide updates on outbreak response and vaccination campaigns.
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