The World Health Organization (WHO) has prequalified a new novel oral polio vaccine type 2 (nOPV2) developed by India-based Biological E. Limited. This milestone is expected to significantly bolster the global response to poliovirus outbreaks and accelerate efforts to eradicate the disease worldwide.
The WHO prequalification confirms that the vaccine meets international standards for quality, safety, and effectiveness, allowing agencies such as UNICEF to procure and distribute it for immunization campaigns across multiple countries.
The vaccine’s updated formulation offers enhanced genetic stability compared to traditional oral polio vaccines, reducing the risk of mutation that can lead to new outbreaks while maintaining high efficacy in stopping virus transmission.
Second Full Manufacturer Joins the Global Effort
With this approval, Biological E. becomes the second full-scale manufacturer of nOPV2, joining Indonesia’s PT Bio Farma. The Global Polio Eradication Initiative (GPEI) stated that expanding production capacity will ensure faster access to vaccines when outbreaks occur.
Biological E. plans to produce up to 600 million doses annually, building on the 700 million doses already supplied to the global stockpile since March 2024.
“When polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped,” said Mahima Datla, Managing Director of Biological E.
The new vaccine specifically targets circulating vaccine-derived poliovirus type 2 (cVDPV2)—a rare but significant challenge that arises in communities with low immunization coverage when older vaccine strains mutate into harmful forms.
Renewed Global Funding Commitment
The expanded vaccine supply aligns with a December 2025 global pledge of $1.9 billion made during the Abu Dhabi Polio Pledging Moment. This funding aims to protect 370 million children annually and narrow the remaining $440 million financial gap in the GPEI’s 2022–2029 strategy.
Since its initial rollout in 2021, more than 2 billion doses of nOPV2 have been administered worldwide. Field data show the vaccine has achieved an 80 percent reduction in the risk of new vaccine-derived outbreaks compared to older versions.
The Fight Against Polio Continues
Although wild poliovirus remains endemic in only Afghanistan and Pakistan, variant outbreaks continue to threaten global progress. WHO officials described the newest prequalification as “a key step toward ensuring that countries can respond rapidly and effectively to outbreaks wherever they occur.”
The development marks another major stride toward a future free of polio—one strengthened by innovation, resilience, and renewed global cooperation.
