Biological E. Ltd, a Hyderabad-based pharmaceutical and biologics company, has recently secured final approval for its Novel Oral Polio Vaccine type 2 (nOPV2) from the World Health Organization (WHO). This important milestone allows Biological E. to manage the entire vaccine manufacturing process internally, enhancing efficiency and production capabilities. Previously, the company had received Phase I approval in June 2024, which limited its production to the final vaccine product using materials sourced from other manufacturers.
“The WHO granted us Phase II Pre-Qualification (PQ) for our nOPV2, covering both the drug substance and drug product manufactured at our facility,” the company announced, underscoring the significance of completing the full manufacturing chain at a single, integrated site. With this approval, Biological E. is now positioned to respond more effectively to global health needs.
To date, Biological E. has produced and delivered an impressive 700 million doses of the nOPV2 vaccine internationally. These vaccines are crucial in campaigns aimed at curbing the outbreaks of circulating vaccine-derived poliovirus. Mahima Datla, Managing Director of Biological E. Ltd, emphasized the urgency of timely responses to polio outbreaks. “When polio outbreaks occur, response time and vaccine availability determine how quickly transmission can be stopped. nOPV2 has already been deployed in over a billion doses globally because it is designed specifically for outbreak control with improved genetic stability,” she stated.
The recent Phase II WHO Pre-Qualification enables complete end-to-end manufacturing at Biological E.’s facilities, making the global vaccine supply chain more resilient and responsive. “Every delay in outbreak response carries real risk for children and communities,” Datla added, highlighting the profound implications of timely vaccine production in safeguarding public health.
Biological E.’s achievements in polio vaccination underscore its commitment to combating infectious diseases that threaten vulnerable populations worldwide. The organization’s proactive measures and the advancements in its manufacturing capabilities will play a vital role in controlling and possibly eradicating polio outbreaks in the near future. With the global health landscape evolving, the integration of efficient, in-house manufacturing processes will be instrumental in ensuring a swift response to future outbreaks.
The progress made by Biological E. reflects the ongoing global effort to eradicate polio and showcases the importance of innovative vaccine solutions in public health. As the world grapples with various health challenges, the ability to produce vaccines rapidly and effectively will remain a cornerstone of disease prevention strategies.
With this new phase of manufacturing capabilities, Biological E. is well-positioned to contribute significantly to global health security and the ongoing battle against polio. The progress made not only signifies an important step for the company but also offers hope for communities impacted by polio across the globe.
Published on February 12, 2026.
Original Source: https://www.thehindubusinessline.com/companies/be-gets-full-who-approval-for-polio-vaccine-nopv2/article70624812.ece
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Publish Date: 2026-02-12 20:18:00
