Breaking Update: Here’s a clear explanation of the latest developments related to Breaking News:BE gets full WHO approval for polio vaccine nOPV2– What Just Happened and why it matters right now.
Biological E. has already produced and delivered 700 million doses of the nOPV2 vaccine to various countries
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Biological E. Ltd (BE), a Hyderabad-based pharmaceuticals and biologics company, has received the final permission for its polio vaccine from the World Health Organisation (WHO). This means the company can handle the entire vaccine manufacturing process in-house.
This qualification is an upgrade from the Phase I approval received in June 2024, which only allowed Biological E. to manufacture the final vaccine product using materials supplied by other companies.
“The WHO granted us the Phase II Pre-Qualification (PQ) for our Novel Oral Polio Vaccine type 2 (nOPV2). It covers both drug substance and drug product manufactured at BE, completing the full manufacturing chain for the vaccine at a single integrated site,” a company statement said here on Thursday.
Biological E. has already produced and delivered 700 million doses of the nOPV2 vaccine to various countries running campaigns to stop outbreaks of the circulating vaccine-derived poliovirus.
“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,” Mahima Datla, Managing Director, Biological E. Ltd, said.
“With Phase II WHO Pre-Qualification enabling full end-to-end manufacturing at our facilities, global supply becomes more resilient and more responsive. That matters because every delay in outbreak response carries real risk for children and communities,” she said.
Published on February 12, 2026