WHO Greenlights India's Biological E as Second Global Manufacturer of Novel Polio Vaccine

A Major Milestone for Global Polio Eradication

The World Health Organisation announced on thirteenth February twenty twenty-six that it has granted prequalification to a novel oral polio vaccine type two manufactured by India-based Biological E Limited. The designation certifies that the vaccine meets international standards for quality, safety, and efficacy, enabling United Nations agencies such as UNICEF to purchase and distribute it for immunisation campaigns worldwide.

Second Full Manufacturer Joins the Fight

With this prequalification, Biological E becomes the second full-scale manufacturer of the novel oral polio vaccine type two, joining PT Bio Farma of Indonesia. The company had previously been involved in fill-and-finish activities using bulk vaccine supplied by Bio Farma, but the new designation covers both the drug substance and the drug product manufactured at a single integrated site following a technology transfer. Biological E is expected to produce six hundred million doses annually, building on the seven hundred million doses it has already contributed to the global stockpile since March twenty twenty-four.

Why This Vaccine Matters

The novel oral polio vaccine type two was developed specifically to address outbreaks of circulating vaccine-derived poliovirus type two, which can emerge in communities with low immunisation coverage when weakened viruses in older vaccines mutate toward harmful forms. Since its introduction in twenty twenty-one, more than two billion doses have been administered globally, with field data showing an estimated eighty percent reduction in the risk of new vaccine-derived outbreaks compared to the older type two vaccine.

Renewed Funding and Ongoing Challenges

The prequalification follows a December twenty twenty-five pledge by global leaders in Abu Dhabi to provide one point nine billion dollars for polio eradication efforts, aiming to protect three hundred and seventy million children annually. Wild poliovirus remains endemic in only two countries, Afghanistan and Pakistan, though variant poliovirus outbreaks continue to pose threats in regions including the Lake Chad Basin and Horn of Africa. The Global Polio Eradication Initiative has set targets to stop wild poliovirus transmission by mid twenty twenty-six and to end all circulating vaccine-derived outbreaks by the end of the year.