WHO Approves New India-Origin Oral Polio Vaccine for Outbreak Fight

The World Health Organization (WHO) has prequalified an additional novel oral polio vaccine type 2 (nOPV2) to strengthen the global supply of the vaccine, stop poliovirus type 2 outbreaks more sustainably and accelerate progress towards polio eradication.The newly approved vaccine was manufactured by Biological E. Limited (BioE), Hyderabad, India, using in-house bulk vaccine following a technology transfer from PT Bio Farma (Persero), Indonesia.The prequalification status means that the vaccine meets international standards of quality, safety, and efficacy for global immunization programmes. It also allows the vaccine to be purchased and supplied through United Nations procurement agencies, including UNICEF, across the world and helps governments prevent and control poliovirus transmission.With the new WHO recommendation, BioE is expected to produce 600 million doses per year of the nOPV2, increasing India's global leadership in vaccine manufacturing and its contributions to expanding access to affordable life‑saving vaccines across the Global South.WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted the impact of vaccination efforts on global polio eradication and said: “Vaccines are also bringing us closer to the eradication of polio, with 41 cases of wild polio reported last year from just 24 districts in Pakistan and Afghanistan, down from 99 cases in 49 districts in 2024."What Is nOPV2?Novel oral polio vaccine type 2 (nOPV2) is a genetically modified, more stable vaccine designed to stop circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. It provides comparable protection to the old type 2 vaccine (mOPV2) but is less likely to cause new vaccine-derived outbreaks.Studies show nOPV2 is safe, well-tolerated and produces similar immunity to mOPV2, with over 500 million doses administered across 23 countries as of early 2024. The vaccine is typically used in targeted, large-scale vaccination campaigns, often for children under five years of age. The oral vaccine is supplied in 20-dose and 50-dose vial presentations. It has a shelf-life of 24 months when stored at temperatures not exceeding –20 °C and can also be stored for up to six months at +2 °C to +8 °C, providing important flexibility for immunization programmes in diverse situations.Mike McGovern, Chair of the International PolioPlus Committee, Rotary International and Chair of the Polio Oversight Board, GPEI, said of the new prequalification: "Expanding nOPV2 manufacturing is essential to ensuring countries can respond quickly to variant poliovirus outbreaks. Biological E’s prequalification status strengthens the global supply and brings us closer to ending these outbreaks for good."Why Is The New Polio Vaccine Useful?Once a global scourge paralysing hundreds of thousands of children globally, polio is now close to eradication as wild poliovirus cases have fallen by more than 99 percent since the 1980s. However, given rising vaccine hesitancy and gaps in immunisation, cVDPV2 can re-emerge in under-immunised communities, triggering outbreaks as seen recently in parts of Africa and Southeast Asia. But nOPV2's genetic stability and increased protection help limit that risk and reduce the chances of a mass outbreak. While India achieved its polio-free certification in 2014, the risk of importations or vaccine-derived outbreaks increases if coverage drops. With the nOPV2's WHO prequalification, officials can safeguard public health by ensuring access to the most advanced tools available.As of August 2022, 18 out of 21 countries had successfully stopped cVDPV2 transmission following two rounds of mass vaccination activity and a further two countries did so after a third round. Data has shown that nOPV2 effectiveness is on par with that of mOPV2, and while evidence of the vaccine’s immunogenicity has already been well established, additional studies continue to be conducted throughout the EUL period to confirm protection against type 2 poliovirus in vaccinated individuals.

WHO Approves New India-Origin Oral Polio Vaccine for Outbreak Fight

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