GENEVA: The World Health Organization has granted prequalification to an additional novel oral polio vaccine type 2, expanding the pool of quality assured vaccines that can be bought for international immunization programmes and deployed in outbreak settings. WHO said the decision confirms the vaccine meets its standards for quality, safety and efficacy and enables procurement through United Nations agencies, including UNICEF, for use by countries and partners responding to poliovirus transmission.
Prequalification is a gatekeeping step used by global health agencies to guide large scale purchases and support regulatory decision making in lower income and emergency contexts. WHO said the newly prequalified vaccine is designed for outbreaks involving circulating vaccine derived poliovirus type 2, a form of poliovirus that can spread in under immunized communities. Type 2 vaccine derived outbreaks remain a recurring challenge for eradication programmes that rely on high vaccination coverage and rapid response.
The newly prequalified product is manufactured by Biological E. Limited in India. WHO said Biological E is producing the vaccine using in house bulk supply following a technology transfer from PT Bio Farma of Indonesia. The additional manufacturing line is intended to broaden supply options for a vaccine that has been used in multiple outbreak responses since its rollout, and to provide greater resilience for countries seeking rapid access to doses.
WHO said the novel oral polio vaccine type 2 is engineered to be more genetically stable than earlier type 2 oral polio vaccines, reducing the likelihood that the vaccine virus will change in ways that could contribute to new outbreaks. The vaccine is used to stop transmission of type 2 poliovirus in communities where the virus is detected through paralysis cases or environmental surveillance, while national programmes work to raise routine immunization coverage.
Vaccine supply and procurement pathway
WHO’s move adds a second fully prequalified manufacturing source for the vaccine, complementing earlier production used to support emergency campaigns. Prequalification allows United Nations procurement agencies to purchase and ship the vaccine for use in eligible countries and helps streamline introduction in settings where regulatory capacity may be limited. WHO said the vaccine can be used across multiple country settings as part of efforts to control and prevent poliovirus transmission.
Global partners have reported that more than 2 billion doses of the novel oral polio vaccine type 2 have been administered since its introduction in 2021, largely through targeted outbreak response campaigns. Those campaigns are typically conducted in repeated rounds to reach children missed by routine services. The vaccine is used alongside surveillance, rapid investigation of detections and community level delivery efforts that aim to interrupt spread before outbreaks grow.
WHO said prequalification supports access to a quality assured product for outbreak response when recommended through established eradication programme procedures. UNICEF is a key channel for purchasing vaccines on behalf of countries and global partners, and prequalification allows procurement at scale under international tenders. WHO’s announcement emphasized that the expanded manufacturing base can support more predictable supply as countries confront ongoing type 2 vaccine derived poliovirus outbreaks.
Polio eradication context
Wild poliovirus remains endemic in Afghanistan and Pakistan, where vaccinators continue to face the operational challenge of reaching every child during campaign rounds. WHO officials have reported that the two countries recorded 41 wild polio cases in 2025, down from 99 in 2024. At the same time, type 2 vaccine derived outbreaks continue to be reported in multiple countries, underscoring the dual task of ending wild polio and controlling vaccine derived transmission in areas with immunity gaps.
WHO said vaccination coverage remains the central defense against all forms of poliovirus, with rapid outbreak response and sustained routine immunization needed to prevent the virus from taking hold. The additional prequalified novel oral polio vaccine type 2 provides another tool for countries and partners working to stop type 2 transmission, while eradication efforts continue to focus on surveillance, campaign quality and consistent delivery of basic immunization services. – By Content Syndication Services.