nOPV2(Fidec Corporation)

The World Health Organization (WHO) has prequalified the novel type 2 oral poliomyelitis (polio) vaccine, nOPV2, to protect children against the disease. The prequalification will ensure broad and long-term accessibility for international agencies to deploy nOPV2 in developing countries. Largely affecting children under the age of five years, polio is a highly infectious disease that is caused by the poliovirus, which can cause paralysis or death. The prequalification highlights the quality of assurance of nOPV2 and will allow countries to access and use the vaccine, including WHO member countries, without the need to meet the strict readiness and monitoring requirements required under the Emergency Use Listing (EUL). The decision follows the analysis of the outcomes of nOPV2 by the Strategic Advisory Group of Experts in Immunization (SAGE), which advises WHO on vaccines and immunisations. SAGE endorsed the strong safety performance of the use of the polio vaccine in real-world settings after reviewing data from the initial use period for nOPV2, which began in November 2020. As well as helping to protect children from the disease, nOPV2 also lowers the risk of vaccine-derived outbreaks. Original oral polio vaccines (OPVs) work by delivering a weakened, live version of poliovirus to children and can be transported over large distances without requiring cold storage to reach hard-to-reach parts of the world. However, in rare instances, the weakened virus in the vaccine can pass among under-immunised populations, where it can mutate into a form that can cause paralysis. nOPV2, which is similarly effective to other OPVs in protecting against polio, significantly reduces the risk of poliovirus mutating and becoming harmful again due to its genetic modifications. In 2021, nOPV2 became the first vaccine to receive a WHO EUL in response to the increased risk of vaccine-derived outbreaks in Africa and Asia. Since then, around 950 million doses have been deployed worldwide. Dr Andrew Macadam, principal scientist at the Medicines and Healthcare products Regulatory Agency, which helped to develop nOPV2, said the announcement from WHO “will mean greater access for many”. “Prequalification has come following years of collaboration, and it’s through continued partnership, fast and accurate detection and broad vaccine coverage, that [we] will finally see polio eradicated,” he said.