ArticleThe Lancet. Global health2025
Safety of nOPV2 administered during a supplementary immunisation activity in Uganda, 2022: data triangulation from a prospective cohort event monitoring programme and vaccine safety surveillance reports.
Article in The Lancet. Global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Immunogenicity and safety of novel oral polio vaccine type 2 (nOPV2) in pediatric populations: a systematic review and Bayesian meta-analysis.BMC infectious diseases · 2026Pooled it
- Strengthening New Vaccine Introduction in Low- and Middle-Income Countries: Establishing Hospital-Based Sentinel Surveillance for Vaccine Safety Monitoring.The American journal of tropical medicine and hygiene · 2025Article
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Authors and funding
15 authors.
Funding
Abstract
backgroundIn November, 2020, WHO authorised novel oral polio vaccine type 2 (nOPV2) use under Emergency Use Listing in response to outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2). Although no concerns were identified in nOPV2 trials, the Global Advisory Committee on Vaccine Safety requested more extensive vaccine safety data during emergency use. The Uganda Ministry of Health declared a cVDPV2 outbreak in 2021 and responded with an nOPV2 campaign in January, 2022. More than 9 million children aged 0-59 months were vaccinated, providing an opportunity to generate robust safety data.
methodsWe monitored the safety of nOPV2 for 42 days post-vaccination using: routine passive surveillance for adverse events following immunisation (AEFI); ongoing acute flaccid paralysis (AFP) surveillance; active, hospital-based surveillance for pre-specified adverse events of special interest (AESI); and active, cohort event monitoring. AFP cases were reviewed by the National Polio Expert Committee. Serious AEFI and all AESI and AFP cases with nOPV2 receipt underwent causality assessment by the National AEFI Committee.
findingsAcross surveillance systems, 1128 children vaccinated with nOPV2 experienced one or more AEFI: 43 children identified through passive surveillance, 128 suspected AFP cases, five AESI cases, and 952 children with reported AEFI through cohort event monitoring. Overall, 109 adverse events were considered serious; six (fever, gastroenteritis (n=3), acute disseminated encephalomyelitis, and encephalitis) were determined by the National AEFI Committee to be consistent with causal association to immunisation with nOPV2. No cases of vaccine-associated paralytic poliomyelitis were detected. One death was detected, considered inconsistent with causal association to immunisation with nOPV2, per the National AEFI Committee.
interpretationNo new safety concerns were identified with nOPV2 use in Uganda following a national vaccination campaign, providing valuable data that informed WHO prequalification and product licensure.
fundingCenters for Disease Control and Prevention. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.
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