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

BACKGROUND: In 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. METHODS: We 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. FINDINGS: Across 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. INTERPRETATION: No 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. FUNDING: Centers for Disease Control and Prevention. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.