Key result
nOPV2 rollout shows a low adverse event incidence of ~1 in 133,000 doses.
Why the study?
WHO emergency use listing requires extensive safety monitoring for adverse events of special interest following the rollout of novel oral poliovirus vaccine type 2.
What is the incidence of Adverse Events of Special Interest (AESI) following the administration of novel oral poliovirus vaccine type 2 (nOPV2) in Nigeria?
Cross-Sectional
Yes
What is the incidence of Adverse Events of Special Interest (AESI) following the administration of novel oral poliovirus vaccine type 2 (nOPV2) in Nigeria?
Active surveillance of nOPV2 rollout in Nigeria demonstrated a low incidence of adverse events of special interest, supporting its safety profile.
Low AESI incidence supports nOPV2 safety in campaigns; leaves open need for sustained surveillance to detect rare signals.
Introduction: novel oral poliovirus vaccine type 2 (nOPV2), designed to be more genetically stable than Sabin-strain oral poliovirus vaccine type 2 (mOPV2), is a new and key component of the Global Polio Eradication Initiative's strategy to combat outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2). The World Health Organization´s (WHO´s) emergency use listing (EUL) requires extensive safety monitoring for Adverse Event of Special Interest (AESI) in its use. We implemented AESI active surveillance to monitor the safety of the nOPV2 in Nigeria. Methods: a cross-sectional assessment was conducted in Nigeria during March-June 2021 in 117 local government areas (LGAs) across 6 states and the Federal Capital Area with confirmed cVDPV2 transmission. We conducted active searches for nOPV2 AESI in all health facilities. Suspected events were ascertained, and vaccination and clinical data abstracted. Events were classified using WHO causality assessment algorithm. Data were analyzed using Epi info7. Results: total of 234 adverse events were reported after 21,997,300 doses of nOPV2 were administered, giving a crude reported incidence of 1 in 94,000 doses of nOPV2. Altogether, 221 of the 234 (94%) adverse events were classified. For 166 AESI ascertained to occur following a dose of nOPV2, the corrected crude incidence rate was 1 in 133,000 doses; 4 of the adverse events, were classified as consistent with casual association with nOPV2 vaccination. Conclusion: we found that nOPV2 had a low incidence of AESI following nOPV2 campaigns and no new or unexpected adverse event was reported. Safety monitoring should be sustained for early detection of signals and uncommon adverse events.
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Abbott et al. (2023) conducted a cross-sectional in circulating vaccine-derived poliovirus type 2 (cVDPV2). novel oral poliovirus vaccine type 2 (nOPV2) was evaluated on Adverse Event of Special Interest (AESI). Active surveillance of novel oral poliovirus vaccine type 2 rollout in Nigeria found a low corrected crude incidence of adverse events of special interest (1 in 133,000 doses).
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