A multisite VISION test-negative study across nine states (Aug 29, 2024–Sep 2, 2025) found that the 2024–25 COVID-19 vaccines targeting Omicron JN.1 provided substantial additional protection against COVID-19–associated ED/UC visits in immunocompetent children—estimated vaccine effectiveness of 76% (95% CI 58%–87%) for ages 9 months–4 years and 56% (95% CI 35%–70%) for ages 5–17 within 7–179 days post-dose. The analysis of >97,000 pediatric ED/UC encounters indicates higher relative benefit in younger children—potentially reflecting lower prior infection rates—and supports the vaccines’ role in reducing medically attended illness amid mixed preexisting immunity. However, low pediatric uptake, incomplete documentation of prior infections, potential residual confounding, and limited power to assess hospitalizations constrain interpretation; the recent shift to shared clinical decision-making for pediatric COVID-19 vaccination may affect coverage and warrants continued vaccine-effectiveness surveillance to inform public‑health and resource planning.
A multisite VISION test-negative study across nine states covering August 29, 2024–September 2, 2025 analyzed 97, and 1,325 case/control-defined pediatric ED/UC encounters and found 2024–2025 COVID-19 vaccines targeting Omicron JN.1 provided statistically significant additional protection: vaccine effectiveness (VE) of 76% (95% CI 58%–87%) for immunocompetent children aged 9 months–4 years during days 7–179 post-dose and 56% (95% CI 35%–70%) for ages 5–17 years in the same interval. The analysis included 44,541 ED/UC encounters for the younger cohort (1,292 cases) and 53,467 encounters for the older cohort (1,325 cases); vaccines became available August 22, 2024 after ACIP recommendation on June 27, 2024. The reported VE is higher than VE estimates for the 2023–24 pediatric season (35% for 9 months–4 years; 44% for 5–17 years) and similar to or higher than contemporaneous adult estimates, suggesting the 2024–25 formulation conferred stronger incremental protection in a population with mixed prior immunity. VE was higher in the youngest group, consistent with lower prior-infection prevalence as a plausible explanatory factor, and sensitivity analyses show some waning in the 5–17 cohort (45% VE over days 7–299). Key caveats constrain commercial interpretation: pediatric vaccination coverage was low, prior infections were incompletely documented, residual confounding is possible, and the study lacked power to robustly estimate hospitalization VE or fine-grained waning. The May 2025 shift to shared clinical decision-making for healthy children introduces uncertainty for future uptake and reimbursement patterns, underscoring the need for ongoing VE and coverage surveillance.
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