Effects of COVID-19 vaccination and previous SARS-CoV-2 infection on omicron infection and severe outcomes in children under 12 years of age in the USA: an observational cohort study

Background Data on the protection conferred by COVID-19 vaccination and previous SARS-CoV-2 infection against omicron (B.1.1.529) infection in young children are scarce. We aimed to estimate the time-varying effects of primary and booster COVID-19 vaccination and previous SARS-CoV-2 infection on subsequent omicron infection and severe illness (hospital admission or death) in children younger than 12 years of age.Methods In this observational cohort study, we obtained individual-level records on vaccination with the BNT162b2 and mRNA-1273 vaccines and clinical outcomes from the North Carolina COVID-19 Surveillance System and the COVID-19 Vaccine Management System for 1 368 721 North Carolina residents aged 11 years or younger from Oct 29, 2021 (Oct 29, 2021 for children aged 5-11 years and June 17, 2022 for children aged 0-4 years), to Jan 6, 2023. We used Cox regression to estimate the time-varying effects of primary and booster vaccination and previous infection on the risks of omicron infection, hospital admission, and death.Findings For children 5-11 years of age, the effectiveness of primary vaccination against infection, compared with being unvaccinated, was 59 center dot 9% (95% CI 58 center dot 5-61 center dot 2) at 1 month, 33 center dot 7% (32 center dot 6-34 center dot 8) at 4 months, and 14 center dot 9% (95% CI 12 center dot 3-17 center dot 5) at 10 months after the first dose. Compared with primary vaccination only, the effectiveness of a monovalent booster dose after 1 month was 24 center dot 4% (14 center dot 4-33 center dot 2) and that of a bivalent booster dose was 76 center dot 7% (45 center dot 7-90 center dot 0). The effectiveness of omicron infection against reinfection was 79 center dot 9% (78 center dot 8-80 center dot 9) after 3 months and 53 center dot 9% (52 center dot 3-55 center dot 5) after 6 months. For children 0-4 years of age, the effectiveness of primary vaccination against infection, compared with being unvaccinated, was 63 center dot 8% (57 center dot 0-69 center dot 5) at 2 months and 58 center dot 1% (48 center dot 3-66 center dot 1) at months after the first dose, and the effectiveness of omicron infection against reinfection was 77 center dot 3% (75 center dot 9-78 center dot 6) after 3 months and 64 center dot 7% (63 center dot 3-66 center dot 1) after 6 months. For both age groups, vaccination and previous infection had better effectiveness against severe illness as measured by hospital admission or death as a composite endpoint than against infection. Interpretation The BNT162b2 and mRNA-1273 vaccines were effective against omicron infection and severe outcomes in children younger than 12 years, although the effectiveness decreased over time. Bivalent boosters were more effective than monovalent boosters. Immunity acquired via omicron infection was high and waned gradually over time. These findings can be used to develop effective prevention strategies against COVID-19 in children younger than 12 years.Copyright (c) 2023 Published by Elsevier Ltd. All rights reserved.