- Patrícia Soares1,*
, Ausenda Machado1,*
, Nathalie Nicolay2
, Susana Monge3,4
, Chiara Sacco5
, Christian Holm Hansen6 , Hinta Meijerink7
, Iván Martínez-Baz4,8
, Susanne Schmitz9 , James Humphreys10
, Massimo Fabiani5
, Aitziber Echeverria8 , Ala’a AlKerwi9 , Anthony Nardone10
, Alberto Mateo-Urdiales5
, Jesús Castilla4,8 , Esther Kissling10 , Baltazar Nunes1,10
, VEBIS-Lot 4 working group11
Background
During the first year of the COVID-19 pandemic, vaccination programmes targeted children and adolescents to prevent severe outcomes of SARS-CoV-2 infection.
Aim
To estimate COVID-19 vaccine effectiveness (VE) against hospitalisation due to COVID-19 in the paediatric population, among those with and without previously documented SARS-CoV-2 infection.
Methods
We established a fixed cohort followed for 12 months in Denmark, Norway, Italy, Luxembourg, Navarre (Spain) and Portugal using routine electronic health registries. The study commenced with paediatric COVID-19 vaccination campaign at each site between June 2021 and January 2022. The outcome was hospitalisation with a laboratory-confirmed SARS-CoV-2 infection or COVID-19 as the main diagnosis. Using Cox proportional hazard models, VE was estimated as 1 minus the confounder-adjusted hazard ratio of COVID-19 hospitalisation between vaccinated and unvaccinated. A random-effects meta-analysis was used to pool VE estimates.
Results
We included 4,144,667 5–11-year-olds and 3,861,841 12–17-year-olds. In 12–17-year-olds without previous infection, overall VE was 69% (95% CI: 40 to 84). VE declined with time since vaccination from 77% ≤ 3 months to 48% 180–365 days after immunisation. VE was 94% (95% CI: 90 to 96), 56% (95% CI: 3 to 80) and 41% (95% CI: −14 to 69) in the Delta, Omicron BA.1/BA.2 and BA.4/BA.5 periods, respectively. In 12–17-year-olds with previous infection, one dose VE was 80% (95% CI: 18 to 95). VE estimates were similar for 5–11-year-olds but with lower precision.
Conclusion
Vaccines recommended for 5–17-year-olds provided protection against COVID-19 hospitalisation, regardless of a previously documented infection of SARS-CoV-2, with high levels of protection in the first 3 months of the vaccination