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Impact and Effectiveness of COVID-19 mRNA Vaccination Against COVID-19 Hospitalisation in Paediatrics: A Cohort Study

Belén Castillo-Cano1,2, Fabio Riefolo2,3, Felipe Villalobos2,4

  • 1Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.

Pharmacoepidemiology and Drug Safety
|October 22, 2025
PubMed

Insights

Two doses of mRNA COVID-19 vaccines showed moderate-to-high effectiveness in preventing paediatric hospitalizations. Effectiveness was higher when COVID-19 was the primary reason for admission.

Area of Science:

  • Pediatric infectious diseases
  • Vaccinology
  • Public health

Background:

  • Over 2 million pediatric COVID-19 cases in Spain by 2024, with a low hospitalization rate (8900).
  • Assessing vaccine effectiveness is crucial for public health strategies in pediatric populations.

Purpose of the Study:

  • To estimate the effectiveness of two-dose COVID-19 vaccination against hospitalization 'with' and 'for' COVID-19 in children aged 5-14 years.
  • To compare vaccine effectiveness based on the classification of COVID-19 as the primary or a contributing cause for hospitalization.

Main Methods:

  • Matched cohort study (1:1) of vaccinated and unvaccinated children (5-14 years) using Spanish SIDIAP and BIFAP databases (Jan 2021-Feb 2022).
  • Exclusion of individuals with prior SARS-CoV-2 infection.
  • COVID-19 hospitalization defined as 'for' (main reason) or 'with' (contributing reason) COVID-19.

Main Results:

  • Vaccination demonstrated high effectiveness (94%) against hospitalization 'for' COVID-19 in the SIDIAP database.
  • Effectiveness against hospitalization 'with' COVID-19 was lower (53%) in the BIFAP database.
  • Few hospitalizations were averted due to the low incidence of severe pediatric COVID-19.

Conclusions:

  • Two-dose mRNA vaccination offers moderate-to-high protection against pediatric COVID-19 hospitalization, particularly when COVID-19 is the primary diagnosis.
  • Defining hospitalization 'with' COVID-19 may underestimate vaccine effectiveness.
  • Further research with larger datasets is needed to precisely determine the impact of vaccines given the rarity of severe pediatric COVID-19.
Abstract

Keywords:
COVID‐19 vaccine effectivenesschildren and adolescentshospital COVID‐19 recordspaediatricsreal‐word dataretrospective cohort study

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