Effectiveness of COVID-19 mRNA Vaccines in Young Children
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Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing COVID-19–Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months–5 Years

VISION Network, United States, July 2022-June 2023

Ruth Link-Gelles, PhD; Allison Avrich Ciesla, PhD; Elizabeth A.K. Rowley DrPH; Nicola P. Klein MD, PhD; Allison L. Naleway, PhD; Amanda B. Payne, PhD; Anupam Kharbanda, MD; Karthik Natarajan, PhD; Malini B. DeSilva, MD; Kristin Dascomb, MD, PhD; Stephanie A. Irving, MHS; Ousseny Zerbo, PhD; Sarah E. Reese, PhD; Ryan E. Wiegand, PhD; Morgan Najdowski, MPH; Toan C. Ong, PhD; Suchitra Rao, MBBSMelissa S. Stockwell, MD; Ashley Stephens, MD; Kristin Goddard, MPH; Yessica C. Martinez, MPH; Zachary A. Weber, PhD; Bruce Fireman; John Hansen, MPH; Julius Timbol, MS; Shaun J. Grannis, MD; Michelle A. Barron, MD; Peter J. Embi, MD; Sarah W. Ball, ScD; Manjusha Gaglani, MBBS; Nancy Grisel, MPP; Julie Arndorfer, MPH; Mark W. Tenforde, MD, PhD; Katherine E. Fleming-Dutra, MD

Disclosures

Morbidity and Mortality Weekly Report. 2023;72(33):886-892. 

In This Article

Abstract and Introduction

Abstract

On June 19, 2022, the original monovalent mRNA COVID-19 vaccines were approved as a primary series for children aged 6 months–4 years (Pfizer-BioNTech) and 6 months–5 years (Moderna) based on safety, immunobridging, and limited efficacy data from clinical trials. On December 9, 2022, CDC expanded recommendations for use of updated bivalent vaccines to children aged ≥6 months. mRNA COVID-19 vaccine effectiveness (VE) against emergency department or urgent care (ED/UC) encounters was evaluated within the VISION Network during July 4, 2022–June 17, 2023, among children with COVID-19–like illness aged 6 months–5 years. Among children aged 6 months–5 years who received molecular SARS-CoV-2 testing during August 1, 2022–June 17, 2023, VE of 2 monovalent Moderna doses against ED/UC encounters was 29% (95% CI = 12%–42%) ≥14 days after dose 2 (median = 100 days after dose 2; IQR = 63–155 days). Among children aged 6 months–4 years with a COVID-19–like illness who received molecular testing during September 19, 2022–June 17, 2023, VE of 3 monovalent Pfizer-BioNTech doses was 43% (95% CI = 17%–61%) ≥14 days after dose 3 (median = 75 days after dose 3; IQR = 40–139 days). Effectiveness of ≥1 bivalent dose, comparing children with at least a complete primary series and ≥1 bivalent dose to unvaccinated children, irrespective of vaccine manufacturer, was 80% (95% CI = 42%–96%) among children aged 6 months–5 years a median of 58 days (IQR = 32–83 days) after the dose.

*Pfizer-BioNTech is recommended as 3 3-μg doses, with ≥3–8 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3.
Moderna is recommended as 2 25-μg doses separated by ≥4–8 weeks.

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