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

Published in the journal Morbidity and Mortality Weekly Report. Here is a link to the article.

Regenstrief Institute authors: Shaun Grannis, M.D., (affiliate scientist) Peter Embí, M.D., M.S.

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. All children should stay up to date with recommended COVID-19 vaccines, including initiation of COVID-19 vaccination immediately when they are eligible.

Authors

Ruth Link-Gelles, PhD, corresponding author,¹, Allison Avrich Ciesla, PhD,^1,2, Elizabeth A.K. Rowley, DrPH,³, Nicola P. Klein, M.D., PhD,⁴, Allison L. Naleway, PhD,⁵, Amanda B. Payne, PhD,¹, Anupam Kharbanda, M.D.,⁶, Karthik Natarajan, PhD,^7,8, Malini B. DeSilva, M.D.,⁹, Kristin Dascomb, M.D., PhD,¹⁰, Stephanie A. Irving, MHS,⁵, Ousseny Zerbo, PhD,⁴, Sarah E. Reese, PhD,³, Ryan E. Wiegand, PhD,¹, Morgan Najdowski, MPH,¹, Toan C. Ong, PhD,¹¹, Suchitra Rao, MBBS,¹¹, Melissa S. Stockwell, M.D.,^8,12,13, Ashley Stephens, M.D.,^8,12, Kristin Goddard, MPH,⁴, Yessica C. Martinez, MPH,³, Zachary A. Weber, PhD,³, Bruce Fireman,⁴, John Hansen, MPH,⁴, Julius Timbol, M.S.,⁴, Shaun J. Grannis, M.D.,^14,15, Michelle A. Barron, M.D.,¹¹, Peter J. Embi, M.D.,¹⁶, Sarah W. Ball, ScD,³, Manjusha Gaglani, MBBS,^17,18, Nancy Grisel, MPP,¹⁰, Julie Arndorfer, MPH,¹⁰, Mark W. Tenforde, M.D., PhD,¹⁹, Katherine E. Fleming-Dutra, M.D. ¹

Author Affiliations

¹Coronavirus and Other Respiratory Viruses Division, National Center for Immunization and Respiratory Diseases, CDC; ²Eagle Health Analytics, San Antonio, Texas; ³Westat, Rockville, Maryland; ⁴Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, California; ⁵Kaiser Permanente Center for Health Research, Portland, Oregon; ⁶Children’s Minnesota, Minneapolis, Minnesota; ⁷Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York; ⁸New York-Presbyterian Hospital, New York, New York; ⁹HealthPartners Institute, Minneapolis, Minnesota; ¹⁰Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah; ¹¹School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado; ¹²Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; ¹³Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York; ¹⁴Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana; ¹⁵School of Medicine, Indiana University, Indianapolis, Indiana; ¹⁶Vanderbilt University Medical Center, Nashville, Tennessee; ¹⁷Section of Pediatric Infectious Diseases, Department of Pediatrics, Baylor Scott & White Health, Temple, Texas; ¹⁸Department of Medical Education, Texas A&M University College of Medicine, Temple, Texas; ¹⁹Influenza Division, National Center for Immunization and Respiratory Diseases, CDC.