News Release

Effectiveness of COVID-19 vaccination for babies and young children confirmed in multi-state study

Peer-Reviewed Publication

Regenstrief Institute

COVID-19 mRNA vaccination protects babies and young children against COVID-19-associated emergency department/urgent care visits, according to a multistate study from the Centers for Disease Control and Prevention’s VISION Network. The study found that children, age five and younger, who received the original COVID-19 vaccine and the updated vaccine were protected against the need for medical care for COVID in an emergency department or urgent care facility.

Emergency department/urgent care visits are considered indicators of moderate disease. The small number of hospitalizations for children ages six months to five years old limited the assessment of vaccine effectiveness against more severe outcomes.

The VISION Network study, one of the first to analyze vaccine effectiveness in babies and young children, was conducted both to determine how well the vaccines work and to help inform and guide development of future vaccine policy for this age group.

Data was collected in eight states -- New York, Wisconsin, Minnesota, Colorado, Utah, Oregon, Washington and California.

“In most cases, we have seen throughout the pandemic that the prevalence of COVID among children has been lower than among adults. But there has been limited analysis of vaccine effectiveness in young children due to limited availability of data. A large research network like the VISION Network provides sufficient data,” said study co-author Shaun Grannis, M.D., M.S., vice president for data and analytics at Regenstrief Institute and a professor at Indiana University School of Medicine. “Based on our analysis we found that, for this age group – children five and younger, even one dose of the two-dose vaccine series provided some protection. Based on this data, parents should consider vaccinating their children for COVID and I further encourage parents to discuss vaccination with their child’s physician.”

As of June 2023, SARS-CoV-2 had resulted in more than two million COVID-19 cases and more than 400 deaths among U.S. children aged six months to four years.

The original monovalent mRNA vaccines were authorized in June of 2022 for children aged six months to four years (Pfizer-BioNTech) and six months to five years (Moderna) with recommendations expanded to include bivalent vaccines in December of 2022. 

According to the CDC, for best protection the COVID-19 vaccine series should be started as soon as children are eligible (age six months) and completed within the recommended time. The study found that protection provided to babies and young children waned in patterns similar to those seen in older children and adults.

A previous VISION Network multi-state study confirmed that the Pfizer-BioNTech mRNA COVID-19 vaccine provided older children and adolescents, ages 5-17, with protection against both moderate and severe COVID-19 outcomes.

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” is published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

All authors and affiliations:

Ruth Link-Gelles, PhD1; Allison Avrich Ciesla, PhD1,2; Elizabeth A.K. Rowley, DrPH3; Nicola P. Klein, MD, PhD4; Allison L. Naleway, PhD5; Amanda B. Payne, PhD1; Anupam Kharbanda, MD6; Karthik Natarajan, PhD7,8; Malini B. DeSilva, MD9; Kristin Dascomb, MD, PhD10; Stephanie A. Irving, MHS5; Ousseny Zerbo, PhD4; Sarah E. Reese, PhD3; Ryan E. Wiegand, PhD1; Morgan Najdowski, MPH1; Toan C. Ong, PhD11; Suchitra Rao, MBBS11; Melissa S. Stockwell, MD8,12,13; Ashley Stephens, MD8,12; Kristin Goddard, MPH4; Yessica C. Martinez, MPH3; Zachary A. Weber, PhD3; Bruce Fireman4; John Hansen, MPH4; Julius Timbol, MS4; Shaun J. Grannis, MD14,15; Michelle A. Barron, MD11; Peter J. Embi, MD16; Sarah W. Ball, ScD3; Manjusha Gaglani, MBBS17,18; Nancy Grisel, MPP10; Julie Arndorfer, MPH10; Mark W. Tenforde, MD, PhD19 and Katherine E. Fleming-Dutra, MD1

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.

About Shaun Grannis, M.D., M.S.
In addition to his role as the vice president for data and analytics at Regenstrief Institute, Shaun Grannis, M.D., M.S., occupies the Regenstrief Chair in Medical Informatics and is a professor of family medicine at Indiana University School of Medicine.

About Regenstrief Institute
Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform clinical practice and improve the lives of patients around the globe.

Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute’s research mission.

About IU School of Medicine
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.


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