A multi-state study from the Centers for Disease Control and Prevention's (CDC's) VISION Network confirms that the Pfizer-BioNTech mRNA COVID-19 vaccine has provided children and adolescents, ages 5-17, with protection against both moderate and severe COVID-19 outcomes.
The study found that for 12-17 year olds, vaccine effectiveness was high against the Delta variant but lower during Omicron dominance, including BA.4 and BA.5. Due to the youngest age (5-11) group's ineligibility for vaccination during Delta predominance, vaccine effectiveness could be estimated for these children only during the Omicron predominant period. Vaccine protection against emergency department/urgent care visits (markers for moderate disease) were similar across the 5-17 age range during Omicron.
In addition to differing by predominant circulating virus variant, vaccine effectiveness against COVID-19-associated emergency department/urgent care visits and hospitalizations fluctuated by vaccination and, if age eligible, a first booster dose. Protection waned substantially five months after a second vaccine dose for all age groups. In adolescents, protection increased after a booster. Children younger than 12 were ineligible for a booster.
COVID-19 in children and teens is often mild but can lead to hospitalization and death. Data reviewed by the study authors showed that 83 percent of COVID positive hospitalizations of 5–17-year-olds were among unvaccinated patients. Of those hospitalized, 38 percent were non-Hispanic White, 26 percent were Hispanic and 17 percent were non-Hispanic Black.
The Pfizer-BioNTech mRNA COVID-19 vaccine was authorized by the U.S. Food and Drug Administration in December 2020 for immunocompetent individuals 16 years or older, in May 2021 for 12–15-year-olds and in October 2021 for 5-11-year-olds.
"This study adds to what we knew about vaccine effectiveness for children and adolescents. Vaccination protected against emergency department/urgent care visits and hospitalizations, indicating that it protected well against the moderate and severe outcomes of COVID-19," said study co-author Shaun Grannis, M.D., M.S., Regenstrief Institute vice president for data and analytics. "This study is important because we weren't sure if the vaccine was going to work well in children and adolescents and how it would work. We found effectiveness decreased during Omicron, which hadn't been clear, but vaccination still provided significant protection. Effectiveness increased after the monovalent booster for those who were eligible.
"We can't predict the future, so we are studying severity and trends through different epochs, different eras of COVID. It's important to continue doing what we're doing, which is monitoring the effectiveness of the vaccines over time, because we're dealing with variants that behave differently," Dr. Grannis observed.
This study included pediatric electronic health record (EHR) data from April 2021 through September 2022 from 201 emergency departments, 105 urgent care clinics and 164 hospitals from nine VISION network partners across 10 states: Baylor Scott and White Health, Columbia University Irving Medical Center, HealthPartners/Children's Minnesota, Intermountain Healthcare, Kaiser Permanente Northern California, Kaiser Permanente Northwest, Paso del Norte Health Information Exchange, Regenstrief Institute and University of Colorado. Vaccination data from state and local immunization registries and claims were also reviewed.
"If parents are looking for support for their decision or inclination to vaccinate their child, this study provides good evidence that the vaccine is helpful and offers protection," said Dr. Grannis, who is also a professor of family medicine at Indiana University School of Medicine. "This analysis also provides scientifically-based guidance to clinicians who care for children and adolescents."
"Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents" is published in Pediatrics, the official peer-reviewed flagship journal of the American Academy of Pediatrics, the largest professional association of pediatricians in the U.S.
Regenstrief Institute authors of this VISION Network study, in addition to Dr. Grannis, are Brian Dixon, PhD, MPA, interim director of the Center for Biomedical Informatics; William F. Fadel, PhD, Nimish Ramesh Valvi, DrPH, MBBS; and former Institute president and current affiliated scientist Peter EmbÍ, M.D.
All authors of the study are:
Nicola P. Klein, M.D., PhD1; Maria Demarco, PhD2; Katherine E. Fleming-Dutra, M.D.3; Melissa S. Stockwell, M.D., MPH4,5,6; Anupam B. Kharbanda, M.D., MSc7; Manjusha Gaglani, MBBS8,9; Suchitra Rao, MBBS, MSCS10; Ned Lewis, MPH1; Stephanie A. Irving, MHS17; Emily Hartmann, MPP11; Karthik Natarajan, PhD6,12; Alexandra F. Dalton, PhD3; Ousseny Zerbo, PhD1; Malini B. DeSilva, M.D., MPH13; Deepika Konatham, B.S.8; Edward Stenehjem, M.D., MSc14; Elizabeth A. K. Rowley, DrPH2; Toan C. Ong, PhD10; Shaun J. Grannis, M.D., M.S.15,16; Chantel Sloan-Aagard, PhD11,18; Jungmi Han, B.S.12; Jennifer R. Verani, M.D.3; Chandni Raiyani, BDS, MPH8; Kristin Dascomb, M.D., PhD14; Sarah E. Reese, PhD2; Michelle A. Barron, M.D.10; William F. Fadel, PhD15,16; Allison L. Naleway, PhD17; Juan Nanez, R.N., BSN11; Monica Dickerson, B.S.3; Kristin Goddard, MPH1; Kempapura Murthy, MBBS, MPH8; Nancy Grisel, MPP14; Zachary A. Weber, PhD, M.S.2; Brian E. Dixon, PhD, MPA15,16; Palak Patel, MBBS, MPH3; Bruce Fireman, MA1; Julie Arndorfer, MPH14; Nimish R. Valvi, DrPH15; Eric P. Griggs, MPH3; Carly E. Hallowell, MPH, M.S.2; Peter J. EmbÍ, M.D., M.S.15,19,20; Sarah W. Ball, ScD, MPH2; Mark G. Thompson3; Mark W. Tenforde, M.D., PhD3; and Ruth Link-Gelles, PhD3.
1Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland;
2Westat, Rockville, Maryland;
3Centers for Disease Control and Prevention
COVID-19 Response Team, Atlanta, Georgia;
4Division of Child and Adolescent Health,
Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York;
5Department of Population and Family Health, Columbia University
Mailman School of Public Health, New York, New York;
6New York-Presbyterian Hospital, New York;
7Children's Minnesota, Minneapolis, Minnesota;
8Department of Pediatrics, Section of Pediatric Infectious Diseases, Baylor Scott & White Health, Temple, Texas;
9Department of Medical Education, Texas A&M University College of Medicine, Temple, Texas;
10Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado;
11Paso del Norte Health Information Exchange (PHIX), El Paso, Texas;
12Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York;
13HealthPartners Institute, Minneapolis, Minnesota;
14Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah;
15Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana; 16Fairbanks School of Public Health, Indiana University, Indianapolis;
17Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; 18Brigham Young University Department of Public Health, Provo, Utah;
19School of Medicine, Indiana University, Indianapolis, Indiana; 20Vanderbilt University Medical Center, Nashville, Tennessee
About Shaun Grannis, M.D., M.S.
In addition to his role as the vice president of data and analytics at Regenstrief Institute, Shaun Grannis, M.D., M.S., holds 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 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.
