The goals of the PROTECT study are to monitor the incidence of infection among children of all ages, examine the impact of currently recommended vaccines for adolescents, and initiate evaluation of COVID-19 vaccines among younger children should the vaccines be authorized. The study seeks to enroll 1,630 children ages 6 months to 17 years in the United States.

There are currently three COVID-19 vaccines that have received emergency use authorization and are recommended in the U.S., including the Pfizer-BioNTech, Moderna and Johnson & Johnson/Janssen vaccines.

To date, only the Pfizer-BioNTech vaccine has received full approval by the Food and Drug Administration (FDA) for individuals 16 years of age and older and authorization for use in children aged 12 years and older. The Moderna vaccine has received authorization for use in adults aged 18 years and older.

Both vaccines have demonstrated high efficacy of over 90% at preventing COVID-19 infection, hospitalization, and death across the different age groups. The Johnson & Johnson/Janssen vaccine has shown over 66% effectiveness based on evidence from clinical trials.

Clinical trials to test the vaccines’ efficacy among younger children began in March 2021. Preliminary results and requests for emergency authorization to the FDA are expected by the end of year.

Moreover, the study will be implemented in four locations across the country, including Temple, TX, Miami, FL, Salt Lake City, UT and Tucson, AZ.

Alberto Caban-Martinez, D.O.,
Ph.D., M.P.H., C.P.H.

"Public health practice is about bringing people and resources together to improve and protect community health across the life course. Partnering with Dr. Lisa Gwynn and our pediatrics colleagues in this timely national COVID-19 research project will allow our research teams to collaborate at improving our understanding of COVID-19 infection and vaccine effectiveness for all children and adolescents," said Alberto Caban-Martinez, D.O., Ph.D., M.P.H., C.P.H., Associate Professor of Public Health Sciences, Assistant Provost for Research Integrity, and MD-MPH Program Deputy Director.

Lisa Gwynn, D.O., M.B.A.,
M.S.P.H.

“Our pediatric mobile team is thrilled to collaborate with Dr. Caban-Martinez on this research project. Gaining a better understanding of COVID-19 infection trends and vaccination uptake in children will hopefully lead to improved mitigation strategies to reduce the spread of the virus,” said Lisa Gwynn, D.O., M.B.A., M.S.P.H., associate professor of clinical pediatrics and public health sciences, interim division chief, child and adolescent health, and program director of Pediatric Mobile Clinic and School Health at the Miller School.

Children accounted for approximately 14% of all COVID-19 cases that were reported to state health departments from April 2020 to May 2021. Although overall COVID-19 cases have decreased since the start of the pandemic, the proportion of new COVID-19 cases among children has increased.

Data in the week ending on May 13, 2021 demonstrated a 24% pediatric incidence of COVID-19 among all COVID-19 cases. According to a recent report from the American Academy of Pediatrics, there was also a 9% increase from early to mid-September in the cumulated number of child COVID-19 cases since the beginning of the pandemic. The increase has been equivalent to 469,350 new cases, which raises the total number of child COVID-19 cases from 5,049,465 to 5,518,815.

COVID-19 vaccination can not only protect children, but also the family. For instance, pediatric influenza vaccination has been proven to prevent transmission and hospitalization in the elderly.

Co-principal investigators of the study include Dr. Alberto Caban-Martinez and Dr. Lisa Gwynn from the Department of Public Health Sciences, Manjusha Gaglani from Baylor Scott and White Health, Sarang Yoon and Kurt Hegmann from the University of Utah, Jeffrey Burgess from the University of Arizona, Mark Thompson and Ashley Fowlkes from the CDC National Center for Immunization and Respiratory Diseases (NCIRD) Influenza Division, and Lauren Olsho from Abt Associates. The PROTECT study is a collaboration between Baylor Scott and White Health, University of Miami, University of Utah, University of Arizona, the Centers for Disease Control and Prevention (CDC), and Abt Associates.

Written by Veronica Bustabad

Published on October 26, 2021