Plain Language Summary of a Clinical Trial Evaluating mRNA-1273, Moderna's mRNA-Based COVID-19 Vaccine, in Children 6 Through 11 Years of Age

Author:

Creech CB1,Anderson E23,Berthaud V4,Yildirim I567,Atz AM8,Baez I Melendez9,Finkelstein D1011,Pickrell P12,Kirstein J13,Yut C111415,Blair R1516,Clifford RA17,Dunn M18,Campbell JD19,Montefiori DC20,Tomassini JE21,Zhao X21,Deng W21,Zhou H21,Schrempp D Ramirez21,Hautzinger K21,Girard B21,Slobod K21,McPhee R21,Pajon R21,Das R21,Miller JM21,Ghamloush S Schnyder21,

Affiliation:

1. Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA

2. Center for Childhood Infections & Vaccines of Children's Healthcare of Atlanta, Atlanta, GA, USA

3. Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA

4. Meharry Medical College, Nashville, TN, USA

5. Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA

6. Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA

7. Yale Institute for Global Health, New Haven, CT, USA

8. Medical University of South Carolina, Charleston, SC, USA

9. Boca Raton Clinical Research Global, Edinburg, TX, USA

10. Capitol Medical Group, Chevy Chase, MD, USA

11. Privia Medical Group, Arlington, VA, USA

12. Tekton Research, Austin, TX, USA

13. Velocity Clinical Research, Banning, CA, USA

14. Highland Woods Health, The Woodlands, TX, USA

15. Javara, Winston-Salem, NC, USA

16. Texas Health Care, Privia Medical Group–North Texas, Fort Worth, & Forest Lane Pediatrics, Dallas, TX, USA

17. Coastal Pediatric Associates, Charleston, SC, USA

18. Quality Clinical Research, Omaha, NE, USA

19. Department of Pediatrics, Center for Vaccine Development Global Health, University of Maryland School of Medicine, Baltimore, MD, USA

20. Department of Surgery, Duke University Medical Center, Durham, NC, USA

21. Moderna, Inc., Cambridge, MA, USA

Abstract

What is this summary about? The PLSP summarizes results from the phase 2/3 KidCOVE trial examining mRNA-1273 (Moderna's COVID-19 vaccine) in children 6 through 11 years of age. What were the results? This study reviewed results from two parts of the KidCOVE clinical trial: Part 1 of the study was performed to select a dose of mRNA-1273 (50 μg or 100 μg) in children. A 50-μg dose was selected for further evaluation based on minimally unwanted side effects and sufficient antibodies (immune responses) against SARS-CoV-2. Part 2 of the study further evaluated the 50-μg dose of mRNA-1273 and compared it with placebo in children. Two 50-μg doses of mRNA-1273 were well tolerated with no new safety concerns. Two 50-μg doses also produced antibodies (immune responses) similar to those in young adults who received mRNA-1273 (100 μg) in a separate phase 3 study (the COVE trial). What do the results mean? Study findings suggest that two 50-μg doses of mRNA-1273 were well-tolerated, and can prevent COVID-19 in children 6 through 11 years of age. Clinical Trial Registration: NCT04796896 ( ClinicalTrials.gov )

Publisher

Future Medicine Ltd

Subject

Virology

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