Moderna’s COVID-19 vaccine is protected and effective in children 6 months to five years of age, a clinical trial co-led by Vanderbilt University Medical Center vaccine expert C. Buddy Creech, MD, MPH, has found.
Results of the two-part KidCOVE study of nearly 13,000 children conducted last yr at 87 sites in the US and Canada were published in The Recent England Journal of Medicine.
The findings echo the outcomes of a previous study reported in May by Creech and his colleagues that found the vaccine was protected and generated robust immune responses in children ages 6 to 11 years.
This work is the capstone of a terrific deal of labor from our team and, just as importantly, the willingness of fogeys and kids to volunteer to search out an answer to the pandemic through vaccines.”
C. Buddy Creech, MD, MPH, Director of the Vanderbilt Vaccine Research Program and Edie Carell Johnson Professor of Pediatrics at VUMC
Creech and Vladimir Berthaud, MD, MPH, professor, and director of the Division of Infectious Diseases at Meharry Medical College, were the paper’s second and third authors. Evan Anderson, MD, from Emory University School of Medicine in Atlanta, was first creator.
“Having a protected and effective (COVID-19) vaccine available for infants, toddlers and young children is critically necessary,” the researchers reported.
COVID-19-related hospitalizations and deaths in children younger than 5 years of age in the course of the height of the pandemic (2020-2021) in the US surpassed annual influenza-related rates observed before the pandemic.
As well as, while infected children could also be asymptomatic or have mild symptoms, they still can transmit the COVID-19 virus, SARS-CoV-2, to other people, including those in danger for serious illness and death in the event that they develop into infected due to their age or underlying health conditions.
In June the U.S. Food and Drug Administration granted emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as 6 months of age. Moderna’s mRNA-1273 vaccine had previously been authorized to be used in adults 18 years and older.
“As we now have seen with older age groups, we expect that the vaccines for younger children will provide protection from essentially the most severe outcomes of COVID-19, corresponding to hospitalization and death,” FDA Commissioner Robert Califf, MD, said in a news release.
The FDA decision was based on an evaluation of safety and effectiveness data reported in The Recent England Journal of Medicine.
Part one among the phase 2-3 clinical trial sought to match two doses of the vaccine -; 25 and 50 micrograms -; in two groups of youngsters, those 6 to 23 months of age and one other group 2 to five years of age.
The 25-microgram dose elicited immune responses consistent with those observed in clinical trials involving higher doses in older children, adolescents and adults. Minor reactions included fatigue, irritability, and fever lasting two to 3 days.
Based on these findings, a randomized, second a part of the study compared two, 25-microgram doses of the vaccine to inactive placebo in children within the two age groups. The doses were administered 28 days apart.
Vaccine efficacy within the study, which was conducted when the more contagious omicron variant was widely circulating, was lower than that reported in previous clinical trials conducted when other variants were predominant. Nevertheless, vaccine efficacy matched that observed in adults studied in the course of the omicron wave.
The 25-milligram dose also was sufficient to elicit robust antibody levels against a broad range of variants in young children, and it was related to a lower rate of COVID-19 infections in comparison with placebo.
Thus, the researchers concluded, “primary vaccination offers protection against (COVID-19-related) hospitalization and death.”
The KidCOVE (Coronavirus Efficacy) trial was supported by the Office of the Assistant U.S. Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority (BARDA), and by National Institutes of Health grants AI148576, AI148452, AI148689, AI148450, AI148372, and AI148575.
Source:
Vanderbilt University Medical Center
Journal reference:
Anderson, E.J., et al. (2022) Evaluation of mRNA-1273 Vaccine in Children 6 Months to five Years of Age. Recent England Journal of Medicine. doi.org/10.1056/NEJMoa2209367.