Moderna’s COVID-19 vaccine is safe and generates robust immune responses in children ages 6 to 11 years, a national clinical trial co-led by Vanderbilt University Medical Center vaccine expert C. Buddy Creech, MD, MPH, has found.

The two-dose vaccine (given approximately one month apart) led to antibody responses in more than 99% of the 4,000 children evaluated in the study. In addition, vaccine efficacy against COVID-19 was 88% beginning as early as two weeks after the first dose of vaccine, Creech and his colleagues reported in the New England Journal of Medicine.

“That’s very similar with what we have seen in the adult COVID-19 vaccine trials, where we see 90-95% vaccine efficacy,” said Creech, director of the Vanderbilt Vaccine Research Program and the Edie Carell Johnson Professor of Pediatrics at VUMC.

The 50-microgram dose of vaccine, half the dose given to adults, produced only minor side effects including injection site pain, headache and fatigue. No serious adverse effects were reported.

Moderna has requested authorization of its COVID-19 vaccine from the U.S. Food and Drug Administration for the 6- to 11-year-old and 12- to 17-year-old age groups, and last month requested authorization for children down to 6 months of age.

So far, Moderna’s vaccine has been cleared only for adults in the United States, though other countries are using the vaccine in their pediatric populations. The other mRNA-based COVID-19 vaccine in the United States, made by Pfizer-BioNTech, was approved for children ages 5 to 11 years old last fall.

“We need more than one vaccine for children,” said Creech, who is co-leading studies of the Moderna vaccine in children in the United States and Canada with Evan Anderson, MD, at Emory University School of Medicine in Atlanta, and Vladimir Berthaud, MD, MPH, at Nashville’s Meharry Medical College.

“Overall, COVID-19 is typically milder in children; however, we’ve seen substantial classroom outbreaks, children transmitting the virus to at-risk parents and grandparents, myocarditis and long COVID,” Creech said, “and we’ve seen far more children die from COVID directly than we see die from influenza every year.”

Creech acknowledged the frustration of many parents that COVID-19 vaccines haven’t been authorized for young children quickly enough.

“There’s been a tension between hurrying to get a vaccine authorized for use in children and making certain that we do not rush the process or cut corners in our evaluation of the vaccines,” he said.

“Evaluating COVID-19 vaccines is really all we’ve done for the last two years,” Creech continued.” Parents can have a lot of confidence that we are doing these studies in the exact same way that we do every other vaccine study, but with even more oversight and scrutiny.”

Creech cautioned against expecting the COVID-19 vaccine to prevent minor symptoms such as runny nose, sore throat, body aches and fever that are hallmarks of the common cold.

“We do not yet have a vaccine for the common cold,” he said. But “if we can turn COVID into nothing more than a common cold, we will consider our pandemic response a success.”

The TeenCOVE and KidCOVE (Coronavirus Efficacy) trials were 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.

— Submitted