Moderna’s COVID-19 vaccine safe, effective in children aged 6 to 11 years
Moderna’s COVID-19 vaccine was found to be safe and effective among children aged 6 to 11 years, according to interim phase 2/3 findings from the KidCOVE trial published in The New England Journal of Medicine.
Researchers estimated that two 50 µg doses of the messenger RNA vaccine had an efficiency of close to 90%. Safety, immunogenicity and vaccine efficacy were all consistent with adolescent and adult trials of the vaccine, according to Healio Pediatrics Editorial Board Member C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program, and colleagues.
In the first part of the trial, 751 children received either 50 µg or 100 µg injections of the mRNA vaccine, and based on safety and immunogenicity results, the 50 µg dose level was selected for part 2.
Creech and colleagues randomly assigned 4,016 children in a 3:1 ratio to receive two 50 µg injections the vaccine or placebo 28 days apart and followed them for a median of 82 days after the first injection.
According to Creech and colleagues, adverse events were mostly low grade and transient — “most commonly injection-site pain, headache, and fatigue,” and to a lesser extent fever, erythema, swelling, lymphadenopathy, chills and nausea or vomiting. The researchers reported that, as of the cutoff date, there were no reported serious vaccine-related adverse events — including cases of multisystem inflammatory syndrome in children, myocarditis or pericarditis.
At 57 days post-first injection, neutralizing antibody titer in children who received the vaccine was 1,610 (95% CI, 1,457-1,780), with serologic responses recorded in at least 99% of participants, the researchers reported.
They estimated that vaccine efficacy was 88% (95% CI, 70-95.8) against COVID-19 occurring 14 days or more after the first injection at a time when the delta variant was prevalent.
“The trial results indicate that a 50 g dose level of the mRNA-1273 vaccine had an acceptable safety profile and was efficacious in children 6 to 11 years of age,” Creech and colleagues wrote. “The trial is ongoing to provide additional safety and efficacy data in this age group as well as in younger children (6 months to 5 years of age). Vaccination of children may help to protect them from COVID-19 and may reduce community circulation of SARS-CoV-2 variants and lead to a return toward normal routines.”
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on June 8, 21 and 22 to discuss emergency use authorization requests filed by Moderna and Pfizer-BioNTech for their pediatric COVID-19 vaccines.
Moderna has asked for EUAs covering children as young as age 6 months. Its EUA application for kids aged 12 to 17 years — originally filed in June 2021 — is still on hold due to concerns related to myocarditis.
Pfizer has the only vaccine authorized for U.S. children or adolescents of any age.
As of May 4, the CDC reported that approximately 8 million children aged 5 to 11 years in the U.S. had received two doses of the Pfizer-BioNTech vaccine, representing just 28% of that population. An additional 1.8 million received one dose.
According to the AAP, pediatric infections have increased in each of the last 4 weeks. More than 62,000 pediatric COVID-19 cases were reported the week ending May 5, an increase of about 69% from 2 weeks ago.
AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published May 5, 2022. Accessed May 12, 2022.
AAP. Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published May 4, 2022. Accessed May 12, 2022.
Coronavirus (COVID-19) update: FDA announce tentative advisory committee meeting schedule regarding COVID-19 vaccines. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding. Published April 29, 2022. Accessed May 12, 2022.