Moderna’s COVID-19 Vaccine Phase 2/3 Study in Young Children Meets Primary Endpoint
Moderna has announced positive interim data from the phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine, mRNA-1273, in children aged 6 months to younger than 2 years and 2 years to under 6 years of age.
The interim analysis showed a robust neutralizing antibody response in both age groups after a 25 µg 2-dose primary series with a favorable safety profile.
Additionally, based on the data, Moderna will submit a request for authorization for the 2-dose series for both age groups to the European Medicines Agency, FDA, and other global regulators in the coming weeks.
"We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults," Stéphane Bancel, CEO of Moderna, said in a statement.
" After consultation with the US FDA, we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data,” she said.
KidCOVE is an observer-blind, placebo-controlled, randomized, study to evaluate the immunogenicity, safety, and tolerability of the 2-dose series for healthy children. The study population was divided into 3 age groups: aged 6 to younger than 12 years, aged 2 to younger than 6 years, and aged 6 months to younger than 2 years.
Overall, the study included approximately 11,700 children from Canada and the United States. There were approximately 4200 children between aged 2 and 6 years, approximately 2500 aged 6 months to 2 years, and approximately 6700 aged 6 months to younger than 6 years.
In the 2 age groups Moderna reported on, the tolerability profile was consistent with that observed in children aged 6 to younger than 12 years, aged 12 to 17 years, and adults. Most adverse events (AEs) were mild or moderate and were most frequently reported after the second dose.
Fevers higher than 100.4ºF were consistent with those resulting from other recommended pediatric vaccines. There was no study pause rules that were met, and no new safety concerns were identified. There were no deaths, myocarditis or pericarditis, and multisystem inflammatory syndrome in individuals.
In both the age groups, the 2 doses of 25 µg provided similar immunogenicity to pediatric individuals to the 2 doses of the 100 µg in adults.
The results also met the non-inferiority criteria and immunobridging, indicating that the benefit of the vaccine conferred to adults was also conferred to children and infants as young as aged 6 months.
The neutralizing antibody geometric mean ratio comparing the response in children aged 6 months to younger than 2 years to the response of young adults from the phase 3 COVE study was 1.3 and was 1 for the aged-2-to-younger-than-6-years age group.
This also helped to predict protection from COVID-19 and severe COVID-19 disease down to aged 6 months.
Moderna announces its COVID-19 vaccine phase 2/3 study in children 6 months to under 6 years has successfully met its primary endpoint. Moderna. News release. March 23, 2022. Accessed March 23, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx