Phase 2/3 clinical trials of Moderna's COVID-19 vaccine for children under 6 years old meet primary endpoint

Compilenewborn

Recently, Moderna announced positive interim data from the Phase 2/3 KidCOVE study of its COVID-19 vaccine (mRNA-1273)

Based on these data, Moderna will submit a license application in the coming weeks to the U.

KidCOVE is a randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of two doses of mRNA-1273, 28 days apart, in a population of healthy children

Data are reported for the age groups 6 months to under 2 years and 2 years to under 6 years

In these 2 age groups, the immunogenicity of the two-dose 25-µg immunization was similar to that of the 100-µg two-dose immunization in adults 18 to 25 years old, meeting noninferiority criteria and immune bridging, indicating that mRNA-1273 was 18-25 The benefits for adults as young as 6 months are also available to children and infants as young as 6 months old

During the KidCOVE study in these young populations, the Omicron variant of SARS-CoV-2 was circulating in the United States

Similar to adults, Moderna is preparing to evaluate the potential of the mRNA-1273 vaccine booster in all pediatric populations, including 6 months to <6 years, 6 to <12 years, and adolescents

Reference source: Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint