Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age.
This interim analysis showed a robust neutralising antibody response in both age groups after a 25 µg two-dose primary series of mRNA-1273 along with a favourable safety profile.
Based on these data, Moderna will submit a request for authorisation of a 25 μg two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the U.S. FDA, the EMA and other global regulators in the coming weeks.
