Moderna To Move Forward With Regulatory Submissions For Vaccination Of Children Under 6 Years Of Age

(RTTNews) - Moderna, Inc. (MRNA) reported positive interim data from the phase 2/3 KidCOVE study of the its COVID-19 vaccine in children 6 months to under 2 years and 2 years to under 6 years of age. The company said the interim analysis showed a robust neutralizing antibody response in both age groups after a 25 µg two-dose primary series of mRNA-1273. In both age groups, the tolerability profile was generally consistent with that observed in children age 6 to under 12, in adolescents age 12 to 17, and in adults, the company stated.

The company will submit a request for authorization of a 25 µg two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the FDA, European Medicines Agency and other global regulators in the coming weeks. Also, the company has initiated a submission to the FDA for emergency use authorization of its COVID-19 vaccine in children ages 6 to 11 years old.

Moderna noted that it is preparing to evaluate the potential of a booster dose for all pediatric populations, including those age 6 months to under 6 years, 6 to under 12 years, and adolescents.