"In early December, Moderna also decided to evaluate the potential of lower doses to meet regulatory guidance for immunogenicity in children 6-11 years of age and in adolescents 12-17 years of age in our ongoing clinical trials. The Company is also evaluating a booster dose in adolescents 12-17 years of age. The Company is in the process of implementing those various protocol amendments."
"We expect to report data in children 2-5 years of age in March. If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter."
The U.S. FDA requested additional participants at a given dose level in pediatric cohorts after the VRBPAC review of requirements for pediatric EUA on June 10, 2021, and Moderna complied at that time. Outside the United States, Moderna has received regulatory authorizations in Europe, UK...
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