Moderna announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg.
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The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 μg two-dose regimen for adolescents aged 12 through 17 years old.
The two-dose regimens, with doses tailored for each age group given one month apart, are well-timed to initiate protection for the start of the school year, as children return to higher-risk classroom and daycare settings.
mRNA-1273 for children and adolescents showed protection starting 14 days after the second dose. Protection was statistically significant, with data coming from large, well-controlled trials of more than 14,000 children and adolescents and a median follow-up of more than 2 months for 6 months through 5 years of age, 5.6 months for 6 through 11 years of age, and 11.1 months for adolescents.
Positive interimresults from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6 months through 5 years of age group consistent with young adults, even at the lower 25 μg dose, along with a favorable safety profile consistent with other age groups.
The antibody titers in the pre-specified 6 months to 23 months and 2 years to 5 years age sub-groups met the success criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study.
The secondary endpoint of vaccine efficacy was observed to be 51% and 37% based on RT-PCR confirmed COVID-19 and CDC case definition in the 6 months through 23 months and 2 years through 5 years age groups, respectively, comparable to the vaccine efficacy observed in adults receiving mRNA-1273 during the same Omicron prevailing period.
Moderna shared interim results of its Phase 2/3 KidCOVE study in the 6 to 11 years of age group in October 2021, which showed non-inferior anti-SARS-CoV-2 neutralizing antibody responses at the 50 μg dose when compared to that in individuals 18 to 25 years old from the Phase 3 COVE study.
The secondary endpoint of vaccine efficacy in the 6 to 11 years of age during the Delta wave was observed to be 88% based on CDC case definition.
In May 2021, the company shared interim results of its Phase 2/3 TeenCOVE study of mRNA-1273 at the 100 μg dose. The non-inferior anti-SARS-CoV-2 neutralizing antibody responses at the 100 μg dose was demonstrated when compared to that in individuals 18 to 25 years old from the Phase 3 COVE study.
The antibody response was also demonstrated to be non-inferior to adults and the vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 93% when using the CDC case definition.
Clinical trials have demonstrated the safety and tolerability of mRNA-1273 in all pediatric age groups, with no deaths or cases of myocarditis or pericarditis reported. The most commonly reported local symptom was injection site pain across all age groups. The most commonly reported systemic symptoms were headache and fatigue in older children and irritability in younger children.
Moderna's COVID-19 vaccine will be available for children and adolescents at select vaccination sites in the coming days. Children vaccinated early this summer with a two-dose regimen will initiate protection as they return to school and daycare settings in the fall. Millions of children and adolescents have been safely vaccinated with mRNA-1273 around the world.
On January 31, 2022, the U.S. FDA approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.
Previously, Moderna's COVID-19 vaccine was available under EUA in the U.S. from December 18, 2020. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age with certain kinds of immunocompromise.
A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older.
A second booster dose at 50 µg is authorized for emergency use in the U.S. under EUA for adults 50 and older and individuals 12 and over who are moderately or severely immunocompromised. ■