Moderna has submitted an Emergency Use Authorization (EUA) request to the Food and Drug Administration (FDA) for use of its COVID-19 vaccine to patients 12 to less than 18 years of age.

The submission is based on data from the phase 2/3 TeenCOVE study (ClinicalTrials.gov Identifier: NCT04649151), which included over 3700 US adolescents aged 12 to less than 18 years. Patients were randomly assigned 2:1 to receive two 100µg doses of the Moderna COVID-19 Vaccine 28 days apart or placebo. The primary endpoint was noninferior immunogenicity based on a comparison of the geometric mean of the serum neutralizing antibody level in the adult phase 3 COVE study (ClinicalTrials.gov Identifier: NCT04470427).

Results showed that the trial met its primary immunogenicity endpoint achieving noninferior immune responses to those observed in an adult comparator group. Vaccine efficacy was observed to be 100% starting 14 days after the second dose; no cases of COVID-19 were reported in the vaccine group. Using the Centers for Disease Control and Prevention (CDC) case definition (1 COVID-19 symptom and a positive SARS-CoV-2 RT-PCR test), vaccine efficacy was reported to be 93% in seronegative participants starting 14 days after the first dose.

The Moderna COVID-19 vaccine was generally well tolerated in adolescents and the safety profile was consistent with that seen in the phase 3 COVE study in adults. The most common adverse reactions observed after the second dose of the vaccine were headache, fatigue, myalgia and chills.


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“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Stéphane Bancel, CEO of Moderna. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.” 

Reference

Moderna files for Emergency Use Authorization for its COVID-19 vaccine in adolescents in the United States. [press release]. Cambridge, MA: Moderna, Inc.; June 10, 2021.