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.
“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.”
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.