Moderna announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, as no cases of COVID-19 were observed in patients who received the two-dose regimen.
Moderna said it plans to submit the data to the U.S. Food and Drug Administration (FDA) in early June.
The study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. In addition, 93% of participants were seronegative, starting 14 days after the first dose, using a secondary definition of COVID-19 from the Centers for Disease Control and Prevention (CDC), which tested for milder disease.
Because the incidence rate of COVID-19 is lower in adolescents, Moderna also evaluated the secondary CDC definition, which requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample that is positive for SARS-CoV-2 by RT-PCR.
The vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.
The Moderna COVID-19 vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.
