Moderna seeks clearance for COVID-19 vaccine to be used in adolescents

Moderna's submission is based on a Phase 2/3 study of mRNA-1273 in adolescents age 12 years old to less than age 18 years old in the United States.
Sandra Levy
Senior Editor
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Moderna has requested an emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine in adolescents. The company said trials have shown the vaccine to be highly effective in preventing infection in adolescents, and that it also had filed for authorization in Canada and Europe for the vaccine's use in adolescents. 

In May, Moderna announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.

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. The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose, using the secondary Centers for Disease Control and Prevention case definition of COVID-19, which tested for milder disease. The study enrolled 3,732 participants age 12 years old to less than 18 years old in the United States.

Moderna noted that its COVID-19 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 majority of adverse events were mild or moderate in severity. 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.

Safety data continues to accrue and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection.