The company’s submission is for teens 12-17 years old and is based on data from its phase 2/3 trial studying its mRNA-1273 vaccine.
Moderna announced today it filed for an Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA).
“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,” Stéphane Bancel, chief executive officer of Moderna, said. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.”
Bancel said the company had already filed with the European Medicines Agency and Health Canada for the pediatric populations.
Last month, the company released data from its phase 2/3 TeenCOVE trial studying adolescents, which showed it met its primary immunogenicity endpoint. In the study, which enrolled more than 3700 adolescents in the United States, Moderna reported that for fully vaccinated participants (2 doses administered) no cases of COVID-19 were reported. In the placebo group, 4 cases were observed.
The vaccine efficacy in the nearly 2500 adolescents who received the mRNA-1273 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 (CDC) case definition of COVID-19, which tested for milder disease.
The mRNA-1273 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 the vaccine were headache, fatigue, myalgia and chills.
No timetable was available for when the company might have its meeting with the FDA.