The company plans to file for Food and Drug Administration (FDA) authorization for the 12-17 year old population in early June.
Moderna announced today its the phase 2/3 study of its mRNA-1273 COVID-19 vaccine in the pediatric population aged 12-17 reached its immunogenicity endpoint.
This news comes from their TeenCOVE study, which enrolled more than 3700 adolescents in the United States. The company reports that for fully vaccinated participants (2 doses administered) no cases of COVID-19 were reported. In the placebo group, 4 cases were observed.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,”Moderna CEO Stéphane Bancel, Moderna, said.
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.
With this new data, Moderna plans to file for authorization. “We will submit these results to the US FDA and regulators globally in early June and request authorization,” Bancel said. “We remain committed to doing our part to help end the COVID-19 pandemic.”