Moderna filed with the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its COVID-19 vaccine in adolescents. In May, the company announced that its Phase II/III TeenCOVE trial in adolescents hit the primary immunogenicity endpoint. The efficacy in almost 2,500 adolescents who received the vaccine was 100%, meaning none came down with COVID-19.
“We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger population,” stated Stephane Bancel, Moderna’s chief executive officer. If granted authorization for this use, Moderna’s vaccine mRNA-1273 will be the second COVID-19 vaccine authorized for adolescents. In May, the FDA expanded the EUA for Pfizer-BioNTech’s COVID-19 vaccine to include individuals aged 12 to 15 years.
Moderna previously announced positive results from its phase 2/3 TeenCOVE study, which evaluated the immunogenicity and safety of mRNA-1273 in adolescents. The study, which involved 3732 adolescents, showed no cases of COVID-19 in participants who received 2 doses of the vaccine. Vaccine efficacy was observed to be 100% when using the same case definition as in the phase 3 COVE study in adults, according to Moderna. The results also showed vaccine efficacy of 93% in seronegative participants starting 14 days after the first dose.
The vaccine safety profile was similar to what was seen with adults, with no major safety concerns identified. Most adverse effects (AE) were mild or moderate in severity. The most common local AE was pain at the injection site. After the second dose, the most common systemic AEs were fatigue, chills, myalgia, and headache. Moderna also recently announced it has initiated the rolling submission process for the biologics license application for mRNA-1273 for full approval of the vaccine in adults.