Moderna asks FDA to clear COVID-19 vaccine for adolescents
Moderna on Thursday said it has filed a request with the Food and Drug Administration (FDA) to use its coronavirus vaccine in adolescents as young as 12 years old.
The emergency use authorization is expected to be granted, and would greatly expand the amount of vaccines available for students in middle and high school ahead of classes resuming in the fall. In the U.S., only adults can get the Moderna vaccine at this point.
Moderna announced late last month that its two-dose vaccine was 100 percent effective among the nearly 2,500 adolescents who received it as part of a study in which more than 3,700 people were enrolled.
Timeline: The FDA examined the data from Pfizer-BioNTech for a little more than a month before granting the authorization, so Moderna is likely operating under the same timeline.
The FDA granted an emergency use authorization for the Pfizer-BioNTech vaccine for 12- to 15-year-olds last month, the first vaccine available to the age group.
Why it’s important: Another authorized vaccine will help the vaccination effort for children as schools prepare to return to normalcy by reopening fully in the fall. Children also need to be vaccinated in order to raise the overall level of immunity in the country and lower the numbers of COVID-19 infections, hospitalizations and deaths.