Moderna asks FDA to clear COVID-19 vaccine for adolescents

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. Nathaniel Weixel TheHill

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. Pfizer and BioNTech received FDA authorization for the same age group last month.

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.

No cases of COVID-19 were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, the company said.

No significant safety concerns have been identified to date, the company added, and the majority of side effects were mild or moderate in severity.

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. ...