FDA Delays Approval For Moderna's COVID-19 Shot In Teenagers: What You Need To Know - Moderna (NASDAQ:MRNA)

Moderna Inc MRNA said that the FDA would require additional time to complete its assessment of its COVID-19 vaccine for use in adolescents aged 12 to 17 years.
The FDA may not complete the Moderna's shot review before January 2022, dealing with a potential setback to the timing of an emergency use authorization (EUA) for that age group.
The Company said that the FDA needed additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.
Related Link: FDA Revises Pfizer, Moderna COVID-19 Vaccine Sheets With Rare Heart Inflammation Warning.
Moderna said it is reviewing new external analyses on the increased myocarditis risk in those under 18 years of age as they become available.
Moderna also said it would delay filing its request for a EUA of 50 µg dose of the vaccine for children ages 6 to 11 years while the FDA completes its review of the 12-17 filing.
Related: FDA May Clear First COVID-19 Vaccine For Younger Kids, Probably Today: NYT.
Price Action: MRNA shares are down 3.20% at $334.15 during the premarket session on Monday's last check.
Image by Spencer Davis from Pixabay