Investing.com – Moderna stock (NASDAQ:MRNA) fell more than 5% Monday as the company said the U.S. Food and Drug Administration will take more time to fully assess its Covid-19 vaccine for use in 12- to 17-year-olds.
The biotech company said the FDA informed it Friday evening it needed more time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has mostly affected young men following the second dose.
After this communication from the regulator, Moderna said it will delay filing a request for emergency use of Covid shots in children aged 6 to 11 while the FDA completes the review of its request for emergency approval for use in adolescents.
The review may not be completed before January, the company said in a statement, a setback to the timing of an emergency use authorization for that age group.