Moderna Inc (MRNA.O) said on Sunday it has been told that the US Food and Drug Administration will require additional time to complete its assessment of the company’s COVID-19 vaccine for use in adolescents aged 12 to 17 years.
The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization (EUA) for that age group.
The U.S. biotech company said it was told late on Friday that the FDA needed the additional 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 primarily affected young males.
Moderna applied for US authorisation of its shot for those aged 12 to 17 in June.