The FDA is probing whether the Moderna vaccine can cause a rare side effect in teens
Author:博沃管理员 Release time:2021-11-09 13:52:25
The U.S. Food and Drug Administration will need more time to decide whether to approve Moderna's COVID-19 vaccine for use in children ages 12 to 17, the company announced Sunday.
The extended timeline is so the FDA can look into reports of a rare side effect — myocarditis, or the inflammation of the heart muscle — in those who've gotten the shot. Moderna said the FDA informed the company of the delay on Friday.
The government's review of Moderna's application for an emergency use authorization of its coronavirus vaccine in adolescents may not be completed before January, the company said. Moderna requested the FDA's authorization for use in adolescents in June.
A recent unpublished study by Sweden's Public Health Agency showed a slightly increased risk of inflammation of the heart muscle and prompted four countries to stop giving the shot to young men and boys. The company's vaccine had previously been approved by The European Medicines Agency for use in children between ages 12 and 17.
The company said Sunday that it would delay applying for emergency authorization for its vaccine to be given to children ages 6 to 11 until the FDA completes its current review.