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November 01, 2021 The Food and Drug Administration will need more time to decide whether to approve Moderna's Covid vaccine for adolescents aged 12-17, to better assess recent international analyzes on the risk of myocarditis and pericarditis after vaccination. This was announced by the pharmaceutical company. "The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," Moderna said in a statement. also informing that it will delay the submission of the request for children between the ages of 6 and 11.
The US government agency's review of Moderna's application for an emergency use authorization for its coronavirus vaccine in adolescents may not be completed until January.
Moderna applied for FDA clearance for use in teens in June.