Moderna Inc. said it would expand an ongoing trial of its coronavirus vaccine in children under 12 years old to gather more safety data amid worries that messenger RNA shots may trigger rare heart side effects.
“The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” a Moderna spokeswoman said in a statement.
Clinical trial timelines are regularly re-evaluated based on regulatory agency discussions and requests, she said, and Moderna expects to have data that would support authorization in late 2021 or early 2022. The Cambridge, Massachusetts-based company is discussing a proposal for a bigger trial with the U.S. Food and Drug Administration, she said.
