Growing pains: Moderna ramps up its child vaccine trial
Side effects from the Moderna and Pfizer-BioNTech vaccines among the young population have raised alarms
Moderna 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 enrol a larger safety database which increases the likelihood of detecting rarer events,” a Moderna spokesperson said.
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 authorisation in late 2021 or early 2022. The company is discussing a proposal for a bigger trial with the US Food and Drug Administration, she said...