FDA scientists said there were no confirmed cases of the heart inflammation in Moderna’s kid studies.
NEW YORK — A government advisory panel met Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens.
The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose.. “It’s just not enough people in the clinical trials to detect” the problem if it’s occurring, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, in a call with reporters earlier this week.
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