FDA Urging Pfizer and Moderna to Include Thousands More Children in Clinical Trials

(The Defender) Citing concerns about the risk of heart inflammation associated with the vaccines, the U.S. Food and Drug Administration asked Pfizer and Moderna to expand the number of children in their clinical trials.

Pfizer and Moderna will increase the number of children in their COVID vaccine clinical trials prior to seeking Emergency Use Authorization (EUA), after the U.S. Food and Drug Administration (FDA) told the vaccine makers the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.

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