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FDA Considers 'Black Box' Warning for COVID Vaccines

12/13/2025

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Summary

Story summary

The U.S. Food and Drug Administration is reportedly considering a 'black box' warning for COVID-19 vaccines.
Public health experts criticize the plan as the most severe FDA warning and signaling serious risks.
Dr. Vinay Prasad, the FDA's chief medical officer, claims at least 10 children died after vaccination, without data.
Experts warn the warning could undermine trust in vaccines, which have prevented millions of deaths globally.

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Story summary

The U.S. Food and Drug Administration is reportedly considering a 'black box' warning for COVID-19 vaccines.
Public health experts criticize the plan as the most severe FDA warning and signaling serious risks.
Dr. Vinay Prasad, the FDA's chief medical officer, claims at least 10 children died after vaccination, without data.
Experts warn the warning could undermine trust in vaccines, which have prevented millions of deaths globally.