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Makary denies plans for COVID-19 black box warning

FDA leaders reviewed safety data and found no evidence warranting the strongest warning on COVID-19 vaccines despite ongoing safety monitoring and disputed claims.

  • On Monday, Food and Drug Administration commissioner Marty Makary announced the agency opted not to place `black box` warnings on coronavirus vaccines, telling Bloomberg News the labels were unnecessary.
  • A recently leaked FDA memo authored by Vinay Prasad announced an internal agency review into possible COVID vaccine-related deaths, sparking expert concern last week.
  • Researchers found that CDC and researchers reported vaccines are safe and beneficial, with 76 percent effectiveness for children aged 9 months to 4 years and 56 percent for ages 5–17, recently.
  • Medical experts widely condemned reports the FDA considered warnings as an attempt by the Trump administration to undermine vaccine trust amid HHS anti-vaccination moves under Secretary Robert F. Kennedy Jr.
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CNN broke the news in Atlanta, United States on Friday, December 12, 2025.
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