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FDA Prepares Black Box Warning for COVID Vaccines

Dec 12, 2025
The FDA is poised to issue a black box warning on COVID-19 vaccines, marking a significant change in safety communications. Critics argue the supporting data is not transparent, raising concerns about public trust. Supporters claim the warning will help people make informed choices about potential myocarditis risks. This pivotal move could reshape the national conversation around vaccine safety and influence public opinion, highlighting the complex interplay between health policy and political trust.
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INSIGHT

FDA Moves Toward Strongest Warning

  • The FDA is preparing a black box warning for COVID-19 vaccines, marking a major regulatory shift.
  • Jeremy frames this as a dramatic change in public portrayal of vaccine safety compared with earlier pandemic messaging.
INSIGHT

New Leadership Driving Safety Review

  • The push reportedly comes from Vinay Prasad, who now oversees the agency's vaccine division and leads a broader safety review.
  • The review examines severe reactions and potential links to reported deaths, including among children.
INSIGHT

Transparency Questions Surround Evidence

  • The data supporting the planned black box warning has not been broadly released to the public.
  • Jeremy notes that experts outside the agency are demanding transparency if such a dramatic step is taken.
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