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FDA Weighs Black Box Warning for Covid-19 Vaccines, CNN Reports

The reported plan follows an internal memo linking vaccination to possible pediatric deaths.

In May, the FDA said it was requiring safety warnings in the prescribing information for the Covid-19 vaccines from Pfizer and Moderna.
President Donald Trump delivers remarks during the Congressional Ball at the White House on Thursday.
One study estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world.
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Overview

  • CNN reports the agency is preparing its strongest label warning for Covid-19 shots, with a final decision not yet made.
  • Officials have not settled whether a boxed warning would cover all vaccines or only mRNA products or which age groups it would address, with timing targeted for year-end.
  • The effort is reportedly led by FDA chief medical and scientific officer Vinay Prasad, whose November memo cited at least 10 pediatric deaths from heart inflammation as probably vaccine-related.
  • HHS says the FDA has widened a safety review to examine deaths across age groups, building on existing labels that already note rare myocarditis and pericarditis risks.
  • Public-health groups warn that a boxed warning without released case-level data could undermine trust, as Trump administration health officials have already scaled back recommendations for healthy children and pregnant women.