US EditionFDA intends to put most serious warning on COVID vaccines, CNN reports
FDA plans a black box warning to highlight rare myocarditis risks and possible vaccine-linked deaths, while affirming benefits outweigh risks, with the decision led by Dr. Vinay Prasad.
- Reports this week say the FDA intends to add a black‑box warning to Covid-19 vaccines, though the plan remains unfinalized, with December 9, 2025, as the referenced date.
- Dr. Vinay Prasad, FDA chief medical and scientific officer and director of CBER, leads the review after a memo claimed at least 10 pediatric deaths and myocarditis cases.
- Trials in about 75,000 people support three FDA‑approved vaccines, including two mRNA types, with a study estimating nearly 20 million deaths averted globally.
- HHS officials deny political interference while Moderna and Pfizer emphasize safety monitoring in more than 90 countries, and a dozen former FDA commissioners warn this could undermine trust in immunizations.
- The FDA may convene an external advisory committee to publicly vet safety data, but several procedural steps not yet taken at FDA and critics including public‑health commentators challenge the plan.
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80 Articles
FDA Set to Give COVID Vaccines Serious 'Black Box' Designation: Report
The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s […] The post FDA Set to Give COVID Vaccines Serious 'Black Box' Designation: Report appeared first on The Western Journal.
FDA Mulling Strict ‘Black Box’ Warning for COVID Vaccines: Report.
PULSE POINTSWHAT HAPPENED: Reports suggest the U.S. Food and Drug Administration (FDA) plans to add a “black box” warning to COVID-19 vaccines, indicating potential severe health risks.WHO WAS INVOLVED: The FDA, Dr. Vinay Prasad, Moderna, Pfizer, Novavax, and U.S. Department of Health and Human Services (HHS) spokesman Andrew Nixon.WHEN & WHERE: The plans are reportedly under development and were disclosed by sources to CNN. Finalization details…
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