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.
78 Articles
78 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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