The US Food and Drug Administration plans to add its most serious “black box” warning to Covid-19 vaccines, CNN reported, citing two sources familiar with the agency’s internal discussions. A boxed warning signals risks that could be life-threatening and requires doctors and patients to weigh benefits against potential harm.
The proposal, driven by FDA chief medical officer Dr. Vinay Prasad, has not been finalized and key details remain unclear, including whether it would apply to all vaccine types or all age groups.
The FDA is finalizing plans to put a "black box" warning on Covid-19 vaccines, sources tell CNN, its most serious alert meant to warn about drug risks.https://t.co/ranaOFz5T0
— CNN Breaking News (@cnnbrk) December 12, 2025
The move comes as the Trump administration intensifies scrutiny of vaccine safety, despite strong evidence from Pfizer, Moderna and global regulators showing no new safety concerns.
Public health experts warn the FDA has not released data supporting Prasad’s claims, including an internal memo alleging pediatric deaths linked to vaccination.
🚨 BREAKING: CHD just filed a massive Citizen Petition demanding the @US_FDA revoke COVID vaccine licenses immediately — after evidence the agency broke its own rules to approve them.
— Children’s Health Defense (@ChildrensHD) December 9, 2025
The FDA must respond.
“The FDA granted full licensure to these vaccines without requiring the… pic.twitter.com/8fLZjXLVtP
Former agency leaders say the process lacks transparency and risks undermining trust in routine childhood immunizations. HHS officials deny political interference.
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TIPP Staff
TIPP Staff
