No Priors AI FDA Prepares Black Box Warning for COVID Vaccines
Dec 12, 2025
The FDA may issue a black box warning for COVID-19 vaccines, raising concerns about transparency. Critics argue that supporting data is not being shared, which could erode public trust. This move might alter the vaccine debate, with some supporters advocating it as necessary for informed consent regarding myocarditis risks. However, opponents worry it could spark panic and diminish vaccination rates among vulnerable populations. The implications touch on political distrust and transparency within health agencies.
AI Snips
Chapters
Transcript
Episode notes
FDA Moves Toward Strongest Vaccine Warning
- The FDA is preparing a black box warning for COVID-19 vaccines, signaling a major change in risk framing.
- This warning is the agency's strongest label and usually follows substantial safety evidence and review.
Leadership Driving The Safety Review
- Vinay Prasad is reported to be leading the internal push and broader safety review at the FDA.
- The review reportedly examines severe reactions and possible links to reported deaths, including among children.
Data Behind Warning Hasn't Been Released
- The data supporting the planned warning has not been broadly released, raising transparency concerns.
- External experts want to see the evidence if the FDA is taking such a dramatic regulatory step.