Exhibit 120 · Journal article by agency officials
US FDA Safety Labeling Change for mRNA COVID-19 Vaccines
The FDA's vaccine chief and commissioner described the evidence for the June 2025 labeling change. An FDA-sponsored retrospective study included 333 patients hospitalized with myocarditis after COVID-19 vaccination. Of cases evaluated by cardiac MRI, 82% (177/216) showed late gadolinium enhancement, a marker of myocardial injury; of those with initial enhancement, 60% (98/161) still showed it at a median of 159 days. The authors wrote that the labeling change should not be seen as a final resolution of the concern.
- Source
- Vinay Prasad and Martin A. Makary, U.S. Food and Drug Administration; JAMA 334(11):945–946
- Date
- 2025 (JAMA 2025;334(11):945-946)
- Grade
- Primary record
- Document
- https://doi.org/10.1001/jama.2025.12675
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit