A few days ago, CNN reported that the FDA planned to add a black box warning to COVID-19 mRNA injections over concerns about serious adverse events, including death. Shortly after, investigative journalist Maryanne Demasi reported a reversal. FDA Commissioner Dr. Marty Makary stated on Bloomberg that the agency now has “no plans” for a black box warning, despite a formal recommendation from the FDA’s own Center for Safety and Epidemiology, citing opposition from internal leadership.
