Recently, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death. However, in a striking reversal, Dr. Marty Makary appeared on Bloomberg and claimed the agency now has "no plans" to implement a black box warning—despite the FDA's own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and "leadership" thought it would be a bad idea.

A few days ago, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death.

However, in a striking reversal first reported by Maryanne Demasi, FDA Commissioner Dr. Marty Makary appeared on Bloomberg and claimed the agency now has "no plans" to implement a black box warning—despite the FDA's own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and "leadership" thought it would be a bad idea.

Dr. Makary stated:

Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine. The Safety and Epidemiology center within the FDA did recommend that it was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.

Because when you have those two doses three months apart, that's when you see the side effects go way up, like myocarditis in young people. Now that it's annual, you may not see that same prevalence.

So we don't want to extrapolate findings to today if it's not transferable.

This rationale is deeply flawed—and gravely worrisome. It assumes that cardiotoxic injury from mRNA injections is acute, transient, and dose-interval dependent, rather than structural, cumulative, and capable of causing delayed fatal outcomes. That assumption is directly contradicted by the peer-reviewed literature.