The Black-Box Warning That Wasn’t

For much of the past week, it appeared that something rare—and overdue—might finally happen at the Food and Drug Administration. Reports circulated that the agency was preparing to place a black-box warning on COVID-19 vaccines, the strongest safety warning the FDA can issue. The story moved quickly across mainstream outlets and social media alike. Even prediction markets weighed in, treating the move as likely. For a brief moment, it seemed possible that the agency charged with protecting public health was finally prepared to confront the consequences of its pandemic decisions.

Then it didn’t happen.

What followed was not a denial that harms exist. That much is now conceded. Instead, FDA Commissioner Marty Makary publicly acknowledged that an internal safety committee had recommended a boxed warning—and that the agency ultimately declined to act on it. The warning was considered, discussed, and rejected.

Those facts are not in dispute. Only their meaning is.

The internal recommendation did not come from activists or outside critics. It came from within the FDA itself, from its safety and epidemiology reviewers—staff whose institutional role is to monitor adverse events, assess post-marketing data, and raise alarms when a product’s risk profile crosses a regulatory threshold. Their recommendation followed closely on the heels of the leaked memo from the FDA’s Center for Biologics Evaluation and Research (CBER) documenting pediatric deaths and under-coded harms associated with COVID vaccination. It also came amid a broader, unavoidable shift: years of minimization giving way to reluctant acknowledgment that serious injuries, including fatal ones, have occurred.

Makary did not dispute the substance of the safety concern. Instead, he confirmed that leadership chose not to issue the warning, pointing generally to changes in how the shots are used today.

What a Black Box Warning Actually Means 

To understand why that matters, it is important to be clear about what a black-box warning is—and what it is not. A boxed warning does not ban a product. It does not remove access. It does not declare a drug ineffective or unlawful. What it does is formally recognize that a product carries a risk of serious injury or death and that this risk must be clearly communicated to physicians and patients. It changes how drugs are prescribed, how consent is obtained, and how risk is discussed. It is the FDA’s clearest signal that safety concerns are no longer theoretical, rare, or dismissible.

In other words, a black-box warning is not alarmism. It is regulatory honesty.

Did Reformers Float the Warning?

Only after understanding that should we ask the more delicate question: did reform-minded officials inside the FDA try to do something—even if they ultimately fell short?

It is at least plausible. The past week’s information environment was unusual. The breadth of coverage, the openness with which internal disagreement surfaced, and the speed with which safety concerns moved into public view suggest more than a routine leak. One charitable interpretation is that reformers attempted to surface the truth about COVID vaccine risks in a way that prepared the public without triggering the immediate legal and institutional consequences of formal action. Perhaps they hoped to shift the conversation, to acclimate stakeholders, or to test whether a boxed warning would be politically survivable.

That interpretation cannot be proven. But it is not unreasonable—and it is worth considering, because even if it is correct, it does not change the outcome.

The warning was not issued. The product remains on the market without the FDA’s strongest safety signal. Those who downplayed or dismissed risks face no consequences. And people continue to be harmed by a product whose dangers are now openly acknowledged but insufficiently regulated.

Intent, however well-meaning, does not protect patients.

Why the FDA Declined to Act

You might expect that a decision to override an internal safety committee’s recommendation for the FDA’s strongest warning would be accompanied by a detailed, data-driven explanation. It was not. In his Bloomberg interview, Marty Makary did not dispute the existence of serious harms or the fact that agency safety reviewers had recommended a boxed warning. Instead, he said simply that the FDA had “no plans” to issue one, gesturing generally to changes in how COVID vaccines are used today—suggesting that less frequent dosing might alter the risk profile.

What he did not provide was a clear scientific rationale. There was no articulation of a regulatory threshold that had not been met, no quantitative risk-benefit analysis shared with the public, and no explanation for why acknowledged risks no longer warranted the agency’s strongest cautionary label. By invoking shifting “use patterns” without explaining how those changes mitigate known harms, the FDA avoided making a concrete claim that could later be tested or challenged—allowing it to acknowledge concern without committing to a formal finding.

Seen in that light, the decision reflects not uncertainty about the evidence, but caution about what acknowledging it would require. A boxed warning is not merely informational; it has legal force. It would amount to a formal admission that COVID vaccines carry risks serious enough to warrant the FDA’s highest level of caution—an admission that would reverberate through the courts and raise uncomfortable questions about why such warnings were not issued sooner. It would also disrupt the broader pandemic framework, from CDC guidance to state mandates and informed-consent practices.

Institutions are built to preserve themselves. Even reformers inherit those incentives.

What the FDA has chosen instead is partial disclosure without accountability. Harms are acknowledged, but only in fragments. Data are discussed, but consequences are deferred. The public is told that injuries occurred—but not in a way that requires decisive regulatory action.

This is not transparency. It is containment. Nor is it public health in any meaningful sense.

Half Measures Won’t Cut It

Public health is not the art of managing outrage or preserving markets. It is the practice of responding proportionally to risk, even when that response is uncomfortable. When a product’s dangers are serious enough to prompt internal calls for a black-box warning, the obligation is not to float the idea or allow speculation to substitute for action, but to warn the public clearly and without equivocation.

What remains instead looks uncomfortably like vaccine promotion by another name. Access is preserved at all costs. Withdrawal is treated as unthinkable. Warning labels are weighed not against evidence of harm, but against institutional risk. The system is protected. The people are not.

FDA leadership has promised reform and credibility. Overriding an internal safety committee’s recommendation for the agency’s strongest warning undermines both, signaling that even now—despite acknowledged harms—there are limits to how much truth the institution will act on.

Some will argue that removing COVID vaccines from the market would provoke backlash. That may be true, but it is beside the point. A black-box warning is not the ceiling of reform; it is the floor.

Reform cannot survive on gestures. Trust is rebuilt when agencies protect people, not when they flirt with honesty and retreat when consequences become real.

If the FDA wants to restore credibility, this is not the way.