According to CNBC, the FDA is preparing to add its strongest “black box” safety warning to Covid vaccines by the end of this year. The plan, first reported by CNN, is being driven by Dr. Vinay Prasad, the agency’s chief medical and scientific officer. This comes as vaccination uptake is already plummeting, with data from IQVIA cited by the National Foundation for Infectious Diseases showing a 27% decrease in Covid shots at retail pharmacies since 2024. The Department of Health and Human Services has not confirmed the plan, calling any claims “pure speculation.” It’s also unclear if the warning would apply to all three available vaccines—from Pfizer, Moderna, and Novavax—or to specific age groups.
Political Science vs. Medical Science
Here’s the thing: this feels less like a data-driven decision and more like a political one. The report notes that HHS Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, and his appointees have previously targeted the mRNA shots. Dr. Prasad himself wrote an internal memo last month trying to link 10 child deaths to the vaccines without providing evidence, as noted by NBC News. So, is this about newly discovered risks, or is it about an administration aligning policy with its ideological stance? The timing and the players involved raise some serious red flags.
Weighing a Rare Risk
The warning is reportedly set to highlight myocarditis, an extremely rare side effect of the mRNA vaccines. But let’s be clear about the context. Global health authorities, including the CDC, have consistently stated that the benefits of vaccination—in preventing severe Covid, death, and even myocarditis from the infection itself—far outweigh this small risk. Cases of vaccine-related myocarditis have also declined dramatically in recent years. A black box warning is the nuclear option, typically reserved for risks like addiction and death from opioids. Applying it here, for a risk that’s been well-characterized as rare and mostly mild, seems like using a sledgehammer to crack a nut. It could massively distort the public’s perception of the risk-benefit analysis.
Manufacturer Pushback and Public Trust
Not surprisingly, the vaccine makers are pushing back. Pfizer pointed to its shot saving over 14 million lives globally in its first year. Moderna, in a September statement, emphasized that its safety is rigorously monitored across 90+ countries with “no new or undisclosed safety concerns.” But their statements might not matter much. The real damage is to public trust. When the NFID warns that people are already skipping life-saving vaccines, adding the scariest possible label to the most high-profile vaccine in a generation could crater uptake completely. What does that mean for the next pandemic, or even the next flu season? This move could have consequences that last for decades, long after this particular political moment has passed.
