Recent turmoil within the FDA has ignited a fierce debate over the future of vaccine regulation in the United States. A senior official’s internal memo, which critics describe as a break from long-standing scientific norms, has proposed a radical overhaul of how vaccines are approved and monitored. To unravel the complexities of this situation, we are speaking with James Maitland, an expert who has closely followed the intersection of public health policy and regulatory science. Our conversation will explore the controversy surrounding the VAERS database, the ethical challenges of redesigning clinical trials, the potential economic fallout for the U.S. vaccine market, and the critical importance of internal scientific debate for maintaining public trust.
Vinay Prasad cited the VAERS database to claim at least 10 child deaths from covid vaccines. Could you walk us through how VAERS actually works and explain why scientists consider using its unverified reports as direct proof of causation to be misleading and dangerous?
It’s a deeply concerning situation because it misrepresents a fundamental tool of public health surveillance. The Vaccine Adverse Event Reporting System, or VAERS, is essentially a public tip line. It’s an open, crowdsourced database where anyone—a patient, a doctor, a parent—can report any health issue that occurs after a vaccination. The article’s example of someone reporting their hair turning purple after a flu shot is a perfect illustration; the report is logged, but it doesn’t mean the shot caused it. Its purpose is to be an “early warning system,” a place to spot unusual patterns that might warrant a real, rigorous investigation. Using these raw, unverified reports as direct proof of causation is scientifically unsound. For instance, the claim of “at least 10” deaths was later contrasted by an internal memo suggesting the number was between zero and seven, while over 2,100 children actually died from COVID. Treating a VAERS report as evidence is like treating a 911 call as a conviction; it’s the beginning of an investigation, not the conclusion, and to present it otherwise directly feeds public fear and erodes trust in the very systems designed to protect us.
Prasad has proposed that the FDA stop using immune markers for vaccine approval and instead require large placebo-controlled trials. Based on the bioethical principles mentioned by Lawrence Gostin, please detail the ethical and practical challenges this would create for updating shots against viruses like influenza.
This proposal strikes at the heart of both medical ethics and practical public health response. Lawrence Gostin articulated the core issue perfectly: there is a “rock-solid principle in bioethics” that you cannot knowingly deny people a safe and effective treatment. In a placebo-controlled trial, one group gets the new vaccine while the other gets a placebo, like a saltwater shot. For a brand-new disease, that’s the gold standard. But for something like influenza, where we already have effective vaccines, it would mean intentionally leaving a control group unprotected against a “dangerous infectious disease.” You would be telling thousands of people, “We are going to let you face the flu season with no protection so we can see if this updated shot works.” Ethically, it’s indefensible. Practically, it’s a disaster. Viruses like influenza and COVID mutate constantly. We don’t have the months or years it takes to run these massive trials for every single update. The current system of using immune markers, like antibody levels, allows us to update shots quickly and save lives. To abandon that would mean we are always a year behind the virus, a delay that would be measured in hospitalizations and deaths.
Former commissioner Robert Califf warned that Prasad’s new framework could make the U.S. vaccine market non-viable. What specific policy changes would likely cause this disruption for manufacturers, and what could the long-term consequences be for childhood immunizations against diseases like measles or polio?
The warning from Robert Califf is stark, and it’s rooted in economic and logistical reality. The specific policy that would cause this disruption is the demand for large-scale, placebo-controlled clinical trials for all new or updated shots. Vaccine development is an incredibly expensive and high-risk endeavor. If manufacturers are told that every seasonal flu shot update or every variant-specific COVID booster requires a new, multi-year trial costing hundreds of millions of dollars, the business model collapses. They simply won’t do it. As Califf said, “it won’t be a viable business.” The immediate consequence would be a crippling slowdown in our ability to respond to respiratory viruses. But the long-term consequences are even more terrifying. If major pharmaceutical companies decide the U.S. market is too unpredictable and costly, they might reduce investment or pull out entirely. This could lead to shortages, fewer innovations, and a fragile supply chain for the bedrock of public health: routine childhood immunizations against diseases like measles, polio, and whooping cough. The doubt cast on the entire regulatory system could destabilize the very market that has protected generations of children.
The memo reportedly told FDA employees who disagree with Prasad’s “core principles” to resign. How does this kind of directive impact the internal scientific debate and the “checks and balances” that experts like Susan Ellenberg argue are essential for ensuring vaccine safety and credibility?
That directive is perhaps the most alarming part of this entire affair. Science isn’t about loyalty or adhering to a “worldview”; it’s about rigorous, open, and often contentious debate. As former FDA director Susan Ellenberg put it, “If disagreement is treated as disloyalty, you lose the only mechanism that keeps science honest.” The process of vetting a vaccine involves hundreds of scientists—statisticians, epidemiologists, immunologists—all challenging each other’s assumptions, scrutinizing the data, and looking for flaws. This internal friction is not a weakness; it is the “checks and balances” that make the system credible and safe. When you issue a top-down directive telling people to resign if they disagree, you foster an environment of fear. You silence the very experts whose job it is to raise red flags. It sends a chilling message that conformity is valued over scientific integrity. Without that robust internal debate, safety reviews become weaker, and the agency’s decisions become less trustworthy, both to the scientific community and to the public.
What is your forecast for the U.S. vaccine pipeline and public trust in immunizations if these proposed changes to the FDA’s “worldview” are fully implemented?
My forecast, based on the warnings from a dozen former FDA commissioners and numerous other experts, is frankly grim. If these changes are fully implemented, we would likely face a two-front crisis. First, the vaccine pipeline itself would become slow and brittle. Requiring lengthy, expensive trials for every update would severely “impede the ability to update vaccines in a timely fashion,” leaving us vulnerable to fast-changing viruses and discouraging companies from investing in the U.S. market. We could see fewer new vaccines and critical shortages. Second, and perhaps more damaging, would be the collapse of public trust. The FDA’s authority rests on the public’s belief that it makes decisions based on the “best scientific evidence.” If families come to believe the agency is misusing data, silencing its own experts, and operating on a political “worldview” rather than impartial science, that trust will “plummet.” This skepticism won’t be limited to new vaccines; it will inevitably spill over to routine childhood immunizations, threatening to undo decades of progress against diseases we thought we had conquered. We could face a future with both a weakened scientific infrastructure and a deeply distrustful public, a combination that would be catastrophic for public health.
