Covid-19 vaccines, what just happened at the FDA, and why it matters

This is not how vaccine policy should be made.

Yesterday, the FDA Commissioner, Marty Makary, and his new advisor, Vinay Prasad, unveiled a major shift in U.S. Covid-19 vaccine policy—via a New England Journal of Medicine perspective piece and a live FDA event.

Their bottom line: Going forward, Covid-19 vaccines will only be recommended for people over 65 or with at least one chronic condition. If manufacturers want to offer updated vaccines to younger adults, they must run a new placebo-controlled trial after a variant arrives. Their rationale is that, given higher levels of population immunity, the original trials are no longer relevant. Vinay followed up by saying, “This is a restoration of trust. It’s bringing us back to evidence.”

On the surface, this sounds reasonable. After all, severe Covid-19 is far less common in healthy young people. Given growing immunity, real scientific questions exist about whether annual boosters are still warranted for everyone. And, yes, other countries do things differently.

But beneath the surface, this move is deeply troubling. It bypasses the scientific systems built to answer these questions, replacing the public process in health policy with the opinions of two political appointees with chips on their shoulders.

Scientific questions deserve a scientific process.

Reassessing Covid-19 vaccine policy isn’t new. In fact, the CDC’s Advisory Committee on Immunization Practices (ACIP)—a group of independent scientists, doctors, and public health experts—has been doing exactly that, using evolving real-world data as the virus changes and immunity shifts.

While early decisions relied on placebo-controlled trials, that approach became impractical as variants emerged quickly. Instead, ACIP adapted—reviewing real-world data on protection, safety, and impact. Each year, they evaluated whether annual vaccines were providing meaningful added protection. And each year, the data said yes—especially for high-risk groups, but also across broader populations. ACIP also considers other factors, including equity, accessibility, ease of implementation, and cost effectiveness.

ACIP was already scheduled to revisit these recommendations this June. (YLE covered this in detail at the last ACIP meeting.)

How vaccine policy should be made

In normal times, the U.S. vaccine process works like this:

1. FDA Approval. Once a vaccine goes through clinical trials, an external advisory committee of experts (called VRBPAC) and FDA assess whether a vaccine is safe and effective. Then that vaccine is given a license. Thereafter, for fast-mutating viruses like flu or Covid they decide whether a vaccine formula needs to be updated based on evolving data.

2. CDC Recommendation. ACIP then reviews how the vaccine should be used: who should get it, when, and how often. Insurance companies use this recommendation to cover vaccine costs for you. Then the CDC Director signs off.

This process is public, deliberative, and based on evidence, ethics, and implementation factors. As STAT pointed out yesterday, during the pandemic, Makary posted on X that making a 2022 decision about Covid vaccines without holding an FDA advisory committee was “unconscionable.”

Yet, here we are. This decision was made without a VRBPAC vote. No ACIP meeting. No new data. No transparency or public discussion. Two FDA appointees decided the Covid-19 vaccine policy needed to change.

Regular vaccine process vs. this week. Figure by Your Local Epidemiologist

Why that’s a big problem

This matters for several reasons:

1. It undermines the evidence-based process.
   Makary and Prasad—neither of whom is a vaccinologist or has experience leading vaccine policymaking—circumvented the rigorous, transparent system in place. This was neither collaborative nor grounded in new evidence. There was no urgent reason to bypass that process. VRBPAC meets this Thursday, just two days after this announcement.

2. It preempts ACIP’s scheduled review.
   ACIP was already preparing to formally reassess Covid-19 vaccine guidance in June. ACIP could still recommend Covid-19 vaccination for younger Americans, even off-label, as has happened with other vaccines like Tdap and flu. But that normally happens in lockstep with FDA—not in conflict. This time, FDA’s move feels like a dare: “Go ahead. Try to contradict us.” If ACIP pushes back, they risk appearing divided— losing public trust and causing confusion. And, in the end, RFK Jr. would likely overrule ACIP anyway, so is this a hill to die on? It’s an impossible decision.

3. It’s impractical—and unethical.
   FDA’s new proposal would require placebo-controlled trials for healthy young adults every time a new variant emerges. But it’s already spreading by the time a new variant is identified. Public health uses predictive modeling (like the flu model) to stay ahead and be proactive (rather than reactive). This is also unethical and not feasible. Scientists can’t give people a saline placebo when we know a vaccine offers protection. No ethical review board would approve this. Also, running an RCT in the seasonal timeframe is unrealistic.

So what does this mean for you?

If you’re under 65 and don’t have a chronic condition, there’s a very real chance you won’t have access to a Covid-19 vaccine this fall. Much depends on what happens next month. ACIP could defy the FDA and recommend vaccines for broader use, but that would be risky. We’ve never been in this situation before.

If this FDA policy goes through, the eligible chronic conditions are below.

Interestingly, some groups are missing despite extensive evidence of their high risk. For example, overweight individuals and caregivers are missing, but a common recommendation in other countries.

Bottom line

This isn’t about whether everyone needs a yearly Covid-19 vaccine—that’s a legitimate, ongoing scientific debate, and one ACIP was already tackling in June.

This is about how decisions are made—and who gets to make them. FDA political appointees are sidelining expert panels, bypassing transparency, and turning public health into a performance. That might fly in other arenas, but shouldn’t when it comes to people’s health and daily lives.

Vaccine decisions must be rooted in evidence, debate, and transparency.

If this is the new model, we should all be alarmed.

Love,
YLE

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Your Local Epidemiologist (YLE) is founded and operated by Dr. Katelyn Jetelina, MPH PhD—an epidemiologist, wife, and mom of two little girls. YLE is a public health newsletter that reaches over 375,000 people in more than 132 countries, with one goal: to translate the ever-evolving public health science so that people are well-equipped to make evidence-based decisions. This newsletter is free to everyone, thanks to the generous support of fellow YLE community members. To support the effort, subscribe or upgrade below: