This Is What Destroying the Vaccine Market Looks Like

THE VACCINE MAKER MODERNA decided this past week to tell the world about bad news it had received from the federal government.

A potentially groundbreaking vaccine for seasonal flu that the Massachusetts-based company had developed would not be getting approval from regulators. In fact, it wasn’t even getting formal consideration, Moderna announced in a Tuesday press release, because officials were refusing to accept the application.

This is not the type of development you would normally expect a pharmaceutical company to broadcast. But that’s because there’s nothing normal about the way the federal government is behaving in this saga—or, for that matter, how the government has been behaving ever since President Donald Trump put anti-vaccination crusader Robert F. Kennedy Jr. in charge of America’s public health.

Moderna’s flu shot, which uses mRNA technology made famous during the COVID-19 pandemic, is the product of a lengthy research and development process that goes back years. Along the way, Moderna scientists consulted directly with officials at the Food and Drug Administration, the agency inside of Kennedy’s department (Health and Human Services) that is responsible for reviewing and approving vaccines.

Such consultation is normal. And a major focus of the discussion between the company and the regulators was how Moderna should test the new shot to demonstrate its safety and effectiveness. There was some back and forth—again, pretty routine—but ultimately the FDA agreed that Moderna’s design for a trial was “acceptable,” according to communication Moderna cited in its press release.

Moderna proceeded with the testing, got promising results and submitted its application. It had good reason to believe it would receive consideration and, in due time, outright approval. Instead, on February 3, Moderna got what’s known as a “refuse to file” letter from the FDA, in which the agency said the company had not put the new vaccine to a sufficiently demanding test.

This was not a decision to reject the Moderna vaccine. It was a refusal even to think about approving it. The FDA rarely takes such a step, and when it does it’s usually because an application is missing a whole component or includes suspect data. Nobody is suggesting Moderna’s application has those kinds of issues.

On the contrary, the available evidence suggests this is a case of the FDA disqualifying a vaccine on questionable grounds, while changing its standards for review late in the process because it was trying to find a way to reject the vaccine. And based on reporting in outlets like STAT and the Wall Street Journal—along with some details I was able to confirm myself—the decision didn’t come from senior career staff working most closely on the application.¹ They actually thought the review should go forward. The decision to refuse instead came directly from Vinay Prasad, a physician-researcher whom Kennedy installed as director of the FDA’s vaccines and biologics division.²

A director overruling career staff on a decision of this magnitude is highly unusual. But it’s indicative of the Trump administration’s broader, dramatic departure from past practices that had emphasized careful deliberation, input from staff and outside experts and lots of public discussion.

“Even if a product didn’t work, ultimately—even if it wasn’t shown to be effective—there was at least a well-defined process to get to that endpoint,” Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told me. “What you saw this past week was the FDA completely turning that process on its head.”

This new way of doing things doesn’t look like the “gold standard science” and “radical transparency” Kennedy promised to bring to HHS. But hypocrisy isn’t the main issue here. Rather, it’s the loss of reliable federal support for vaccines, and how that loss is already dissuading companies from developing new shots that could someday protect hundreds of millions of people from dangerous, even lethal infections.

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SEASONAL FLU IS ONE of those diseases. You probably know all about the symptoms, which include fever and chills plus an assortment of respiratory and gastrointestinal problems that resemble a common cold or stomach bug except that they are more severe. What you may not know—or, at least, may not fully appreciate—is that for many hundreds of thousands of Americans every year the flu won’t simply knock them out of work or school for a few days. It will send them to the hospital and, in the most dire cases, to the morgue.

The Centers for Disease Control and Prevention estimates that last season’s flu, circulating in late 2024 and early 2025, killed tens of thousands (and maybe more than 100,000) in the United States. The toll from this season’s flu will depend in part on how many people get a vaccine, which research has shown significantly reduces the risk of hospitalization and death.

But the flu shot is better at reducing disease severity than preventing infection. And its effectiveness varies from season to season because the virus mutates so frequently. When designing each year’s new vaccine, scientists have to predict which strains are likely to circulate. That is not easy and they have to do so with plenty of lead time, because the companies create the key material for most of today’s flu shots by growing it inside