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