United States | News & Politics

A potentially groundbreaking vaccine for seasonal flu 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.

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.