FDA rebuff of Moderna is rattling the industry

The Food and Drug Administration's refusal to review Moderna's mRNA flu vaccine — with a center director overruling staff and issuing a rare refuse-to-file letter over trial design — has deepened industry fears that shifting standards under the Trump administration could chill U.S. vaccine development.

The move, led by the FDA's Vinay Prasad, is raising doubts across the industry about whether prior regulatory guidance can be trusted — particularly amid broader policy upheaval under HHS Secretary Robert F. Kennedy Jr.

While some companies are betting the pendulum will swing back after 2028, others are reconsidering new programs, especially in the mRNA space.

"We had discussions with a number of vaccine developers, and all will say privately this has put a damper on any kind of future for mRNA technology," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told STAT's Jason Mast.

vaccines

Pediatricians confront HHS in vaccine showdown

The American Academy of Pediatrics has emerged as the chief institutional opponent to health secretary Robert F. Kennedy Jr.'s vaccine policy overhaul, STAT's Daniel Payne writes. The group is suing to restore the earlier childhood immunization schedule, and challenging changes to federal advisory panels — stepping into a quasi-governmental role while issuing guidance to pediatricians amid measles resurgences and mounting parental confusion.

The nearly 67,000-member group says it has grown more vocal out of necessity, after losing $12 million in federal grants and facing an FTC investigation.

"We haven't changed. The environment has," said Susan Kressly, immediate past president of the academy. "Our advocacy has become more vocal out of necessity."

research

NIH narrows clinical trial definition

The National Institutes of Health will stop classifying basic experimental studies involving humans, or BESH, as clinical trials. The move rolls back a 2014 definition that had swept much behavioral and foundational research into the same regulatory bucket as drug testing, STAT's Ed Silverman writes.

The change, set to take effect in May, relieves certain researchers of requirements to register and report results on ClinicalTrials.gov — a move many scientists say reduces red tape and fixes an overbroad policy that complicated grant writing and oversight.

But critics, including former ClinicalTrials.gov director Deborah Zarin and transparency advocates, warn the shift could weaken public reporting.

podcast

More Moderna — and an interview with Stephen Hoge

We're devoting our entire episode this week to one controversial and impactful topic: the FDA's decision to block the review of Moderna's mRNA flu shot.

STAT was the first to report that Vinay Prasad, the agency's top regulator of vaccines, overruled the head of the FDA's vaccine office and other staffers in making that decision. Prasad's action has renewed concerns about the FDA's regulatory posture under the Trump administration.

To help us dig deeply into this important story and its ramifications, we bring on STAT reporters Lizzy Lawrence and Matthew Herper. We also chat with Moderna President Stephen Hoge and former FDA official Jesse Goodman.

Listen here.

And read the full transcript with Hoge here.

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