Fda's Reversal On Moderna Flu Shot Bid Followed White House Pressure

The FDA's decision this week to reverse course and review Moderna's seasonal flu vaccine application followed a meeting in which President Donald Trump expressed frustration to Commissioner Marty Makary over the agency's handling of vaccine issues, according to two people familiar with details of the meeting.

Makary was called to the White House Thursday, two days after the company disclosed the agency's letter refusing to accept the application, said the people, who were granted anonymity to discuss the matter. The so-called Type A meeting that followed between Moderna and FDA officials — which companies can request after regulators refuse to accept an application as-is — was scheduled more quickly than is typical and "gave them a public way to save face," one of the people said of the agency.

A White House official denied that Trump has raised any issues with the FDA's posture on vaccines or influenced its reversal on the Moderna application. "Nothing the FDA has done recently on this has been choreographed," said the official, who was granted anonymity to speak candidly.

The FDA accepted Moderna’s application to license its seasonal flu vaccine after the company proposed an amended filing to address the agency’s concerns with its clinical trial design, the messenger RNA vaccine maker said Wednesday.

During the Type A meeting, Moderna suggested an alternative approach to considering its vaccine for approval based on age, the company said. The FDA accepted the application for review after Moderna amended it to seek full approval for 50- to 64-year-olds and accelerated approval for adults 65 and older, with a post-marketing requirement to study the vaccine further in the older age group to address the agency’s initial concerns.

"We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," Moderna CEO Stéphane Bancel said in a statement Wednesday. "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."

The FDA has set Aug. 5 as its target date for an approval decision, Moderna said.

“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” HHS spokesperson Andrew Nixon said. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”

The FDA refused to accept Moderna’s initial filing earlier this month because Center for Biologics Evaluation and Research Director Vinay Prasad took issue with the control arm of the company’s late-stage clinical trial for the shot. Moderna compared its candidate to a standard-dose flu vaccine rather than one of three shots the CDC preferentially recommends for older adults as more protective against the virus.

Moderna defended its approach by pointing to communications with the agency in 2024 showing that officials had deemed its trial design “acceptable” while acknowledging they’d noted a preference for one of the three high-dose vaccines.

Makary insisted as recently as Tuesday that the review team’s feedback in 2024 was “far from accepting” and that those scientists had called for Moderna to ensure trial participants had “informed consent” about which shots they might receive if the company stuck to its preferred control.

“They don't like it when companies do not follow their guidance,” Makary said at a drug industry event, referring to FDA review teams.

Still, he added that the FDA’s refusal-to-file letter was “part of a conversation” with the company, suggesting that the two parties could find a path toward regulatory review.

“They can always, after that letter, ask for the more detailed review, but that's part of the process,” Makary said.

Tim Röhn is the senior editor of the Axel Springer Global Reporters Network.