Politics

The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval.

The refusal was revealed last week in a sharply worded press release from Moderna. Subsequent reporting found that the decision was made by political appointee Vinay Prasad, the Trump administration’s top vaccine regulator, who overruled a team of agency scientists and a top career official in rejecting Moderna’s application.

In an announcement Wednesday morning, Moderna said the FDA has now agreed to review its vaccine after the company held a formal (Type A) meeting with the FDA and proposed a change to the regulatory pathways used in the application.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Moderna’s CEO, said in the announcement. “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 agency is expected to provide a decision on the vaccine by August 5, 2026.