Moderna's Flu Vaccine: A Regulatory Rollercoaster with the FDA

Moderna's flu vaccine journey took a sudden turn as the FDA decided to review the shot after initially rejecting it. With public scrutiny and discussions with regulators, Moderna submitted a revised application for approval, highlighting concerns over the regulatory process and the evolving vaccine policy.

In a surprising regulatory twist, Moderna announced that the U.S. Food and Drug Administration has reversed its earlier decision and will now review the company's new flu vaccine. This comes mere days after the original submission was rejected, prompting concerns among investors and highlighting changes in policy under President Donald Trump's administration.

Moderna faced an unusual public conflict with the FDA, revealing the agency's initial refusal to review the vaccine. The refusal was based on trial design issues, with the FDA voicing concerns over not administering a higher-dose vaccine to older trial participants. However, a revised application has now been accepted, paving the way for potential approval.

Following discussions with the FDA, Moderna agreed to conduct further studies in older adults. Dr. Jesse Goodman, former chief scientist at the FDA, called the final approach sensible yet criticized the handling of the approval process. Moderna hopes to introduce the vaccine for the 2026/2027 flu season.

(With inputs from agencies.)