FDA Overturns Own Decision—”Out of Control”

The FDA’s stunning reversal on Moderna’s mRNA flu vaccine within days of rejecting it exposes regulatory chaos that experts warn demonstrates the agency is “out of control,” raising serious questions about bureaucratic competence and consistency that American families deserve answers to.

Story Snapshot

FDA rejected Moderna’s flu vaccine application on February 10, 2026, then reversed course within one week after industry backlash
Expert Michael Osterholm states “we have no idea why” the FDA reversed its decision, calling the agency “out of control on vaccines”
The regulatory flip-flop occurred despite FDA having previously approved the exact trial designs it later deemed inadequate
The reversal followed a Type A meeting with Moderna and a revised filing splitting approval pathways by age group
FDA official Vinay Prasad overruled career scientists in the initial rejection before the agency’s about-face

FDA’s Inexplicable About-Face Stuns Vaccine Experts

The FDA issued a refusal-to-file letter to Moderna on February 10, 2026, rejecting the company’s mRNA-1010 influenza vaccine application for review. The agency claimed the trial comparator did not match the best-available standard of care, specifically criticizing the use of standard-dose vaccines instead of high-dose vaccines for seniors aged 65 and older. Within just one week, the FDA completely reversed its position and accepted a revised filing for review, targeting an August 5, 2026 decision date. This rapid turnabout has left public health experts scratching their heads and questioning the agency’s decision-making process.

Regulatory Inconsistency Undermines Public Trust

The FDA’s reversal is particularly troubling because the agency had previously approved the exact phase 3 study designs that it later rejected. Michael Osterholm from the Center for Infectious Disease Research and Policy stated bluntly that “we have no idea why” the FDA reversed course, adding that this “demonstrates FDA out of control on vaccines” and urging consistent policy. The initial rejection letter was signed by Dr. Vinay Prasad, who reportedly overruled career scientists in making the decision. This kind of bureaucratic inconsistency erodes confidence in regulatory processes and leaves both industry and consumers uncertain about what standards actually apply.

Moderna’s Revised Strategy Splits Approval Pathways

Following the initial rejection, Moderna held a Type A meeting with the FDA and submitted an amended application. The revised filing splits the approval pathway by age group, seeking full approval for adults aged 50-64 and accelerated approval for those 65 and older, with post-marketing studies required for the senior population. This approach attempts to address the FDA’s concerns about comparing against high-dose vaccines for elderly patients, as recommended by the Advisory Committee on Immunization Practices. CEO Stéphane Bancel stated the company appreciates the FDA’s engagement and emphasized providing seniors with new vaccination options. Moderna’s stock jumped seven percent to $47 in premarket trading following the announcement.

Broader Implications for Medical Innovation

This regulatory whiplash sends a concerning message to biotech innovators about the unpredictability of federal oversight. The incident highlights how bureaucratic inconsistency can deter companies from investing in breakthrough technologies that could benefit Americans. William Blair analysts noted the revised filing “reopens U.S. flu market opportunity” and called Moderna’s pivotal data “worthy of approval,” suggesting the science was sound from the start. While mRNA technology holds promise for rapidly adapting to new flu strains, regulatory volatility creates unnecessary barriers to medical advancement. The FDA’s erratic behavior underscores the need for principled, consistent standards rather than arbitrary decision-making that serves neither public health nor scientific progress.