FDA Rejects Moderna’s Experimental Flu Vaccine Over Trial Standard Concerns

The Food and Drug Administration (FDA) has denied a review to the pharmaceutical giant Moderna over its latest experimental flu vaccine.

The FDA’s chief vaccine official, Dr. Vinay Prasad, declined to sign off on Moderna’s submission after raising objections to how the study was conducted.

Regulators took issue with the company’s decision to benchmark its new vaccine against the less effective Fluarix Quadrivalent.

Prasad, who serves as director of the Center for Biologics Evaluation and Research (CBER), said that the Moderna trial was not sufficiently “adequate and well-controlled” because comparing it with standard flu shots “does not reflect the best-available standard of care.”

In a press release on Tuesday, Moderna’s CEO Stéphane Bancel complained that the FDA had not identified “any safety or efficacy concerns with our product.”

He also accused the FDA of failing to “further our shared goal of enhancing America’s leadership in developing innovative medicines.”

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” he continued.

“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations.”

I see widespread criticism of @VPrasadMDMPH and FDA decision to not review Moderna vaccine

Why has no one on this website considered the potential upside of requiring industry to fund and conduct more rigorous trials? Would this not improve trust in vaccines?

If we are to have…

— John Mandrola, MD (@drjohnm) February 11, 2026

Meanwhile, the company’s president, Dr. Stephen Hoge, told the New York Times that he was left confused by the change.

“This refusal to start a review is all confusing, to say the least,” he said. “It is surprising, and we’re trying to understand what has changed.”

The decision is a sign of how the agency, which is now under the control of long-term vaccine critic Robert F. Kennedy Jr., is holding large pharmaceutical companies to far higher standards in the wake of their dodgy COVID-19 vaccine.

Prasad signs letter indicating FDA refusing to review new Moderna mRNA flu vaccine because of the control used, which is an existing FDA approved flu vaccine that the FDA earlier agreed was an appropriate control. pic.twitter.com/nFP77YqVNR

— Prof Jeffrey S Morris (@jsm2334) February 11, 2026

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