The United States Food and Drug Administration has rejected pharmaceutical and biotechnology giant Moderna’s application for its mRNA-based flu vaccine, the drugmaker said. The move is the latest sign that the FDA, under Health Secretary Robert F. Kennedy Jr., is slow-walking vaccine approvals and taking a harder line on shots that use messenger RNA technology.

The vaccine made by the Cambridge-based company uses the same mRNA technology as its COVID-19 shot.

Moderna accused the FDA of not identifying any safety or efficacy concerns with the vaccine and instead taking issue with the “comparator” in its clinical trial - the vaccine the company used as a benchmark to evaluate its own shot.

The FDA, in turn, said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.” The standard flu shot is FDA-approved. However, Moderna, in a news release, said that the agency’s stated reason is “inconsistent” with what regulators had told the company in 2024 and 2025.

“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,” Moderna CEO Stéphane Bancel said in the release. He referred to the FDA’s Centers for Biologics Evaluation and Research, which reviews and approves vaccines, as well as other treatments like gene therapies.

NBC reported that the Department of Health and Human Services, which oversees the FDA, would not comment on regulatory communications to individual sponsors.

Kennedy has ordered that all vaccines would need to go through placebo-controlled clinical trials

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In 2025, Kennedy had ordered that all vaccines would need to go through placebo-controlled clinical trials.

When vaccines are already available for a disease, it's considered unethical to give clinical trial participants a placebo, rather than compare the new vaccine to the existing one. Giving a placebo would leave people who would be otherwise protected vulnerable to infection.

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