By Blessing Nweke
The Food and Drug Administration has rejected Moderna’s application for its mRNA-based influenza vaccine, the company announced Tuesday, marking the latest setback for messenger RNA vaccines under Health Secretary Robert F. Kennedy Jr.
Moderna said the FDA did not raise concerns about the shot’s safety or effectiveness. Instead, regulators objected to the “comparator” used in the Phase 3 clinical trial — the standard flu vaccine that served as the benchmark for measuring Moderna’s performance.
According to the company, the FDA said the use of a standard flu shot as a comparator “does not reflect the best-available standard of care,” despite the fact that the vaccine is FDA-approved. Moderna CEO Stéphane Bancel called the agency’s reasoning “inconsistent” with prior discussions in 2024 and 2025 with the FDA’s Center for Biologics Evaluation and Research.
“It should not be controversial” to rely on an agreed-upon, FDA-approved comparator, Bancel said in a statement.
Last year, Moderna reported its mRNA flu vaccine was 26.6% more effective than a standard flu shot in a late-stage trial.
The decision comes amid broader shifts in federal vaccine policy. Kennedy has ordered that all new vaccines undergo placebo-controlled trials, a requirement that experts say raises ethical concerns when effective vaccines already exist. Using a placebo in such cases could leave participants vulnerable to infection.
An HHS spokesperson said the FDA “generally does not comment on regulatory communications to individual sponsors.”
Moderna previously withdrew its application for a combined flu and Covid mRNA shot after the FDA requested additional data. Meanwhile, regulators in the European Union, Canada and Australia have accepted the company’s flu vaccine application.
Original article
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