FDA Refuses Moderna's Application for New mRNA Flu Vaccine

Moderna says the agency objected to how it conducted a key clinical trial for the vaccine.

Published on Feb. 10, 2026

Got story updates? Submit your updates here. ›

The Food and Drug Administration has refused to consider Moderna's application for a new flu vaccine made with mRNA technology, the company announced. Moderna says the FDA cited issues with how it conducted a clinical trial comparing the new vaccine to a standard flu shot, despite previously agreeing to the trial design.

Why it matters

The decision highlights the heightened scrutiny that mRNA vaccines are facing under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., who has been critical of the technology. It also raises concerns about the FDA's willingness to approve innovative vaccine approaches, which could impact the development of future flu and other respiratory virus vaccines.

The details

Moderna says it received a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new mRNA-based flu vaccine to a standard flu shot. The FDA vaccine director said the trial did not compare the new vaccine to "the best-available standard of care" for seniors, even though the agency had previously agreed to the trial design. Moderna says it also provided additional data from another trial, but the FDA still refused to consider the application.

  • Moderna announced the FDA's decision on February 11, 2026.
  • The clinical trial that the FDA objected to concluded prior to the application being submitted.

The players

Moderna

A biotechnology company that develops vaccines and therapeutics, including the first authorized mRNA-based COVID-19 vaccine.

Robert F. Kennedy Jr.

The current U.S. Secretary of Health and Human Services, who has been critical of mRNA vaccine technology in the past.

Dr. Vinay Prasad

The director of the FDA's vaccine division, who wrote the letter objecting to Moderna's clinical trial design.

Got photos? Submit your photos here. ›

What they’re saying

“The FDA 'did not identify any safety or efficacy concerns with our product' and 'does not further our shared goal of enhancing America's leadership in developing innovative medicines'.”

— Stephane Bancel, CEO, Moderna

“American vaccine policy has been hijacked by a conspiracy theorist—yet most Republicans are happy to just sit on their hands.”

— Patty Murray, U.S. Senator, Democrat from Washington (X)

What’s next

Moderna has requested an urgent meeting with the FDA to discuss the decision, and noted that it has applied for the vaccine's approval in Europe, Canada and Australia.

The takeaway

The FDA's refusal to consider Moderna's mRNA flu vaccine application highlights the growing political challenges facing innovative vaccine technologies, as the agency faces increased scrutiny from the current administration. This decision could impact the development of future flu and respiratory virus vaccines in the United States.