FDA Reverses Decision, Agrees to Review Moderna's Flu Vaccine

Moderna's persistence pays off as the company makes modifications to its mRNA influenza vaccine approach

Apr. 10, 2026 at 10:34pm

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A translucent, ghostly X-ray photograph showing the internal structure of a syringe filled with a glowing, luminescent liquid vaccine, conceptually representing the innovative yet controversial nature of mRNA technology in the development of new flu shots.An X-ray view of a vaccine syringe, symbolizing the technological advancements and ongoing debates surrounding mRNA-based influenza shots.Kansas City Today

In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has agreed to reconsider Moderna's mRNA flu vaccine application, marking a significant shift from its previous stance. This decision comes just a week after the FDA's initial rejection, leaving many in the medical community intrigued and eager to understand the reasons behind this reversal.

Why it matters

The use of mRNA technology in vaccines, particularly for COVID-19, has been a game-changer, credited with saving countless lives. However, under the leadership of U.S. Health Secretary Robert F. Kennedy Jr., a known anti-vaccine activist, there has been a shift in health policy regarding mRNA vaccines. This shift has sparked debates and raised questions about the future of vaccine development and funding.

The details

Moderna, a leading biotechnology company, has successfully convinced the FDA to review its influenza vaccine application, despite an earlier setback. The company's persistence paid off, as it made modifications to its approach, which the FDA has now accepted. The FDA initially defended its decision to reject Moderna's application, citing concerns about the strength of the vaccine given to older patients in the trial's control arm. However, Moderna addressed these concerns by revising its approach, seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and above. The company also plans to conduct a post-marketing study in older adults, ensuring the vaccine's safety and efficacy.

  • The FDA is expected to make a decision by August 5, 2026.
  • Health Canada has already accepted the vaccine for review, with a decision anticipated within 300 days.

The players

Moderna

A leading biotechnology company that has developed an mRNA flu vaccine application.

U.S. Food and Drug Administration (FDA)

The regulatory agency that initially rejected Moderna's flu vaccine application but has now agreed to reconsider it.

Robert F. Kennedy Jr.

The U.S. Health Secretary, known as an anti-vaccine activist, whose leadership has led to a shift in health policy regarding mRNA vaccines.

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What they’re saying

“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu.”

— Stéphane Bancel, CEO of Moderna

What’s next

The FDA is expected to make a decision on Moderna's flu vaccine application by August 5, 2026. Health Canada has also accepted the vaccine for review, with a decision anticipated within 300 days.

The takeaway

Moderna's persistence in addressing the FDA's concerns and the agency's willingness to reconsider the application highlight the ongoing debate around mRNA vaccine technology and its role in the future of public health. This decision will have implications for vaccine development, funding, and access, particularly for vulnerable populations like the elderly.