FDA Refuses to Review Moderna's Flu Vaccine Application

Moderna announced that the U.S. Food and Drug Administration (FDA) has refused to review its application for an experimental flu shot, known as mRNA-1010. The FDA issued a Refusal-to-File (RTF) letter, meaning the agency will not start a formal review process for this vaccine at this time.

According to Moderna, the FDA cited concerns that the study testing the flu vaccine was not sufficient. As a result, the application will not be considered unless further information or changes are made.

Moderna stated that this decision was unexpected, especially since the application was accepted for review by health authorities in the European Union, Canada, and Australia. The company has requested a meeting with the FDA to better understand the reasons behind the refusal and to find a way forward.

Moderna does not expect this development to affect its financial guidance for 2026.

It means that the FDA will not begin the process of reviewing Moderna's request to approve its new flu vaccine because the agency found the application or supporting data to be insufficient.

The FDA's refusal was based on concerns about the sufficiency of the testing, not necessarily about safety or effectiveness. More information or additional studies may be needed before the vaccine can be reviewed.

Yes. The application for the vaccine has been accepted for review in the European Union, Canada, and Australia.

Moderna has stated that it does not expect this decision to impact its financial guidance for 2026.

CNBC

The Food and Drug Administration refused to start a review of Moderna's application for its experimental flu shot, the company said. It's another sign of the Trump administration's influence on tightening vaccine regulation in the U.S.

Accesswire

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forward mRNA-1010 has been submitted and accepted for review in the EU, Canada and Australia Company does not expect any impac...

WSJ

The company said the agency wouldn't review its application on the grounds that the study testing the shot wasn't sufficient.

Reuters

Moderna said on Tuesday the U.S. Food and Drug Administration will not review its approval application for its influenza vaccine.

Investors Business Daily

The FDA rejected Moderna's experimental flu vaccine Tuesday in a move that proved to be a blow to recently hot Moderna stock.

WSJ

The company said the agency wouldn't review its application on the grounds that the study testing the shot wasn't sufficient.

Reuters

Moderna shares opened 14% lower in Frankfurt on Wednesday in low volume after the U.S. Food and Drug Administration refused to review the company's approval application for its influenza vaccine.

Barrons

The vaccine maker says the Food and Drug Administration has refused to review its application to sell a new seasonal flu vaccine.

Market Watch

The biotech company said the FDA won't review its flu vaccine, in the latest hit to mRNA development.

Zacks Investment Research

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns despite no safety flags.

Proactive Investors

Moderna Inc (NASDAQ:MRNA, XETRA:0QF) shares fell almost 6% after the drugmaker announced that the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has issued a Refusal-to-File (RTF) letter for the company's biologics license application for its investigatio...

Forbes

In this week's edition of InnovationRx, we look at the FDA's refusal to review Moderna's flu vaccine, the healthcare giants on Forbes new Greatest Innovators list, why Garner Health is worth $1.35 billion, and more. To get it in your inbox, subscribe here.

New York Post

The new shot was not compared to “the best-available standard of care in the United States at the time of the study,” an FDA official told Moderna.

WSJ

The head of the agency's vaccine division, Vinay Prasad, has overruled pushback from career staffers.

Fast Company

The U.S. Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.The news is the latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr....

Show All Sources