Moderna says US refuses to review mRNA-based flu vaccine

February 11, 2026 / 1:51 PM

Sharjah24 - AFP: Moderna has announced that the US Food and Drug Administration (FDA) is refusing to review its application for the company’s first mRNA-based influenza vaccine. The decision follows broader FDA discussions on reconsidering approval procedures for certain vaccines, including influenza, amid proposed federal policy changes under President Donald Trump.

Refusal-to-file letter issued

The FDA reportedly issued a Refusal-to-File letter, indicating that Moderna’s submission did not meet requirements for a substantive review, despite the company having tested its new vaccine against an existing approved flu shot, Fluarix from GSK. The letter cited no safety or efficacy concerns.

International approvals and company response

Moderna said the decision contradicted prior communications with the FDA’s Centre for Biologics Evaluation and Research (CBER) and noted that the vaccine has been accepted for review in the European Union, Canada, and Australia.

Policy shift under US health leadership

The development comes amid a shift in US federal health leadership under Trump’s second term, with Robert F. Kennedy Jr., a long-time vaccine sceptic, influencing vaccine policy and federal research priorities, including mRNA vaccine development.