Moderna announced that the US Food and Drug Administration has refused to review its application for the company’s first mRNA-based flu vaccine. The FDA cited concerns that Moderna’s clinical trial was not “adequate and well-controlled” and had not compared the experimental shot against the best available influenza vaccine on the market. In the trial, Moderna had used Fluarix, an approved flu vaccine from GSK, as the comparator.
Moderna stated that the FDA’s decision was inconsistent with previous communications with its Center for Biologics Evaluation and Research (CBER) and noted that the refusal-to-file letter did not raise any safety or efficacy issues. Moderna CEO Stephane Bancel said the company had requested a meeting to discuss the decision, emphasizing that the trial design had been agreed upon with CBER prior to initiation.
The company highlighted that the mRNA flu vaccine has been accepted for review in the European Union, Canada, and Australia. mRNA technology, widely used during the Covid-19 pandemic, was previously praised for its ability to quickly develop vaccines and save millions of lives.
Moderna’s statement comes amid changes in federal vaccine policy under President Donald Trump’s second term, with Robert F. Kennedy Jr., a long-time vaccine skeptic, leading the health agency. Kennedy’s leadership has involved reshaping federal health agencies, spreading misinformation about vaccines, and cutting federal research grants that previously supported mRNA technology development.
