FDA to review Moderna’s mRNA flu vaccine after initial rejection
The US Food and Drug Administration has reversed its earlier decision and will now review a new mRNA flu vaccine from Moderna, the pharmaceutical company announced Wednesday, reports BritPanorama.
About two weeks prior, the FDA had sent a letter to Moderna refusing to accept the application for its first mRNA seasonal flu vaccine. This rejection marked a rare move for the federal agency.
According to the letter posted online by Moderna, the FDA stated that the application lacked an “adequate and well-controlled” trial, noting that the control arm did not reflect the “best-available standard of care in the United States at the time of the study.” However, the agency did not identify any safety or efficacy concerns.
In response, Moderna has proposed a revised regulatory approach following meetings with the FDA, suggesting different pathways by age for the approval process. The company is now seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, alongside a requirement to conduct an additional study in older adults after marketing.
If the FDA grants approval, the vaccine could be available for individuals aged 50 and older in time for the 2026-2027 flu season.
Moderna previously indicated that the initial refusal from the FDA was inconsistent with prior feedback received from the agency.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Moderna CEO Stéphane Bancel in a statement. “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.”
The ongoing dialogue around the vaccine underscores the complexities in vaccine approval, especially as the landscape evolves with emerging health threats.
