In a surprising twist that has left many scratching their heads, the FDA recently sent Moderna packing with a refuse-to-file letter for its mRNA-1010 influenza vaccine application. Yes, you read that right. They took one look at the Phase 3 trial and said, “Nope.” The letter, dated February 3, cited the trial as not being adequate or well-controlled. Oddly enough, there were no safety, immunogenicity, or efficacy concerns. It’s like the FDA had a change of heart midway through a romance novel.
Moderna’s trial involved a whopping 40,000 participants, mainly adults over 50. The mRNA-1010 managed to reduce flu-like illness risk by 27% compared to the standard-dose seasonal flu vaccine. However, the FDA’s concerns focused on the chosen comparator in the trial, which did not reflect the best-available standard of care in the U.S. So, that’s a hard no from them. This shift in the FDA’s regulatory approach may alter future clinical trial strategies for mRNA vaccines.
Moderna wasn’t just going to take this lying down. They fired back, arguing that the FDA’s guidance didn’t specify that they had to use the best comparator. CEO Stéphane Bancel even threw a little shade by saying this decision doesn’t help advance innovative medicines. They went so far as to publish the redacted RTF letter—definitely not the norm.
Now they’re clamoring for an urgent meeting with the FDA.
This decision comes at a time when mRNA vaccines are under heightened scrutiny—thanks, Biden-era FDA leadership. It contradicts earlier feedback that accepted the standard-dose comparator. Talk about a mixed message!
Meanwhile, Moderna’s shares took a nosedive. Financial goals are now shaky, and the future of their combination flu shot hangs in the balance. They’re still looking for international approvals, aiming for late 2026 or early 2027.
But right now? It’s looking a bit bleak.
