The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
The FDA will review Moderna’s mRNA-based influenza vaccine prior to the start of the 2026-2027 flu season after all. The company announced Wednesday that the two parties have reached an agreement on an amended filing for the candidate, after the FDA originally refused to consider the candidate last week.
Following receipt of a Refusal-to-File (RTF) letter—which Moderna revealed on February 10—the company quickly met with the FDA in a Type A meeting. This resulted in the agency accepting Moderna’s proposal of a regulatory pathway based on age, in which it will file for full approval of mRNA-1010 for adults 50 to 64 years, and accelerated approval for those 65 and older.
In the RTF—which Moderna took the unusual step of publishing with redactions on its website—the FDA claimed that Moderna failed to support mRNA-1010’s application with an “adequate and well-controlled” trial. The main point of contention, however, had to do with older adults. The agency had recommended in 2024 that Moderna use a comparator high-dose vaccine preferentially recommended for older adults by the CDC’s Advisory Committee on Immunization Practices. Moderna submitted data on a high-dose vaccine tested in adults aged 65 and older at the FDA’s request in August 2025.
“Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists,” Department of Health and Human Services spokesperson Andrew Nixon said during a press call last Wednesday, according to Scientific American. “The most protective flu shots for seniors are a subset of high-dose flu shots recommended by the [ACIP], which would have served as the proper control in this study.”
The FDA has now accepted Moderna’s amended biologics license application (BLA) for review, with a target action date of August 5.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement on Wednesday.
Moderna’s shares rose more than 8.5% to $47.67 as the market opened on Wednesday morning.
Back On Track
The rapid turnaround comes amid a particularly challenging flu season in the U.S. due to a mismatch in circulating strains as compared to the existing shots.
Moderna believes its mRNA technology—which uses a faster production process than traditional vaccines—could solve this dilemma. “We do think this year in particular, where there’s a potential for a mismatch in one of the strains, it’s particularly important that technologies like Moderna’s mRNA platform are used to advance new and potentially improved products,” Stephen Hoge, the company’s president and R&D chief, said during a fourth-quarter earnings call on Friday.
The RTF had thrown Moderna’s quest to reach breakeven status by 2028 into question, with William Blair saying in a February 11 note that following the news, they were reworking their models of Moderna’s future potential earnings on the fly. mRNA-1010 is expected to contribute billions in revenue, along with the company’s combo flu/COVID vaccine mRNA-1083. Moderna had been waiting for the regulatory process for mRNA-1010 to advance before moving an application forward for the combo vaccine.
Now, order may be restored. On Wednesday, Jefferies noted that by 2027-28, Moderna could launch seven or more products in the respiratory, oncology and rare disease spaces.
“Continued cost reductions could allow MRNA to achieve cash breakeven guidance by 2028,” the analysts wrote.
The 8-day resolution to the mRNA-1010 imbroglio is reminiscent of the turnaround that essentially ended the FDA’s back-and-forth with Sarepta Therapeutics last summer.
After requesting that Sarepta discontinue shipments of its Duchenne muscular dystrophy gene therapy Elevidys on July 21, the regulator reversed course just over a week later, recommending that the voluntary hold be lifted for ambulatory patients. Like Moderna’s RTF for mRNA-1010, 2025’s Sarepta saga played out prolifically in the media.
