The Food and Drug Administration has reversed course and will review the application for Moderna’s mRNA-based influenza vaccine. Previously, the vaccine manufacturer said the agency declined to review its application for an “investigational influenza vaccine.” Moderna Says FDA Declined To Review Application For “Investigational” Vaccine "To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults," Moderna stated in a release. "Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season," it continued. "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. "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," he continued. Today we announced that, in response to a prior Refusal-to-File letter, we engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for our investigational seasonal influenza vaccine candidate, mRNA-1010. Read more:… pic.twitter.com/ME92rJkNJq — Moderna (@moderna_tx) February 18, 2026 BioSpace has more: 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. "mRNA-1010 has now been accepted for review in the United States, Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews," Moderna stated in the release. NPR shared further: Health and Human Services Department spokesman Andrew Nixon said in an emailed statement to NPR last week that "the FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy." On Wednesday, Nixon said in an email to NPR that the FDA had a meeting with Moderna, leading the company to amend its application for the experimental shot, which the FDA accepted. "FDA will maintain its high standards during review and potential licensure stages as it does with all products," he said. Moderna says it agreed to add a confirmatory study in older adults that will use a high-dose flu shot after the mRNA vaccine is on the market, the company confirmed to NPR.