Reversing Course, FDA Will Now Review Moderna's Influenza Vaccine

After refusing to review Moderna’s investigational influenza vaccine, mRNA-1010, the company announced today that the US Food and Drug Administration (FDA) will initiate a formal review of its biologics license application following a constructive Type A meeting with regulators. The FDA’s Center for Biologics Evaluation and Research has now accepted the amended submission and assigned a Prescription Drug User Fee Act goal date of August 5, 2026.

The review marks a significant turnaround after the FDA previously issued a refusal-to-file letter, citing the need for additional clarification on the regulatory approach. In response, Moderna proposed a revised pathway that differentiates approval by age group. Under the amended strategy, the company is seeking full approval for adults aged 50 to 64 years and accelerated approval for adults 65 years or older, coupled with a postmarketing commitment to conduct an additional study in older adults.

If approved, mRNA-1010 could become available to US adults 50 years or older in time for the 2026-2027 influenza season. The vaccine is designed to target seasonal influenza using Moderna’s messenger RNA (mRNA) platform, which gained global prominence during the COVID-19 pandemic and is now being applied across respiratory and combination vaccines.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Moderna’s CEO, said in a statement. He added that, pending approval, the company looks forward to providing seniors with “a new option to protect themselves against flu.”

Beyond the United States, mRNA-1010 is already under regulatory review in Europe, Canada, and Australia, with additional submissions planned throughout 2026. Moderna expects the first potential approvals to occur later this year, subject to the outcome of ongoing evaluations in multiple regions.

The FDA’s back-and-forth decision to proceed with review underscores heightened scrutiny for vaccines. For the company, the upcoming months will be pivotal as it seeks to establish its mRNA influenza vaccine in a competitive market.

Reference
Moderna announces the U.S. Food and Drug Administration will initiate the review of its investigational seasonal influenza vaccine submission. Press release. Moderna. February 18, 2026. Accessed February 18, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=8923338804483797&symbol=MRNA