WASHINGTON — A panel of advisers to the U.S. Food and Drug Administration (FDA) has recommended approval of Moderna’s mRNA-based influenza vaccine candidate, marking a step toward what could become the first seasonal flu vaccine using the technology in the United States, according to the FDA and news reports on Thursday, June 18, 2026. The FDA’s Vaccines and Related Biological Products Advisory Committee voted that the benefits of the vaccine outweighed the risks for adults aged 50 and older.
The vaccine, known as mFlusiva, is being developed by Moderna and uses messenger RNA technology, the same general platform used in several COVID-19 vaccines. The company is seeking regulatory approval for use among adults 50 and older, according to FDA documents and Moderna’s submission reviewed by the agency.
The advisory committee’s recommendation is not a final approval decision. The FDA said advisory committee votes are considered as part of its review process, but the agency makes the final determination on whether a medical product can be authorized. The FDA’s final decision timeline was expected later in 2026, according to reports on the review process.
During the meeting, FDA staff reviewed data submitted by Moderna, including results from clinical studies assessing immune responses and effectiveness compared with existing influenza vaccines. FDA staff said the available data could support use of the vaccine in older adults, while also noting limitations in the available evidence for some groups, according to regulatory briefing documents.
Moderna said its goal is to provide another option for influenza prevention, particularly as flu viruses change from season to season. The company has previously developed mRNA vaccines using the same platform for other respiratory illnesses. Moderna did not immediately provide additional details beyond its regulatory updates.
Public health officials have said influenza remains a significant seasonal health concern, especially for older adults. Existing flu vaccines are already available and recommended for different age groups, including enhanced vaccines for some older populations, according to health authorities.
The FDA panel also reviewed safety information. Reports from the meeting said common vaccine reactions were observed, while no major safety concerns were identified in the reviewed data. The FDA and Moderna will continue evaluating information submitted as part of the application process.
As of Sunday, June 21, 2026, Moderna’s vaccine candidate remained under FDA review. The agency had not announced a final approval decision, and further regulatory steps were pending, according to FDA review information and company statements.
