The U.S. biotechnology company announced on Wednesday that the U.S. government has agreed to review its seasonal flu vaccine, mRNA-1010, following a meeting to amend the application after an initial rejection. The current season of the disease in the country, which runs until April, has caused at least 11,000 flu-associated deaths, according to the Centers for Disease Control and Prevention (CDC). Moderna specified in a press release that it is seeking full approval for adults aged 50 to 64 and accelerated approval for those over 65, with an additional post-marketing study in the elderly. If approved by the U.S. Food and Drug Administration (FDA), the vaccine would be available for adults aged 50 and older in the 2026/2027 flu season. The company recalled that mRNA-1010 is also under review in Europe, Canada, and Australia, with new applications planned for 2026. Stéphane Bancel, CEO of Moderna, said in a statement that he appreciates the FDA's participation in a 'constructive' meeting and their agreement to advance our application for review. 'Subject to FDA approval, we expect to make our flu vaccine available later this year for older adults in the U.S. to have a new option to protect themselves from the flu,' he added. After submitting the amended application, the FDA accepted the biologics license application for review and set the next meeting for August 5. According to the CDC, influenza in the country remains elevated during the 2025-2026 season, with an estimated 20 million cases, approximately 270,000 hospitalizations, and around 11,000 flu-associated deaths. After three weeks of decline, cases have started to rise again, and influenza type B is beginning to circulate more widely alongside type A, while medical visits for flu-like symptoms remain above usual levels for this time of year. Messenger RNA (mRNA) technology, used by Moderna and utilized in several COVID-19 vaccines, works through a temporary genetic molecule that instructs cells to produce a specific protein, such as a harmless part of the virus. mRNA does not modify DNA and naturally degrades after it has fulfilled its function.
