The American biotechnology company Moderna announced this Wednesday that the United States Government agreed to review its seasonal flu vaccine, mRNA-1010, after a meeting to amend the application after an initial rejection.
The country’s current flu season, which runs through April, has caused at least 11,000 flu-associated deaths, according to the Centers for Disease Control and Prevention (CDC).
Moderna said in a statement that it is seeking full approval for adults ages 50 to 64 and accelerated approval for those ages 65 and older, with an additional post-marketing study in older people.
If approved by the Food and Drug Administration (FDA), the vaccine would be available to adults 50 years of age 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 presentations planned during 2026.
Stéphane Bancel, Moderna’s chief executive, said in a statement that he appreciates the FDA’s participation in a “constructive” meeting and its agreement to advance our application for review.
“Subject to FDA approval, we hope to make our flu vaccine available later this year so that older Americans have access to a new option to protect themselves against the flu,” he added.
After submitting the amended application, the FDA accepted the biological license application for review and assigned August 5.
According to the CDC, influenza in the country remains high during the 2025-2026 season, with at least 20 million estimated cases, approximately 270,000 hospitalizations and about 11,000 flu-associated deaths.
After three weeks of decline, cases have increased again and influenza type B is beginning to circulate more widely along with type A, while doctor visits for flu symptoms remain above usual levels for this time of year.
Messenger RNA (mRNA) technology, used by Moderna and used in several COVID-19 vaccines, works by using a temporary genetic molecule that instructs cells to produce a specific protein, like a harmless part of the virus. This allows the immune system to generate defenses without exposing the body to the full virus. mRNA does not modify DNA and is naturally degraded after fulfilling its function.
