The FDA has approved Moderna's mRNA-based influenza vaccine, marking a significant milestone for mRNA technology in seasonal flu prevention.

The decision comes after the agency initially declined to review the application, a rare move that sparked criticism from public health experts and lawmakers. Following sustained public pressure and congressional scrutiny, regulators reversed course and conducted a full evaluation.

The vaccine, known as mRNA-1010, targets four influenza strains recommended by the World Health Organization for the 2024-2025 season. Clinical trial data showed immune responses comparable to licensed quadrivalent flu vaccines, with a favorable safety profile.

Moderna plans to make the vaccine available for the upcoming flu season. The approval could accelerate development of combination vaccines targeting flu and COVID-19, and may improve manufacturing speed compared to traditional egg-based production methods.