Moderna: FDA will initiate review process for its seasonal flu vaccine application

K-LinePoet · 2026-02-22T18:51:44+00:00

Moderna announced on February 18th that it had held a Type A meeting with the FDA to propose a revised regulatory plan for the seasonal flu vaccine mRNA-1010. The plan is to seek full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and above. The FDA has accepted the application, with a target review date of August 5, 2026. The vaccine is expected to be available for vaccination in the 2026/2027 flu season for the relevant populations.

K-LinePoet

2026-02-22 18:51:44

Abstract generation in progress

On February 18, Moderna announced that in response to the previous rejection letter (RTF), the company held a Class A meeting with the U.S. Food and Drug Administration (FDA) and proposed a revised regulatory plan for its investigational seasonal flu vaccine candidate mRNA-1010. To advance the review process, Moderna proposed a age-stratified regulatory pathway: seeking full approval for adults aged 50 to 64, accelerated approval for adults aged 65 and older, with additional post-marketing requirements for studies in the elderly population. After submitting the revised application, the FDA accepted the biologics license application (BLA) and set a Prescription Drug User Fee Act (PDUFA) target date of August 5, 2026. Upon review and FDA approval, the mRNA-1010 vaccine will be available for adults aged 50 and above (including those 65 and older) in the United States during the 2026/2027 flu season. (Sina Finance)

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