The U.S. FDA has granted Fast Track Designation to ARCT-2304 (LUNAR-H5N1), a self-amplifying mRNA (sa-mRNA) vaccine developed by Arcturus Therapeutics to combat pandemic influenza A (H5N1). The vaccine is part of the company’s STARR mRNA platform, designed to enable rapid and scalable immunization in response to pandemic threats.
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| Photo by Ben Moreland on Unsplash |
Fast Track status allows for expedited development through increased FDA interaction, rolling submissions, and possible priority review.
The vaccine entered Phase 1 clinical trials in November 2024, enrolling 200 healthy adults aged 18–80 across various U.S. locations. The study examines different dosing schedules and evaluates immune response using standard assays. Interim results are expected in late 2025.
Key features of ARCT-2304 include:
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Self-amplifying mRNA technology requiring smaller doses.
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Lyophilized and refrigerator-stable formulation, easing storage and distribution.
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Enhanced immune response and durability compared to conventional vaccines.
The CDC currently has no approved H5N1 vaccine for public use but has prepared candidate vaccine viruses (CVVs) for rapid production if necessary.
This development aligns with U.S. pandemic preparedness efforts and addresses the lack of vaccines against avian influenza strains like H5N1.
