The Trump administration has granted Fast Track designation to a groundbreaking — and controversial — self-amplifying mRNA (sa-mRNA) vaccine candidate targeting the H5N1 avian influenza virus.
The vaccine, ARCT-2304, developed by Arcturus Therapeutics, is now in Phase 1 trials and has been positioned by federal health authorities as a front-line defense against a potential bird flu pandemic.
The designation, announced April 10, was awarded by the U.S. Food and Drug Administration (FDA) in partnership with the Department of Health and Human Services and its Biomedical Advanced Research and Development Authority (BARDA).
The Fast Track designation from the FDA expedites the review of drugs intended for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
Unlike traditional vaccines, the ARCT-2304 candidate uses a self-replicating mRNA platform, meaning the genetic material continues reproducing inside the recipient’s cells to boost production of flu-fighting proteins. Arcturus claims this results in a stronger immune response with smaller doses.
BARDA, the same agency involved in Operation Warp Speed under the previous Trump term, has been given sweeping authority to fund and fast-track pandemic-related vaccines and therapeutics.
Concerns about side effects have been voiced, especially given the rapid rollout and the unprecedented scale of vaccination.
www.thegatewaypundit.com
The vaccine, ARCT-2304, developed by Arcturus Therapeutics, is now in Phase 1 trials and has been positioned by federal health authorities as a front-line defense against a potential bird flu pandemic.
The designation, announced April 10, was awarded by the U.S. Food and Drug Administration (FDA) in partnership with the Department of Health and Human Services and its Biomedical Advanced Research and Development Authority (BARDA).
The Fast Track designation from the FDA expedites the review of drugs intended for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
Unlike traditional vaccines, the ARCT-2304 candidate uses a self-replicating mRNA platform, meaning the genetic material continues reproducing inside the recipient’s cells to boost production of flu-fighting proteins. Arcturus claims this results in a stronger immune response with smaller doses.
BARDA, the same agency involved in Operation Warp Speed under the previous Trump term, has been given sweeping authority to fund and fast-track pandemic-related vaccines and therapeutics.
Concerns about side effects have been voiced, especially given the rapid rollout and the unprecedented scale of vaccination.

Trump Administration Fast-Tracks Controversial Self-Amplifying mRNA Vaccine for H5N1 Bird Flu | The Gateway Pundit | by Jim Hᴏft
The Trump administration's Fast Track designation for an innovative self-amplifying mRNA vaccine against H5N1 raises critical questions about public health strategies and the balance of risk and reward in pandemic preparedness.
