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.
This designation aims to get new treatments to patients faster by encouraging more frequent communication between the FDA and the drug developer and allowing for a rolling review of the application.
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.
“We are pleased to receive Fast Track Designation from the FDA for ARCT-2304,” said Joseph Payne, President and CEO of Arcturus Therapeutics.
“We remain steadfast in our commitment to the U.S. government to develop safe and effective STARR® next-generation mRNA vaccines to protect U.S. citizens from future pandemic threats. This designation from the FDA is an important step forward in our mission to provide protective solutions for global health crises.”
This experimental technology, dubbed STARR® and powered by Arcturus’ proprietary LUNAR® delivery system, allows the vaccine to be freeze-dried and stored in refrigerators, avoiding the ultra-cold storage problems that plagued early COVID-19 rollouts.
Federal taxpayers are footing the bill — again. ARCT-2304 is being developed under a BARDA contract (No. 75A50122C0007), highlighting yet another example of public-private partnerships where the pharmaceutical industry reaps the profits and the people carry the risk.
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.
During the COVID-19 pandemic, many people reported side effects from mRNA COVID-19 vaccines, such as those from Pfizer-BioNTech and Moderna, leading to widespread complaints.
The mRNA vaccines work by instructing cells to produce a piece of the SARS-CoV-2 virus’s spike protein, triggering an immune response. Approved under emergency use authorizations initially, these vaccines have been administered to billions globally, with full approvals following for certain age groups.
Despite their efficacy, concerns about side effects have been voiced, especially given the rapid rollout and the unprecedented scale of vaccination.
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