https://ir.arcturusr...ack-designation
"SAN DIEGO--(BUSINESS WIRE)--Apr. 10, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicine company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024.
Fast Track Designation from the FDA is granted to vaccines intended to prevent serious conditions caused by infectious disease. The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA and eligibility for priority review, and the possibility of a rolling review.
“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 project has been supported in whole with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C0007.
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It's unclear to me if a person getting this can then shed the mRNA to another host.
According to AI:
Self-amplifying mRNA (saRNA) vaccines do not cause shedding, meaning they do not release the mRNA or any infectious virus particles into the environment that could potentially infect others. The saRNA mechanism involves a viral replicase encoded within the saRNA itself, which amplifies the RNA within the vaccinated individual's cells. This amplification leads to increased antigen production, but the saRNA does not replicate outside of the cells.
Here's why saRNA vaccines don't shed:
No Viral Replication Outside Cells:
The saRNA itself is not infectious and does not replicate outside of the cells in which it is delivered.
No Viral Components Released:
The saRNA contains a viral replicase, but this is not a viral particle and is not released into the environment.
Temporary Expression:
The encoded protein (antigen) is expressed by the cells, stimulating the immune system, but the cells eventually stop producing the protein, and the saRNA degrades.
In essence, the saRNA vaccine works by tricking the body's cells into temporarily producing the protein that triggers an immune response, without causing any shedding or infection.
Edited by zorba990, 17 April 2025 - 10:02 PM.
