The Food and Drug Administration (FDA) recently granted a Fast Track Designation for an mRNA vaccine targeting bird flu.
The vaccine, developed by Arcturus Therapeutics, is in Phase 1 trials and is supported by the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority (BARDA).
“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,” a news release from the company says, explaining that the designation is intended 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.”
Joseph Payne, President and CEO of Arcturus Therapeutics, said in a statement that the company is “pleased” to have received the Fast Track Designation.
“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,” Payne said. “This designation from the FDA is an important step forward in our mission to provide protective solutions for global health crises.”
According to the company, the STARR technology enables “lower doses than conventional mRNA vaccines.”
Several states, including Idaho and Montana, have introduced legislation banning mRNA technology. A proposed Idaho Senate bill would pause the administration of mRNA vaccines for ten years, while Montana’s bill would also ban the distribution of mRNA vaccines.
