The company making the shot, Arcturus Therapeutics, confirmed the development.
The Food and Drug Administration (FDA) moved last week to fast-track an mRNA vaccine candidate for a type of avian influenza, or bird flu, that has sickened more than 70 Americans this year, according to the company that developed the vaccine.
Arcturus Therapeutics said in an April 10 statement that the vaccine, ARCT-2304, is now in its Phase 1 trials.
“We are pleased to receive fast-track designation from the FDA for ARCT-2304,” Joseph Payne, the CEO of Arcturus Therapeutics, said in the statement. “We remain steadfast in our commitment to the US government to develop safe and effective … next-generation mRNA vaccines to protect US 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.”
According to the health agency, a fast-track designation means that the FDA will expedite the review process on drugs or vaccines to treat serious conditions or to fill unmet medical needs. The Pfizer and Moderna COVID-19 vaccines, which use mRNA technology, both received fast-track designations from the agency.
The Arcturus Therapeutics vaccine, which uses “self-amplifying mRNA” technology, is “designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine,” the company said in its statement.
It added that the shot could be used to “address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk.”
The vaccine project has been backed in its entirety by federal funds issued by the Department of Health and Human Services, it said.
According to the CDC, 70 people have contracted H5N1 avian influenza in the United States since March 2024, leading to one death, an elderly person with preexisting medical issues in Louisiana in December 2024, officials said.
Meanwhile, the current risk to the public from that strain of bird flu is low as of an update issued on April 11 by the CDC. There is also no confirmed person-to-person transmission of the virus.
