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 people in the United States 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, 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 Centers for Disease Control and Prevention (CDC) and state health officials, 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.
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.
“While the current public health risk is low, CDC is watching the situation carefully and working with states to monitor people with animal exposures,” the agency stated.
Despite the low risk, bird flu has led to the culling of tens of millions of egg-laying hens in the United States. Officials have said outbreaks at U.S. poultry farms and the resulting culling of birds is a primary driver of
record-high egg prices in recent months.
More than 166 million birds have been slaughtered to contain the virus. More than 30 million egg layers have been wiped out just since January, significantly disrupting egg supplies. The Department of Agriculture’s longstanding policy has been to kill entire flocks anytime the virus is found on a farm.
Last week, Cal-Maine Foods
acknowledged that it is being investigated by the antitrust division of the Department of Justice, which is looking into egg price increases. Cal-Maine said it is cooperating with the investigation.
The Epoch Times contacted the FDA for comment on April 14.
The Associated Press contributed to this report.
