FDA Awards Fast-Track Designation for Potential mRNA Vaccine Against Bird Flu, Company Reports

April 14, 2025 TruthUSA

The organization responsible for the vaccine, Arcturus Therapeutics, has officially acknowledged the advancement.

Last week, the Food and Drug Administration (FDA) initiated the fast-tracking of an mRNA vaccine candidate aimed at a strain of avian influenza, commonly known as bird flu, that has affected over 70 Americans this year, as reported by the vaccine’s developer.

On April 10, Arcturus Therapeutics announced that their vaccine, ARCT-2304, has now entered Phase 1 trials.

“We are thrilled to have received fast-track designation from the FDA for ARCT-2304,” stated Joseph Payne, CEO of Arcturus Therapeutics, in the announcement. “We are committed to working with the US government to create safe and effective next-generation mRNA vaccines that will safeguard US citizens against future pandemic threats. This fast-track designation from the FDA marks a significant achievement in our efforts to offer protective solutions during global health emergencies.”

The health agency noted that fast-track designation allows the FDA to accelerate the review process for drugs or vaccines targeting serious conditions or addressing unmet medical needs. Both the Pfizer and Moderna COVID-19 vaccines, which utilize mRNA technology, have previously obtained fast-track designations from the FDA.

The vaccine developed by Arcturus Therapeutics employs “self-amplifying mRNA” technology, which is “intended for active immunization to protect against disease caused by the influenza A H5N1 subtype included in the vaccine,” the company elaborated in its statement.

They also mentioned that the vaccine could help “meet the unmet medical needs for the prevention of illnesses caused by the pandemic influenza A virus H5N1, posing a significant global health threat.”

The vaccine initiative has been fully funded by federal allocations from the Department of Health and Human Services, as stated by the company.

According to the CDC, 70 cases of H5N1 avian influenza have been reported in the United States since March 2024, resulting in one death, which involved an elderly individual with underlying health conditions in Louisiana in December 2024, officials reported.

Currently, the CDC has updated that the public’s risk from this bird flu strain remains low as of April 11. Additionally, there have been no confirmed instances of person-to-person transmission of the virus.

“While the present public health risk is low, the CDC is closely monitoring the situation and collaborating with states to track individuals with animal exposures,” the agency noted.

Despite the low risk, avian influenza has necessitated the culling of millions of egg-laying hens across the United States. Officials attribute the ongoing outbreak and subsequent culling of birds as a primary factor contributing to record-high egg prices in recent months.

In total, over 166 million birds have been killed to control the virus, with more than 30 million egg layers lost since January, severely impacting egg supplies. The Department of Agriculture has long upheld a policy of culling entire flocks whenever the virus is detected on a farm.

Recently, Cal-Maine Foods acknowledged that it is under investigation by the antitrust division of the Department of Justice regarding the increase in egg prices. Cal-Maine has stated it is cooperating fully with the investigation.

The Epoch Times reached out to the FDA for comment on Monday.

This report includes contributions from the Associated Press.

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