FDA Grants Fast-Track Designation for Possible mRNA Bird Flu Vaccine, Company Says

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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. 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. 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 said. 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. The Epoch Times contacted the FDA for comment on Monday.

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