FDA Chief Informs Senate About Agency’s Readiness for Avian Influenza Mutation

The Food and Drug Administration (FDA) informed legislators on Wednesday that the agency is taking precautionary measures in case the current avian flu is able to mutate and transmit to humans on a large scale.

Bird flu, known as H5N1, is often fatal in poultry and can spread to other bird and animal species. The recent outbreak has affected dairy cows, raising concerns about potential widespread contamination. The mortality rate for cattle is below 1%.

FDA Commissioner Robert Califf informed the Senate Appropriations Committee that although the risk to the public is low, early intervention is crucial: “If we implement countermeasures now and limit the spread of the virus … we are less likely to see a mutation that can transfer to humans, for which we are unprepared.”

The FDA discovered that approximately 20% of raw, unpasteurized milk from bulk tanks tested positive for virus samples. The agency emphasized that pasteurized milk, which is the majority of milk consumed in the United States, showed “no evidence of live virus.”

“So we need testing, antivirals, and a vaccine ready to be deployed. We have been diligently preparing in case the virus mutates and crosses over to humans on a larger scale,” Califf stated to the senators.

Serving Committee member Sen. John Hoeven, R-N.D., noted that there has already been a human infection, a dairy farm worker in Texas. Texas Health and Human Services reported that the patient developed conjunctivitis.

During the hearing, Califf presented the FDA’s budget for 2025, amounting to $7.2 billion, which is a $341 million increase from the 2024 budget. He also discussed the FDA’s “largest reorganization” in history with a heightened focus on food safety.

“We are currently in a favorable position compared to any other point in history,” Califf stated. “Viruses are relatively simple, so developing a corresponding vaccine is entirely feasible within a short timeframe.”