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FDA urges screening blood donations for Zika

30 August 2025

FDA first issued guidance on February 16 recommending that only areas with active Zika virus transmission screen donated blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain blood and blood components from areas of the United States without active virus transmission. "But in the absence of active transmission in the state, we have four weeks to start that and gives us time to do this in a much more thoughtful way that prevents errors", he said.

The FDA has authorized use of two experimental blood screening tests for Zika, one made by Roche and another from Hologic Inc. and Grifols. The FDA issues such Emergency Use Authorization during public health emergencies. Rep. Doggett wrote to FDA Commissioner Dr. Robert Califf and the letter said, "If we wait for the first confirmed locally transmitted Zika case to begin testing, we risk serious harm to the stability of our blood supply", according to The Hill. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus.

Studies show the Zika virus, borne typically by mosquitoes and occasionally through sexual intercourse, can be very risky to pregnant women.

She was initially tested and admitted to hospital after suffering symptoms of joint pain and red eyes.

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The mosquito-borne Zika virus has triggered an epidemic of birth defects that leave newborns with abnormally small heads and underdeveloped brains. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the USA blood supply.”.

Some 9,000 additional cases have been reported in United States territories, including Puerto Rico.

Per recent reports from the Center for Disease Control and Prevention (CDC), 471 new confirmed cases were reported from Florida, 601 from NY, 152 from California, 125 from Texas and 91 from New Jersey. For the rest of the US, the FDA plans to enforce the guidelines within 12 weeks of the announcement. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA urges screening blood donations for Zika