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America's Blood Centers
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      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
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September 20, 2024

FDA Communication Regarding Oropouche Virus and Blood Donation

By America's Blood Centers

In the wake of the Centers for Disease Control and Prevention (CDC) health advisory warning of an increase in Oropouche virus (OROV) disease in the Americas region, the U.S. Food and Drug Administration (FDA) issued a communication for blood establishments on September 13th regarding Oropouche virus and blood donation. In the FDA communication regarding Oropouche virus and blood donation, the agency provided background information on OROV and noted that, โ€œ[w]orldwide, there have been no reports of transmission of OROV by transfusion of blood or blood components.โ€

The FDA communication regarding Oropouche virus and blood donation also provided considerations for blood establishments in the communication explaining that, โ€œ[r]outine measures used to screen every blood donor effectively prevent individuals with symptomatic infections from donating blood. For example, blood donors must be in good health and must have a normal temperature on the day of donation (21 CFR 630.10). These safeguards likely identify individuals who present to donate who may have symptoms of OROV disease or have been diagnosed with OROV disease. In addition, blood establishments typically instruct blood donors to report illnesses or symptoms that develop shortly after blood donation so that the blood establishment can assess if their donation is suitable for transfusion.โ€

The agency added in the FDA communication regarding Oropouche virus and blood donation that, โ€œ[t]aking into consideration the existing safeguards for blood safety, the current small number of OROV disease cases among U.S. travelers, and no reports of OROV transmission by blood and blood components, screening donors by asking them specific questions about exposure to OROV or travel to areas with OROV outbreaks is not warranted at this time.ย  A screening test for OROV is not available. The blood establishment responsible physician must determine donor eligibility and may wish to consider a short deferral (e.g., 4 weeks) if a donor volunteers that they were recently diagnosed with or have recovered from OROV disease.โ€ย 

OROV is transmitted, โ€œby biting insects (midges) and certain mosquito species. Approximately 60 percent of individuals infected with OROV will experience symptoms, including fever, severe headache, chills, muscle aches, and joint pains. Other individuals infected with OROV do not experience symptoms.โ€

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