REGULATORY UPDATE: FDA Provides Important Information for HCT/P Establishments Concerning Oropouche Virus and Donor Eligibility Determinations

Screening donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with questions about exposure to Oropouche virus (OROV) or travel to areas with OROV outbreaks is not warranted at this time, the Food and Drug Administration said in a Nov. 1 safety and availability communication. 

In its communication, FDA cited the robustness of existing donor screening measures, the current low number of OROV disease cases among U.S. travelers and the absence of reports of OROV transmission through HCT/Ps. 

However, based on information about the OROV incubation period and detection in serum and semen, the agency noted that establishments may wish to consider whether, in the six weeks prior to HCT/P recovery, the donor has been diagnosed with or suspected of having OROV, or if they have developed an abrupt onset of symptoms such as fever, severe headache, chills, myalgias, arthralgias, rash or other indicators associated with OROV.

AABB has developed a toolkit, Oropouche Virus Information and Resources, that contains currently available information for both blood collection establishments and HCT/P facilities. 

AABB also encourages members to review AABB’s OROV fact sheet for additional information about OROV transmission, presentation and prevention. 

About Oropouche Virus

Oropouche virus is endemic to the Amazon basin and has spread to new areas in South America, Central America and the Caribbean, where it is transmitted by biting insects and certain mosquito species. Currently, there are no vaccines or treatments available for OROV. The Centers for Disease Control and Prevention recently reported cases of OROV infection in Americans who have returned from areas experiencing outbreaks, including Cuba.

AABB reminds members that there have been no alleged or suspected cases of transfusion- or HCT/P-related OROV to date. According to CDC, approximately 60% of people infected with OROV become symptomatic after an incubation period of 3-10 days. For the purpose of making a donor eligibility determination, FDA has affirmed that routine screening measures are in place to prevent individuals with risk factors or clinical evidence of certain infections from donating HCT/Ps.