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  1. Safety & Availability (Biologics)

Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak

March 11, 2020

FDA is working closely with CDC and other federal and international agencies to monitor the evolving outbreak of the 2019 novel coronavirus that was first identified in Wuhan, Hubei Province, China. The virus has been named “SARS-CoV-2” and the disease it causes has been named coronavirus disease 2019 (abbreviated COVID-19). The potential for transmission of SARS-CoV-2 by blood and blood components is unknown at this time. However, respiratory viruses, in general, are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus.

Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood. For example, blood donors must be in good health and have a normal temperature on the day of donation (21 CFR 630.10).

As communities are affected, it is imperative that healthy individuals continue to donate blood.

Considerations

  • FDA supports the recommendations of AABB’s Interorganizational Task Force, encouraging healthy individuals to make plans to donate blood to maintain the adequacy of the nation’s blood supply.
  • Blood centers should prepare and evaluate their emergency plans to address possible challenges, such as effects on the availability of blood donors and staff.
  • At this time, FDA does not recommend using laboratory tests to screen asymptomatic blood donors. Based on available information, detection of SARS-CoV-2 in blood samples has only been seen in severely ill patients, not in asymptomatic individuals.
  • FDA is aware that some blood establishments are considering donor education and/or donor deferral measures in response to COVID-19. FDA recognizes that deferral solely for travel to areas with cases of COVID-19 may not be feasible.
  • Blood establishments may wish to consider donor educational materials to instruct individuals to self-defer and refrain from blood donation if they have:
    • cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19;
    • been diagnosed with or suspected of having COVID-19.
  • The blood establishment’s responsible physician must evaluate the prospective donor and determine eligibility (21 CFR 630.5). Based on the limited information available at this time, we suggest individuals refrain from donating blood at least 28 days after resolution of symptoms after a diagnosis of COVID-19 or 28 days after the last possible close contact exposure to a person with COVID-19.
  • Blood establishments may wish to consider updating post-donation instructions provided to all donors of blood and blood components to ask donors to report a subsequent diagnosis of COVID-19 as soon as possible to the blood establishment. Blood establishments may wish to consider retrieval and quarantine of blood and blood components collected in the 28 days prior to or after COVID-19 symptom onset; or collected in the 28 days prior to or after possible exposure to patients with COVID-19.
  • FDA will continue to monitor the situation and issue updated information as it becomes available.

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