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March 17, 2025

Blood Community Malaria Comments on FDA Guidance

By America's Blood Centers

The blood community has responded with malaria comments regarding the U.S. Food and Drug Administration’s guidance on transfusion-transmitted risk. America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross (ARC) have submitted joint comments to the U.S. Food and Drug Administration in response to the agency’s Malaria Draft Guidance.

In the March 13th blood community malaria comments, the organizations made the following requests:

  • β€œan option to continue the present transfusion-transmitted malaria (TTM) risk reduction questioning without testing as reasonable given little to no expected reduction of the already exceedingly low residual risk under the proposed testing schema and already low numbers of ethnically diverse donor deferrals in many blood centers. [Additionally, ABC, AABB, and ARC asked FDA to] perform real world modeling studies to determine the sensitivity of available tests, including studies performed in malaria-endemic locations and including data on semi-immune donor populations, and ensure any testing burden, including costs, is justified by a commensurate increase in safety;
  • reinstatement of the definition β€˜malaria-endemic area’ along with a three-month travel deferral with no testing;
  • a universal testing option [as difficulties] associated with the complexity of donor history questionnaire (DHQ) algorithms, donor recall, and response interpretation, sample tube management, and test ordering may make universal testing operationally more feasible for some centers should substantial testing volume be mandated [with] collectors implementing universal testing not be[ing] required to ask any malaria risk questions;
  • clarify the details on how information on malaria symptoms should be elicited from the donor;
  • maintain as-proposed testing of donors reporting a history of malaria at every presentation but continue to allow a three-month deferral without testing after travel to malarial areas for donors never residing in an endemic country (i.e., those not at risk for partial immunity);
  • [a] limited period of every presentation testing of prior residents [since it] can identify whether intermittent hepatic reservoir parasitemia occurs in prior residents of endemic countries. This additional testing should be offset by removing the requirement to test travelers never residing in an endemic country, a large donor group from which only one TTM case has ever been reported;
  • [s]hould FDA feel one-time testing is sufficient for residents of malaria-endemic countries, the [a]gency should clarify how a second period of residence in a malaria-endemic country triggering subsequent testing should be elicited from the donor. FDA should also address the logical inconsistency of only considering endemic area travel within the past 12 months as a reinfection risk in populations likely to be partially immune;
  • that FDA better describe the number of cases required and geographical rules to be employed (how donors’ home/work/travel zones impact the size of affected collection zones);
  • that, when a donation tests reactive for malaria, and the testing was triggered due to travel or a local outbreak, that FDA shorten the lookback period to no longer than the time between the date on which the travel or local outbreak commenced, and the donation occurred; [and]
  • [an] extended implementation period [as after the] final guidance [is published], many centers will require a long horizon (β‰₯12 months) for implementation. FDA should commit to β‰₯12 months, currently listed as only one potential choice in the Guidance.”

America’s Blood Centers (ABC) previously submitted malaria testing recommendations in comments to the FDA Blood Products Advisory Committee (BPAC) in May 2024 that, β€œstrongly recommended” that the agency delay publishing draft guidance until modeling studies are finished and additional malaria testing assays are approved and available. We will continue to provide updates as they become available.

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Posted in ABC Newsletter
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