Pipeline News for Malaria from the Blood Banking Industry and How it Could Impact the Tissue Banking Industry
Thanks for joining! Today we’re going to briefly review the Food and Drug Administration’s (FDA) guidance, “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria” which is currently in its comment period and has yet to be implemented. This guidance updates information for blood establishments regarding risk and will supersede the same titled guidance document “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria, Guidance for Industry,” dated December 2022), once implemented. The scope of this guidance applies to whole blood and blood components except source plasma where source plasma undergoes additional inactivation of pathogens and malaria has not been found to be transmitted from licensed plasma derivatives. How will this impact the tissue industry (Human Cells, Tissues, and Cellular and Tissue-Based Products – HCTPs)? Let’s take a closer look!
Malaria is a life-threatening disease spread to humans by some types of mosquitoes. It’s typically found in tropical countries and is preventable and curable. It mostly spreads to people through infected female Anopheles mosquitoes of the Plasmodium parasite (i.e., P. falciparum, P. vivax, P. malariae, P. ovale, and P. knowlesi). Blood transfusion and contaminated needles may also transmit malaria [1] .
Although most cases of malaria transmission are mosquito-borne, malaria can be transmitted through transfusion of blood, and blood components, or less commonly through organ transplantation, or congenital transmission from a mother to fetus. Transfusion-transmitted malaria (TTM) occurs when the recipient receives a donor’s red blood cells that are parasite-infected. Blood donors who are asymptomatic with dormant liver-stage or chronic, asymptomatic blood-stage parasitic infection may not show any signs because the disease doesn’t cause any pain, as it persists for years.
Previously, there was an absence of licensed, approved, or cleared donor screening tests for malaria, so time-limited deferrals were recommended for screening criteria (either 3-month or 3-year deferral period based on different risk factors). Malaria is considered to be a relevant transfusion-transmitted infection (RTTI), and one of the challenges in donation is the genetic diversity pool of donors available, which was impacted based on the stringent screening criteria.The first FDA licensed nucleic acid donor screening test (NAT) became available in March 2024. FDA’s proposal is that testing for malaria is necessary and that selective testing is an acceptable alternative testing procedure as it identifies donations at greatest risk of transmitting malaria and reduces the TTM while improving availability of genetic diversity of the blood supply. In addition, if using an FDA-approved pathogen reduction device (against Plasmodium falciparum), FDA is not requiring deferral of donors for a history of malaria, prior residence in a malaria endemic country, and/or travel to a malaria-endemic country including regions of the U.S. with local mosquito-borne malaria transmission if testing or pathogen reduction is performed.
FDA has determined as an alternative to testing each donation, blood establishments may implement one of the following procedures:
A selective testing strategy to 1) test donations from donors who have had malaria or resided in or traveled to a malaria-endemic country, and 2) test donations collected in regions of the U.S. that FDA identifies as having local, mosquito-borne malaria transmission; or
Implementation of pathogen reduction technology for platelets and plasma donations using an FDA-approved pathogen reduction device indicated for use against P. falciparum, according to the manufacturer’s instructions for use, when collected from donors who have had malaria or resided in or traveled to a malaria-endemic country or collected in regions of the U.S. that FDA identifies as having local, mosquito-borne malaria transmission.
Donor history questionnaires must include elements to assess prospective donors for malaria risk at each donation, these include:
A history ever of malaria
A history ever of prior residence in a malaria-endemic country; and
A history in the past twelve months of travel to a malaria-endemic country
Donor deferral and donation testing areas of the guidance dive into specifics for testing donors based on their scenarios of traveling to or living in endemic areas, reporting a history of malaria, and those who were prior residents of malaria-endemic countries including certain timeframes. Requalification of previously deferred donors may be eligible if they have not had a positive test for malaria in the past year and meet all eligibility criteria and the donations from the donor must be tested for malaria or for platelet and plasma donations (using pathogen reduction technology is allowed).
The guidance also gives more clarification on product management, retrieval and quarantine, notification of consignees as well as disposition and labeling. Specifics for releasing donations that are nonreactive for malaria are provided and where a donation is reactive for malaria and has been shipped, proper quarantining and notifications to consignees are required. It’s also required that licensed blood establishments must report changes to their donor history questionnaire and accompanying materials, as well as any testing implementation.
So how does this potentially impact the tissue industry? With updated guidelines permitting the donation pool acceptance to increase, this could impact certain areas of the HCT/P industry and possibly allow more donors based on the updated methods in addition to screening. Since the NAT testing has become available, it can help provide more evidence for acceptance or deferral and mitigate the risk for transmitting malaria outside of screening alone. Although there are more discussions to come and this document is still in its comment period, the possibility of HCT/P establishments being able to accept potentially more donors with a way to mitigate transmission of malaria through transplantation would be a great stride forward.
Thanks for joining and check out our blog next week!
Reference:
[1] https://www.who.int/news-room/fact-sheets/detail/malaria