Malaria

Overview

Malaria is a serious and sometimes fatal disease that can be caused by any of the following four Plasmodium species: P. falciparum; P. malariae; P. ovale; or P. vivax. About 1,500 cases of malaria are diagnosed in the United States each year, the vast majority of which are found among travelers and immigrants returning from countries where malaria transmission occurs. FDA’s Guidance, Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria, updated in August 2014, defines exposure timeframes for residence in, or travel to, a malaria-endemic country or malaria endemic area. As noted in the title, the guidance provides recommendations for questioning and deferring donors, reentry criteria and product management to reduce the risk of transfusion-transmitted malaria.

What actions should be taken to reduce the risk of transfusion-transmitted malaria?

Refer to the Flowcharts found on the Donor History Questionnaire webpage. These flowcharts are designed to guide you through donor eligibility decisions, including timeframes of exposure in malaria-endemic countries and areas. All information on the DHQ webpage is consistent with FDA recommendations, to assist with donor eligibility decisions.

AABB’s Regulatory Affairs staff, Transfusion Transmitted Diseases (TTD) Committee and Donor History Task Force work closely with the FDA and CDC to monitor emerging malaria risks and to provide information and current recommendations from CDC. AABB alerts members of new malaria outbreaks through the “AABB Weekly Report” and/or “AABB News Flash.”

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Recent Actions

05/04/18
CDC updated the Malaria Information and Prophylaxis website for Costa Rica on May 4 following a report of P. falciparum malaria in a U.S. traveler to the Osa Peninsula in Puntarenas Province, Costa Rica, in mid-April.

04/16/18
CDC recently updated the Malaria Information and Prophylaxis website for Costa Rica. On April 16, health authorities in Costa Rica reported that no new cases of malaria have been reported in Costa Rica since December 2017. CDC continues to recommend mosquito avoidance measures for travelers to Costa Rica.

04/12/18
CDC recently updated the Malaria Information and Prophylaxis website for Cape Verde, Capital City, Praia. On April 12, health authorities in Cape Verde reported that no new cases of malaria have been reported in Praia since January 4, 2018. CDC no longer recommends antimalarials to prevent malaria for travelers to Praia.

08/19/13
AABB posted an analysis of the guidance for industry titled “Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria.”