In April 2020, the U.S. Food and Drug Administration (FDA) issued four blood donor eligibility guidelines—including one for malaria—to help alleviate blood shortages during the COVID-19 pandemic. In December 2022, the FDA issued new guidance to reduce the risk of transfusion-transmitted malaria, which is unchanged from the April 2020 guidance. Between 2000 and 2021, twelve case of transfusion-transmitted malaria were reported in the U.S. All these cases were associated with asymptomatic donors who previously resided in malaria-endemic countries or had a prior malaria infection; none of the cases were associated with travelers from non-endemic countries. Since 94% of U.S. travelers to endemic locations develop clinical symptoms within three months and anti-malaria immunity wanes after three years in individuals with prior residence in a malaria-endemic country, the FDA recommends a three-month deferral or pathogen reduction using an FDA-approved device for Plasmodium falciparum for the following:
- Potential donors who reside in a non-endemic country who travel to a malaria-endemic area
- Potential donors who have resided in a non-endemic country for more than 3 years who previously lived in a malaria endemic country and travel to a malaria-endemic location
The FDA recommends a three-year deferral for the following:
- Potential donors who reside in a malaria-endemic country
- Potential donors who previously resided in a malaria-endemic area but are currently living in a non-endemic country (for less than three years)
- Any potential donor with a diagnosis of malaria
The FDA recommends this guidance should be implemented immediately with accompanying changes to donor history questionnaires.
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