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The FDA could change its rules for blood donation to protect against malaria transmission

The FDA has announced that it’s considering introducing a new requirement for blood banks to implement a test that can detect malaria parasites in donors’ blood. The FDA is consulting its independent advisers on how to achieve zero transfusion-related malaria cases without unnecessarily excluding potential donors.

According to the World Health Organization, malaria remains a major global health issue, with 249 million cases and over 608,000 deaths reported in 2022.

Although malaria is not a big threat to the US blood supply compared to other countries, nearly 28 million US residents travel annually to regions where malaria is prevalent. The US records about 2,000 malaria cases each year, mostly linked to travel, per the CDC.

In March, the FDA approved the Cobas malaria test, developed by Roche, which can detect RNA and DNA from the malaria parasite in donor blood, organs, and tissues.

While malaria transmission via blood transfusion is rare, it can cause severe symptoms and even death. A CDC study found 93 cases of transfusion-transmitted malaria in the US from 1963 to 1999, resulting in 10 deaths. Another study identified 13 such cases between 2000 and 2021, with seven involving donors who met current FDA eligibility criteria.

The FDA informed its advisory committee that the current guidelines are complex, requiring blood bank workers to evaluate multiple risk factors. 

Blood banks use a donor history questionnaire to screen people who have had malaria or lived in an endemic country in the past three years. 

Potential donors are also deferred if they have travelled to a malaria-endemic country in the previous three months, were residents of an endemic country but spent less than three consecutive years there, or travelled to an endemic area within the past three years.

The FDA is also considering mandatory testing of all blood donations from areas with even a single recent case of locally transmitted malaria, though the committee expressed uncertainty about this proposal.

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