The US Food and Drug Administration (FDA) is contemplating the implementation of a new requirement for blood banks to adopt a test capable of detecting malaria parasites in certain blood donors. Seeking input from independent advisors, the FDA aims to strike a balance between achieving zero transfusion-related malaria cases and ensuring accessibility to blood donation.
Malaria, identified by the World Health Organization (WHO) as a significant global health challenge, recorded staggering figures in 2022, with 249 million cases and over 608,000 deaths.
Although malaria doesn’t pose a significant threat to the US blood supply compared to some other nations, approximately 28 million US residents travel to malaria-endemic regions annually. As travel increases and the planet warms, experts predict a potential rise in malaria cases in the US, despite aggressive mosquito control measures.
Historically, the US effectively tackled malaria, notably during World War II when a concerted effort to combat mosquitoes led to a drastic reduction in cases. By 1949, malaria was no longer considered a significant health issue in the US, with the WHO declaring the country malaria-free in 1970. However, sporadic cases persist, mainly travel-related.
In March, the FDA approved the Cobas malaria test, a pivotal development in screening donor blood for malaria parasites. While transfusion-related malaria cases are rare, they can lead to severe complications and even death.
The FDA acknowledges the complexity of current guidelines, which rely on donor history questionnaires. These questionnaires, while useful, have limitations, leading to the disqualification of healthy potential donors. The FDA estimates that between 50,000 to 160,000 donors are deferred annually, with many not returning to donate even when eligible.
To address these challenges, the FDA is exploring two main strategies: selective testing based on malaria history and travel, or universal testing followed by selective testing of at-risk donors. While most advisory committee members favor the former approach, concerns remain about the logistical and practical aspects of widespread testing.
During a public comment period, leaders from blood supply organizations urged the FDA to approach guideline changes cautiously. While acknowledging the potential of the new malaria test to improve blood safety and donor availability, they stressed the need for evidence-based decisions and flexible testing strategies.
The committee refrained from voting on proposed strategies, with the FDA committing to consider the discussion in its decision-making process. As the FDA weighs changes to its guidance, the goal remains clear: to enhance blood safety while ensuring the continued availability of blood donations.
