Indian medical experts stress on need for USFDA advice to reduce risk of transfusion-transmitted malaria
Indian medical experts stress on the need for USFDA advice to reduce the risk of transfusion-transmitted malaria. This is because the life-threatening infectious disease is a major health challenge not just in the country but many developing countries.
Malaria is a life-threatening disease primarily found in tropical countries. India carries 2% of the global malaria case burden, 2% of global malaria fatalities which is 52% of all malaria deaths outside of sub-Saharan Africa, and 85.2% of the malaria burden in South East Asia.
The guidance from USFDA provides blood establishments that collect blood and blood components, the global regulatory recommendations to reduce the risk of transfusion-transmitted malaria (TTM).
The recommendations apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk. USFDA said this guidance replaces the guidance titled ‘Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry’ dated April 2020.
To address the urgent and immediate need for blood and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 the global regulatory issued revised recommendations to reduce the risk of TTM during the public health emergency.
Malaria is a mosquito-borne parasitic infection caused by five Plasmodia species:P. falciparum; P. malariae; P. ovale; P. vivax; and P. knowlesi), which can also be transmitted by transfusion of blood and blood components collected from an infected but asymptomatic donor. Although Malaria was eradicated in the U.S. in the 1950s, yet the Anopheles mosquito vector exists in many states.
Plasmodia infections can be asymptomatic or can range in severity from a mild febrile illness to life-threatening complications or death. Plasmodium falciparum causes the most severe disease and accounts for 90% of the malarial deaths in sub-Saharan Africa.
TTM rarely occurs in the U.S. but remains a serious concern in transfusion medicine The transfusion risk stems from asymptomatic blood donors with newly-acquired or chronic malaria infection, which can be indolent and persist for years. The risk of TTM is currently estimated at less than 0.1 per million red blood cell (RBC) transfusion, or about 1 case every 2 years Whole blood or RBC components are implicated 94% TTM cases, with the remainder caused by platelet components.
Medical experts from India note that highest malaria occurs in Orissa, followed by Andhra Pradesh, Arunachal Pradesh and Assam. Karnataka too cases and fatality is prevented because of stringent surveillance. Yet the risk of risk of transfusion-transmitted malaria prevails.
The guidance recommends mandatory need for donor history. This is to ascertain history of malaria in the past three years. It also needs to know the details of prior residence in a malaria-endemic country; travel to a malaria-endemic area in the past three months; and if previously a resident of a malaria-endemic country.
“Such information is compulsory to prevent fatality with the risk of transfusion-transmitted malaria looming high. Hence, the guidance from USFDA is of particular significance,” said the medical experts.
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