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The US Food and Drug Administration is considering a requirement that would allow blood banks to use a new test to detect malaria pathogens in the blood of certain donors, and is seeking input from its independent advisers on the best way to achieve that goal. Zeroing in on issues related to unnecessary transfusions to prevent some people from donating blood.
Malaria is a WHO disease. A significant global health issue249 million cases and more than 608,000 deaths in 2022 alone.
Malaria is not considered as big a threat to the US blood supply as it is in other countries. But about 28 million Americans travel to parts of the world where malaria is endemic each year, according to the FDA, and as more Americans travel and the planet warms, scientists predict the disease will worsen. More likely In the US, even with aggressive mosquito control.
In the year In the late 1940s, the U.S. had about 65,000 cases of malaria a year, the U.S. Centers for Disease Control and Prevention told an FDA advisory committee Thursday — but that changed when the country needed healthier service members to fight the world. The second war. Knowing that many would breed in malaria-prone areas of the South, President Franklin Delano Roosevelt's administration waged a war on mosquitoes, and it paid off.
In 1949 CDCMalaria was not considered a major health problem in the United States, and the World Health Organization declared the United States free of the disease in 1970.
The US still has about 2,000 cases a year. According to the CDC, But most of them are related to travel.
Although the risk of local malaria in the United States was “extremely low,” the CDC said last summer. He warned doctors to monitor cases found in the area. Last year there were a handful of non-travel-related cases in Texas, Florida, Maryland and Arkansas, the first domestic malaria cases in the US since 2003.
In March, the FDA approved the first test intended to screen donors Blood Evidence for malaria. Cobas malaria test, Made by my doorsIt can isolate RNA and DNA from the parasite that causes malaria in the blood, organs and tissues of donors.
Transmission of malaria through blood is not common, but infection can cause severe symptoms and even death. Studies show. A CDC study found that from 1963 to 1999, only 93 cases in the US were transmitted through donated blood, but 10 of those people died.
Another study found 13 cases of malaria linked to blood donations between 2000 and 2021, the FDA said, but seven of those cases involved donors who met current FDA eligibility criteria.
“It's complex, and it doesn't rule out all cases,” Jennifer Sharpf, associate director of policy at the agency's Office of Blood Research and Evaluation, said of the current guidance.
The FDA told the committee Wednesday Current guidance It comes with a high level of “complexity” and blood bank staff must evaluate a number of possible risk factors.
Blood banks use a history questionnaire from donors to screen people who have had malaria in the past three years or who have lived in a country where the disease is endemic. People are banned from donating if they have traveled to a country with malaria in the past three months. Or if you are a resident of a country with malaria, if you have one Have spent less than three consecutive years in a malaria-endemic country or have a history of travel to an area with malaria in the past three years. The rules are slightly different for the collection of platelet and plasma components.
These questionnaires have limitations and the screening process is “prone to error,” the FDA said. In particular, in residents of malaria-endemic countries, the delay period may not be sufficient to capture asymptomatic donors because they may be partially immune to preexisting infection.
On the other hand, current guidelines make a larger group of healthy donors eligible, the FDA said. Some estimates say 1% to 3% of donors turn away based on travel history, and blood banks say they never get enough donors.
Sharpf told the committee that studies show that between 50,000 and 160,000 donors may be delayed each year, and that many who are late often do not return even if they are eligible to donate.
FDA is considering two strategies for updating the guidelines.
The first thing to consider is screening blood donors based on their history of malaria and whether they have traveled to a malaria-endemic area or lived in a malaria-endemic country in the past three months. Another option is to test all donors at least once, and then screen only those at high risk, including those who have had a history of malaria and those who have traveled to an area with malaria in the past three months.
Most of the advisory committee members seem to support the first option, saying that the second one seems to be overcrowded.
“This is a very low incidence and very treatable disease,” said committee member Dr. Richard Scanlan, vice chair of the Laboratory Medicine Transfusion Service and medical director at Oregon Health & Science University.
The FDA is considering testing all blood donated in areas where there has been even a recent outbreak of locally transmitted malaria. But the committee members seem less convinced about this idea.
Committee member Dr. Sanjay Ahuja, director of the Rainbow Hemostasis and Thrombosis Center at Rainbow Babies and Children's Hospital in Cleveland, said the decision to screen all donor blood from the area if there is confirmed transmission is “difficult.” He said.
“There are so many variations to this,” Ahuja said. “In my opinion, I think it might be a little bit small, but I don't know if there will be more evidence of local distribution before we say 'yes' to this.”
During public comment at the meeting, leaders of some blood supply organizations encouraged the FDA to take a cautious approach to changing the guidance.
Ralph Vassallo, chairman of the Committee on Transfusion-Transmitted Diseases of Blood and Biotherapy, said his group has joined forces with American blood centers and the American Red Cross to believe the new malaria test will improve blood safety and possibly improve blood safety. Improving the supply of donors by eliminating “unnecessary donor transfers” of donors with abnormal blood types, especially from Latin American, Asian and African countries.
But he told the committee there were no clinical studies showing the test could reduce the risk of transfusion-transmitted malaria.
Vassallo also encouraged the FDA to use more flexible testing strategies, and said that although the group supports limiting all donations in a zip code to local malaria transmission, one case should not be enough to trigger such testing.
“Before issuing final guidance, the FDA should support formal modeling studies designed in consultation with malaria practitioners using best estimates of parasite levels,” he said.
The committee did not vote on the proposed strategies, but the FDA said it will take the discussion into account when it considers changing the guidance.