FDA gives top priority to protecting the blood supply from Zika virus

By Neil Murthy

The Food and Drug Administration is turning to technology to protect the nation’s blood supply from Zika, as the virus continues to sweep across the Americas and Chicago reported the first case here last week.

Currently there have been no confirmed cases of Zika virus transmission through blood transfusions in the United States, according to the Centers for Disease Control and Prevention. However, multiple cases of Zika virus transmission associated with blood transfusions have occurred in Brazil—ground zero of the current Zika epidemic. As a result, the FDA considers finding a way to protect the nation’s blood supply a “top priority,” according to FDA public affairs specialist Tara Goodin.

What You Need to Know About Zika Virus:
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The FDA is looking into  Pathogen Reduction Technology—a process that involves ultraviolet light and other chemicals to alter the genetic material of disease-causing bacteria and viruses so that they are not able to replicate in blood. Although the technology is not specifically approved for Zika, the FDA did approve this technology in December 2014 for a “panel of viruses, including flaviviruses such as dengue and West Nile.” And since Zika virus is a type of flavivirus,  scientists are investigating if this technology can be used in the battle to fight Zika. A study published in January in the journal Transfusion shows that pathogen reduction is effective at removing Zika virus from blood products.

In its latest guidance regarding blood transfusions, the FDA already  recommended using this technology to clean donated blood products in Puerto Rico—an area where there is active Zika transmission.

“Pathogen reduction technology has been widely used in over 100 blood centers in over 20 countries,” said Stacey Leaños, associate director of Investor and Public Relations at CERUS Corporation, the manufacturer that makes the FDA-approved technology.

Furthermore, this technology is not new and its safety profile has been well established.

According to CERUS, pathogen reduction was first introduced in Europe in 2002. Switzerland made it mandatory to use the technology in 2013. In December 2015, in the midst of the current Zika virus outbreak, Brazil got on board and is now using this technology to clean their blood products.

But startup time means that protecting blood supplies through pathogen reduction requires moving forward now.

“We just can’t start this up tomorrow,” said Dr. Julie Cruz, medical director of the Heartland Blood Centers, a major blood bank that serves the greater Chicago area. “You have to make some physical adjustments in terms of space, train the staff and perform quality steps. All of this requires FDA approval.”

Cruz said that the technology is something they that are “considering and would want to employ” in the future.

Other blood banks have already made plans to start using the technology. The American Red Cross, which supplies 40 percent of the nation’s blood supply, just signed a contract with CERUS last month to start implementing pathogen reduction technology starting this summer.

However, there are some drawbacks to the technology.

Currently, the process is only approved for plasma and platelet donations, and not for whole blood, since a protein found in red blood cells called hemoglobin interferes with ultraviolet light. As a result, the technology as it stands now can only be used to clean a portion of the blood supply. CERUS has acknowledged that research is in the pipeline to see if pathogen reduction technology can be expanded in the future to clean all blood products.

And lastly, there is the issue of cost associated with this technology.

Dr. Robert Allison, who is the Deputy Section Chief of the Infectious Diseases Section of the National Institutes of Health, believes that the reason why more blood banks are not using pathogen reduction technology is because of issues surrounding cost and reimbursement.

“A unit of blood in the United States costs about $400 on average for all of the testing and processing,” said Allison at the American College of Preventive Medicine annual conference in Washington, D.C.  last week. “When you add pathogen reduction, it’s about $25 more. The problem is that there is no mechanism for reimbursing it. If you are a blood center, you are just losing that $25 for every single unit of blood,” said Allison.

Currently, the Centers for Medicare and Medicaid Services provide a single bundle payment for blood transfusions and the compensation is the same whether a blood product is pathogen reduced or not. Allison said that the lack of reimbursement for pathogen reduction is the reason why more blood centers are not utilizing this technology.

That may change as the Zika virus outbreak continues to spread.

“Safety always trumps cost,” Cruz acknowledged. “First and foremost, we want to make sure that our product is safe and that we are doing the right thing for donors and recipients.”

Photo at top: Graphic illustrating mosquito bite (From the Zika virus animation scripted by Neil Murthy/Medill; produced by Next Media Animation)