By: Peter Marks, M.D., Ph.D., and Luciana Borio, M.D.
Each day in the United States, thousands of people receive transfusions of blood or blood products as part of their medical treatment. Although such transfusions can save lives, like most medical treatments they may also carry some risks. Among the most concerning risks is the chance that a patient might get an infection from a transfusion. Some of these risks, like hepatitis and HIV, have been known for some time. Others, like the Zika virus, have emerged more recently.
One of FDA’s top priorities is to help assure that the blood supply is safe for all those who need these potentially life-saving products. This mission is accomplished through close collaboration with other government agencies, such as the Centers for Disease Control and Prevention, and non-governmental partners, such as blood collection establishments and screening test developers.
These coordinated efforts are crucial because blood safety relies on a combination of factors, including understanding the epidemiology of infectious disease transmission and the testing that can be done to detect it.
Our experience with other infectious agents has positioned us well to address Zika virus. We have worked closely with the CDC since the outbreak began to emerge. We have also been in continual contact with blood collection establishments, screening test manufacturers, and local health authorities.
When it became apparent early in 2016 that Zika virus could pose a risk to the blood supply in the United States, FDA issued recommendations to reduce the risk of its transmission through blood transfusions by deferring those donors at risk of being infected with Zika virus as well as by screening donated blood in certain areas. Given the large amount of scientific data that is emerging and the rapid spread of the outbreak in the Western hemisphere, FDA understands that it may need to revisit and update this guidance soon to maintain the safety of the blood supply.
As part of the overall response, FDA also collaborated with the HHS Office of the Assistant Secretary for Health to ensure that safe blood was available to those needing a transfusion in Puerto Rico and other areas at risk before a blood screening test for Zika virus became available. The Agency also worked with manufacturers to help speed the development of screening tests to detect Zika virus at the earliest point in time after infection. We also worked with the Biomedical Advanced Research and Development Agency to help facilitate the evaluation of these tests and other measures.
Helped by these and other ongoing collaborations with federal and non-federal partners, FDA is able to pursue its mission of protecting and promoting your health.
Peter Marks, M.D., Ph.D., is Director of FDA’s Center for Biologics Evaluation and Research
Luciana Borio, M.D., is FDA’s Acting Chief Scientist