Legislative Challenges to Blood and Organ Donation in a COVID-19 Endemic World

The U.S. Food and Drug Administration (FDA) is one of the government bodies that regulates the functions of blood banks and is the trusted source of information when it comes to blood product safety. Their most up to date recommendations indicate that SARS-CoV-2, as a respiratory virus, “is not known be transmitted by blood” and that donors who otherwise qualify and “who received a nonreplicating, inactivated, or mRNA-based COVID-19 vaccine can donate blood without a waiting period.” In following these recommendations, clinicians are encouraged to hold conversations with patients to address concerns and to approach this topic using a shared decision-making framework. Unfortunately, several US state legislators are determined to obtrude in this process and make it harder for blood products to reach patients by instituting requirements for donors and blood banks that could lead to delays in care. 

As of this writing, lawmakers in Illinois, Kentucky, Missouri, Montana, Rhode Island, South Carolina, and Wyoming, have introduced bills that would require additional procedures for the blood from vaccinated donors to be allowed into the blood supply. These in many cases almost identical bills, may require: 

• that blood banks test donated blood for evidence of any COVID-19 vaccine and any other messenger ribonucleic acid (mRNA) vaccine components --- (Illinois HB4243). 

• a blood donor to disclose if they have ever received a COVID-19 vaccine or any other mRNA vaccine (Kentucky HB163). 

• that blood be labeled if it tests positive for COVID-19 vaccine or any other mRNA vaccine component or if the donor stated having ever received the vaccine (Missouri SB1429 and HB2759). 

South Carolina (H5060) and Montana (HB645) bills go even further to include organ donation. Both bills require that tissues and organs be tested for “the presence of high-count spike proteins from long COVID-19” as well as any drugs that contain mRNA or DNA biotechnology. The argument being made by several legislators implies that segregating blood products this way would allow people to choose blood that has not been genetically modified and is thus, safe. Some of the language in these bills may penalize donors if, for example, they were exposed to COVID-19 but did not test positive, declare they have never had COVID-19 at the time of donation, and are later found to have antibodies to the disease. These bills are even more unreasonable as a report by the Centers for Disease Control and Prevention found over 96% of eligible donors had either received the COVID-19 vaccine or become sick and recovered. 

The Association for the Advancement of Blood and Biotherapies (AABB), America’s Blood Centers and the American Red Cross made a statement indicating there are no documented cases of harm during transfusions due to donor’s COVID-19 vaccine status, and “no medical reason to distinguish or separate blood donations from individuals who have received a COVID-19 vaccination.” They warn lawmakers that these bills could lead to blood shortages and delays in care for patients needing emergency surgery, those who have suffered deadly injuries, or who depend on blood products as therapy such as cancer, sickle-cell, and thalassemia patients. Some lawmakers appear to have taken notice, as the most recent bill introduced in Rhode Island (RI H7881) requires that recipients be permitted, “in nonemergency situations, to inquire whether the blood originates from someone who has received” a COVID-19 or mRNA vaccine. 

Blood donation practices should not be static, and they should allow for change based on science and evidence. For example, the FDA regulates testing of blood and organs for blood-borne infectious diseases, such as HIV or Hepatitis, which protects patients from potential contagion. However, for over 30 years, the FDA’s official stance was to ban members of the LGBTQ+ community from donating based on misconceptions regarding their sexual practices. Only in 2023 did these misguided conjectures officially become a thing of the past, as they were debunked thanks to the ADVANCE study and many other efforts by advocates and scientists. Now the FDA uses an individualized approach for donor screening, which can help increase the donor pool while maintaining the safety of blood products.  

Thus a better strategy for the current dilemma would be for government officials to support and fund state-of-the-art studies, like ADVANCE, looking specifically at blood and organ donation by people who have come in contact with the SARS-CoV-2 virus in any of its forms. Science is a process, and it is acceptable to look at emerging evidence and address the impact of novel interventions on the well-being of society through legislation. However, there are times when misinformation can result in the creation of inadequate policies that, if implemented, might have serious repercussions for patients in need of life saving therapies such as transfusion and transplantation. These are medical therapies that, although not completely free of risk, have contributed to saving countless patients' lives.  

Regarding these bills, it is good to know that common sense can prevail. The Wyoming bill (HB0115), which was introduced February 1, 2024, was dead on arrival. One can only hope that the other bills, which are currently in various stages of consideration by their respective state legislatures, will share this fate. If you live in any of the states listed above, we urge you to contact your legislators and ask them to stop these bills from moving forward. The AABB has shared the following resources (see below), which can be helpful to educate others regarding this topic. As laboratory professionals, we have the knowledge and skills to advocate for evidence-based practice and scientific inquiry to prevail so we can maintain the safety and availability of blood, tissues, and organs for patients in need of life-saving care. 

• FDA Information on Directed Blood Donations 

• AABB About Blood Donation Infographic 

• AABB: How the Blood Community Ensures the Safety of Blood in the United States 

• Joint Statement: Blood Community Reiterates the Safety of America’s Blood Supply for Patients 

• AABB Vaccination and Blood Donation Information 

• Centers for Disease Control and Prevention Blood Safety Basics 

• FDA Information on Directed Blood Donations 

• American Medical Association (AMA) House of Delegates Blood Transfusion and Vaccines Resolution 

• Roubinian NH, et al.; NHLBI Recipient Epidemiology and Donor Evaluation Study-IV-P (REDS-IV). Clinical outcomes in hospitalized plasma and platelet transfusion recipients prior to and following widespread blood donor SARS-CoV-2 infection and vaccination. Transfusion. 2024 Jan;64(1):53-67.  

*Note: ASCP is in support of AABB’s campaign to stop these bills.