The COVID-19 pandemic posed unprecedented challenges to the US blood supply. Blood collection activities were significantly impacted, and donor participation decreased due to social distancing measures and cancellation of voluntary blood drives in response to stay-at-home orders issued by local, state, and federal governments, leading to critical blood shortages.1,2 Despite these challenges, the US healthcare system demonstrated resilience and ensured the availability of critical blood supplies by adopting several measures. Hospitals reduced and/or canceled elective surgical procedures. Healthcare providers implemented patient blood management (PBM) initiatives to reduce avoidable transfusions. Blood donor centers increased collections by implementing enhanced safety protocols, scheduling appointment-only donations, increasing mobile blood drives, relying on regular donors, revisiting deferral criteria, and launching public awareness campaigns and community partnerships.3-6
Post-COVID-19, the blood supply status has generally stabilized but continues to face challenges due to fluctuating donor turnout, reduced school and business-based blood drives, and ongoing public health concerns. These issues compound long-term trends that already impact the nation’s blood supply, including declines in the overall number of individuals donating blood each year, fewer donors under the age of 50, and a lack of diversity in the donor pool.7,8
New Challenges: Requests for Blood from Unvaccinated Donors
The post-COVID-19 era has introduced a new challenge to the already strained blood supply: an increasing number of patient requests for blood and blood products from unvaccinated donors or those who have not had COVID-19.9-11 This refusal to accept blood from vaccinated donors is closely linked to widespread misinformation about COVID-19 and mRNA vaccines that polarized public opinion throughout the pandemic.12,13 The FDA and major US blood donation organizations issued multiple notices to counter medical skepticism and misinformation, aiming to reassure the public about the safety of the blood supply.14-18 However, public distrust persists and is further fueled by certain state governments introducing bills that could undermine donor anonymity and confidentiality, jeopardizing the blood supply for patients in need.19,20
Scientific Evidence on Transfusion Safety
Initially, concerns were raised about the potential for virus transmission via transfusion, but these were quickly dismissed as respiratory viruses, including SARS-CoV-2, are generally not transmitted via blood transfusion. There were no reported cases worldwide of SARS-CoV-2 being passed from donor to recipient.21-22 Nevertheless, skepticism continued, particularly regarding the potential adverse effects of transfusing blood from donors who received SARS-CoV-2 vaccines (COVID-19 vaccines), especially mRNA vaccines. Concerns included the potential for passive transmission of the vaccine through transfusion, alleged adverse events like myocarditis, and fears that circulating mRNA could cause changes in DNA, leading to oncogenic mutations, sterility, or birth defects.23 There is no evidence to support these concerns.24
COVID-19 mRNA vaccines were developed relatively recently, but mRNA vaccine technology has been studied for more than 15 years. Two of the four FDA-approved and authorized COVID-19 vaccines use mRNA. Current evidence indicates that after injection, the mRNA does not enter the cell’s nucleus and cannot interact with DNA. While vaccine components, including mRNA and SARS-CoV-2 spike protein antigens produced in response to mRNA vaccines, can be detected beyond the injection site for days after the injection at picogram levels, this is many orders of magnitude below what is initially injected (microgram levels).25 The FDA explicitly allows the collection of blood from donors who have recently received approved or authorized COVID-19 vaccines if they are healthy on the day of donation and meet all other eligibly criteria. Although fetal tissues were involved in previous mRNA vaccine research, they are not used in the production of available mRNA vaccines.26
The donor questionnaire ensures safe and effective blood donations by screening those who have recently received live vaccines. Since live vaccine viruses can replicate and presumably circulate after injection, donors recently immunized with live viral vaccines are excluded for an appropriate interval. Since the COVID-19 mRNA vaccines are not live and cannot replicate SARS-CoV-2 virus in a donor, blood centers, in accordance with federal requirements and professional standards, do not defer donors based on vaccination status. As a donor’s COVID-19 vaccination status does not pose a safety risk for transfusion, it is not recorded and cannot be conveyed to hospitals, physicians, or patients. The FDA finds no current evidence to support concerns related to the safety of vaccinated individuals.27 Hence, recent requests for blood from unvaccinated donors are medically unfounded.
Strategies for Managing Requests for Blood from Unvaccinated Donors
Despite the absence of scientific evidence, requests for blood components from unvaccinated donors persist, fueled by misinformation propagated on social media and other mass communication platforms. As healthcare providers, it is crucial to adopt a non-judgmental, collaborative approach and involve patients in the decision-making process to address these concerns.
When faced with requests for unvaccinated blood, healthcare providers must be well-prepared to discuss the safety of the blood supply and address patient and family concerns. Providers should be aware of the widespread hesitancy against vaccinations, understand the concerns of patients who refuse transfusions from vaccinated donors, and be knowledgeable about the current lack of evidence for adverse outcomes in recipients of such transfusions.9,11
Educating patients about the safety of blood donation and transfusion is vital. This includes explaining the donation process, the blood supply chain, and the risks associated with demanding blood from specific donors. The current US blood donor screening process is rigorously regulated by the FDA, with additional accreditation by the Association for the Advancement of Blood and Biotherapies (AABB) and the College of American Pathologists (CAP). Blood centers are required to obtain a comprehensive medical and behavioral history from prospective donors and conduct infectious disease screenings for various pathogens. The risk of transfusion-transmitted infections is extremely low, and there is no evidence to suggest that SARS-CoV-2 virus can be transmitted through blood transfusion.21,22,28-31. Hence, the FDA does not recommend the use of COVID-19 laboratory tests for the routine screening of blood donors.15
Addressing Persistent Requests for Blood from Unvaccinated Donors
Despite efforts to adopt a non-judgmental, collaborative approach, some patients or families may persist in refusing blood from vaccinated donors and request blood from unvaccinated donors. In pediatric cases, it is crucial to recognize situations where family authority may need to be overridden to protect children from serious harm.9 In these settings, several options can be considered for patients and families requesting unvaccinated blood: 1) managing them as any other transfusion-declining patient, 2) offering autologous blood donation, and 3) addressing donation from directed donors.11
Each option has availability, safety, and cost implications. Healthcare providers should always use blood judiciously and implement Patient Blood Management (PBM), a patient-centered, systematic, evidence-based approach to improve patient outcomes by managing and preserving the patient’s own blood while promoting patient safety and empowerment.6,32 In certain settings and clinical conditions, and depending on the urgency, it is possible to optimize patients beforehand to completely avoid blood transfusions during treatment or procedures. Autologous donation, depending on the patient’s clinical situation, is not always an option. Autologous donations, if eligible, present numerous collection and logistical challenges. These collections are not feasible at every facility and typically require careful coordination with organizations such as the American Red Cross or other community blood donor centers to handle the collection, labeling, transportation, and tracking of these units in inventory.33 Directed donations, involving donors selected by the potential recipient, must meet all allogeneic criteria to undergo collection. Compared to volunteer donors, directed donations pose heightened safety concerns, including increased risks of transfusion-transmitted infections due to higher rates of positive infectious markers in first-time donors, transfusion-associated acute lung injury from the directed donation of maternal blood products, HLA alloimmunization, and transfusion-associated graft-versus-host disease. In the latter, allogeneic transfused T lymphocytes from directed donors escape detection and destruction because the host does not recognize the transfused lymphocytes as foreign due to HLA similarity.34-36
Healthcare providers should discourage requests for blood from unvaccinated donors and encourage patients to accept blood from the general inventory or offer PBM bloodless alternatives to transfusion. There is no scientific evidence demonstrating adverse outcomes from transfusions of blood products collected from COVID-19 vaccinated donors, and thus no medical reason to distinguish or separate blood donations from individuals who have received a COVID-19 vaccination. Accordingly, that information is neither collected nor labeled on blood products.
The legal guidelines regarding the obligation of a hospital to satisfy requests for autologous, directed donations, and other special accommodations are state-dependent. Reviewing hospital transfusion consent and updating hospital policies in conjunction with key hospital administration and legal departments regarding these issues is recommended.
In conclusion, as requests for blood from unvaccinated donors become more frequent, it is imperative for healthcare providers to develop a comprehensive policy that provides clear and consistent guidance. This policy must involve collaboration with all relevant stakeholders and be communicated effectively to both healthcare teams and patients. By doing so, healthcare institutions can ensure a unified approach to managing these requests, while maintaining the safety and integrity of the blood supply (Table 1).
Table 1: Key considerations for healthcare providers managing requests for blood from unvaccinated donors
| Key Point | Details |
| Scientific Evidence on Safety |
|
| Current Blood Donation Policies |
|
| Patient Education |
|
| Handling Requests for Blood from Unvaccinated Donor |
|
| Alternatives to Blood from Unvaccinated Donors |
|
| Legal and Policy Considerations |
|
| Communication with Patients |
|
| Focus on Patient Blood Management (PBM) |
|
Health researchers are sounding the alarm after noticing more people refusing life-saving blood transfusions because they come from vaccinated donors.
In a study out of Vanderbilt University Medical Center, 15 patients or families of patients who needed blood transfusions rejected them because they requested blood from donors who were not vaccinated.
The majority of patients were children or teenagers.
The refusal led one patient to go into shock, another to develop anemia and others to have their surgeries delayed.
Now, doctors involved say they fear more Americans, spurred by vaccine-suspicious health secretary Robert F Kennedy Jr, will follow.
Over a two-year period, the researchers found requests for non-anonymous – meaning patients can choose specific donors for their transfusion – had increased because the patients specifically wanted blood from unvaccinated individuals.
The patients had told doctors they wanted unvaccinated blood because they believed it was safer, but their exact safety concerns are unclear.
Researchers noted that while the total number of these donations was small, the requests caused delayed care and could have contributed to complications of not receiving a timely blood transfusion, which can include organ failure, stroke and death.