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Every 2 seconds someone in the United States needs blood or platelets. With nearly 16 million blood products transfused each year, blood transfusion is one of the most common medical procedures in the United States, contributing to life-saving medical care for millions annually.1 Despite the recent unparalleled blood shortages resulting from the COVID-19 pandemic, the US health care system has largely managed to weather the potentially catastrophic situation of an inadequate blood supply, partially attributed to the development of COVID-19 vaccines blunting the pandemic and resulting demand. The result is maintenance of available blood for individuals with both emergent and nonemergent indications. On February 17, 2023, however, a state representative introduced Montana House Bill No. 645, which attempts to prohibit donation of blood from COVID-19 (SARS-CoV-2)–vaccinated individuals.2 The bill also punishes individuals who “knowingly use, receive, accept, ship, transfer, or administer” blood from a COVID-19–vaccinated donor. Violations would result in a misdemeanor punishable by monetary penalty. This type of legislation would impose liability on numerous individuals—donors, patients, blood donation industry workers, health care professionals, etc. Although individuals refusing blood transfusion from COVID-19–vaccinated donors is not novel,3 this legislation seeks to validate unfounded, misinformed, and sometimes conspicuously prejudiced beliefs. We initially hesitated to address this effort with a formal response at the risk of conferring legitimacy, but we believe that such legislation threatens the very foundation of American health care so comprehensively that official condemnation is necessary. The evolution of COVID-19 vaccination skepticism has progressed from mere uncertainty to unsubstantiated medical misinformation and even intentional falsification. Vaccination misinformation has affected health care in a variety of settings,4 but threats to the US blood supply have prompted federal regulators to refute these claims.5 Maintaining the safety of the blood supply is a guiding principle in blood collection, and the lay public should be reassured that blood donors must be in good health at the time of donation. Donors must pass a health evaluation, including vital sign assessment, travel and contact history review, and extensive eligibility screening concerning pertinent therapies and illnesses. Every blood donation also undergoes testing for infectious agents that may be transmitted by blood. Further, the US blood donation system has existing deferral strategies for certain vaccinations, and vaccines are evaluated to determine whether donation deferral is necessary. Although no studies have been undertaken to directly assess the effect of transfusion from vaccinated blood donors on recipients, there is no historical or contemporary scientific basis to believe that this blood poses any risk. As the COVID-19 vaccines do not contain live virus, there is no evidence that they pose an infection risk to recipients of the donated blood. Further, there is no evidence—and no logical reasoning—to believe that these vaccines would alter the genetic material of the vaccinated individual or blood transfusion recipient. Thus, legislation pertaining to risk should not be made until such data are reviewed. Notably, as of February 23, 2023, 81.2% of the US population had received at least one COVID-19 vaccine dose.6 Although the exact proportion of COVID-19–vaccinated US blood donors is unknown, a June 2022 study demonstrated an increase in the seroprevalence rate in blood donors from 3.5% in July 2020 to 20.2% for SARS-CoV-2 infection–induced antibodies to 83.3% for combined SARS-CoV-2 infection– and vaccine-induced antibodies by May 2021, higher than the general population rate at that time.7 The combined seroprevalence increased further to 94.7% by December 2021, highlighting the significant uptake of at least 1 vaccine dose across the United States.7 Despite this finding, no adverse effects in recipients of blood transfusion from vaccinated donors attributable to the vaccine have been described to date. Further, as data have shown that blood donors tend to be vaccinated against COVID-19 at higher rates than the general public, these types of proposals could contribute to blood shortages in regions and jurisdictions in which the laws are enacted. Likewise, if additional states were to adopt such a restricted approach, these policies could pose a theoretical risk to the adequacy of the US blood supply on a larger scale. With no US Food and Drug Administration–approved blood substitute available, clinical outcomes in regions with a lack of blood availability would regress. Perhaps just as significantly, these proposals would prohibit research and emergency use authorization therapies essential for responding to and preventing pandemics, including those not directly involving vaccines. For instance, numerous hospitals used blood products containing SARS-CoV-2 infection–induced antibodies collected from blood donors previously infected with SARS-CoV-2 (ie, convalescent plasma) as a therapeutic strategy for COVID-19 before the advent of vaccines. Objections to the use of blood products from vaccinated donors may be related to the fact that such donations are not distinctly labeled to promote awareness and choice; however, if labeling were present, it would simply demonstrate that the majority of products are from vaccinated donors, without a valid clinical reason to do so and potentially inducing a chilling effect on both donation and receipt of such blood.7 Notwithstanding the ethical considerations of this practice, the financial and administrative burden for such unfounded implementation would further negatively affect the blood donation infrastructure. Unfortunately, the looming threat to patient care is not limited to Montana. Proposed Connecticut Senate Bill No. 531, introduced on January 18, 2023, would amend Connecticut law to “permit an individual the right to choose blood transfusion from an unvaccinated individual.”8 This bill presumes that the blood transfusion recipient, physician, or the hospital itself knows the blood donor’s vaccination status, which is not the case in the United States. Blood products are not labeled with the donor’s COVID-19 vaccination status because this information has no clinical impact on the transfusion recipient, similar to other individual characteristics, such as race and ethnicity. Essentially, this bill implies that a patient should be able to request a directed donation from a particular donor based on vaccination status. Although we acknowledge patients’ general rights of autonomy and therefore refusal of therapy, in the absence of another justification, such as a rare blood type, there is no evidence that blood from a directed donor is safer than standard volunteer blood. Further, social pressures associated with directed donations may compromise the reliability of the donor history questionnaire, a crucial risk-mitigation strategy.9 Although the proposed legislation in Montana has been tabled, hopefully ending any meaningful consideration, it is noteworthy that the subcommittee did not vote it down outright. The Connecticut legislation has been referred to the state’s Senate Joint Committee on Public Health and is pending action. We believe that elected officials should proceed with extreme caution before proposing bills that may have profound impacts on health care without medical or scientific evidence to support their claims. These legislative precedents could set the stage for an impending legal, medical, and ethical battle among lawmakers, health care professionals, and vaccine skeptics, with the safety and sufficiency of the blood supply in the balance.
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