Ease restrictions on U.S. blood donations

With a vaccine for coronavirus disease 2019 (COVID-19) likely more than a year away, we must identify effective therapies for patients now. One promising approach is the use of plasma from patients who have recovered from COVID-19 (1, 2). To facilitate this strategy, the U.S. Food and Drug Administration (FDA) recently revised some of the restrictions on blood donation, including a decrease in deferral time for men who have sex with men (MSM) to 3 months (3). This is a positive change to an outdated guideline, but it does not go far enough.

In 1983, the FDA indefinitely barred all MSM from donating blood for fear of transmitting human immunodeficiency virus (HIV) and hepatitis B/C by transfusion. In 2015, the lifetime ban was changed to 12 months from last sexual contact (4). Today, the risk of contracting HIV or hepatitis B/C through transfusion is less than 1 in 2 million, and the incidence is substantially lower (5). This success is due to advances in screening, not to banning MSM from donating blood. The false-negative rates of modern HIV nucleic acid tests fall around 0.05%. The window period between infection and detection has dropped to 9 days (5, 6). Despite this improvement, the FDA continues to exclude otherwise healthy MSM through arguably discriminatory policy. Although a step forward from the 12-month policy, a deferral period of 3 full months is not necessary to protect patients (7, 8). Moreover, this revised policy may not meaningfully increase the donor pool, given that waiting until 3 months after sexual contact amounts to a lifetime blood donation ban for many men.

The demand for healthy blood and convalescent plasma will accelerate as COVID-19 infects more Americans. To address the acute shortage (9), the deferral period should be decreased to 2 weeks, after which we can reliably screen for HIV. More granular deferrals could also be introduced. Instead of a blanket discriminatory ban on MSM blood donations, we could evaluate donors based on concrete risky behaviors, such as having unprotected sex with multiple sexual partners or sharing needles. Alternatively, we could inactivate pathogenic DNA and RNA with intercalating molecules such as amotosalen, which European blood centers already do routinely (10, 11). Coupled with robust testing and screening, these approaches will exclude fewer healthy donors while still minimizing the risk of transfusion-transmitted HIV.

The FDA’s policies must be grounded in science. Safely lifting the restrictions on blood donations has the potential to save millions of lives in a normal year (12). Now, plasma may play a crucial role in treating patients suffering from COVID-19. We cannot afford to turn away HIV-negative blood with lifesaving antibodies just because the donor is gay or bisexual.