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Modeling US blood donor deferrals under a policy of individual risk assessment for HIV risk sexual behavior
Barbee I Whitaker1, Yin Huang1, Diane Gubernot1
1FDA Center for Biologics Evaluation and Research, Office of Biostatistics and Pharmacovigilance, Silver Spring, Maryland, USA.
Insights
The FDA
Area of Science:
- Blood Transfusion Safety
- Public Health Policy
- Epidemiology
Background:
- FDA updated blood donor eligibility in May 2023, removing the 3-month deferral for men who have sex with men (MSM).
- A new individual risk assessment policy now applies to all donors, evaluating sexual behavior and partners within the last 3 months.
- This policy change aims to broaden the donor pool while maintaining blood safety.
Purpose of the Study:
- To model the potential impact of the FDA's new individual risk assessment policy on the US blood donor population.
- To estimate the percentage of blood donors who would be deferred under the revised eligibility criteria.
- To assess the likely effect of the policy change on blood supply availability.
Main Methods:
- A computational model was developed to simulate donor deferral rates.
- The model integrated demographic data of US blood donors.
- National survey data on HIV risk behaviors, including age, sex, and sexual activity, informed the model.
Main Results:
- The individual risk assessment policy is estimated to defer approximately 1.2% of US blood donors.
- This represents a minor reduction in the overall donor base.
- The impact is projected to be less significant than previous time-based deferral policies for men who have sex with men (MSM).
Conclusions:
- Replacing time-based deferrals with individual risk assessment is predicted to have a minimal impact on blood donor numbers.
- The new policy is unlikely to negatively affect the availability of blood and blood components.
- Further research is needed to observe the real-world effects as blood centers implement the policy, considering potential donor gains.
Background:
In May 2023, the Food and Drug Administration (FDA) released final guidance for blood donor eligibility that recommended the elimination of 3-month deferral for men who have sex with men (MSM) and the related deferral for women who have sex with MSM. In its place, FDA introduced an individual risk assessment policy of asking all presenting blood donors, regardless of sex or gender, if they have had a new partner or more than one sexual partner in the last 3 months and deferring those who also report anal sex (penile-anal intercourse) during this period. We modeled the possible impact of this policy on the US blood donor base.
Study Design And Methods:
We developed a computational model to estimate the percentage of blood donors who would be deferred under a policy of individual HIV risk assessment. The model incorporated demographic information about donors and national survey data on HIV risk behaviors and included age and sex distributions and dependencies.
Results:
Our model estimates that approximately 1.2% of US blood donors would be deferred under the individual HIV risk assessment paradigm.
Discussion:
The model predicts a relatively minor effect of replacing the time-based deferral for MSM with individual risk-based deferral for sexual behavior. As US blood centers implement this new policy, the effect may be mitigated by donor gains, which warrant further study. The new policy is unlikely to adversely affect the availability of blood and blood components.
