In guidance issued by the Biden administration's Food and Drug Administration, they state that a person's race may make an an individual more "high risk" if they have contracted COVID-19, placing them higher on the list for receiving monoclonal antibodies and oral antivirals used to treat the virus.
The fact sheet released by the FDA, which approved the emergency use authorization of monoclonal antibody treatment sotrovimab, states that only patients considered "high risk" should be given the treatment. The guidance was updated in December of 2021, according to Fox News.
Conditions that would make a person high risk include: pregnancy, diabetes, obesity, cardiovascular disease, and chronic lung diseases like asthma and cystic fibrosis.
A paragraph at the end of the list goes on to state that "Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above."
Some states have issued their own guidances on administering the potentially life saving treatments, with New York and Utah explicitly stating that their risk factors include the race or ethnicity of the patient.
The New York State Department of Health issued guidelines as the end of last year outlining conditions that would qualify a person for these treatments, in light of the shortage of oral antibody and monoclonal antibody treatments in the state.
"Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19," the eligibility requirements state.
Guidelines issued by the state of Utah for the administration of monoclonal antibodies state that residents who are "non-white race or Hispanic/Latinx ethnicity" would receive two additional points when calculating their "COVID-19 risk score."
"Race/ethnicity continues to be a risk factor for severe COVID-19 disease, and the Utah COVID Risk Score is one approach to address equitable access to hard hit communities," the Utah guidance stated, adding a reminder that national guidance from the FDA "specifically states that race and ethnicity may be considered when identifying patients most likely to benefit from this lifesaving treatment."
Similarly, in Minnesota, the state's Department of Health wrote in their "Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic" that "Clinicians and health systems should consider heightened risk of progression to severe COVID-19 associated with race and ethnicity when determining eligibility for mAbs."
"FDA's acknowledgment means that race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for mAbs," the framework states. "It is ethically appropriate to consider race and ethnicity in mAb eligibility decisions when data show elevated risk of poor COVID-19 outcomes for Black, Indigenous and other people of color (BIPOC populations), and that this risk cannot be adequately addressed by determining eligibility based on underlying health conditions (perhaps due to underdiagnosis of health conditions that elevate risk of poor COVID-19 outcomes in these populations)."
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