The fact sheet issued by the FDA, which approved the emergency use authorization of monoclonal antibody treatment Sotrovimab, declares that just 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 section at the end of the list continues 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."
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Some states have issued their own guidance on distributing the possibly life-saving treatments, with New York and Utah explicitly declaring that their risk factors include the race or ethnicity of the patient.
The New York State Department of Health published guidelines at the end of last year summarizing conditions that would qualify a person for these treatments, in light of the state’s shortage of oral antibody and monoclonal antibody treatments.
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"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.
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Guidelines published by the state of Utah for administering monoclonal antibodies state that residents who are "non-white race or Hispanic/Latinx ethnicity" would get two further points when calculating their "COVID-19 risk score."
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"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 declared, 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."
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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 the 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 declares.
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