FDA guidance: Race matters

Similar to the New York state Department of Health, the Food and Drug Administration is urging health-care providers to consider race or ethnicity, as well as underlying medical conditions, when classifying individuals as high risk for progression to severe COVID-19 and qualifying for antibody treatment.

A fact sheet issued by the FDA detailing the emergency-use authorization of the drug sotrovimab for treatment of mild to moderate COVID-19 cases includes a list of medical conditions that may qualify patients for its use.

The document also notes that “[o]ther medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19.”

Those conditions include advanced age (65 or older), obesity, pregnancy, diabetes, cardiovascular disease, chronic lung disease and neurodevelopmental disorders.

As the treatment is specified as being for mild to moderate cases, it is not authorized for patients who are hospitalized because of COVID-19, require oxygen therapy due to the virus or require an increase in oxygen flow.

A recent notice from the New York Health Department detailing the criteria for individuals to receive oral antiviral treatment said that “nonwhite race or Hispanic/Latino ethnicity should be considered a risk factor” due to systemic health and social inequities that have “contributed to an increased risk of severe illness and death from COVID-19.”

In Utah, officials are using a point system to determine who receives monoclonal antibody treatment. When calculating “risk score,” the state gives two points to patients who are of “Non-White race or Hispanic/Latinx ethnicity.” The same number of points is given to patients who have “Highest-Risk Comorbidities,” such as obesity.