New guidance issued by the FDA and the Biden administration states specific people may be considered a higher risk based on race or ethnicity and more easily qualify for monoclonal antibody and oral antiviral treatments for COVID-19.
An updated fact sheet for healthcare providers from the Food and Drug Administration approved emergency use authorizations of Sotrovimab only to patients considered “high risk.”
The update from December 2021, says “medical conditions or factors such as race or ethnicity place individual patients at high risk for progression to severe COVID-19.”
The FDA still considers older age, obesity, pregnancy, chronic kidney disease, diabetes, and cardiovascular disease as medical conditions that place someone in a high-risk category.
States such as New York and Utah have made it clear they will prioritize certain racial minorities over other high–risk patients regarding the distribution of particular COVID treatments.
New York’s Department of Health released a document detailing its plan to distribute monoclonal antibody treatment and antiviral pills late last week.
The new plan contains a section on eligibility for antiviral pills people must meet in order to receive the treatment. The eligibility statement includes a line stating a person needs to have “a medical condition or other factors that increase their risk for severe illness.”
One such factor listed is a race or ethnicity that is not White. The factor is a priority due to “longstanding systemic health and social inequities.”
“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,” per the updated memo.
Utah’s recently issued guidelines for distributing monoclonal antibodies in the state say that residents who are “non-white race or Hispanic/Latinx ethnicity” will 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.
The 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.”
The state of Minnesota’s updated framework advises clinicians and health systems to “consider the heightened risk of progression to severe COVID-19 associated with race and ethnicity when determining eligibility.” The framework applies specifically to the state’s distribution and administration of monoclonal antibody treatments.
The Minnesota framework states that “race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for mAbs.”
“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),” according to the framework.
More states are expected to adopt the same practice as guidance from the FDA is integrated into each state’s healthcare protocol.
