Expansion of Treatment for Outpatients with Mild-to-Moderate COVID-19

At a time when effective therapies against the Omicron and Delta variants are in high demand, the U.S. Food and Drug Administration (FDA) recently approved Veklury (Remdesivir) to treat non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19, including hospitalization or death. This approval expands the role of Veklury, which is the antiviral standard of care for treating patients hospitalized with COVID-19. The drug had previously been limited to hospitalized patients.


Additionally, the FDA expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who test positive for COVID-19 and are at high risk for progression to severe COVID-19.


Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Eligible American Indians and Alaska Natives are to get vaccinated and received booster to help protect their communities. Vaccination prevents serious outcomes related to COVID-19, including hospitalization and death. If you have been vaccinated continue to show an Act of Love by wearing a mask to help keep elders, young children, your community, and yourself healthy.


Safety information about using Veklury to treat COVID-19 in certain non-hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and parents/caregivers.


Additional Resources:

National Institutes of Health COVID-19 Treatment Guidelines for High-Risk, Non-hospitalized Patients with Mild to Moderate COVID-19