Search
Close this search box.
Search
Close this search box.

Recent News & Advisories

Visit the Health News and Alerts page

Health Advisory: Evusheld No Longer Authorized for COVID-19 Prevention

Published Jan. 31, 2023

On January 26, 2023, the Food and Drug Administration (FDA) announced that Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for use in the U.S.

Facilities and providers should continue to store Evusheld in the event that variants susceptible to Evusheld become more prevalent.

Evusheld Effectiveness

Evusheld is unlikely to be active against SARS-CoV-2 variants projected to make up more than 90% of the variants currently circulating in the U.S. This means that Evusheld is not expected to protect against developing COVID-19 if exposed to those variants.

Authorized COVID-19 Treatments

The following treatments, all of which work against currently circulating variants, are authorized or approved to treat patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should assess whether treatments are right for their patients.

  • Paxlovid is authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing.
  • Lagevrio (molnupiravir) is authorized to treat mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
  • Veklury (remdesivir) is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized.
  • COVID-19 Convalescent Plasma with high titers of anti-SARS-CoV-2 antibodies is authorized to treat COVID-19 in patients with an immunosuppressive disease or receiving immunosuppressive treatment in inpatient or outpatient settings.

Learn more at COVID-19 Treatment Information for Providers (tpchd.org)

Evusheld Storage

While the U.S. government and AstraZeneca have paused the distribution of Evusheld until further notice, the Office of the Assistance Secretary for Preparedness and Response (ASPR) and the U.S. Department of Health and Human Services (HHS) recommend that facilities and providers continue to store Evusheld in the event that variants susceptible to Evusheld become more prevalent. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.

References

ASPR/HHS

AstraZeneca

CDC

FDA

Washington State Department of Health (DOH)