Evusheld deauthorized for COVID-19 prevention

Available in Spanish

photo of FDA headquarters in D.C.

The U.S. Food and Drug Administration has announced that, until further notice, Evusheld is no longer authorized for emergency use because it is not expected to protect against the COVID-19 subvariants currently circulating in the United States. As a result, it cannot be used for new patients or for patients who have received it in the past.

What is Evusheld?

Evusheld is a monoclonal antibody therapy that has been used to prevent COVID-19 in people with compromised immune systems who may not be good candidates for the COVID-19 vaccine, or who have had a negative medical reaction to the vaccine.

Why is Evusheld no longer authorized for use?

Evusheld is unlikely to protect patients from newer COVID-19 subvariants such as XBB, XBB.1.5, BQ.1 and BQ.1.1. These subvariants are currently causing an estimated 94% of new COVID-19 cases, making Evusheld considerably less effective than it was earlier in the pandemic.

I was taking Evusheld. What do I do now?

To help prevent COVID-19 illness, consider taking precautions like wearing a well-fitting mask indoors, washing your hands and avoiding crowds when possible. In the event of infection, you may be eligible for one of the approved and authorized treatment options for COVID-19 including Paxlovid (nirmatrelvir/ritonavir), Veklury (remdesivir) and Lagevrio (molnupiravir). These medicines must be prescribed by a health care professional and are expected to remain effective against currently circulating COVID-19 variants.

Am I eligible for treatment?

People with mild to moderate symptoms of COVID-19 are eligible for the above treatments if they:

  • are age 50 or older, or
  • have an underlying condition, especially moderate to severe immunosuppression, or
  • remain unvaccinated.

If you fall into one of these categories, you are at risk for severe COVID-19 illness and should get tested as soon as possible after symptom onset. If you test positive for COVID-19, you should start receiving treatment with one of the approved treatment options within five to seven days of symptom onset.

How do I get treatment?

OHA has partnered with the telehealth service Color Health, Inc. to offer free online or telephone support to get COVID-19 antivirals to eligible people within 24-48 hours, regardless of health insurance or citizenship status. The entire process, including remote evaluation by a health care professional and the medication itself, is completely free.

There are two options for using Color Health’s telehealth service, which is available every day, 8 a.m. to 8 p.m., in multiple languages.

  1. Visit this website and use the online form.
  2. Call 833-273-6330 (toll-free).

The federal Test to Treat (T2T) program is another way to receive COVID-19 treatments. Use this online locator tool to find a T2T location near you. The process is free with insurance, though some insurance policies will have a co-pay. If you don’t have insurance, the COVID-19 test and medication are free, but you may be charged a fee for the medical evaluation. Pharmacies should not ask for any fees associated with the medication itself, including dispensing fees. Proof of citizenship is not required.

For more information on how to use Test to Treat, check out our blog.