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In December 2021, the U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) for a new anti-COVID-19 medication, the AstraZeneca product called Evusheld™. This monoclonal antibody preparation is designed to prevent COVID-19 infection in vulnerable and immunocompromised individuals who may not mount an adequate immune response to COVID-19 vaccination.
The EUA allows Evusheld to be given as pre-exposure prophylaxis for individuals age 12 and older who are moderately to severely immunocompromised, or for whom vaccination is not recommended due to a history of severe allergic reactions to vaccines. It is not intended as a substitute for vaccination. It is given as an injection into the muscle.
Learn more about other monoclonal antibody treatments for COVID-19.
Here’s what to know about Evusheld.
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Monoclonal Antibody: What Is Evusheld?
Evusheld, made by AstraZeneca, is a combination of tixagevimab and cilgavimab.
It is currently the only antibody authorized in the United States for pre-exposure prophylaxis. Pre-exposure prophylaxis means that patients receive the drug before being exposed to or infected with SARS-CoV-2.
Who Is Eligible For Evusheld?
The FDA has given an EUA for this medicine to be given to those with specific illnesses or medical situations that put them at high risk of developing severe COVID-19 illness.
Adults and pediatric individuals (12 years of age and older) weighing at least 88 pounds (40 kg):
- Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, AND:
- Who are moderately to severely immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, OR
- For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Situations that could make someone moderately to severely immunocompromised and eligible for Evusheld include:
- Receiving active chemotherapy for any solid tumor malignancy.
- Hematological malignancy.
- Solid organ transplant and taking immunosuppressants.
- Receipt of CAR-T within two years or maintained on immunosuppression.
- Hematopoietic cell transplant within the past two years or maintained on immunosuppression or IgG replacement.
- Primary immunodeficiency.
- AIDS (CD4 count < 200 or 15%).
- Graft-versus-host disease (GVHD) receiving immunosuppression.
- Receiving T- or B- cell compromising drug.
- Anatomic or functional asplenia.
- Sickle cell anemia or thalassemia.
- Aplastic anemia.
- Stage IV chronic kidney disease (CKD) or worse (i.e., requiring renal replacement therapy).
- Neutropenia (ANC < 1000).
- Myelodysplastic syndrome on therapy.
- Age ≥65 AND:
- Nonresponsive antibody assay OR
- Two or more impairments of Assisted Daily Living (ADL).
- SARS-CoV-2 antibody seronegative after three previous vaccines.*
- All other immunosuppressive conditions receiving immunotherapy.**
*Routine evaluation of vaccine response by antibody titer is not recommended. Evusheld is indicated for individuals at risk for vaccine non-response and seronegative despite three vaccine doses.**This includes patients receiving corticosteroids at a dose equivalent to either ≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg when administered for ≥14 consecutive days.
This list does not include all medical conditions defined as moderately to severely immunocompromised. People with rare medical conditions not listed may be appropriate for Evusheld and the vaccine schedule for immunocompromised individuals.
How Does Evusheld Work?
Evusheld is a medication called a monoclonal antibody. It is given to patients to help prevent COVID-19. Evusheld works by preventing the virus from entering your body.
This medication is given as two shots in one visit. After receiving the shots, you will be monitored for one hour for side effects.
Evusheld is designed to recognize and attach to a specific part of the virus — the spike protein of SARS-CoV-2. It is designed to protect immunocompromised patients from the virus. However, unlike the COVID-19 vaccines, Evusheld provides the antibodies to you directly instead of training your body to make them.
How Can I Receive Evusheld?
Contact your UPMC provider if you think you qualify for Evusheld. UPMC providers can refer you to a UPMC infusion center to receive Evusheld. Some providers are also offering Evusheld in their clinics.
For more information about Evusheld and monoclonal antibodies, visit our website.
Editor's Note: This video was originally published on , and was last reviewed on .
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