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Monoclonal Antibody Pre-Exposure Prophylaxis for Immunocompromised Patients

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld™ (tixagevimab and cilgavimab). Evusheld is a potent new COVID-19 protective measure (monoclonal antibody) designed to prevent COVID-19 infection in vulnerable and immunocompromised individuals who may not mount an adequate immune response to COVID-19 vaccination.

What Is Evusheld And How Is It Administered?

In immunocompromised patients, a vaccination may not generate enough immune response, so they are still vulnerable to severe infection. Evusheld gives additional immunity to help prevent COVID-19.

Evusheld is a combination of two monoclonal antibodies given in two consecutive injections in the arm, in one visit, to qualifying patients who do not have COVID-19. Patients will be monitored for one hour afterward for any side effects.

UPMC also offers monoclonal antibody treatment for patients with COVID-19.

Who Is Eligible For Monoclonal Antibody Pre-Exposure Prophylaxis (Evusheld)

The current FDA has given an EUA for this medicine to be given to those with specific illness or medical situations which puts them at high-risk of developing severe COVID-19 illness.

Prioritization Guidelines

Because of current limited supply, patients will be prioritized based on risk of severe disease and likelihood to have adequate response to vaccine, and then put into a lottery-based allocation system to determine the order in which they will be offered the drug.

Eligibility Criteria:

Adults and pediatric individuals (12 years of age and older weighing at least 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 have moderate to severe immune compromise 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).

How Will Patients Find Out If They Qualify?

At this time, UPMC is directly contacting patients who are allocated medication in the lottery. UPMC will reach out to all qualifying patients as soon as possible, but it will likely take months until all eligible patients are able to receive this medication due to supply constraints.