Evusheld Treatment
December 16, 2021
What is the “Evusheld” treatment and how does it work?
Evusheld is a pre-COVID protection option developed by AstraZeneca that combines two monoclonal antibodies (tixagevimab and cilgavimab) in one injection. In a study of persons who were at high risk of severe illness, hospitalization, or death from COVID-19 because they were immunocompromised or ineligible to receive a COVID-19 vaccination, Evusheld was shown to reduce the risk of developing COVID-19 compared to those who received a placebo.
This drug combination can help to prevent COVID-19 by providing antibodies directly to a person through an injection. These antibodies work similarly to the antibodies developed after a COVID-19 illness or vaccination but instead of your own body producing the antibodies, these antibodies are already formed, ready for action, and are long-acting.
Tixagevimab and cilgavimab , the two long-acting monoclonal antibodies in Evusheld, target the spike protein of SARS-CoV-2, blocking the viruses’ attachment and entry into human cells.
Who is eligible to receive Evusheld?
The FDA has given an Emergency Use Authorization [EUA] for the use of this drug in persons aged 12 and older weighing at least weigh at least 40 kg [88 pounds] who, even though they have been vaccinated, have an immune disorder that may prevent them from developing an adequate supply of their own antibodies. It has also been approved for use in persons who have had an allergic response to a COVID-19 vaccine or are allergic to a vaccine component.
Some of the conditions that impair immune responses and would make persons eligible for this product include: primary immunodeficiency disorders, active treatment of cancer, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, advanced or untreated HIV infection. Those who are receiving certain medications such as a TNF inhibitor or immunosuppressive drugs designed to prevent the rejection of organ transplants are also eligible. If you have a weakened immune system and think your situation qualifies for treatment with Evusheld, contact your PCP to discuss your eligibility.
To qualify you cannot have been currently exposed to or infected with COVID-19.
This drug is not authorized for persons who have chosen not to be vaccinated, for treatment of a COVID-19 exposure, or for treatment of a COVID-19 infection. Those persons who develop early symptoms of COVID-19 and are diagnosed with the infection by their health care provider are reminded to seek treatment using a different monoclonal antibody product. For more information see the COVID-19 Treatment FAQ document.
Why did the FDA give Evusheld an EUA?
Evusheld’s emergency use approval followed the findings of a Phase 3 study in a trial called PROVENT. This drug trial enrolled over 5,000 people who were unvaccinated, had never had COVID-19, and were either 60+ years of age, had a pre-specified co-morbidity (obesity, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, immunocompromised state, or previous history of severe or serious adverse event after receiving any approved vaccine), or were at increased risk of SARS-CoV-2 infection due to their living situation or occupation.
How is Evusheld given?
Evusheld is administered by a health care provider as two consecutive intramuscular injections: 150 mg of tixagevimab and 150 mg of cilgavimab. The preferred injection site is the gluteal muscle.
The manufacturer recommends the patients be observed for approximately one hour after injection to make sure they do not experience any adverse effects.
What are the side effects of Evusheld?
In the clinical trials using Evusheld the most common side effects were headache, fatigue and cough.
Serious adverse events were rare in the PROVENT drug trial. The most serious adverse effects were heart-related (including heart attack). Persons with underlying heart disease who are also immunocompromised or allergic to the COVID-19 vaccine should discuss the benefit and risk of getting Evusheld with their health care provider.
What if I qualify but have been vaccinated?
The current recommendation is to wait for a minimum of 2 weeks after vaccination to receive an Evusheld injection.
How long does Evusheld protect a person from severe COVID-19?
Current evidence is the drug provides protection for approximately 6 months. Eligible persons can receive the injections every 6 months. However, AstraZeneca has not yet provided any safety or efficacy data on repeat injections except what is being observed in clinical trial data.
Sources:
FDA Fact Sheet for Healthcare Providers on Evusheld