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​​​Evusheld

Important Information About Evusheld

Healthcare providers can administer Evusheld (AZD7442) for pre-exposure prophylaxis (PrEP) of symptomatic COVID-19, prior to exposure to the virus for prevention of COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40 kg). The drug can provide protection for those not expected to mount an adequate immune response following vaccination, including those who are immunocompromised due to a medical condition or immunosuppressive medications, as well as those individuals for whom COVID-19 vaccination is not recommended. Evusheld (AZD7442) is a combination of two long-acting antibodies (tixagevimab and cilgavimab) and is administered by intramuscular (IM) injection. Healthcare providers should only administer Evusheld to individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to someone infected with SARS-CoV-2.

Emergency Use Authorization of Evusheld

AstraZeneca received initial Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational long-acting antibody (LAAB) combination therapy, Evusheld (tixagevimab co-packaged with cilgavimab) on December 8, 2021, and the EUA was updated on February 24, 2022. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.

Threshold Determination and Distribution of Evusheld

In alignment with the terms of the EUA for Evusheld (AZD7442), the U.S. Department of Health and Human Services (HHS) oversees the distribution of this product to administration sites across the country. Recurring threshold determinations (maximum available amount a central partner can order for a given distribution period) are made to state and territorial health departments, federal entities, and federal pharmacy partners on a monthly basis. These determinations are based on the total adult population within the jurisdiction (pro rata population distribution). Based on their respective threshold allotment, health departments then determine where in their jurisdictions product is distributed and how much.

Small Volume Ordering for Evusheld

HHS/ASPR partnered with AstraZeneca to establish an additional pathway for providers to access Evusheld for use with eligible patients. Individual providers and smaller sites of care that do not currently receive Evusheld through the HHS Health Partner Order Portal (or HPOP) distribution process can now order small, limited quantities of product (1-3 patient courses) directly from the manufacturer, AstraZeneca, through Evusheld’s sole distributor, AmerisourceBergen.

AstraZeneca has established a helpline to receive general product information as well as guidance for ordering.

Evusheld FDA EUA Resources

Evusheld Informational and Personal Story Videos

What is Evusheld?

 

Evusheld

Hello, I am Dr. Michael Anderson. I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID-19 therapeutics as well as focus on a pediatric response agenda. I’d like to talk with you about a very unique therapeutics that is used to prevent infection and that’s called Evusheld.

What is Evusheld?

Evusheld is a long-acting antibody used for pre-exposure prophylaxis, also known as PrEP. The drug can provide protection against infection of people not expected to mount an adequate immune response.

Who is eligible for Evusheld?

Evusheld is for adults and children 12 and over who are immunocompromised due to a medical condition or immunosuppressive medications. Evusheld is also for rare individuals for whom vaccination is not recommended due to a medical, health reason. Evusheld of course is not a substitute for vaccination.

As a PrEP treatment, Evusheld is for people not currently infected with COVID-19 and who have not been recently exposed to COVID-19. Evusheld is not a treatment for active COVID-19 infections. For more information about patient eligibility and administration of Evusheld, please see the resources found in the description and other videos in this series.

How is Evusheld administered?

Evusheld is given as two intramuscular injections at one sitting, ideally into the gluteal muscle. Before going home, patients should monitored for one hour after injection for any signs of severe but very rare allergic reactions.

What are the limitations of use for Evusheld?

Evusheld is not for people who test positive for COVID-19. Vaccination and boosters are recommended for immunocompromised individuals and any close contacts or household members. Evusheld does require a prescription and patients should wait at least 2 weeks after getting the COVID-19 vaccine before receiving Evusheld. Evusheld should be administered with caution in patients who have a coagulopathy or patients at risk for cardiovascular disease.

Evusheld is one of several COVID-19 therapeutics. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

Evusheld protects those who are not expected to mount an adequate immune response following vaccination. This video featuring Michael Anderson, MD, MBA, senior advisor at ASPR, discusses the use of Evusheld, a long-acting monoclonal antibody combination for use in pre-exposure prophylaxis (PrEP) of COVID‑19.

Patient Story

 

My name is Lashon Berry. I'm 45 years old and I live in Mesquite, Texas.

I was diagnosed with pulmonary fibrosis in April of 2012. When the COVID pandemic first arrived on the scene, it was very frightening. As a lung transplant recipient, our lungs are already very sensitive to just the simple things in the air outside. So, now we have this COVID-19 on the scene that can cause even more damage to our lungs. So, at this point, I've made a decision that I'm totally in place in the house - quarantining myself so that I can keep my lungs safe.

So, that means no hospital visits. There's no grocery stores. That means increased masks, sanitizer.

When a transplant patient thinks of COVID, unfortunately, the first thing you think of is your demise. Because for the average person, that is not immunosuppressed, a cold is something simple to them. But it's the flu to us. The flu to the average person is pneumonia to us. Pneumonia to the average person is just like death to us.

My medical team did inform all transplant patients that the vaccines would not give us the same amount of protection as it would an average person that was not immunosuppressed.

But, you always want to increase your chances of protecting this organ. The gift of organ donation is absolutely one of the best gifts that one could give the opportunity to save someone else's life in such a selfless moment.

It's amazing to me. I'm grateful for my donor family. The feeling of protecting my gift after receiving the Evusheld shot was one of a little more freedom. I felt like now I could breathe a little bit, maybe go out to the grocery stores again, just begin to live more and not live in fear.

Evusheld has been an opportunity for me to continue to enjoy my gift and to live life, to go and do things such as attend my son's football games this fall, to attend my nephew's wedding, just to be able to enjoy the gift and enjoy life.

Millions of people can benefit from Evusheld, a drug for the prevention of severe COVID-19 symptoms in immunocompromised people. Watch Lashon Berry share her inspiring story about her double-lung transplant, and how she felt Evusheld helped her get back to living life.

Patient Story

 

Hi. I'm Dr. Brian Koffman. I'm a retired family doctor, and I live in Los Angeles County.

In 2005, I was diagnosed with chronic lymphocytic leukemia. Our cancer is a cancer of the immune system, and as such, we were extraordinarily vulnerable to the ravages of a COVID infection.

Evysheld provides similar levels of protection to those who cannot mount a response to the vaccines, which should be the frontline protection for the majority of people.

I think it's important to understand how Evusheld works. It's only used to prevent COVID, just like a vaccination.

This is the pre-exposure prophylaxis. Evusheld is giving me antibodies that my B-cells can't make. And it's two antibodies that attach to different parts of the spike protein - the coronavirus that causes COVID-19. And these have been proven to be very effective neutralizing antibodies.

Once I had Evusheld on board, it was a sense of, "Now I'm protected." I have the same kind of protection that someone who's been vaccinated and has had a robust response to the vaccine enjoyed. I did feel more comfortable going on a plane to see my daughter and grandkids who I had not seen in two years.

I did feel more comfortable meeting with colleagues to discuss some of the research and things we were doing with the Evusheld aboard. I felt like, "Hey, I can reengage in the world." It was incredibly liberating.

As a health care provider speaking to another health care provider, I say, "Don't leave the immunocompromised patients behind. Pre-Exposure prophylaxis with Evusheld is probably your absolute best option for protecting these patients from symptomatic COVID and death."

Dr. Brian Koffman, Evusheld recipient and Chief Medical Officer/Executive Vice President of the Chronic Lymphocytic Leukemia Society, shares his experience with receiving the drug.

Doctor Explanation

 

Hello. My name is Alfredo Meno Lora. I'm an infectious disease specialist and I work at Saint Anthony Hospital in Chicago and the University of Illinois at Chicago.

Monoclonal antibodies are very interesting therapeutics because we can create monoclonal antibodies, which are basically photocopies of antibodies against a specific target. And for COVID, our specific target, similar to vaccines, is the spike protein. So, what you get are antibodies ready-made that will attack the spike protein of the coronavirus.

What makes Evusheld different and interesting is that it's a long acting version of this medication and therefore people can receive the medication and it remains in their body for a prolonged period of time. And when they get exposed to COVID 19, they will have the defenses ready to protect them against the disease.

So, it is a prophylactic drug rather than a therapeutic drug. It is meant to prevent the disease rather than treat the disease.

Evusheld is recommended for folks who can't take the vaccine. And this could be for a variety of reasons, including adverse events or allergies or contraindications to the vaccines. The reality is that those indications are relatively rare and Evusheld is mostly used for individuals who have immuno-compromising conditions that despite the vaccine, are unable to have the full response from it.

Evusheld is available not just for adults but for children above the age of 12 who weigh over 40 kilograms.

There are no major contraindications for Evusheld. In general, what you should look out for is if you have any history of allergies to make sure that none of the components of Evusheld are something that you are allergic to.

Patients should wait about approximately two weeks after getting their COVID vaccine in order to get every shot. And this is true for boosters and for your initial doses of the vaccine as well. And the concept here is similar to actively having COVID 19 or being exposed to somebody with COVID-19 recently. You want to make sure that you use Evusheld when you're going to get the maximum benefit from it.

I think the importance of a tool like Evusheld cannot be understated. Vaccines are the most important choice, but in individuals where the vaccines can't go as far as the general population, Evusheld is an extremely important and the best tool in the toolbox to keep you healthy and safe in addition to vaccines, if you can take them.

Dr. Alfredo J. Mena Lora, Infectious Disease Specialist at St. Anthony Hospital in Chicago, explains how health care professionals can use Evusheld in their practice for people who are immunocompromised or cannot get the COVID-19 vaccine.

Evusheld Frequently Asked Questions

Evusheld is a combination of two monoclonal antibodies (tixagevimab and cilgavimab) that is authorized to prevent coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are unable to receive or unable to respond to vaccination to prevent COVID-19. Evusheld is a pre-exposure preventative medication authorized only for individuals that are not infected and have not had a recent exposure to an individual known to be infected with SARS-CoV-2.

Evusheld is authorized for adult and pediatric individuals (12 years of age and older weighing at least 40 kg) who are not currently infected or recently exposed to SARS-CoV-2 and have moderate to severe immune compromise or for whom vaccination with any available COVID-19 vaccine 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). When supply of Evusheld is limited, the NIH COVID-19 Treatment Guidelines Panel has outlined recommendations for priority of use within the eligible population.

HHS will utilize a state and territory-coordinated process for the distribution of Evusheld. HHS will determine the amount of product each state and territory receives on a recurring basis. State and territorial health departments will then determine exactly where within their jurisdictions the product will be allocated. Federal allocations to state/territorial health departments are provided free of charge and are determined based on the adult population within the jurisdiction (pro rata basis).

Initial treatment with Evusheld is administered as two separate intramuscular injections of each monoclonal antibody (tixagevimab and cilgavimab).

Evusheld will be available to eligible patients at little to no cost. While the drug is free to eligible individuals, there may be an associated administration fee.

Yes, a prescription is required to receive Evusheld.

Recent data demonstrate reduced potency of Evusheld against some variants of concern, including B.1.1.529/BA.1 (Omicron) and BA.1.1 (Omicron subvariant). Subsequent modeling has informed an initial dose increase to provide adequate neutralization for all currently circulating SARS-CoV-2 variants of concern.

The U.S. Food and Drug Administration and AstraZeneca are providing public information to promote awareness of the immediate need for a second dose of Evusheld for patients who received an initial dose since December 2021 prior to the change in dosing. This need is also being communicated directly to healthcare providers through a Dear Healthcare Provider letter and through informational briefings with patient organizations and care providers who represent or treat immune compromised individuals.

Contact your healthcare provider to confirm your current eligibility to receive Evusheld and to receive guidance concerning your need for additional doses.

Whether or not you previously received preventive treatment with Evusheld, it is important to act promptly to self-test or otherwise be tested for COVID-19. If your test for the virus is positive, you should contact a healthcare provider as soon as possible about your options for early treatment to prevent development of severe disease.

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