Editor’s note: The FDA has revised the emergency use authorization for Evusheld, limiting its use. This is because data shows that Evusheld is unlikely to offer protection against certain SARS-CoV-2 variants currently in circulation.
Much of the nation has unmasked, considering the Centers for Disease Control and Prevention’s COVID-19 community level guidance. While this has given many Americans a sense of liberation from the exhausting precautionary rituals of pandemic existence, the situation is different immunocompromised patients.
The United States still needs to navigate the pandemic amid the search for a new normal, which also means protecting more than 7 million people with compromised immune systems who remain vulnerable to COVID-19 and many other infectious diseases. But with the availability of Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention, there’s some help these patients.
Evusheld received emergency use authorization from the Food and Drug Administration (FDA) in December for those 12 or older who weigh at least 88 pounds and are moderately to severely immunocompromised due to a medical condition or immunosuppressive medications or treatments, or those unable to get vaccinated with any available COVID-19 vaccine due to a history of severe adverse reaction to a COVID-19 vaccine or vaccine component.
The medication can offer lifesaving protection for people whose immune systems have not mounted responses to one of the three COVID-19 vaccines available in the U.S.
Evusheld was studied in a randomized, double-blind, placebo-controlled clinical trial among patients 59 or older, or who had a chronic condition, or were at higher risk of SARS-CoV-2 infection and hadn’t received a COVID-19 vaccination and had no history of SARS-CoV-2 infection.
The 3,441 people getting Evusheld saw a 77% lower risk of developing COVID-19 compared with the 1,731 patients who got a placebo, according to the FDA. That was by day 183 of the trial. That risk reduction was maintained for the Evusheld patients through six months.
It can be hard for patients to understand what Evusheld is, said AMA member Erin Schwab, MD, a hematologist-oncologist in Breckenridge, Colorado
“This is a very generic way of saying this: We’re putting in antibodies to bind the SARS-CoV-2 virus to make it so that they don’t get sick,” said Dr. Schwab, also an alternate delegate for the American Society for Clinical Oncology. “That’s about as basic as I can make it,” she added, noting that the concept can be hard for many patients to grasp.
Patient “hesitations are often about what it is they are getting, but a lot of these patients are already getting antibody-based treatment, so they kind of understand,” she said. Dr. Schwab shared some tips for physicians to consider when prescribing and administering Evusheld.
As a combination of the monoclonal antibodies tixagevimab and cilgavimab, Evusheld is used for patients with compromised immune systems to “decrease severe infections and hospitalizations,” said Dr. Schwab. “At the day-of injection with Evusheld, they cannot be currently infected with SARS-CoV-2, not had any known exposure within the last 10 days and not had a COVID-19 vaccine within the past two weeks.”
“Evusheld is for prophylaxis and got the approval for solid-tumor and hematological malignancies, transplant, chimeric antigen receptor T cell therapy, moderate to severe primary immunodeficiency, advanced and untreated HIV, and those on high-dose corticosteroids,” she said.
Additionally, patients with chronic lymphocytic leukemia “don’t mount responses really well to vaccination,” Dr. Schwab said. “We’ve had one or two who refuse to get the vaccine because they don’t see the point of putting this in their body when they know they won’t mount a response, but they’re OK with Evusheld and the literature does support that too.”
“It does have side effects like an allergic reaction, pain at the site where it’s given. But overall, we haven’t had any reactions to it at this point,” Dr. Schwab said, noting “there is a rare side effect of a cardiac event … but that occurs mostly in people who have had some sort of heart issues before.” According to the FDA, “It is not clear if Evusheld caused these cardiac adverse events.”
“I’m used to the allergic reactions in our patient population because of the drugs I give,” she said. But “we’re pretty prepared when we see that because we keep the patients here for about an hour while we wait to see if there is a reaction that happens.”
There is a lot of information associated with administering Evusheld, so Dr. Schwab makes sure she has the handout readily available for each patient. This allows her to follow a checklist to ensure the patient is eligible for Evusheld and it is administered properly.
“We have to go over why we're doing it, how it works, and you have to literally hit the check marks as you go through it,” she said. That’s why she recommends keeping Evusheld fact sheets on hand. Learn more from the FDA’s fact sheet for physicians and other health professionals (PDF), as well as one for patients, parents and caregivers (PDF).
In February, the FDA revised the dosing regimen for Evusheld because available data indicated that a higher dose may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized dose.
Physician practices should contact patients who received the previously authorized Evusheld dose and ask them to return for an additional 150 mg tixagevimab and 150 mg cilgavimab dose as soon as possible.
Visit the AMA COVID-19 resource center for clinical information, guides and resources, and updates on advocacy and medical ethics.