The FDA has authorized the antibody drug Evusheld for use in people who can’t get COVID-19 vaccines. HUIZENG HU/Getty Images
- Federal authorities have granted emergency use authorization for Evusheld, an antibody combination drug.
- The two-dose injection is authorized for use in some groups of people who aren’t eligible for COVID-19 vaccines.
- Evusheld works by supplying people with antibodies to fight off infections from the coronavirus.
There’s a new tool in the fight against COVID-19, but it’s not a vaccine.
An antibody combination drug known as Evusheld has received an emergency use authorization from the Food and Drug Administration (FDA) to help prevent COVID-19 in some adults and children over the age of 12 who are at least 88 pounds.
Under this therapy, a person receives two injections, administered within the same medical appointment. It protects from the illness for about 6 months.
The FDA authorized Evusheld for two groups of people:
- People with moderate to severe compromised immune systems from medical conditions or medications who might not adequately respond to vaccines. This group includes people receiving chemotherapy for cancer and those who have previously had a transplant and are on immunosuppressant medications.
- People who have had a severe adverse reaction to the COVID-19 vaccine or its ingredients.
Vaccines are still considered the best defense against developing COVID-19 or experiencing severe illness, being hospitalized, or dying.
However, Evusheld is an alternative for people who cannot receive the vaccine.
The research on Evusheld
A 2021 study at Vanderbilt University in Nashville, Tennessee, looked at the effectiveness of Evusheld at preventing COVID-19.
The research included 5,172 people over the age of 59 or with certain chronic health conditions. Participants had not received a vaccine, did not have a history of COVID-19, and did not test positive for it at the beginning of the trial.
Of the participants, 3,441 received the double injection of Evusheld, and 1,731 received a placebo.
Researchers kept track of whether participants were diagnosed with COVID-19 before day 183 of the trial.
Researchers reported that people who received Evusheld had a 77 percent reduced risk of developing COVID-19 compared with the group that received a placebo. The protection from Evusheld lasted for 6 months.
Additional research performed by the FDA and the Centers for Biologics Evaluation and Research looked at whether Evusheld can help in the fight against the Omicron variant.
“The study shows Evusheld retains neutralization activity against the Omicron variant. By combining two potent antibodies with different and complementary activities against the virus, Evusheld was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants,” said Menelas Pangalos, the executive vice president of biopharmaceutical research and development at AstraZeneca, in a statement.
The side effects
The FDA reported that the most common side effects of Evusheld are headache, fatigue, and cough.
The study listed other possible side effects as hypersensitivity reactions, including anaphylaxis, and bleeding at the injection site.
Serious cardiac events were infrequent in participants at risk of cardiac disease. However, more participants who received Evusheld experienced adverse cardiac events than those who received a placebo.
All participants who had cardiac issues during the study period had a history of cardiovascular disease, so it’s not clear whether Evusheld contributed to the cardiac problems during the study period.
Evusheld vs. vaccines
Despite its protective properties, Evusheld is not a vaccine.
“Vaccines work by teaching the body how to quickly develop antibodies and white blood cells when exposed to a virus. For some people, even after they get vaccinated, their bodies do not develop a sufficient immune response to develop the needed antibodies to fight the infection. Instead of relying on your body to create the antibodies, Evusheld provides them directly,” explained Beth Beatriz, PhD, an epidemiologist with the Massachusetts Department of Public Health and public health expert at Parenting Pod.
“But for most people, the vaccines are best because they teach your body to react using many infection-fighting tools,” Beatriz told Healthline. “Evusheld is a good option for the small portion of the population for whom the vaccines are unlikely to work or who have severe reactions.”
Evusheld is not currently used to treat coronavirus infections.
However, it is currently being studied as a post-COVID-19 treatment for hospitalized patients and as an additional medication for treatment while in the hospital, according to AstraZeneca officials.