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 receivedTrusted Source an emergency use au-thorization 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 condi-tions or medications who might not adequately re-spond to vaccines. This group includes people re-ceiving chemotherapy for cancer and those who have previously had a transplant and are on immu-nosuppressant medications.
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. A 2021 studyTrusted Source 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 injec-tion 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 comple-mentary 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.
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The study listed other possible side effects as hyper-sensitivity 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.
