US health officials on Wednesday authorized the use of synthetic antibodies developed by AstraZeneca to prevent COVID-19 infection in people who react badly to vaccines.
This was the first time the Food and Drug Administration had given emergency authorization for such a purely preventive treatment.
The FDA warned that the Evusheld drug “is not a substitute for vaccination in individuals for whom COVID-19 vaccination has been recommended” and may only be authorized for people with weakened immune systems or who were not vaccinated for medical reasons. Can be, such a strong allergic reaction.
In those cases, the drug can be given to people 12 years of age and older.
Evushield combines two types of synthetic antibodies (tixagvimab and silgavimab), and is given as two intramuscular injections, one after the other. These antibodies help the immune system fight the virus by targeting its spike protein, which allows it to enter cells and infect them.
The FDA said the treatment “may be effective for pre-exposure prevention for up to six months.”
It cannot be administered to someone who is already infected with the virus, the FDA said, although AstraZeneca is testing it for such treatment.
Side effects may include allergic reaction, bleeding from the injection site, headache and fatigue.
The FDA authorization was based on a clinical trial conducted on non-vaccinated people over the age of 59, or with a chronic disease, or at high risk of infection.
The drug was given to 3,500 people while 1,700 people got a placebo. The trial showed that the treatment reduced the risk of developing COVID-19 by 77%.
Two cocktails of antibodies, made by Regeneron and Eli Lilly, are currently authorized for the prevention of infection in the United States, but only in people who have been exposed to the virus shortly before, or who are at high risk of exposure. such as employees of retirement homes or prisons.
In addition to being immunized or uninfected, these people should also be at high risk of developing a severe case of the disease.