The US health authorities today have approved the use of Evosheld.
Washington, USA:
US health authorities on Wednesday authorized the use of synthetic antibodies developed by AstraZeneca to prevent Covid-19 infection in people who have reacted badly to the vaccine.
This is the first time the Food and Drug Administration has granted emergency authorization for such a purely preventive treatment.
The FDA warned that the drug Evusheld “is not a substitute for vaccination in people who are recommended to be vaccinated against Covid-19” and may only be given to people with weakened immune systems or who cannot be vaccinated. for medical reasons, allergies.
In those cases, the drug may be given to people 12 years of age and older.
Evusheld combines two types of synthetic antibodies (tixagevimab and cilgavimab), and is given as two consecutive intramuscular injections. These antibodies help the immune system fight the virus by targeting its spike protein, allowing it to enter cells and infect them.
The FDA says that the treatment “may be effective in preventing pre-exposure for six months.”
The FDA says it cannot be used for people who are already infected with the virus, although AstraZeneca is testing it for such a treatment.
Side effects may include allergic reactions, bleeding from the injection site, headache, and fatigue.
The FDA’s approval was based on a clinical trial conducted in unvaccinated people who were over 59 years old, had a chronic illness, or were at high risk for infection.
The drug was given to 3,500 people while 1,700 people were given a placebo. The trial showed that the treatment reduced the risk of developing Covid-19 by 77%.
Two antibody-containing cocktails, led by Regeneron and Eli Lilly, are currently authorized to prevent infection in the United States, but only in people who have been briefly exposed to the virus or who are likely to have been exposed to the virus. high exposure, such as staff at a retirement home or prison.
In addition to being immunocompromised or unvaccinated, these people must also be at high risk of developing a severe case of the disease.
