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U.S. health authorities have approved the use of a drug containing synthetic antibodies to protect people against corona infection. The U.S. Food and Drug Administration (FDA) granted emergency approval Wednesday (local time) for Evusheld, a drug developed by AstraZeneca. However, the agency warned the drug is “not a substitute” for people in whom vaccination is recommended. The European Medicines Agency (EMA) also launched a “rolling review” process on Evusheld ready in October.
The drug may be used in the U.S. only in people with weakened immune systems or those who cannot be vaccinated for medical reasons such as a severe allergic reaction to vaccines. In these limited cases, the drug can be given to affected individuals age 12 and older.
Evusheld combines two types of synthetic antibodies that are administered in the form of two shots, one directly after the other. These antibodies help the immune system fight the virus by targeting the spike protein that allows the virus to enter the body’s cells.
According to the FDA, the drug protects against corona infection for up to six months. According to the agency, it cannot be given to people who are already infected – but AstraZeneca is exploring an appropriate use. Potential reactions to administration of the drug may include an allergic reaction, bleeding at the injection site, headache and fatigue.
FDA approval is based on a clinical trial conducted in unvaccinated people over 59 years of age or with a chronic disease or high risk of infection. During the study of 3500 people, about half of the participants were given a placebo. The study showed that the treatment reduced the risk of getting Covid-19 by 77 percent. Six months after treatment, the figure was 83 percent.
- source: kleinezeitung.at/picture:pixabay.com
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