On Wednesday, the US Food and Drug Administration approved the use of AstraZeneca’s synthetic antibodies to prevent Covid-19 infections in persons who have had a severe reaction to vaccinations.
The Food and Drug Administration granted emergency approval for such a purely preventative treatment for the first time.
The medicine Evusheld, according to the FDA, is “not a substitute for vaccination in those for whom Covid-19 immunization is advised” and can only be used by patients with a weaker immune system or who are unable to be vaccinated due to medical reasons, such as a severe allergic response.
The medicine can be given to people aged 12 and up in those circumstances. Evusheld is a drug that combines two synthetic antibodies (tixagevimab and cilgavimab) and is administered as two intramuscular injections, one after the other. These antibodies aid the immune system in combating the virus by focusing on the virus’s spike protein, which permits it to enter and infect cells.
The FDA stated that the medication “may be beneficial for six months for pre-exposure prophylaxis.”
The FDA stated that it cannot be given to someone who is already infected with the virus, though AstraZeneca is testing it for this purpose.
Allergic reactions, bleeding from the injection site, headaches, and lethargy are all possible side effects.
The FDA’s approval was based on a clinical trial that included unvaccinated adults over the age of 59, those with a chronic disease, and those who were at high risk of infection.
3,500 patients were given the medicine, while 1,700 were given a placebo. The therapy reduced the probability of developing Covid-19 by 77 percent in the experiment.
