The Food and Drug Administration has approved the use of Evusheld, a combination of long-acting antibodies, for prevention of Covid-19, FDA director Paisal Dankhum said on Wednesday.
Evusheld combines monoclonal antibodies for the prevention, not treatment, of Covid-19. It is not intended to be a substitute for coronavirus vaccines.
It was developed by AstraZeneca and approved by the FDA for emergency use on June 27. It has also been authorised for emergency use by the US Food and Drug Administration and the European Union.
Evusheld is a combination of two active substances, tixagevimab co-packaged with cilgavimab, and works on the principle of "passive immunisation".
It is administered as two injections, with protection lasting for at least six months.
It can be used in adults and children from 12 years of age up weighing at least 40 kilogrammes.
Dr Paisal said people who need to use this medicine should provide doctors with information such as their history of allergies, treatment for coronary artery disease, pregnancy and vaccination history.