The European Medicines Agency (EMA) now recommends granting a marketing authorisation for the Evusheld vaccine, developed by AstraZeneca, against the coronavirus.
The vaccine can be administered to people from 12 years old weighing at least 40 kg, before potential exposure to the virus, announced EMA’s human medicines committee (CHMP) on Thursday.
Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to attach to the spike protein of the coronavirus. "When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection," said EMA.
The Agency evaluated data from a study in over 5,000 people showing that Evusheld – given as two injections of 150 mg tixagevimab and 150 mg cilgavimab – reduced the risk of Covid-19 infection by 77%, with the duration of protection from the virus estimated to be at least six months.
In the study, adults who had never had Covid-19 and had not been vaccinated with another vaccine received Evusheld or a placebo. Of the people given Evusheld, 0.2% (8 out of 3,441) had lab-confirmed breakthrough Covid-19 in the first six months after treatment, compared with 1.0% (17 out of 1,731) of the people who received placebo.
Side effects of vaccination were generally mild, with a small number of people reporting reactions at the injection site or hypersensitivity. "The CHMP concluded that the medicine’s benefits are greater than its risks in the approved use and will now send its recommendation to the European Commission for a rapid decision applicable in all EU Member States."