Evusheld – is authorised for use in the European Union

Evusheld is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission.

Evusheld is a medicine used to prevent COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kilograms.

Evusheld contains two active substances, tixagevimab and cilgavimab.

How is Evusheld used?

Evusheld is given as two injections of 150 mg tixagevimab and 150 mg cilgavimab at different sites, preferably in the gluteal muscles.

The medicine can only be obtained with a prescription and should be given under conditions that allow patients to be adequately monitored and managed in case they develop severe allergic reactions, including anaphylaxis.

How does Evusheld work?

Evusheld contains tixagevimab and cilgavimab, two monoclonal antibodies. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Tixagevimab and cilgavimab have been designed to attach to the spike protein of SARS-CoV-2 (the virus that causes COVID-19) at two different sites. 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.

What benefits of Evusheld have been shown in studies?

One main study involving over 5,000 people showed that Evusheld reduced the risk of COVID-19 infection by 77%, with 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 received a COVID-19 vaccine or other preventative treatment received Evusheld or placebo (a dummy injection). Of the people given Evusheld, 0.2% (8 out of 3,441) had lab-confirmed breakthrough COVID-19, compared with 1.0% (17 out of 1,731) of the people who received placebo.

The study data were collected before the emergence of the Omicron variant. Laboratory studies show that the Omicron BA.1 variant may be less sensitive to tixagevimab and cilgavimab at 150 mg doses than the Omicron BA.2 variant.

What are the risks associated with Evusheld?

The most common side effects with Evusheld (which may affect up to 1 in 10 people) are hypersensitivity (allergic reactions) and reactions at the site of injection.

For the full list of side effects and restrictions of Evusheld, see the package leaflet.

Why is Evusheld authorised in the EU?

Evusheld was shown to reduce the risk of COVID-19 infection in the first six months after treatment. The safety profile of Evusheld is favourable and side effects are generally mild.

The European Medicines Agency therefore decided that Evusheld’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Evusheld?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Evusheld have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Evusheld are continuously monitored. Suspected side effects reported with Evusheld are carefully evaluated and any necessary action taken to protect patients.

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