Arexvy
Authorised
This medicine is authorised for use in the European Union
Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Arexvy is a vaccine used to protect adults 60 years of age and older against lower respiratory tract disease (LRTD, diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV).
It can also be used in adults from 50 to 59 years old who are at increased risk for RSV disease.
Arexvy contains a version of a protein found on the surface of the virus called RSVPreF3.
The recommended dose is a single injection into a muscle, preferably into the muscle of the upper arm.
The vaccine can only be obtained with a prescription and should be used according to official recommendations issued at national level by public health bodies.
For more information about using Arexvy, see the package leaflet or contact your doctor or pharmacist.
Arexvy works by preparing the immune system (the body’s natural defences) to defend itself against a LRTD caused by RSV. Arexvy contains a protein from the surface of RSV. When a person is given the vaccine, the immune system treats the virus protein as ‘foreign’ and makes defences against it. If, later on, the vaccinated person comes into contact with the virus, the immune system will recognise the protein and be prepared to attack it. This will help to protect the person against LRTD caused by RSV.
In a study in over 25,000 adults aged 60 years and above, people who received Arexvy had a 83% reduction in their risk of getting LRTD caused by RSV compared with those who had a dummy injection.
In the group that received Arexvy, 7 out of 12,466 people got LRTD, while in the group that received a dummy injection, 40 out of 12,494 people got the disease.
A second study involved 386 people aged 50 to 59 years at increased risk of LRTD caused by RSV. Following vaccination with Arexvy, the immune response in these people was comparable to that seen in people 60 years old and above.
For the full list of side effects and restrictions with Arexvy, see the package leaflet.
The most common side effects with Arexvy (which may affect more than 1 in 10 people) include injection site pain, tiredness, muscle pain, headache and joint pain. These side effects are usually mild or moderate in intensity and resolve within a few days after vaccination.
At the time of authorisation of Arexvy, there was no vaccine to prevent RSV and no treatment other than supportive care for people 60 years of age and older and adults between 50 and 59 years of age who are at increased risk for RSV disease.
Arexvy was found to be effective in preventing LRTD caused by RSV in people 60 years of age and older. By preventing LRTD caused by RSV, the vaccine is also expected to reduce the risk of severe RSV disease in these people. In addition, data in adults aged 50 to 59 years of age showed a comparable immune response to that seen in people 60 years old and above. The vaccine is therefore expected to protect against LRTD caused by RSV in this group of people. There are no serious safety concerns with Arexvy and the European Medicines Agency therefore decided that it’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arexvy have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Arexvy are continuously monitored. Suspected side effects reported with Arexvy are carefully evaluated and any necessary action taken to protect patients.
Arexvy received a marketing authorisation valid throughout the EU on 06 June 2023.
Product information
Latest procedure affecting product information:
II/0008
26/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Arexvy
- Active substance
- Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology
- International non-proprietary name (INN) or common name
- Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
- Therapeutic area (MeSH)
- Respiratory Syncytial Virus Infections
- Anatomical therapeutic chemical (ATC) code
- J07
Pharmacotherapeutic group
VaccinesTherapeutic indication
Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in:
• adults 60 years of age and older;
• adults 50 through 59 years of age who are at increased risk for RSV disease.
The use of this vaccine should be in accordance with official recommendations.
News on Arexvy
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