mResvia

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

The most common side effects with mResvia (which may affect more than 1 in 10 people) include pain at the injection site, tiredness, headache, muscle pain and joint pain. These side effects are usually mild in intensity and resolve within 1 to 2 days after vaccination.

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

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

mResvia received a marketing authorisation valid throughout the EU on 22 August 2024.

The main study found that mResvia is effective at preventing lower respiratory tract disease due to RSV in older adults. The vaccine has also been shown to provide an adequate immune response in people aged between 18 and 59 years who are at increased risk for lower respiratory tract disease caused by RSV; it is therefore expected to be effective at preventing disease in this population. The vaccine is generally well tolerated, with mild to moderate side effects that resolve within a few days.

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

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.

The recommended dose is a single injection into the muscle of the upper arm.

For more information about using mResvia, see the package leaflet or contact your doctor or pharmacist.

mResvia works by preparing the body to defend itself against RSV. It contains a molecule called mRNA which has instructions for making the RSV-A glycoprotein F. This is a protein on the surface of RSV-A (a subtype of RSV), which the virus needs to enter the body’s cells.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the RSV-A glycoprotein F. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (a type of white blood cells) to attack it. This immune response will also recognise a similar protein called RSV-B glycoprotein F, which is found on the RSV-B subtype.

If, later on, the person comes into contact with RSV, their immune system will recognise it and be ready to defend the body against it.

After vaccination, the mRNA from the vaccine is broken down and removed from the body.

A main study involved over 35,000 adults aged 60 years and above who received either mResvia or a dummy injection. Around 4 months after vaccination, people who received mResvia had an 84% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received a dummy injection. During this period, 9 out of 17,572 people who received mResvia got lower respiratory tract disease due to RSV with 2 or more symptoms compared with 55 out of 17,516 people who received a dummy injection.

Around 9 months after vaccination (by which time around 1,000 more people had joined the study), vaccination with mResvia was found to reduce the risk of RSV-associated lower respiratory tract disease by 63%. During this period, 47 out of 18,112 people vaccinated with mResvia got lower respiratory tract disease due to RSV with 2 or more symptoms, compared with 127 out of 18,045 people who received the dummy injection.

A second main study involved 502 people aged between 18 and 59 years who were at increased risk for lower respiratory tract disease caused by RSV. The study looked at the immune response triggered by the vaccine 29 days after vaccination, by measuring the blood levels of antibodies produced against the virus in the blood. The results showed that one dose of mResvia produced antibody levels against both RSV-A and RSV-B strains that were comparable to those seen in older vaccinated adults in the first main study. The effectiveness of the vaccine is therefore expected to be similar in younger adults at increased risk of disease and in people aged 60 years and older.