Vaxneuvance

Vaxneuvance is given as a single injection in the muscle of the upper arm. The vaccine can only be obtained with a prescription.

For more information about using Vaxneuvance, see the package leaflet or contact your healthcare provider.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again. This helps to protect against the disease.

Vaxneuvance contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule’ that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified, then ‘conjugated’ (attached) to a carrier protein to help the immune system recognise them. The vaccine is also ‘adsorbed’ (fixed) onto an aluminium compound to enhance the immune response.

The ability of Vaxneuvance to produce antibodies that can protect against S. pneumoniae infection was shown in two main studies comparing the immune response measured 30 days after a single dose of Vaxneuvance with that caused by a single dose of a similar vaccine authorised in the EU (Prevenar 13) that contains 13 of the 15 different types of the S. pneumoniae bacterium contained in Vaxneuvance.  

In the first study, involving 1205 adults aged 50 and above, 52% to 81% of the 602 participants who were given Vaxneuvance had at least four times more antibodies against the 15 different types of S. pneumoniae than before vaccination. This response was comparable to that seen in the 600 participants who were given Prevenar 13.

The second study involved 1515 adults aged 18 to 49 years (including individuals at increased risk of pneumococcal disease). Of the 1133 participants who were given Vaxneuvance, 51.5% to 87.5% of participants had at least four times more antibodies for the 15 different types than before vaccination. This immune response was comparable to that seen in the 379 patients who were given Prevenar 13.

The most common side effects with Vaxneuvance (which may affect more than 1 in 10 people) are tiredness, muscle pain, and headache, as well as pain, swelling and reddening of the skin at the site of injection. Vaxneuvance must not be used in people who are hypersensitive (allergic) to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).

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

Vaxneuvance was shown to cause an immune reaction to different types of S. pneumoniae. This reaction is comparable to that caused by another authorised pneumococcal conjugate vaccine. It is therefore reasonable to conclude that Vaxneuvance can provide similar protection. Vaxneuvance also contains two types of S.pneumoniae not contained in the other vaccine. In addition, its most common side effects are mild and manageable. Therefore, the European Medicines Agency decided that Vaxneuvance’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 Vaxneuvance have been included in the summary of product characteristics and the package leaflet.

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

Vaxneuvance received a marketing authorisation valid throughout the EU on 13 December 2021.