Capvaxive
Authorised
This medicine is authorised for use in the European Union
pneumococcal polysaccharide conjugate vaccine (21-valent)
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Capvaxive is a vaccine to protect adults against pneumonia (infection of the lungs) and invasive disease caused by the bacterium Streptococcus pneumoniae (S. pneumoniae). It is also used in adolescents and children from two years of age who previously completed a primary pneumococcal vaccination regimen for children.
Invasive disease occurs when the bacterium spreads through the body, causing conditions such as septicaemia (blood infection) and meningitis (infection of the membranes around the brain and spine).
Capvaxive contains parts from 21 different types of S. pneumoniae.
Capvaxive can only be obtained with a prescription. The vaccine is given as a single injection into a muscle, preferably of the upper arm.
The vaccine should be used according to official recommendations issued at national level by public health bodies.
For more information about using Capvaxive, see the package leaflet or contact your doctor or pharmacist.
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. This helps to protect against the disease.
Capvaxive contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule’ that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified and then ‘conjugated’ (attached) to a carrier protein to help the immune system recognise them.
Capvaxive contains the polysaccharides from 21 different types of S. pneumoniae (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B).
Two main studies involving over 4,000 adults showed that Capvaxive is effective at triggering the production of antibodies targeting the 21 different types of S. pneumoniae. These studies compared the level of antibodies triggered by Capvaxive to those generated by two authorised pneumococcal vaccines 30 days after vaccination. These included Prevenar 20, which contains 10 of the 21 S. pneumoniae types in Capvaxive, and Pneumovax 23, which contains 12 of the 21 S. pneumoniae types in Capvaxive.
In the first study, among adults aged 50 years and older, people given Capvaxive produced similar levels of antibodies as those given Prevenar 20 for the 10 types of S. pneumoniae polysaccharides they have in common. Adults aged 50 years and older who were given Capvaxive also produced more antibodies against 10 of the other 11 types of polysaccharides that are not in Prevenar 20. Further data showed that antibody levels triggered by Capvaxive for all 21 polysaccharides in adults aged 18 to 49 years was comparable to those in adults aged 50 to 64 years.
In the second study, among adults aged 50 and older, people given Capvaxive produced similar levels of antibodies as those given Pneumovax 23 for the 12 types of S. pneumoniae polysaccharides they have in common. The study also showed that Capvaxive was more effective than Pneumovax 23 for the 9 other polysaccharides.
An additional main study involved 882 adolescents and children from two years of age with one or more long-term conditions known to increase the risk of pneumococcal disease (including diabetes, heart and kidney disease) and who had completed a primary pneumococcal vaccination regimen at least 8 weeks before entering the study. The study compared the level of antibodies triggered by Capvaxive to that generated by Pneumovax 23, measured 30 days after vaccination.
The study showed that adolescents and children given Capvaxive produced similar levels of antibodies as those given Pneumovax 23 for the 12 types of S. pneumoniae polysaccharides the vaccines have in common. The study also showed that Capvaxive was more effective than Pneumovax 23 for the 9 other polysaccharides unique to Capvaxive, as expected.
Studies carried out with Capvaxive are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Capvaxive, see the package leaflet.
The most common side effects with Capvaxive in adults (which may affect more than 1 in 10 people) include pain at the injection site, tiredness, headache and myalgia (muscle pain). The most common side effects in adolescents and children from two years of age (which may affect more than 1 in 10 people) include pain, redness or swelling at the injection site, tiredness, headache, feeling generally unwell and irritability.
Most side effects with Capvaxive are usually mild or moderate and get better within three days after vaccination.
Capvaxive must not be used in people who are hypersensitive (allergic) to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Capvaxive triggered a strong immune response against 21 types of S. pneumoniae, as well as one additional, related type, as shown by the production of antibodies that protect against pneumococcal disease. Capvaxive is expected to provide a broader protection against different types of S. pneumoniae, making it particularly valuable in areas where there is a risk of infection with S. pneumoniae types not covered by existing vaccines, and in children and adolescents with one or more long-term conditions (including diabetes, heart and kidney disease) known to increase the risk of pneumococcal disease. The safety profile of Capvaxive is comparable to that of other pneumococcal vaccines, with most side effects being mild or moderate and resolving within a few days after vaccination.
The European Medicines Agency therefore decided that Capvaxive’s benefits are greater than its risks and that 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 Capvaxive have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Capvaxive are continuously monitored. Suspected side effects reported with Capvaxive are carefully evaluated and any necessary action taken to protect patients.
Capvaxive received a marketing authorisation valid throughout the EU on 24 March 2025.
Product information
Latest procedure affecting product information:VR/0000294070
30/04/2026
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
- Capvaxive
- Active substance
- pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein
- International non-proprietary name (INN) or common name
- pneumococcal polysaccharide conjugate vaccine (21-valent)
- Therapeutic area (MeSH)
- Pneumococcal Infections
- Anatomical therapeutic chemical (ATC) code
- J07AL02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae
Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in children and adolescents 2 to less than 18 years of age who previously completed a primary paediatric pneumococcal vaccination regimen.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Capvaxive should be in accordance with official recommendations.
News on Capvaxive
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