pneumococcal polysaccharide conjugate vaccine (adsorbed)

This medicine is authorised for use in the European Union.


Vaxneuvance is a vaccine used to protect against three types of infections caused by the bacterium Streptococcus pneumoniae (S. pneumoniae):

  • acute otitis media (ear infection), in children aged from 6 weeks to less than 18 years
  • pneumonia (infection of the lungs), in adults and children from 6 weeks of age;
  • invasive disease in adults and children from 6 weeks of age. (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)).

Vaxneuvance contains parts from 15 different types of the S. pneumoniae bacterium. It also contains an adjuvant, a substance containing aluminium, to stimulate a better immune response.

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
Agency product number
Active substance
pneumococcal polysaccharide conjugate vaccine (adsorbed)
International non-proprietary name (INN) or common name
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
Pneumococcal Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

26/04/2023 Vaxneuvance - EMEA/H/C/005477 - II/0013

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

pneumococcus, purified polysaccharides antigen conjugated

Therapeutic indication

Vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

Vaxneuvance 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. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.

The use of Vaxneuvance should be in accordance with official recommendations.

Assessment history

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