Vaxneuvance

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Table of contents

Opinion

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Vaxneuvance. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted an extension to the existing indication for prophylaxis against pneumonia and acute otitis media caused by pneumococcal disease, and associated invasive disease, in infants, children and adolescents.

For information, the full indications for Vaxneuvance will be as follows1:

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Vaxneuvance
Agency product number
EMEA/H/C/005477
International non-proprietary name (INN) or common name
  • pneumococcal polysaccharide conjugate vaccine (adsorbed)
Active substance
  • pneumococcal polysaccharide conjugate vaccine (adsorbed)
Therapeutic area
Pneumococcal Infections
Additional 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.

Date opinion adopted
15/09/2022
Company name
Merck Sharp & Dohme B.V. 
Status
Positive
Application type
Post-authorisation

Related content

How useful was this page?

Add your rating