Capvaxive - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

pneumococcal polysaccharide conjugate vaccine (21-valent)

Opinion

On 26 March 2026, 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 Capvaxive. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted an extension of the existing indication as follows:

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.

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

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Capvaxive (VR/0000294070)

Adopted Reference Number: EMADOC-1700519818-3006977

Key facts

• Name of medicine:
  Capvaxive
• EMA product number:
  EMEA/H/C/006267
• 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 therapeutical chemical (ATC) code:
  J07AL02
• 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.

• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.
• Date of opinion:
  26/03/2026
• Status:
  Positive