Vaxneuvance

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Table of contents

Opinion

On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.

The applicant for this medicinal product is Merck Sharp & Dohme B.V.

Vaxneuvance will be available as suspension for injection. The active substance of Vaxneuvance is pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), a vaccine (ATC code: J07AL02) eliciting an immune response to all 15 serotypes contained in the product.

The benefits of Vaxneuvance are the presumed protection against pneumococcal disease (based on immunobridging data). The most common side effects are injection site pain, fatigue and headache.

The full indication is:

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 summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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 serotype 1
Therapeutic area
Pneumococcal Infections
Date opinion adopted
14/10/2021
Company name
Merck Sharp & Dohme B.V. 
Status
Positive
Application type
Initial authorisation

How useful was this page?

Add your rating
Average
1 rating