Respiratory syncytial virus vaccine (bivalent, recombinant)

This medicine is authorised for use in the European Union.


Abrysvo is a vaccine for protecting against lower respiratory tract disease (LRTD; diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

It is also for use in mothers during pregnancy to protect their infants against LRTD from birth through 6 months of age.

Abrysvo contains versions of two proteins found on the surface of the virus called RSV subgroup A stabilised prefusion F and RSV subgroup B stabilised prefusion F.

This EPAR was last updated on 26/09/2023

Authorisation details

Product details
Agency product number
Active substance
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein
International non-proprietary name (INN) or common name
Respiratory syncytial virus vaccine (bivalent, recombinant)
Therapeutic area (MeSH)
Respiratory Syncytial Virus Infections
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

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
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Boulevard de la Plaine 17
1050 Bruxelles

Product information

Abrysvo - EMEA/H/C/006027 -

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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


Therapeutic indication

Abrysvo is indicated for:

  • Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.
  • Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.

The use of this vaccine should be in accordance with official recommendations.

Assessment history

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