Europe's Second RSV Vaccine Authorization Proceeds

The European Medicines Agency (EMA) today announced it recommended granting marketing authorization in the European Union (EU) for ABRYSVO™, a bivalent respiratory syncytial virus (RSV) vaccine produced by Pfizer Inc.

As of July 21, 2023, the EMA opinion was sent to the European Commission for the adoption of a decision on an EU-wide authorization.

Once granted, decisions about price and reimbursement will take place at the level of each EU Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

Abrysvo is indicated for passive immunization of infants from birth through 6 months of age following the administration of the vaccine to the mother during pregnancy. This vaccine is also indicated for active immunization of adults aged 60 years and older.

The EMA says RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can cause severe consequences for children and older adults. In fact, RSV is a leading cause of pediatric hospitalisation in children in Europe.

RSV infections may cause bronchiolitis and pneumonia, leading to fatal respiratory distress.

Furthermore, RSV is a seasonal disease whose impact varies by country and time of year.

In the U.S., the Food and Drug Administration Approved ABRYSVO for Older Adults on May 31, 2023, and should be available for the 2023-2024 RSV season.