European Commission Approves Pfizer's RSV Vaccine for Wider Adult Use
The European Commission has expanded the marketing authorization for Pfizer's respiratory syncytial virus (RSV) vaccine, ABRYSVO. The vaccine can now be used to protect adults aged 18 to 59 against lower respiratory tract disease caused by RSV.
Pfizer Inc. announced that the European Commission has amended the marketing authorization for its respiratory syncytial virus (RSV) vaccine, ABRYSVO. The decision allows for the vaccine to be used for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 18 through 59 years.
This approval broadens the vaccine's prior authorization, which covered individuals aged 60 and older, and maternal immunization to protect infants. Pfizer states that ABRYSVO now holds the broadest RSV vaccine indication in the EU, including active immunization for adults 18 and over, and passive protection for infants via maternal immunization.
RSV is a contagious virus that commonly causes respiratory illnesses worldwide and can lead to severe disease. The company reports that RSV causes approximately 158,000 adult hospital admissions annually across the EU. The expanded indication is expected to help reduce the burden of RSV in future seasons.
The amended marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on data from the pivotal Phase 3 clinical trial (MONeT). This study evaluated the safety, tolerability, and immunogenicity of ABRYSVO in adults aged 18–59 at risk of RSV-associated LRTD due to certain chronic medical conditions.