Pfizer announced that the European Commission (EC) has amended the marketing authorisation for ABRYSVO, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to include the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 to 59. The expansion builds on the existing authorisation for individuals aged 60 and older. The updated indication allows for active immunisation of individuals aged 18 and older for the prevention of RSV-related LRTD and passive protection against RSV-related LRTD in infants from birth through six months following maternal immunisation during pregnancy.
Alexandre de Germay, Chief International Commercial Officer and Executive Vice President at Pfizer, stated, “We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening. With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorisation for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion supporting this decision. The authorisation applies across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The approval is based on data from the Phase 3 MONeT clinical trial (NCT05842967), which evaluated the safety, tolerability, and immunogenicity of ABRYSVO in adults aged 18 to 59 who are at risk of RSV-associated LRTD due to chronic medical conditions. The decision was also supported by data from clinical trials involving thousands of vaccinated individuals in this age group.
In August 2023, the European Commission granted initial marketing authorisation for ABRYSVO for adults aged 60 and older, as well as maternal immunisation to protect infants. The U.S. Food and Drug Administration (FDA) also approved ABRYSVO in 2023 for similar indications. In October 2024, the FDA expanded the approval to include individuals aged 18 to 59 at increased risk for RSV-related LRTD. ABRYSVO has received regulatory approvals in multiple countries for use across its authorised indications.
In the U.S., ABRYSVO is approved for the prevention of RSV-related LRTD in adults aged 60 and older, the prevention of RSV-related LRTD in adults aged 18 to 59 at increased risk for severe RSV illness, and the prevention of RSV-related LRTD and severe LRTD in infants from birth to six months through maternal immunisation at 32 to 36 weeks gestational age.
ABRYSVO is contraindicated in individuals with severe allergic reactions to any component of the vaccine. Clinical trials have reported an increased risk of Guillain-Barré syndrome and fainting post-vaccination. Individuals with weakened immune systems may experience a reduced immune response. In adults aged 60 and older, common adverse reactions include fatigue, headache, injection site pain, and muscle pain. In adults aged 18 to 59, commonly reported side effects include pain at the injection site, muscle pain, joint pain, and nausea. In pregnant individuals, the most frequent adverse events include injection site pain, headache, muscle pain, and nausea. Clinical trials have also observed low birth weight and jaundice in infants born to vaccinated individuals.