Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:
- Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV
- Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy
"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," said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. "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 authorization 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 amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group.1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals.
ABOUT RSV
Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide.5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.6,7,8 There are two major subgroups of RSV: RSV-A and RSV-B.9 Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years.10
ABOUT ABRYSVO
ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer's RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.
In August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both adults aged 60 years and older and maternal immunization to help protect infants.
In the U.S in October 2024, the FDA approved ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Prior, in May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age and older. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.
In addition to the most recent EU approval, ABRYSVO has received approvals for both indications in multiple countries worldwide.
U.S. INDICATIONS FOR ABRYSVO
ABRYSVO® is a vaccine indicated in the U.S. for:
- the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
- the prevention of LRTD caused by RSV in people 18 through 59 years of age who are at increased risk for LRTD caused by RSV
- pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
IMPORTANT U.S. SAFETY INFORMATION FOR ABRYSVO
- ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
- An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO
- For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
- Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
- Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
- Vaccination with ABRYSVO may not protect all people
- In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
- In adults 18 through 59 years of age, the most common side effects (≥10%) were pain at the injection site, muscle pain, joint pain, and nausea
- In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea
- In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)
View the full ABRYSVO Prescribing Information.
